Synthes MAXFRAME AUTOSTRUT User Manual Download

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OrthoSpin Ltd.
An Affiliate of DePuy Synthes
13 Hayetzira St. Yokneam
Business Park Israel

www.depuysynthes.com

© DePuy Synthes Trauma, a division of Synthes GmbH. 2022. All rights reserved.
OrthoSpin Document #IFU-0140 Rev. C 07/2022

Distributed by:
Synthes GmbH
Luzernstrasse 21
4528 Zuchwil
Switzerland

Summary of Contents for MAXFRAME AUTOSTRUT

Page 1: ...MAXFRAME AUTOSTRUT Multi Axial Correction System Physician User Manual...

Page 2: ......

Page 3: ...NGS Image intensi er control Physician User Manual 1 Welcome 2 2 Introduction 3 3 Product Description 6 4 Surgical Technique 9 5 Care and Maintenance 48 6 Software Updates or Patches 49 7 Symbols Glos...

Page 4: ...utoStrut G2 1 2 Notes and Precaution Statements Notes and precaution statements are used throughout this document to provide additional information and emphasize important information You should read...

Page 5: ...utomatically adjusts the motorized struts according to the prescribed treatment regimen supplied by the MAXFRAME System software The motorized struts are designed to produce a similar speed and accura...

Page 6: ...the security metal detector will alarm and may interfere with the MAXFRAME AUTOSTRUT System functionality Patient should request a hand pat search and avoid the metal detector Additionally patient may...

Page 7: ...nditional please see its IFU for specific conditions 2 8 Software Requirements In order to install the MAXFRAME AUTOSTRUT Soft ware the physician will need administrator privileges on the computer Ope...

Page 8: ...ME AUTOSTRUT system includes the following hardware components 3 1 1 Struts MAXFRAME AUTOSTRUT hexapod struts are designed to shorten and lengthen according to the treatment regi men prescribed by the...

Page 9: ...he ring sides each cable splitter is connected to two struts The control system kit contains the following compo nents 1 Control box containing a Two 9V Lithium batteries Note The battery cannot be re...

Page 10: ...AME System 3 2 Software MAXFRAME AUTOSTRUT Software is used by the physician Applications of the software include 1 Converting the treatment plan file supplied by MAXFRAME Software 2 Downloading the t...

Page 11: ...made by rotating the blue manual rotation knob Before use strut assemblies should be cleaned manually or mechanically with a manual pre clean Ultrasonic cleaning is not recommended Sterilize the strut...

Page 12: ...the MAXFRAME AUTOSTRUT with the intended hole on the proximal ring It is recommended to place struts in default holes when adjacent hardware allows This will simplify the MAXFRAME Software workflow Th...

Page 13: ...e torque Ensure that the wrench is fully seated Notes If there is not enough room to place the 11mm socket of the Torque Wrench 10Nm remove the socket on the torque wrench to expose a 5mm hex that mat...

Page 14: ...r torque is not provided the force of the Torque Wrench 10Nm could damage the strut Using the Torque Wrench 10Nm tighten the shoulder bolt until you feel the wrench slip indicating it has reached the...

Page 15: ...e Surgeon Planning Worksheet section in MAXFRAME System Surgical Technique 2 5 Perform final tightening of all shoulder bolts on the proximal and distal rings Place the 11mm end of the Wrench 8 0 11 0...

Page 16: ...ch the MAXFRAME AUTOSTRUT Control Box interface to appropriate holes in the proximal ring Verify that all strut bolts are firmly tightened by using the Wrench 8 0 11mm Check product expiration date on...

Page 17: ...UTOSTRUT System Physician User Manual Take out the control box ring interface Attach control box ring interface with the 2 Allen screws by using 3mm Allen key You can place it in any free space near t...

Page 18: ...al MAXFRAME AUTOSTRUT System Carefully pull out the control system with the 6 motors attached to it Slide the control box onto the box interface until it clicks in place Verify that it can t slide bac...

Page 19: ...ysician User Manual Snap the two cable splitters into their place on the upper ring You can place them in any free space near the connection with the side struts It is preferred to place them as close...

