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Orthofix AccelStim 4300 Instruction Manual

Bone healing therapy
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AccelStim
™
Bone Healing Therapy
Instruction Manual
Model 4300

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Diana E Weaver
March 27, 2025

Does the strap go between your skin & transducer?

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1 comments:
Mr. Anderson
March 27, 2025

No, the strap does not go between the skin and the transducer. It secures the transducer holder against the skin to prevent motion or slippage.

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Summary of Contents for Orthofix AccelStim 4300

  • Page 1 AccelStim ™ Bone Healing Therapy Instruction Manual Model 4300...
  • Page 2 EQUIPMENT CLASSIFICATION AND DEVICE SYMBOL Symbol Meaning Catalogue number: This symbol specifies the catalogue number so that ISO 15223-1 5.1.6 the medical device can be identified. Serial number: This symbol specifies the medical device serial number. ISO 15223-1 5.1.7 IEC 60601-1 Read instructions for use: Failure to read the instructions may result in ISO 7010-M002 a hazard.

  • Page 3: Table Of Contents

    1 - Literature Pack 1 - Ultrasound Transducer 1 - Elastic Strap with Transducer Holder 1 - Power Supply 1 - Ultrasound Gel Orthofix Patient Services: 800-535-4492 or 214-937-2718 To learn more about Orthofix, please visit our website at www.orthofix.com.

  • Page 4: Prescription Information

    PRESCRIPTION INFORMATION Indications for Use The AccelStim™ device is indicated for the noninvasive treatment of established nonunions excluding skull and vertebra, and for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature adult individuals when these fractures are orthopedically managed by closed reduction and cast immobilization.

  • Page 5: Precautions

    hematoma, or abscess. The impact of such soft tissue abnormalities within the effective radiating area of the transducer has not been studied by any manufacturer. Precautions • The AccelStim device will not correct or alter post-reduction (when your fracture is initially set and placed in a cast) aspects of a fracture such as displacement, angulation or malalignment.

  • Page 6: Accelstim Device Description

    intensity is comparable to diagnostic ultrasound (1 to 50 mW/cm ), such as the intensities used in obstetrical sonogram procedures (fetal monitoring). In addition, there is no evidence of nonthermal adverse effects (cavitation). While no device related adverse reactions or medical complications were reported in the referenced clinical studies (see “Clinical Studies”...

  • Page 7: How The Accelstim Device Works

    How the AccelStim Device Works The AccelStim device is a medical device that applies ultrasound to the treated area to accelerate the osteogenic process, thereby reducing healing times. The application of this ultrasound transducer is simple and does not require any assistance by specialized medical staff, as the patient can apply it on their own.

  • Page 8: Accelstim Device Operation

    DEVICE OPERATION 1. The battery charge status 2. The daily treatment timer 3. The lowest part of the screen will display all symbols related to the execution of the treatment and error messages 4. Function button to start or pause the treatment 5.
  • Page 9 7. The USB port marked with the symbol 8. The charging port marked with the symbol 9. The transducer port marked with the symbol...

  • Page 10: Quick Operation

    The AccelStim device is powered by a rechargeable lithium-ion battery pack. The battery pack will provide up to five treatments when fully charged. A power supply to charge the battery is provided with the device. Use only the Orthofix provided power supply to charge the battery.

  • Page 11: Follow These Steps To Charge The Battery

    Follow these steps to recharge the battery 1. Open the charging port cover. 2. Plug the power supply into the charging port located on the AccelStim device. 3. Plug the power supply into an outlet. 4. Please refer to Visual and Audio Battery Indicators. When the power is connected, the battery charging process starts and a flash symbol appears on the battery status symbol.

  • Page 12: Visual And Audio Indicators

    Visual and Audio Battery Indicators Battery charge status is shown on the upper right corner of the display. When the battery is fully charged, the AccelStim device can deliver up to five treatments. Once powered on, the AccelStim device will wait to start treatment.
  • Page 13 • If the device is not used for long periods, the internal battery may be completely discharged. It is recommended to recharge the battery before starting the treatment. • If the battery does not allow treatment completion, fully recharge the battery. If the problem persists, contact Patient Services for assistance.
  • Page 14 Display Message Audio Signals Problem and Solution Three short beeps every Fault Detected. If the AccelStim device detects an 3 seconds. anomaly in the transducer or device operation, treatment is stopped. Check the presence of gel on the transducer which must form a 1-2 mm thick Three short Three short layer to the transducer.

