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Kolibri StarDevice User Manual

Shock-wave therapy device
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User's manual of the
shock-wave therapy device
®
StarDevice
UA.TR.099
Version 1EN

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Summary of Contents for Kolibri StarDevice

  • Page 1 User’s manual of the shock-wave therapy device ® StarDevice UA.TR.099 Version 1EN...
  • Page 2 This provision concerns, copying, translating, micro photocopying, and placing and processing in electronic systems ® – the registered trademark STARDEVICE prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...

  • Page 3: Table Of Contents

    2.1 Safety signs on the device 2.2 Warnings and safety instructions 2.3 Measures to prevent damage of equipment and the device ® 3 A brief description of the device STARDEVICE ® 4 Before using the device STARDEVICE 4.1 The list of the preparatory actions 4.2 The operator’s qualification...
  • Page 4 13 Product acceptance protocol 14 Packing list 15 The warranty certificate 16 Pictures of treatment procedures ® 17 Marking of the device STARDEVICE 18 Decommissioning and disposal of software ® 19 The complete set of STARDEVICE 20 Document history and version control prepared by Pulavskyi A., Kolyesnik O.

  • Page 5: Symbols And Conventional Signs

    To increase frequency To increase force To decrease frequency To decrease force Manufacturer Enter a value Serial number of the Date of manufacture device It is disposed as used electronic equipment prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...

  • Page 6: General Review

    1 GENERAL REVIEW 1.1 PURPOSE OF THE DEVICE ® The shock-wave therapy the device STARDEVICE (hereinafter - the device) is intended for the treatment of the musculoskeletal system, rehabilitation of back and head injuries, including those complicated by partial or complete paralysis. Also, the device can be used for other types of therapy, which require forced stimulation of blood circulation in tissues.

  • Page 7: Contraindications

    • In case of systemic or local infection is present (sepsis, osteomyelitis, tuberculosis) or if a patient has a fever; • For patients with malignant tumours, undiagnosed tumours and neoplasms; prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...

  • Page 8: Side Effects

    After a course of shock-wave therapy, the pain syndrome can be increased, the chronic process exacerbated, which depends solely on the strength and intensity of the exposure and the individual susceptibility of patients. prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...

  • Page 9: Warnings And Safety Instructions

    Certified and safe materials are used for the device. Potentially, a patient's allergic reaction to parts that come in contact with the skin surface during the treatment procedure is possible. prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...
  • Page 10 Therapy with shock waves can make an undesirable effect on a heart. It is necessary to continuously monitor a patient's condition during the procedure. The patient is allowed to act no more than 3000 shocks per a treatment session. prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...

  • Page 11: Measures To Prevent Damage Of Equipment And The Device

    It is forbidden to install the device on slippery surfaces to prevent the device from falling. ® 3 A BRIEF DESCRIPTION OF THE DEVICE STARDEVICE ® The device STARDEVICE is intended for the treatment of the musculoskeletal system, rehabilitation of back and head injuries, including complicated partial or complete paralysis.

  • Page 12: Before Using The Device Stardevice

    • To make sure that the power supply network is used with a protective ground; that the voltage in the ® network is in the range 100 - 240V, 50 - 60 Hz. The device STARDEVICE is intended for connection to type F (Schuko) sockets (European socket with CEE 7/4 grounding, DIN 49440 standard).

  • Page 13: An Operating Procedure Of The Device Stardevice

    • Method of functional verification of the device. Further recommendations for training may vary depending on the country. Please contact your local representative of SC KOLIBRI LLC for more information on training the operation of this device. ® 5 AN OPERATING PROCEDURE OF THE DEVICE STARDEVICE...

  • Page 14: The Operator's Position When Performing Therapy On A Spine

    They are used for correction used for therapy of trigger and treatment of small joints all the segments of the spine. points and acupuncture and muscles massage. TIP #7 TIP #8 TIP #9 prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...

  • Page 15: How To Hold The Manipulator

    The angle of the manipulator application is 90 ° when correcting other anatomical areas. prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...

