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TF.16 IFU StarDevice.003.10-EN 2021-01-12

prepared by Pulavskyi A., Kolyesnik O.

14 PACKING LIST

The device

STARDEVICE

, №

____________________ is packed in the company SC

KOLIBRI LLC in accordance with the technical requirements.

Date of packing «_________» ____________________ 20_____.

A packer:

Signature

First name and Last name

Scientific company
KOLIBRI LLC

Prov. Kinnyi 8a. Kharkiv,
61001, Ukraine
Tel.: +380913011110
email:

[email protected]

URL:

https://kolibri.cloud

The official representative in the EU:
“ONKOCET Ltd.”

4 Kutuzova str., 90201 Pezinok, Slovakia,

tel.: +421 (2) 44 64 09 77

Email:

[email protected]

URL

www.onkocet.eu

Содержание StarDevice

Страница 1: ...User s manual of the shock wave therapy device StarDevice Version 1EN UA TR 099...

Страница 2: ...90201 Pezinok Slovakia tel 421 2 44 64 09 77 Email onkocet onkocet eu URL www onkocet eu The user s manual including all its sections is protected by the copyright Any use of materials from this manu...

Страница 3: ...CE 13 5 1 The patient s location 13 5 2 The operator s position when performing therapy on a spine 14 5 3 Tips 14 5 4 How to hold the manipulator 15 5 5 Recommended treatment protocols 16 5 6 Switchin...

Страница 4: ...o resolve them 56 12 Checklist 57 13 Product acceptance protocol 58 14 Packing list 59 15 The warranty certificate 60 16 Pictures of treatment procedures 61 17 Marking of the device STARDEVICE 61 18 D...

Страница 5: ...he instruction Degree of protection of the device against penetration of solid objects Protective ground Working part of type BF To turn the power on Supply voltage of the device To turn the power off...

Страница 6: ...therapy orthopaedics neurology rheumatology cosmetology getting rid of cellulite and many others The usage of the device in those or other cases is limited only by the knowledge of the specialist Main...

Страница 7: ...the Instruction No claims regarding the completeness or unlimited duration of this list of contraindications are accepted Before carrying out the procedures a medical specialist should be convinced of...

Страница 8: ...doprosthesis and the metal implants Above the open plate after laminectomy splitting of the spine In the eye area In the field of reproductive organs Directly above the carotid artery the stellate gan...

Страница 9: ...lder The operator must inspect the housing of the electronic unit the manipulator and the tips as well as the power cord and the manipulator cable before using the device to ensure there is no externa...

Страница 10: ...nnection and disconnection of the power cord from the mains to quick disconnection of the device from the mains in emergency situations Do not allow humidity to enter the electronics housing and the m...

Страница 11: ...e manipulator to be on the floor This device complies with the requirements of the EMC standard IEC 60601 1 2005 12 3rd ed As a rule the level of emitted electromagnetic interference is not sufficient...

Страница 12: ...f the operator so that the device is placed on a solid smooth dry and not slippery surface and to comply with the measures listed in the paragraph 2 3 Remove the device from its packaging Check if the...

Страница 13: ...e 5 AN OPERATING PROCEDURE OF THE DEVICE STARDEVICE The user is obliged to be healthy and vigorous rested during the use of the device because a patient s health and even his life is highly dependent...

Страница 14: ...d segments The tips are inserted into the manipulator with pushing the rod of the tips into the hole of the manipulator Before use and after use wipe the tip with a water alcohol solution The surface...

Страница 15: ...ngle of application is chosen by the doctor at his own discretion based on the tasks assigned Stabilization of the tip It is also necessary to stabilize the tip to prevent it from slipping and to prev...

Страница 16: ...covers his mouth so that only 50 of the movement of the joint is involved 25 75 in the process of correction Repeat the previous steps check the movement of the lower jaw joint Do not make more than...

Страница 17: ...eck in both directions pay attention to the improvement Repeat the protocol three times a week for one to three weeks Instruct the patient at home to apply ice for 20 minutes then remove ice for 40 mi...

Страница 18: ...head to the neutral position Repeat the procedure at the level of T2 and T3 points 2 and 3 each time returning the patient to a neutral position Finally place the tip on the very back of the thoracic...

Страница 19: ...xtensors of the hand and fingers Follow 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...