  • Page 15: Device Application

    Device Interference: Electromagnetic interference, such as active cellular phones, radio-frequency identification (RFID) readers, electronic security systems (e.g., metal detectors, electronic article surveillance), near-field communications (NFC) systems, wireless power transfer and unique medical emitters such as electrocautery, electrosurgical units, and diathermy equipment can interfere with the normal AccelStim device operation.
  • Page 16 Turn on the device by pressing the on/off button for two seconds. Once you hear a beep, release the button, and the display lights up. The Orthofix logo will appear on the display screen. The device is now ready for treatment and will display 20 minutes of treatment time along with a play symbol.

  • Page 17: Patient Adherence

    PATIENT ADHERENCE The AccelStim device is equipped with an internal memory that records compliance related to treatments performed up to 365 days from the first use. Both the day and the duration of the treatment performed on that day are recorded and displayed as a calendar.
  • Page 18 To Enter Calendar Mode To enter calendar mode, the AccelStim device should be June 2022 off. To begin entering calendar mode,, hold down the On/ Off button for at least 5 seconds until you hear a short beep followed by a longer beep. The display will show data recorded in the first month of treatments, as shown in the image.

  • Page 19: Device Use And Care

    Treatment Data Export The user can export treatment data to a portable USB storage device. In order to do this, please proceed as follows: 1. Insert a portable USB storage into the USB port. 2. Turn on the AccelStim device in calendar mode, as specified in “To Enter Calendar Mode”. 3.
  • Page 20 • A comprehensive understanding and ability to follow the instructions provided in this manual are critical for the use of the AccelStim device. Users who cannot read, understand, and/or follow these instructions should be carefully and closely supervised during use. •...
  • Page 21 • Avoid the use of cellular phones or other devices that may cause interference or disruption while using the AccelStim device. • Position the AccelStim device so that disconnection from the power supply is easy to achieve. • WARNING: Only use the supplied power supply. The manufacturer is not responsible for damage to the AccelStim device, battery, or harm to the user caused by using a different power source.

  • Page 22: Storage And Operating Environments

    STORAGE AND OPERATING ENVIRONMENTS When moving the AccelStim device from very cold or very hot storage areas (like your car), wait at least an hour to use or charge the device. The device requires time to return to a safe operating temperature Environmental Operating Conditions (Lower / Upper Limits) Ambient temperature: 10/35°C...

  • Page 23: Service

    Recycles To help reduce waste from going to the landfill, Orthofix is happy to help you recycle your AccelStim device after your treatment is complete and your physician has advised you to discontinue use.

