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Ossur PROPRIO FOOT Technical Manual

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Technical Manual
PROPRIO FOOT
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Summary of Contents for Ossur PROPRIO FOOT

  • Page 1 Technical Manual PROPRIO FOOT ®...

  • Page 2: Table Of Contents

    Safety precautions Introduction Technical specifications Setup Basic operation Calibration Functions Advanced operation Maintenance Training tips Warranty Electromagnetic compatibility precautions Category selection chart...
  • Page 4 Keypad Battery Control button Warning Indicates 2× beep approx. 120 min left 3× beep approx. 60 min left 4× beep approx. 30 min left 5× beep Foot will return to neutral Stair mode Hold Press Sound Sequence Stair Mode 4° 2×...

  • Page 5: Safety Precautions

    SAFETY PRECAUTIONS • When the battery charge is low, proprio foot will return to the last preset heel height position. A warning ® signal will occur (see “Charging and power”). • When making adjustments to proprio foot ® ensure the user is seated or in a stable standing position.
  • Page 6 Meets IEC type B leakage current requirements CE label with Notified Body indentification number Must be disposed of or recycled properly DC in Connection for DC power supply Connection for battery extension cable to PROPRIO FOOT DC out Manufacturer Date of manufacture INDICATOR...

  • Page 7: Introduction

    IEC/EN60601-1, standard of electrical safety of ® medical devices and IEC/EN60601-1-2, electromagnetic compatibility for medical electrical devices and ISO 10328. The company fulfills the requirements of ISO13485, MDD 93/42/EEC, and proprio foot carries the ®...

  • Page 8: Setup

    700 - 1060 hPa pressure SYSTem comPonenTS PRX0XYYZ Kit PROPRIO FOOT PRX00431 Batterie provisoire PRX60137 Kit d’entretien PROPRIO FOOT cleaRance and dimenSionS (figure a) Clearance 180 mm–190.5 mm (7"–7½") Sizes 22 - 30 Heel hights 0–50 mm (2") SYSTEM DIAGRAM (Figure B)
  • Page 9 • Place the wedge in the angle of the heel and foot module. • Secure the wedge in position with tape wrapped around the foot module. Permanently fix wedges when proprio foot is used for more than a couple of days.
  • Page 10 • Connect the power source to the battery pack. Allow 3–4 hours to ensure a full charge. Battery charge • The LED lights indicate the charge state of proprio foot ® • Press the control button to check the charging level. When the battery is fully charged all LED lights will turn green.

  • Page 11: Basic Operation

    • It is recommended not to use any foam covering except the foot cover supplied. BASIC OPERATION POWER ON 2× • To turn on the proprio foot, hold both buttons at least one second. » The system confirms with two beeps and vibrations.
  • Page 12 HEEL HEIGHT ADJUSTMENT 1×/1×/1× The proprio foot can be adjusted for variable heel ® height. The heel height adjustment ensures correct alignment of the prosthesis which is essential for proper Terrain Logic™ function. Heel height adjustment on the bench • Wear suitable footwear and ensure free ankle motion.

  • Page 13: Calibration

    CALIBRATION Calibration must be performed during the initial fitting to calibrate the proprio foot ® to the user’s individual gait. During calibration, proprio foot ® recognizes the user’s specific gait parameters, allowing for accurate and consistent terrain detection. For calibration the user must walk on level ground for at least 15 consecutive strides without interruption.

  • Page 14: Functions

    • During ramp ascent, proprio foot gradually raises the toe of the prosthetic foot. Adaptation begins on ® the second step and makes small changes until it reaches the gradient of the ramp. proprio foot ® continuously adapts on every step.

  • Page 15: Advanced Operation

    The ankle will move to dorsiflexion that will enable the user to bring the leg further back, providing more controlled transition from sitting to standing. The ankle will move back to neutral after the first step. Tapping on the heel will move proprio foot ®...

  • Page 16: Maintenance

    ® To ensure proper function, it is recommended that proprio foot is inspected every six months by a ® qualified professional. Check for signs of unusual wear.

  • Page 17: Training Tips

    Relax Mode the prosthesis has to be slightly unloaded PROPRIO FOOT will move into a plantar flexed position (toe down). Chair Exit Mode: Ask the user while in a seated position to move the prosthesis under or close to the chair. PROPRIO FOOT will dorsiflex (toe up) to facilitate standing up. Level ground: Ask the user to walk at slow and fast speed.
  • Page 18 guidance and manufacturer’s declaration – electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or user of device should assure that it is used in such an environment. emissions Test compliance electromagnetic environment – guidance RF Emissions CISPR 11 Group 1 The device uses RF energy only for its internal function.
  • Page 19 guidance and manufacturer’s declaration – electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or user of the device should assure that it is used in such an environment. immunity Test iec 60601 Test level compliance level electromagnetic environment –...

  • Page 20: Category Selection Chart

    Recommended separation distances between portable and mobile Rf communications equipment and the device. The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
  • Page 21 In the standard mentioned, test levels (P) are assigned to a certain maximal body masses (m in kg). In some cases, which - “P” - “m”kg *) are marked with, no test level is assigned to the product related maximal body mass. In these cases, the test loads have been adapted adequately on the basis of the specified load level.
  • Page 23 en – caution: Össur products and components are designed and tested according to the applicable official standards or an in-house defined standard when no official standard applies. Compatibility and compliance with these standard is achieved only when Össur products are used with other recommended Össur components. If un-usual movement or product wear is detected in a structural part of a device at any time, the patient should be instructed to immediately discontinue use of the device and consult his/her clinical specialist.
  • Page 24 Tel: +46 1818 2200 Tel: +39 05169 20852 Tel: +1 800 233 6263 Fax: +46 1818 2218 Fax: +39 05169 22977 Fax: +1 800 831 3160 info@ossur.com orders.italy@ossur.com ossurusa@ossur.com Össur Iberia S.L.U Össur APAC Össur Canada Calle Caléndula, 93 - 2F, W16 B 2150 –...

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