bone4ce device


Description
bone4ce is a LIPUS-F (Low Intensity Pulsed Ultra Sound) device.


Clinical Benefit

The LIPUS-F device is a bone growth stimulator supporting and accelerating the healing process of non-healing or fresh bone fractures.


Device Components
The following components are part of your bone4ce ultrasound therapy device:

  • Melmak Device Electronic Control Unit and its components
  • Transducer including cable



Electronic Control Unit
The electronic control unit of the bone4ce device generates the ultrasonic signal for the non-invasive therapy the patient accomplishes during the standard/average treatment period of 20 minutes per day as per professional or physician prescription.

The low intensity high frequency signal will be transmitted to the fracture by the applied ultrasound gel. With an intensity of 30mW/cm² the ultrasound signal is comparable to the intensity of a diagnostic ultrasound signal; the patient will not or barely sense the signal. The device is equipped with detection modes advising the patient of insufficient performance of the device.

The electronic control unit consists of a backlit liquid crystal display (LCD), two push buttons and an USB-Connector, described as follows:

 

Display
The LCD provides the patient with information about:

  • the remaining treatment time
  • the number of treatments left
  • the battery status
  • Error symbols (if a failure mode occurs)


Device Accessories
The following components are part of your bone4ce ultrasound therapy device shipment:

  • Transducer holder
  • Gel bottle
  • Transducer strap
  • Transducer felt pad
  • Transducer foam pad
  • Battery charger (including adapters, cable length 1,8m)
  • User manual
  • USB cable, 2m)
  • Physician software CD


Transducer Holder
During each treatment, the transducer has to be held properly in place for an efficient treatment. This will be ensured by using the destined transducer holder.

To assemble the transducer holder, open the holder cover by pushing the two features towards the centre of the cover. Insert the transducer with its flat surface at the bottom and the cable end at the top. Make sure the cable is routed thru the destined cut out in the cover to avoid damage of the transducer cable.

The spring mechanism in the inner of the holder cap ensures an efficient therapy signal transmission by providing a light pressure to the transducer and therefore coupling the transducer signal via the gel to the fracture.

 

Strap
The strap is used for fixation of the transducer holder in case of on- or non-cast application by using the velcro fastening mechanism.

 

Felt Pad
The felt pad is used for on-cast-application of the transducer holder for balancing the thickness of the cast. The circular felt spacer might be necessary for ensuring the contact of the transducer surface with the skin or for closing the circular hole in the rectangular felt pad after holder disassembly at the end of each treatment.

 

Foam Pad
The foam pad is used for non-cast-application of the transducer holder.

 

Gel
The supplied ultrasound gel has to be applied before starting the treatment. The gel ensures the transmission of the ultrasound signal from the transducer surface to the skin at the fracture site. A small portion (approximately diameter 1.5 cm)) is recommended for proper treatment.

 

Charger including adapter
The USB-Connector (4) is used for charging the internal non-replaceable rechargeable battery of the bone4ce ultrasound therapy device. For international use several country specific adapters are supplied with the charger.

While charging the battery the device cannot be operated!

During the charging process, the LCD will show a “” indicating the battery being charged. Simultaneous the individual animated segments of the battery symbol will be lit. Depending on the battery status the three battery symbol segments are lit (battery fully charged) up to none of the segments are lit (battery empty).

 

User Manual
The supplied user manual describes how to operate and use the bone4ce ultrasound therapy device.

 

USB-Cable (for Physicians only)
The supplied USB cable is used for either charging the bone4ce ultrasound therapy device via the PC or for connection to a PC for set up or data logging.

 

Physician Software (for Physicians only)
The physician software is a data management system that

  • enables the authorized person to allocate a preset no. of treatments to a patient (max 1500 treatments)
  • gives the physician the feasibility to monitor the patient’s treatments

 

To correctly operate the Physician software and operate the hardware the following requirements must be met:

  • Windows XP, Vista or 7 (meeting each operating system minimum requirements to run normally)
  • Minimum of 1 GB of RAM
  • 100 MB of hard drive space
  • Minimum screen resolution 1280 x 1024
  • Keyboard and Mouse
  • An unoccupied USB port

 

 

 

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