Страница 20: ...treatment Shoulder Force Frequency Load line The number of shocks per point 20 12 90 to the surface 15 20 or up to an automatic stop Tip Tip No 6 A small rubber protocol tip Note Percuss by points mak...

Страница 21: ...shoulder not by the elbow Repeat the procedure twice Follow the protocol three times a week for 1 4 weeks Instruct the patient at home to apply ice for 20 minutes then to remove the ice for 40 minute...

Страница 22: ...ides Points 5 6 and 7 are diagonally oriented starting from a point 52 mm lateral to S3 every 52 mm following the gluteus majorus above the sciatic notch towards the left thigh Points 8 9 and 10 are t...

Страница 23: ...Tip Tip No 6 A small rubber protocol tip Note Points 1 and 2 are 13 mm from the corners of the sacrum on both sides Points 3 and 4 are 26 mm lateral to S2 on both sides Points 5 6 and 7 are diagonally...

Страница 24: ...opposite to the painful side Point 2 is 26 mm lateral at level S3 on the same side as point 1 Point 3 is 52 mm lateral at level S5 on the same side as points 1 and 2 Points from 4 to 6 are the same as...

Страница 25: ...a middle standard tip Note Test the range of motion Start with the cervical spine in full inflexion Set the head on T1 and percuss during the extensional process Continue to percussion when the patie...

Страница 26: ...ks 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 Hamstring Force Frequency Load line The n...

Страница 27: ...Posterior tibia a small rubber protocol tip Points 1 7 are the middle of Achilles from the heel of the calcaneus to the connection with the gastrocnemius muscle Point 8 is the medial aspect of the low...

Страница 28: ...apping Point 5 7 is a mirror reflection of points 1 3 on the left side Point 8 is the lowest aspect of the sagittal seam Point 9 is 26 mm above the point 8 along the sagittal suture Point 10 is 52 mm...

Страница 29: ...se outgrowth T3 Follow the protocol three times a week for 1 3 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...

Страница 30: ...ome to apply ice for 20 minutes then remove ice for 40 minutes Repeat the procedure three times a day on a day of treatment Trigeminal Systemic Regulation Force Frequency Load line The number of shock...

Страница 31: ...ch of the supraorbital nerve both are extensions of the ophthalmic branch of the trigeminal nerve at the medial end of the eyebrow 6 Gabella 7 Supraorbital nerve additional 1 3 points on the pupil lin...

Страница 32: ...TF 16 IFU StarDevice 003 10 EN 2021 01 12 prepared by Pulavskyi A Kolyesnik O 32 1 Press OK to start working 2 Then the window of main menu will appear The device is ready to work...

Страница 33: ...s OK menu exit menu 5 8 MAIN MENU Main menu contains the following information The number of shocks per session Total shocks counter The number of performed shocks Shocks frequency Shocks force Correc...

Страница 34: ...he spine For the cervical spine 10 15 For the thoracic spine 15 25 For the lumbar spine 25 35 The doctor chooses the settings for other joints soft tissues at his own discretion 5 9 SUBMENU You need t...

Страница 35: ...layed for a second and then automatically switches to the main menu The calibration of the manipulator The calibration of the manipulator sets the force with which the manipulator must be pressed To e...

Страница 36: ...r operation of the device will become possible see 5 5 The beep sound turns off 5 11 COMPLETION OF WORK WITH THE DEVICE To complete the work with the device you need To switch off the device using the...

Страница 37: ...s in your Windows operating system to display the program in full screen mode The start window will appear after starting the program If you did not connect the StarDevice to the computer a warning en...

Страница 38: ...evice 003 10 EN 2021 01 12 prepared by Pulavskyi A Kolyesnik O 38 INTERFACE SETTING OF SOFTWARE STARDEVICE V1 33 Use the following bottoms to set a language To set a photo model male or female use the...

Страница 39: ...TF 16 IFU StarDevice 003 10 EN 2021 01 12 prepared by Pulavskyi A Kolyesnik O 39 Depending on your choice the program interface will look like this or...

Страница 40: ...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 independentl...

Страница 41: ...the manipulator by moving the slider 50 100 150 shocks or NL an unlimited number of shocks You can set the position of the slider Skin thickness to a division of 1 2 or 3 when performing the procedure...