  • Page 16: Recommended Treatment Protocols

    Point 6: 12mm above the glabella. Point 7: 25mm above the glabella. Percuss the points mentioned above and then repeat the procedure again. Perform as necessary for 1-4 weeks. Cervical ROM prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...
  • Page 17 Instruct the patient to apply ice for 20 minutes at home, then to remove the ice for 40 minutes. Repeat the procedure three times on a day of treatment. prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...
  • Page 18 Force Frequency Load line The number of shocks per point: 90° to the spine/a limb 30-35 10-15 Tip: (Tips No1, 6) a medium standard and a small rubber protocol tips. prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...
  • Page 19 Perform the protocol three times a week for 1-4 weeks. Instruct the patient at home to apply ice for 20 minutes, then remove ice for 40 minutes. Repeat the procedure three times a day on a day of treatment. prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...
  • Page 20 Instruct the patient at home to apply ice for 20 minutes, then to remove the ice for 40 minutes. Repeat the procedure three times a day on a day of treatment. prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...
  • Page 21 90 degrees. The doctor passively turns his hand to the end when the active limit of the range of movement is reached. At the same time, he holds the patient by the houlder, not by the elbow. prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...
  • Page 22 Force Frequency Load line The number of shocks per point: Bottom-up, from the 15-20 or up to an medial to the lateral at the automatic stop junction of the sternum prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...
  • Page 23 Low Back Unlock Force Frequency Load line The number of shocks per point: 90° to the surface 15-20 or up to an automatic stop Tip: (Tip No.3) a long horn tip Note prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...
  • Page 24 Bottom-up, from the 15-20 or up to an medial to the lateral at the automatic stop junction of the sternum and cartilage. Tip: (Tip No.6) A small rubber protocol tip Note prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...
  • Page 25 Knees Force Frequency Load line The number of shocks per point: 90° to the surface (Tip No.6) A small rubber protocol tip prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...
  • Page 26 40 minutes. Repeat the procedure three times a day on a day of treatment. Cuboid Ankle Force Frequency Load line The number of shocks per point: 90° to the cuboid bone 15-20 Tip: (Tip No.6) A small rubber protocol tip prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...
  • Page 27 Plantar Fascitis Force Frequency Load line The number of shocks per point: 90° to the surface Tip: (Tip No.8) A big rubber protocol tip. prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...
  • Page 28 1-3 weeks. Instruct the patient at home to apply ice for 20 minutes, then to remove the ice for 40 minutes. Repeat the procedure three times a day on a day of treatment. Asthma Force Frequency Load line The number of shocks per point: prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...
  • Page 29 Follow the protocol three times a week for 1-3 weeks. Constipation Force Frequency Load line The number of shocks per point: 90° to the surface. 10-15 Tip: (Tip No.7) a middle rubber protocol tip prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...
  • Page 30 ® protocols and medications provided by the device STARDEVICE . It can also be used to enhance the response of the central nervous system to treatment.

  • Page 31: Switching The Device On

    3. The opening window will be displayed on the build-in display of the device: A global pulse counter Global working hours The indicator of the connection of the manipulator The instructions about the beginning of work prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...
  • Page 32 1. Press «OK» to start working 2. Then the window of main menu will appear The device is ready to work. prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...

  • Page 33: Description Of Controls

    The doctor sets the correction settings, depending on the area of influence and the desired effect at his discretion. The manipulator automatically stops and a beep sounds after the specified number of shocks have been executed. prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...

  • Page 34: Submenu

    / left are performed by using the buttons FR + and FR-, respectively. To apply the parameters, you need to move the carriage to the next line and to press the central button «OK». prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...
  • Page 35 You should select "SAVE" and click «OK" to apply this data. If you do not want to apply this calibration, you should select "EXIT" and click "OK". Submenu screen is displayed after completing the process of calibration. prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...

  • Page 36: Messages

    FIRST START OF THE STARTEVICE SOFTWARE V1.3. To install the software on your computer, run the installation package. An icon will be created on the desktop of your computer to start the program after the installation of the StarDevice V1.3 program is completed.
  • Page 37 The start window will appear after starting the program. If you did not connect the StarDevice to the computer, a warning entry "Star device is не подключен" or "Star device is not connected!" would appear in the upper right corner of the program's working window.
  • Page 38 INTERFACE SETTING OF SOFTWARE STARDEVICE V1.3 3 Use the following bottoms to set a language To set a photo model (male or female) use the other buttons. prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...
  • Page 39 Depending on your choice, the program interface will look like this: prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...
  • Page 40 DESCRIPTION OF THE SOFTWARE INTERFACE ELEMENTS STARDEVICE V1.3 The window for calculating shocks of the manipulator. The previous value of the number of shocks of the manipulator and the total number of shocks per session. The choice of the shocks frequency is displayed as follows. You can independently choose the frequency of the manipulator's shocks with the help of the plus and minus buttons, or with the help of the slider.
  • Page 41 You can set the position of the slider "Skin thickness" to a division of 1, 2 or 3, when performing the procedure in manual mode. Usually 1 is chosen for face (head) therapy, where the skin has the smallest thickness. To set or exit the manual mode, use the buttons: prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...
  • Page 42 SELECTION OF PRESET THERAPY PROTOCOLS Use the menu buttons on the left side of the StarDevice 1.3 main screen to select a preset therapy protocol. You will get a drop-down menu with a list of protocols by clicking on the button. Use it to select.
  • Page 43 If you select the button "LEGS", the interface will change: Use the list to select the desired protocol. Use the bottom to review a protocol’s description. prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...
  • Page 44 Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...
  • Page 45 When choosing the protocol, you need, the program can show a hint about the need to change the tip in the manipulator, by showing its appearance in the upper left corner of the program interface. prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...
  • Page 46 Places for the procedure of the treatment are marked with green dots with consecutive numbering starting with the digit "1" on the image of the model. prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...
  • Page 47 You can independently switch to the point you need by using the buttons "-" or "+". The number in the middle indicates the point number that is proposed for therapy (treatment). prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...

