SpineScan Instructions for Use
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1 Introduction... 2 Operating Instructions... 3 Trunk Angle Application... 4 Kyphosis Application... 6 ROM Applications... 7 Lateral Bending Application... 7 Flexion/Extension Application... 8 Rotation Application... 9 Body Balance Application Normal Values SSIFU002 version 01 - SpineScan Instructions for Use, page 1
2 Introduction SpineScan is a hand-held, stand-alone device that provides automated means for screening and followup of spinal deformities postural disorders and range of motion. The information obtained by the SpineScan device should be used as guidelines for the decision whether further medical evaluation is needed. The examination procedure should be held according to the common procedures applied for assessment of patients. SpineScan reliability of angle measurements is proved as being in the same direction and in the range of ±0.5º compared to a known, pre-measured angle. SpineScan can be used by school nurses, chiropractors, physiotherapists and physicians. Inclusion Every person that is able to bend or stand for the duration of the exam. Exclusion & Contraindications None, except for person that cannot stand or bend forward. General instructions The SpineScan can be cleaned with 70% alcohol pads between exams. Operating conditions should be: temperature between C, humidity 20~80%RH, Atmospheric pressure range of 700 hpa-1060hpa. Warnings! Do not use the SpineScan while charging its battery! Fully charge the battery and disconnect the charger before using the device. Do not use the SpineScan while connected to a computer! Disconnect the device from the computer before using it. The SpineScan is not waterproof and therefore should not be immersed in water or any other liquid. The unit is classified as continuously operated device, with type BF applied part without signal input output parts. Storing and maintenance Charging the device s battery shall be done using only with the supplied AC/DC adaptor. Time to fully charge: approx. 5h. While not in use it is recommended to store the SpineScan in its original package. The SpineScan should be stored in temperature between 0-50 C, humidity 20~80%RH, Atmospheric pressure range of 700 hpa-1060hpa. The SpineScan should be kept away from any liquid due to its non-waterproof nature. The device is not sterile. Technical details Model SH-115, Display: LCD, Measurement range: 0-90º, Measurement accuracy: ±0.5º, Dimensions: 180mm x 85mm x 25mm - 7" x 3 3/8" x 1", weight 250gram ounce, Power: rechargeable lithium battery, Adaptor: TC-L X Symbols Type BF applied part Attention, consult accompanying documents Alerts / Error message Beep Reason Start/Stop button was pressed in order to start a scan SSIFU002 version 01 - SpineScan Instructions for Use, page 2 Action to take If indicated, wait 2 seconds for initialization. Beep End of initialization Start scanning Beep Start/Stop button was pressed in order to indicate scan end View results on screen Error message: Calibration out of range Error message: Time limit error Beep every 15sec Error message: Low battery During initialization (first 2 seconds) the SpineScan was inclined toward the horizon in an angle higher than 60 The overall examination procedure took more than 10 seconds, or, the Start/Stop button was not pressed within 10 seconds. Battery reached low level charging Battery reached low level charging Repeat measurement Repeat measurement Recharge the battery using the original charger. Recharge the battery using the original charger.
3 Operating Instructions SpineScan Instructions for Use Preparations Before first use, charge the battery for 10 hours. To charge the battery, connect the AC/DC adaptor cable to the designate outlet in the SpineScan left side (3). To turn on the SpineScan, slide the On/Off switch (2). LCD Screen (1) will light up. Wait for 2 minutes before scanning. Waiting time is counted on the screen in seconds. 1. LCD Screen 4. Start/Stop Button 2. On/Off Switch 3. Power source 5. Buzzer Browsing and selecting an application When the Change mode screen appears press shortly on the Start/Stop button (4) to switch between the following modes: Trunk Angle Kyphosis Lateral Bending Flexion/Extension Rotation Body Balance To select an application press the Start/Stop button (4) and hold it pressed until a beep is heard and the application Ready for scan screen appears. The device is now ready to begin scanning at the chosen mode. To return to the main menu from the application screen, press the Start/Stop button (4) and hold it pressed until a beep is heard. The Change mode screen will appear and the device is ready to switch between applications. SSIFU002 version 01 - SpineScan Instructions for Use, page 3