  • Page 24: Clinical Studies And Information

    US FDA approval for the prior product is therefore being presented in support of the Orthofix AccelStim. Please note that the clinical studies leveraged to support the safety and effectiveness of the AccelStim device may not necessarily be applicable to patients of all races and ethnicities.
  • Page 25 rates seen with atrophic and oligotrophic non-unions (80% and 92% respectively) where some biological deficiency may contribute to the original nonunion. Additionally the application of EXOGEN to hypertrophic nonunions, which might usually be considered as requiring revised treatment to correct fracture instability, was successful in 80% of cases.
  • Page 26 Clinical Results EXOGEN treatment accelerated healing by 38% (61±3.4 days in the active group versus 98±5.2 days in the control group; p<0.0001). The effect of EXOGEN pulsed low-intensity ultrasound on fracture reduction during healing was also assessed. The subset of fractures which were satisfactorily reduced having presented with at least 10 degrees of negative volar angulation were analyzed.
  • Page 27 Analysis of Fresh Fracture Studies Cook et al. retrospectively studied the tibial and distal radius fracture data of Heckman et al. and Kristansen et al. to analyze the impact of low-intensity pulsed ultrasound on the incidence of delayed unions, and on the healing time of smokers. Significant reductions in time to healing of tibial shaft fractures were observed in the active ultrasound treatment group with casting versus the casting only placebo control group (a 41% reduction for those who smoked, p<0.006;...
  • Page 28 Table 1: Efficacy Results for SAFHS® Treated Completed Cases * Categorical Variable Prior to Start of SAFHS® Total Healed Failed %Healed p-value* Treatment Gender: Female 0.19 Male Age: <17 100% 18-29 30-49 0.52 50-64 >65 100% Weight: <65kg. 65-80 kg. 0.65 >80kg Fracture Age:...
  • Page 29 Table 1: Efficacy Results for SAFHS® Treated Completed Cases * Bone: Tibia/Tibia-Fibula/Fibula Femur Radius/Radius-Ulna/Ulna Humerus 100% Metatarsal 0.03 100% Other Foot Bones (calcaneus) Ankle* Scaphoid Other Hand Bones (metacarpal) 100% Other (4-clavicle, 1-pelvis, 1-rib) 100% *Tibio-talar arthrodesis Long Bone vs. Other Bones: Long Bones -28 tibia -13 femur...
  • Page 30 Table 1: Efficacy Results for SAFHS® Treated Completed Cases * Initial Fracture Type: Missing Closed 0.16 Open Arthrodesis Osteotomy 100% Fixation Present at Start of and During SAFHS® Treatment IM Rod; Only for Long Bone Cases (N=59) 100% 0.31 Open Reduction, Internal Fixation (ORIF) 1.00 External Fixation;...

  • Page 31: Accelstim Device Classifications

    Such demographic details were not provided in the referenced clinical studies. ACCELSTIM DEVICE CLASSIFICATIONS • Product Family Name: Orthofix AccelStim Device. • Equipment is internally powered or may be used with provided external power supply cable.

  • Page 32: Operating Specifications

    External power supply used as battery recharger Model* ME10A0503B01 SL POWER ELECTRONICS Brand 100 - 240 VAC Input power *Orthofix reserves the right to provide different models 50 – 60 Hz Mains voltage of power supply, tested and Max. input current 0,3 A...

  • Page 33: Compliance Statements

    COMPLIANCE STATEMENTS IMPORTANT! Changes or modifications not approved by Orthofix could void the user’s authority to operate the equipment. NOTE: These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
  • Page 34 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The AccelStim device is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment. Electromagnetic Environment- Emissions Test Compliance Guidance The AccelStim device uses RF energy only for its internal function.
  • Page 35 IEC 60601 Compliance Electromagnetic Immunity Test Test Level Level Environment - Guidance Floors should be wood, concrete or ceramic tile. Electrostatic ± 6 kV contact ± 6 kV contact If floors are covered with discharge (ESD) ± 8 kV air ±...
  • Page 36 IEC 60601 Compliance Electromagnetic Immunity Test Test Level Level Environment - Guidance Portable and mobile RF communications equipment Conducted RF 3 Vrms should be used no closer to IEC 61000-4-6 150 kHz to 80 3 Vrms any part of the AccelStim device, including cables, than the recommended separation Radiated RF...
  • Page 37 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the AccelStim device The AccelStim device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the AccelStim device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the AccelStim device as recommended below, according to the maximum output...

  • Page 38: Warranty

    WARRANTY Orthofix US LLC (“Orthofix”) warrants the AccelStim device to be free from defects in materials and workmanship for one year from the date of first use. Provided that all terms and conditions of this Limited Warranty are complied with, Orthofix will replace defective components.
  • Page 39 References 1. Cook SD, Ryaby JP, McCabe J, Frey JJ, Heckman JD, Kristiansen CT Brighton and SR Pollock, San Francisco Press. 331-341, TK. Acceleration of tibia and distal radius fracture healing in 1991. patients who smoke. Clin Orthop Relat Res. 1997;337:198- 21.
  • Page 40 Orthofix US LLC. Carpi (MO) Italy 3451 Plano Parkway Tel. 39 059 699600 Lewisville, Texas 75056-9453 Fax. 39 059 695778 Tel 214-937-2718 igeamedical.com info@igeamedical.com Patient Services 800-535-4492 toll free Orthofix.com BoneGrowthTherapy.com P/N 20126753 Rev AD 2022-04-21 AS-2102 © Orthofix US LLC 03/2022...

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