Kinematic Rapid Assessment

Transcription

1 Kinematic Rapid Assessment

2 Use conditions and safety precautions To ensure the safety of the patient and of the user, and to ensure the correct functioning of the system, it is necessary to use the system and its accessories following the precautions reported as follows. Before using the system make sure that all the safety requirements are respected. The system must not be connected with other instruments until the safety conditions are restored. It is strongly recommended to check the system before use. In case of troubles or malfunctioning, shut down the system and disconnect it from the main power supply. The communication is based on Bluetooth technology. Any active wi-fi system in the proximity of the device may influence the communication performance of the device itself. Verify the presence of wi-fi systems, in the testing area, before use. Information about the manufacturer and distributor Orthokey is responsible for the safety and the reliability of efficiency of the system only if used following the conditions reported as follows: Calibration, modifications and maintenance must be done only by qualified personnel expressly authorized by Orthokey. Unauthorized use of non-certified systems\components\ accessories and consumables of KiRA not provided by Orthokey is forbidden. Orthokey is not responsible for any damages related to use systems\components\accessories and consumables not provided by Orthokey. If KiRA is used under such circumstances is no longer covered by warranty The system must be used in an environment that respects the safety conditions. The general power supply must be protected following the required standards and must work properly. The use and the maintenance of the system and of its accessories must be done following the instructions reported in this manual. In order to perform maintenance to parts of the system, that are considered maintainable, by qualified personnel, the manufacturer can deliver, under specific request, electrical schemes or component list. Information about this manual This document contains proprietary information. Any reproduction or publication of part of this manual is forbidden without the permission of the owner. The information contained in this document may change without any notification to the user. This manual is part of the system. During first installation please read carefully the information contained and verify its integrity and completeness. If this manual is damaged, incomplete or inadequate please contact Orthokey for replacement. Following the procedures and the warnings described in this manual ensures the minimal requirements for the correct working and the safety of the patient and of the operator. This manual has to be read completely before starting using the system, so that it is possible to acquaint with the operative procedure, the controls, the connections and the precaution for a correct use. This manual must be stored, complete and accessible in every part, in a safe place but at the same time easily accessible to the user during the working of the KiRA system. Safety Information

3 Producer ORTHOKEY Italia S.r.l. Piazza G.Puccini Firenze - ITALY Producer and distributor 0476 Index Safety Information p.2 Producer and distributor p.3 System registration p.4 System start p.4 Connect the sensor p.4 Sensor power up p.5 Sensor battery charging p.5 Sensor positioning p.5 Pivot-shift description p.6 Pivot-shift test execution p.6 Pivot-shift test recording p.6 Lachman test description p.7 Lachman test execution p.7 Lachman test recording p.7 Limb Comparison p.8 Session management p.9 Patient history p.9 Previous sessions p.9 Settings p.10 Recharge session on the device p.10 Troubleshoting p.11

4 System registration Press KiRA icon to start the app. At first app boot system registration is necessary. Please fill the registration form. Hint is shown to retrieve password after three failures. Sensor connection Press the Start button to connect the sensor to the app. NOTE: Please ensure that the sensor is on and with green blinking led. Please ensure that your tablet has the Bluetooth enabled. System startup Insert the password to log in the system. The app looks for the sensor and, when found, automatically. it is paired Sensor led becomes green. System is ready to use. Test screen appears. System Initialisation

5 Turn on sensor To turn on the sensor, press the button for 1 seconds. The LED turns on. Yellow for one second and then starts blinking green, waiting for connection. If the battery charge is tool low. The led will turn off after blink. In this case it is necessary to charge the battery. Positioning the Sensor The device must be not-invasively fixed on the skin of the patient, securely fixed by means of common unallergic tapes or with a shin guard. The long side of the device must be placed parallel to the shank axis (see figure). Power\command button MiniUSB charge port Power Supply Battery Charge Connect the mini USB cable to KiRA and to the power supply, or to the tablet. Press the power button to verify charging state. LED is yellow during charging phase. When charge is full LED becomes green. NOTE: If the sensor stops working one of the possible cause is due to low battery charge. In this case connect the provided power supplier/battery charger to the sensor through the specified connection. When connected to the power supply / battery charger the sensor stops to work and to communicate in order to ensure correct charging phase and to avoid any electric risk for the user and the patient. If not differently specified this sensor can NOT be sterilized and can NOT be used intra-operatively. For a correct functional evaluation of the patient, please refer to the conventional procedures If the test is performed without anaesthesia, in order to not effect the results, it is very important that the patient relaxes the muscles. Place the shin guard distally on the tibia, in order to achieve an optimal stability during Lachman test execution. Place the sensor between the lateral aspect of anterior tuberosity and Gerdy's tubercle in order to achieve an optimal stability during Pivot shift test execution. Sensor