  • Page 48: Service Of The Device Stardevice

    ® 6 SERVICE OF THE DEVICE STARDEVICE CLEANING OF THE DEVICE Regular cleaning of the device ensures reliable and trouble-free operation of the device ® STARDEVICE You should disconnect the manipulator from the electronic unit and the electronic unit itself from the mains before beginning any cleaning and / or repair operations.

  • Page 49: Maintenance And Security Check

    ® PRODUCT DISPOSAL: The device STARDEVICE consists of various materials. Nevertheless, all of them (metal, plastic, electrical conductors, printed circuit boards, chips, etc.) do not contain hazardous substances and they can be transferred to special processing centres in the same way as electronic equipment.

  • Page 50: Repairs

    STARDEVICE (from 2013). ® • 4 years or 10 000 operating hours - for the electronic unit of the device STARDEVICE • 2 million shocks for the manipulator; • 12 months for the tips. The probability of failure of the components and the accessories of the device increases after exceeding of the shelf-life.

  • Page 51: General View Of The Device

    8 GENERAL VIEW OF THE DEVICE ® 8.1 The device STARDEVICE ® 8.2 The device STARDEVICE prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...

  • Page 52: Technical Descriptions

    ® 8.3 The manipulator of the device STARDEVICE 9 TECHNICAL DESCRIPTIONS ® 9.1 CLASSIFICATION OF THE DEVICE STARDEVICE The device belongs to the 1-st class with a working part of type BF according to the method of protection from electric shock.
  • Page 53 ® The documentation for repair and service of the device STARDEVICE (electric schematic diagrams, instructions for repair and calibration, etc.) is provided to the local representative of SC KOLIBRI LLC on request. prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN...

  • Page 54: Storage And Transportation

    STORAGE AND TRANSPORTATION ® Transportation and storage of the device STARDEVICE is only permitted in the manufacturer's packaging. You should avoid shaking and impacting of the package during transportation and storage.

  • Page 55: Warranty Commitments

    The warranty is cancelled if the customer has made a modification or made any uncoordinated changes to the software of the device without the written consent of the company SC KOLIBRI LLC. For all questions regarding the operation of the device, please contact our customer service:...

  • Page 56: Possible Errors And Malfunctions. Ways To Resolve Them

    Check the installed refractory fuses; replace the or missing damaged ones or install the missing ones. ® Check connection device The device STARDEVICE ® STARDEVICE to the computer with a USB not connected to the computer with a USB cable. cable.

  • Page 57: Checklist

    12 CHECKLISTS Date Comment Remark Performer Sign Director ________________. prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...

  • Page 58: Product Acceptance Protocol

    13 PRODUCT ACCEPTANCE PROTOCOL ® The device STARDEVICE , No. SD___________________ complies with the technical requirements and is completely serviceable. The warranty period is 36 months from the date of delivery of the equipment. Date of manufacture “______” ________________ 20___.

  • Page 59: Packing List

    14 PACKING LIST ® , № SD ____________________ is packed in the company SC The device STARDEVICE KOLIBRI LLC in accordance with the technical requirements. Date of packing «_________» ____________________ 20_____. A packer: Signature First name and Last name Scientific company...

  • Page 60: The Warranty Certificate

    61001, Ukraine tel.: +421 (2) 44 64 09 77 Tel.: +380913011110 Email: onkocet@onkocet.eu email: info@kolibri.one URL: www.onkocet.eu URL: https://kolibri.cloud All valid permits and certificates are available on the manufacturer's website kolibri.one/certificate prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...

  • Page 61: Pictures Of Treatment Procedures

    16 PICTURES OF TREATMENT PROCEDURES ® 17 MARKING OF THE DEVICE STARDEVICE prepared by Pulavskyi A., Kolyesnik O. TF.16 IFU StarDevice.003.10-EN 2021-01-12...

  • Page 62: Decommissioning And Disposal Of Software

    18 DECOMMISSIONING AND DISPOSAL OF SOFTWARE To remove the program from your computer, use the standard procedure for OS Windows. The software does not contain or store any personal data. 19 THE COMPLETE SET OF STARDEVICE Name of a part Quantity...

  • Page 63: Document History And Version Control

    USB-A to USB-B cable Packaging for transportation and storage ® of the STARDEVICE device IFU (offered in electronic form available on web) 20 DOCUMENT HISTORY AND VERSION CONTROL Version Version Summary of changes Author Related documents Date 2021-01-12 Created Pulavskyi A, Kolyesnik O prepared by Pulavskyi A., Kolyesnik O.

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