4 Trunk Angle Application Scoliosis affects about 4% of youngsters between the ages of 9 and 14 and results in an abnormal curvature of the Spine. One aspect of the scoliosis deformity is the asymmetry of the trunk, which is emphasized when the patient bends forward. SpineScan quantifies this asymmetry and provides the maximal angle of the inclination as well as graphical representation of all the inclination angles measured along the back. Starting Trunk Angle Application the Trunk Angle mode screen appears. the Trunk Angle mode Ready for scan screen appears. Have the patient extend his/her arms forward and place his/her palms flat against each other. Have the patient bend forward 90 degrees, head down, knees straight, arms hanging and palms kept together. Verify that the patient s shoulders are at least at hip level (if possible). Gently pull down the patient s joined palms to ensure maximal bending. Beware! Incorrect SpineScan results can be obtained if a knee is bent, the hands are resting on the thighs or the palms are not joined. Start Stop Position the SpineScan between the patient s shoulders with the semicircular notch over the spinous process. Both sides of the SpineScan should touch the back. Let the SpineScan rest gently on the skin; do not push down. Press the Start/Stop button. Hold the SpineScan steady and wait for 2 seconds until the buzzer is heard. Slide the SpineScan along the back while keeping the semi-circular notch over the spinous process. Both sides of the SpineScan should continuously touch the back. Press the Start/Stop button again when L2 area is reached. SSIFU002 version 01 - SpineScan Instructions for Use, page 4
5 SpineScan Instructions for Use Read the maximal angle measured along the back, its location (thoracic / lumbar) and direction (Lt / Rt) on the LCD screen. Press shortly the Start/Stop button to switch to a graphic presentation of the results. For new exam press the Start/Stop button for 5 seconds until the Ready for scan screen appears. Notes: When starting an exam: Do not forget to hold the SpineScan steady for 2 seconds until the buzzer is heard. When sliding the SpineScan along the back: Keep both sides of the SpineScan in contact with the back. Keep the SpineScan perpendicular to the spinous process line. Do not forget to press the Start/Stop button when L2 area is reached. The exam will be invalid if: During initialization (first 2 seconds) the SpineScan was inclined toward the horizon in an angle higher than 60. The overall examination procedure took more than 10 seconds. The Start/Stop button was not pressed when L2 was reached. SSIFU002 version 01 - SpineScan Instructions for Use, page 5
6 Kyphosis Application Kyphosis is a progressive spinal disorder that can affect children or adults. This disorder is most common in the thoracic spine and may cause a deformity described as humpback or hunchback. SpineScan quantifies the thoracic Kyphosis angle and provides graphical representation of all the sagittal thoracic angles measured along the back. Starting Kyphosis Application the Kyphosis mode screen appears. the Kyphosis mode Ready for scan screen appears. Place the SpineScan bellow C7, between the patient s shoulders. The SpineScan s rear side should touch the back. Let the SpineScan rest gently on the skin. Press the Start/Stop button. Hold the SpineScan steady and wait for 2 seconds until the buzzer is heard. Slide the SpineScan along the back. SpineScan should continuously touch the back. Press the Start/Stop button again when L2 area is reached. Start Stop Read the Kyphosis angle on the LCD screen. To start a new exam press the Start/Stop button for 5 seconds until the Ready for scan screen appears. Notes: When starting an exam: Do not forget to hold the SpineScan steady for 2 seconds until the buzzer is heard. The exam will be invalid if: The overall examination procedure took more than 10 seconds. The Start/Stop button was not pressed when L2 was reached. SSIFU002 version 01 - SpineScan Instructions for Use, page 6
7 ROM Applications Evaluating the range and patterns of movement is a key concern in the diagnostic and functional assessment of patients. Bending in different directions measures flexibility and may aid in the evaluation of stiffness and abnormal curvature of the spine. SpineScan measures spinal and cervical ranges of motion and provides quantitative assessment of spine and head flexibility in three spatial directions. Lateral Bending Application Starting Lateral Bending Application the Lateral Bending mode screen appears. the Lateral Bending mode Ready for scan screen appears. Place the SpineScan at the appropriate location according to the required measurement: Occipital for cervical ROM T1 for thoracic spine ROM T12 for lumbar spine ROM Press the Start/Stop button Hold the SpineScan steady and wait for 2 seconds until the buzzer is heard. Keep SpineScan on the back and ask the patient to bend to the left or to the right as far as possible. Press the Start/Stop button again when maximal bending to this side is reached. Read the lateral ROM angle and its direction (Left/Right) on the LCD screen. In order to measure another bending angle, position the patient upright again and place the SpineScan at the appropriate location. Press the Start/Stop button shortly. Repeat patient scanning procedure. Read the lateral ROM angle and its direction (Left/Right) on the LCD screen As long as you do not leave the lateral bending application, previous measurements of the opposite side will also appear on the screen. Notes: Do not forget to press the Start/Stop button when maximal bending is reached The exam will be invalid if: The overall examination procedure took more than 10 seconds. The Start/Stop button was not pressed when maximum bending was reached. SSIFU002 version 01 - SpineScan Instructions for Use, page 7