Страница 42: ...lator with numbers from 0 to 9 If you need to erase an incorrectly entered number use the C button reset the whole number or E delete the last entered number SELECTION OF PRESET THERAPY PROTOCOLS Use...

Страница 43: ...evice 003 10 EN 2021 01 12 prepared by Pulavskyi A Kolyesnik O 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 protoco...

Страница 44: ...TF 16 IFU StarDevice 003 10 EN 2021 01 12 prepared by Pulavskyi A Kolyesnik O 44...

Страница 45: ...of its use and also read about the sequence of actions when performing it All recommended treatment protocols are described in detail in this manual in section 5 5 When choosing the protocol you need...

Страница 46: ...Device 003 10 EN 2021 01 12 prepared by Pulavskyi A Kolyesnik O 46 Places for the procedure of the treatment are marked with green dots with consecutive numbering starting with the digit 1 on the imag...

Страница 47: ...e angle at which the procedure should be performed correctly Detailed information on the angle is contained in the description of each protocol section 5 5 of this manual When you finish the manipulat...

Страница 48: ...should not contain alcohol 6 2 CLEANING OF THE TIPS Cleaning of the tips is performed with the help of medical alcohol wipes or wadded disks soaked in 70 96 aqueous alcoholic solution Attention It is...

Страница 49: ...vice STARDEVICE is disposed of as used electronic equipment after the end of its useful life Please dispose of the device in accordance with the applicable regulations in your country Packaging dispos...

Страница 50: ...ng storage transportation and use conditions set forth in this manual is established according to the characteristics of similar equipment on the market as well as the actual period of existence of th...

Страница 51: ...TF 16 IFU StarDevice 003 10 EN 2021 01 12 prepared by Pulavskyi A Kolyesnik O 51 8 GENERAL VIEW OF THE DEVICE 8 1 The device STARDEVICE 8 2 The device STARDEVICE PC...

Страница 52: ...the electronic unit of the device is long However the manipulator of the device is not designed for continuous operation Maximum operating time of the manipulator is 10 minutes the minimum time of an...

Страница 53: ...manipulator The frequency of the manipulator s work 4 Hz 12 Hz The ambient temperature during the operation process 5 40 C The ambient temperature during a storage and transportation 25 C without rel...

Страница 54: ...essary to connect SD via USB 1 for printer optionally if necessary Bluetooth 3 0 and higher Antivirus software Medical grade computer is recommended for use in combination with the MD SD In any case t...

Страница 55: ...complete configuration in its pure form without external mechanical damages and traces of disassembly opening Transportation costs and the risk of accidental loss during the delivery of the returned p...

Страница 56: ...the device Connect the manipulator to the device the same as 1 The mechanical parts of the manipulator are broken down Contact the service center in your area or the manufacturer 3 The device does no...

Страница 57: ...TF 16 IFU StarDevice 003 10 EN 2021 01 12 prepared by Pulavskyi A Kolyesnik O 57 12 CHECKLISTS No Date Comment Remark Performer Sign 1 Director ________________...

Страница 58: ...viceable The warranty period is 36 months from the date of delivery of the equipment Date of manufacture ______ ________________ 20___ Scientific company KOLIBRI LLC Prov Kinnyi 8a Kharkiv 61001 Ukrai...

Страница 59: ...echnical requirements Date of packing _________ ____________________ 20_____ A packer Signature First name and Last name Scientific company KOLIBRI LLC Prov Kinnyi 8a Kharkiv 61001 Ukraine Tel 3809130...

Страница 60: ...ls The warranty for such a device does not apply if there are faults caused by the user due to a violation of the operating rules of the device described in this manual or the usage of the device for...

Страница 61: ...TF 16 IFU StarDevice 003 10 EN 2021 01 12 prepared by Pulavskyi A Kolyesnik O 61 16 PICTURES OF TREATMENT PROCEDURES 17 MARKING OF THE DEVICE STARDEVICE...

Страница 62: ...WARE 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 Quanti...

Страница 63: ...UMENT HISTORY AND VERSION CONTROL Version Version Date Summary of changes Author Related documents 1 0 2021 01 12 Created Pulavskyi A Kolyesnik O USB A to USB B cable 1 Packaging for transportation an...

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