6 Pivot-shift Description The Pivot-Shift Phenomenon - In an ACL deficient knee pivot-shift phenomenon consists in an increased of the tibia rotation about its long axis and in an increased of the lateral tibial plateau translation (anterior subluxation). Pivot-Shift test recording Once the sensor is positioned on the limb select the limb side (left or right) on the left corner of the screen and select Pivot shift test. Press START button or the button on sensor to record the manoeuvre. Do not move the tibia until the traffic light is shown. Do the test. Press stop or button on sensor to end acquisition. Pivot-shift test execution 1. Let the patient lie on the couch in supine position with both the limbs extended. 2. Stay lateral to the patient. 3. Grab the limb by the ankle and lift it. 4. Grasping the foot, rotate internally the tibia (about 20 degrees). 5. Grasp with the opposite hand the lateral portion of the leg. 6. While maintaining the tibia internally rotated, apply a valgus stress on the knee while slowly flexing the joint. 7. After reached degrees of flexion, stop flexing and wait 2 seconds before newly extending the limb. 8. Carry back the limb to the initial neutral position. The acquisition of the Pivot-Shift manoeuvre is highly influenced by the user experience on the manoeuvre itself. Please review your Pivot-Shift testing according with the clinical indications given in this manual. The graph shows the tibial acceleration during manoeuvre. The software recognise the pivot-shift curve and shows on the left the value obtained for the limb. It is possible to modify the pivot-shift interval by double tap on the graph, near the desired area. NOTE: In order to improve the accuracy of the system, once you push the START button just keep the leg firmly in full extension until the signal displayed on the real-time window is completely stable. Then start the test. NOTE: The pivot-shift test should be done according to clinical indications provided. Lachman test execution

7 Lachman test Description The Lachman test consists in an anterior translation of the tibia applying an anterior stress in the proximal part of the tibia with the knee at 20 of flexion Lachman test recording Once the sensor is positioned on the limb select the limb side (left or right) on the left corner of the screen and select Pivot shift test. Press START button or the button on sensor to record the manoeuvre. Do not move the tibia until the traffic light is shown. Do the test. Press stop or button on sensor to end acquisition. Lachman test execution 1. Let the patient lie on the couch in supine position with the knee in flexion (15-25 ). 2. Position the shin guard on the proximal part of the tibia. 3. Stay lateral to the patient. 4. With a hand hold firmly the distal part of femur. Femur must not move during test execution. 5. Apply an anterior stress test to proximal part of the tibia. 6. In an healthy subject a sudden block is felt, which normally is absent in an ACL deficient knee. 7. Carry back the limb to the initial neutral position. The acquisition of the Lachman manoeuvre is highly influenced by the user experience on the manoeuvre itself. Please review your Lachman testing according with the clinical indications given in this manual. The graph shows the tibial displacement (in mm) during manoeuvre. The range of translation is shown on the left for the selected limb. It is possible to modify the translation interval by double tap on the graph, near the desired area. NOTE: In order to improve the accuracy of the system, once you push the START button just keep the femur firmly until the signal displayed on the real-time window is completely stable. Then apply the stress and maintain in the position for 1 second. NOTE: The Lachman test should be done according to clinical indications provided. Pivot-shift test execution

8 Test selection It is possible to do multiple repetitions of pivot-shift and Lachman tests. The last three tests are shown in the left bar. To select and display the desired test, press on the result on the left. The selected test is orange, while the other tests remain grey. Limb comparison To compare results of both legs, press the menu button left corner. on upper The results slide appears from left showing data from the selected tests. White values, identified with a T, show the difference between limbs. Below it is possible to mark the extimated IKDC score for this patient. In the lower part sensor information are is shown: battery level, communication speed and sensor mode. Limb Comparison

9 Session Manager Once the test is done, press the Close button. Patient history Selecting the patient it is possible to see his history. The graph shows a curve with results of all previous tests saved in the different sessions. The app ask to save data. Press YES to go to patients database, press NO to exit without saving, press CANCEL to return to test session. Select an existing patient from the list or create a new one pressing the + button. Press the Export button to generate a PDF report. In the document patient name, surgeon name, tests graph, numerical values for both limbs and IKDC scores are reported. Patient Management

10 Previous sessions In the graph screen, pressing on the circle related to the interested session, it is possible to see data and graphs recorded during session. KiRA device, sessin recharge KiRA device has a preset number of session loaded. To see the remaining tests, connect the device to the app and show the lateral menu pressing the button. Below you can find the number of remaing tests Settings In the settings scrren of the tablet it is possible to modify KiRA settings. Recharge Press the icon on the upper orange band. The charge screen appears. Recharge is done via QR code. To obtain a QR code contact Deactivate single device to allow the connection of 2 sensors. Activate Exports each test via to have automatic export of data in txt format, after each test is performed. Insert the e-activate the mail address to automatically send the PDF your local distributor or Orthokey Italia directly. To recharge press the QR button and frame the QR code sent to you. Settings

11 Troubleshooting Sensor is not connecting: If sensor battery is low connection is not possible. Please charge the sensor. Pivot-shift test is not recognized: Manoeuvre is not correct or it has been performed too fast. Please try again pivot-shift manoeuvre. Lachman test results show high translation pattern: Measured translation can be jeopardized by femoral movement. Try to block antero-posterior femoral translation during the test execution. I can t select the desired result on the graph with a souble tap: Zoom the graph with two fingers, in the desiderd zone and retry. Troubleshooting

12 KIR-MUC-0916-E