Page 20: ...ides Confirm the clip is engaged by gently pulling the motor to ensure the motor cannot be displaced Verify that motor adaptor and motor are perpendicular to ring tangent especially important in the s...

Page 21: ...anual Please keep at least one knob for future use such as strut size replacement Verify that motor number 1 is positioned in the correct strut according to the MAXFRAME plan Check that motor numbers...

Page 22: ...20 Physician User Manual MAXFRAME AUTOSTRUT System Place and snap cable wrapper in a free space on both sides of the upper ring Wrap excess cable around the cable wrapper 4 Surgical Technique...

Page 23: ...21 MAXFRAME AUTOSTRUT System Physician User Manual If needed attach free cable to free rings holes with the cable clips...

Page 24: ...22 Physician User Manual MAXFRAME AUTOSTRUT System Keep strut lockers 3mm Allen key and motor clip tool for the end of the treatment You are now ready for system activation 4 Surgical Technique...

Page 25: ...ng treatment plan Connect the magnetic USB in the appropriate orientation to the connector at the front side of the control box Open MAXFRAME AUTOSTRUT Software Login using your MAXFRAME 3D II Softwar...

Page 26: ...ation you will see a green check There is a an Offline Mode checkbox on this page If this box is checked it is possible to advance through the software without being connected via USB cable to the Con...

Page 27: ...em Physician User Manual New Treatment Select New Treatment If the device has a prior treatment plan loaded it will be stopped This Resume Treatment notice is displayed and the Resume Treatment button...

Page 28: ...ressing its test button while holding the strut by the hand and physically feeling its movement A check will appear if each motor test passes After all motors passed press the top right arrow to move...

Page 29: ...hysician User Manual Upload patient treatment plan Only MAXFRAME treatment plans within strut size short medium and long are allowed Treatment plans containing X Short and XX Short strut sizes will be...

Page 30: ...TOSTRUT System Review and approve selected treatment plan Select the number of segmentations per day up to 20 and treatment time according to patient s daily activity Verify that the time refers to pa...

Page 31: ...at exceed 1mm per adjust ment OR when treatment days are not valid such as dates in the past for example will be highlighted in yellow Correction prior to treatment plan upload is required The treatme...

Page 32: ...zone other than the current local time zone you will need to first set your computer to the current local time zone Upload treatment plan When uploading or downloading data from the device you will se...

Page 33: ...rom the laptop computer Disconnect USB cable After 30 seconds each strut will lengthen by 0 1mm Then after another 2 minutes each strut will shorten by 0 1mm This is done to verify the system works pr...

Page 34: ...tening each one of the struts electronically in case of such clinical need Press the manual mode button to open the relevant screen Select the desired strut and the movement direction and press on the...

Page 35: ...rent Select a local log file and view relevant treatment data show log from device view graphical display resume treatment export CSV log file download text log file or shut down device When uploading...

Page 36: ...icators that are activated during treatment These produce lights and sounds that are subtle enough to let the patient know when the system is performing a treatment You should ask your patients if the...

Page 37: ...ne second every minute If pressed while the device is not in active treatment nothing will happen until it is time for the next active treatment to occur When this time comes the device will sense tha...

Page 38: ...K and the button is not released you will see a message indicating that the emergency stop button still needs to be released to continue If you press cancel without pressing the Emergency Stop Button...

Page 39: ...Attach strut gear lockers to each strut See section 4 1 4 Treatment does not Replace the control system with a new one If a replacement is not available remove occur for example struts MAXFRAME AUTOST...

Page 40: ...of the struts Strut changes are determined by the physician during patient follow up Note Prior to strut removal reinforcement of the frame with the MAXFRAME System Strut Swap Kit is required Refer t...

Page 41: ...the clinic release the distal side of the strut by opening the shoulder bolt According to the defined activation clock verify that the replacement is not performed during the next session Release the...

Page 42: ...he 10 Nm Torque Wrench is calibrated for one direction only By using the bolts removed from the previous strut tighten the new strut in place With torque wrench 10 Nm tighten the shoulder bolt until y...