8 Flexion/Extension Application Starting Flexion/Extension Application the Flexion/Extension mode screen appears. the Flexion/Extension mode Ready for scan screen appears. Place the SpineScan at the appropriate location according to the required measurement: Occipital for cervical ROM T1 for thoracic spine ROM T12 for lumbar spine ROM Press the Start/Stop button Hold the SpineScan steady and wait for 2 seconds until the buzzer is heard. Keep SpineScan on the back and ask the patient to bend backward or forward as far as possible. Press the Start/Stop button again when maximal bending is reached. Read the measured ROM angle on the LCD screen: Extension (Back) or Flexion (Fwd). In order to measure another flexion/extension angle, position the patient upright again and place the SpineScan at the appropriate location. Press the Start/Stop button shortly. Repeat patient scanning procedure. Read the measured ROM angle according to its direction (Fwd/Back) on the LCD screen As long as you do not leave the flexion/extension application, previous measurements of the opposite side will also appear on the screen. Notes: Do not forget to press the Start/Stop button when maximum flexion is reached. The exam will be invalid if: The overall examination procedure took more than 10 seconds. The Start/Stop button was not pressed when maximum flexion was reached. SSIFU002 version 01 - SpineScan Instructions for Use, page 8
9 Rotation Application Starting Rotation Application SpineScan Instructions for Use the Rotation mode screen appears. the Rotation mode Ready for scan screen appears. Place the SpineScan at the appropriate location according to the required measurement: Occipital for cervical ROM T1 for thoracic spine ROM T12 for lumbar spine ROM Keep SpineScan steady on the back. Press the Start/Stop button. Hold the SpineScan steady and wait for 2 seconds until the buzzer is heard. Keep SpineScan steady on the back and ask the patient to turn as far as possible to the right or to the left. Press the Start/Stop button again when maximal rotation is reached. Read the rotation range and its direction on the LCD screen. To start a new exam press the Start/Stop button for 5 seconds until the Ready for scan screen appears. In order to measure another rotation angle, position the patient upright again and place the SpineScan at the appropriate location. Press the Start/Stop button shortly. Repeat patient scanning procedure. Read the measured rotation angle according to its direction (right/left) on the LCD screen As long as you do not leave the rotation application, previous measurements of the opposite side will also appear on the screen. Notes: Do not forget to press the Start/Stop button when maximum rotation is reached. The exam will be invalid if: The overall examination procedure took more than 10 seconds. The Start/Stop button was not pressed when maximum rotation was reached. SSIFU002 version 01 - SpineScan Instructions for Use, page 9
10 Body Balance Application The level of the head, shoulders and hips is important in determining if there is a spinal problem. Head, shoulders and hip asymmetries can be measured with SpineScan for quantitative assessment of posture asymmetries. Starting Body Balance Application the Body Balance mode screen appears. the Body Balance mode Ready for scan screen appears. Place the SpineScan at the appropriate location according to the required asymmetry measurement, for example: Shoulders line PSIS line Press the Start/Stop button. Read the asymmetry angle and its direction on the LCD screen. In order to reset and start a new exam press the Start/Stop button. The Ready for scan screen will appear. SSIFU002 version 01 - SpineScan Instructions for Use, page 10
11 Normal Values Trunk Angle - Scoliosis SpineScan Instructions for Use This value is measured when performing screening for scoliosis in the forward bending position. When the measured angle is 7 or above the child should be referred to a doctor and undergo full spine x-ray to decide whether he suffers from scoliosis. Kyphosis The normal range of the thoracic Kyphosis angle is degrees. Normal Ranges of Motion Range of Motion of Cervical Spine Motion Plane Normal Ranges (degrees) Flexion / Extension Sagittal Lateral Bending Frontal Rotation Rotation Range of Motion of Thoracic spine Motion Plane Normal Ranges (degrees) Flexion Sagittal 0 90 Extension Sagittal 0 30 Lateral Bending Frontal Rotation Rotation Range of Motion of Lumbar spine Motion Plane Normal Ranges (degrees) Flexion Sagittal 0 50 Extension Sagittal 0 20 Lateral Bending Frontal Rotation Rotation SSIFU002 version 01 - SpineScan Instructions for Use, page 11
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