Page 43: ...clip is snapped on both sides Confirm the clip is engaged by gently pulling the motor to ensure the motor cannot be displaced If removed motor activates during a strut swap proce dure physician will n...

Page 44: ...ngs Place the 11mm end of the Wrench 8 0 11 0mm on the flats provided on the end of the spherical hinge to provide counter torque Precaution If counter torque is not provided the force of the Torque W...

Page 45: ...mantling after the motorized treatment is ended After the motorized treatment is ended the control system and motors are dismantled from the struts and ring Instead of the motor a gear locker must be...

Page 46: ...tors from the struts and detach the control box from the control box inter face and splitters from the upper ring Then release the control box interface from the upper ring Release the relevant motor...

Page 47: ...45 MAXFRAME AUTOSTRUT System Physician User Manual Release wire attachments and cable splitters from the ring...

Page 48: ...46 Physician User Manual MAXFRAME AUTOSTRUT System Press down control box release button and pull out the control box Unlock the screws holding the control box interface 4 Surgical Technique...

Page 49: ...struts to prevent any undesired strut movement when the motors are not engaged Place upper part in place according to adaptor contour Then insert the locking pin from the opposite side and press it a...

Page 50: ...Autoclavable Oil 519 97 Important Prior to use and while cleaning visually inspect the in strument Do not use the instrument if damaged Exam ples of damage include but are not limited to corrosion rus...

Page 51: ...may release software updates or patches from time to time and if needed Such software updates and patches will be released according to Manufacturer s procedures and will adhere to all regulations Us...

Page 52: ...icates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot for a variety of reasons be presented on the medical...

Page 53: ...e which poses unacceptable risks to the patient medical staff or other persons within the MR environment IP68 IEC 60529 Degrees of protection provided by enclosures IP Code No ingress of dust complete...

Page 54: ...Weight Dimensions Weight Short Size Strut S 97 135 65g Medium Size Strut M 126 193 74g Long Size Strut L 185 309 87g Control Box LWH 110 60 50 600g 8 2 Storage Conditions Temperature range 30 C to 60...

Page 55: ...low and are not likely to cause any interference in nearby electronic equipment Harmonic emissions IEC 61000 3 2 Class A The system is suitable for use in all establishments other than domestic and m...

Page 56: ...ut lines IEC 61000 4 11 0 UT 0 5cycle at 0 45 90 135 180 225 270 and 315 0 UT 1cycle and 70 UT 25 30 cycles Single phase at 0 0 UT 250 300 cycle 0 UT 0 5cycle at 0 45 90 135 180 225 270 and 315 0 UT 1...

Page 57: ...licable to the frequency of the transmitter Recommended separation distance d P 3 5 V1 d P 12 V2 d P 12 E1 d P 23 E1 80 MHz to 800 MHz 80 MHz to 2 5 GHz Where P is the maximum output power rating of t...

Page 58: ...150 kHz to 80 MHz outside ISM bands d P 3 5 V1 150 kHz to 80 MHz in ISM bands d P 12 V2 80 MHz to 800 MH d P 12 E1 800 MHz to 2 5 GHz d P 23 E1 0 01 0 12 0 2 0 4 1 0 1 0 37 0 64 1 3 2 6 1 1 17 2 4 8 1...

Page 59: ...ulse modulationb 217 Hz 0 2 0 3 9 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulationb 18 Hz 2 0 3 28 28 870 930 1720 1 700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT...

Page 60: ...apod Strut short 1100010 01 MAXFRAME AUTOSTRUT Hexapod Strut medium 1100011 01 MAXFRAME AUTOSTRUT Hexapod Strut long 1100007 01 MAXFRAME AUTOSTRUT Automated Hexapod Control System Kit 1100022 01 MAXFR...

Page 61: ...ns relating to electromagnetic compatibility EMC for this type of product if used for the intended purposes Such standards and regulations define the electro magnetic emissions level coming from the p...

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Page 64: ...thospin com OrthoSpin Ltd An Affiliate of DePuy Synthes 13 Hayetzira St Yokneam Business Park Israel www depuysynthes com DePuy Synthes Trauma a division of Synthes GmbH 2022 All rights reserved Ortho...

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