Otto Bock 1B1-2 Meridium Instructions For Use Manual
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Otto Bock 1B1-2 Meridium Instructions For Use Manual

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1B1-2=* Meridium
Instructions for use (qualified personnel) .................................................................
4

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  • Page 1 1B1-2=* Meridium Instructions for use (qualified personnel) ..............
  • Page 2 DE | INFORMATION Zusätzlich zu der gedruckten Gebrauchsanweisung, sind auch weitere Sprachen auf CD beigelegt (siehe rückseitigen Um­ schlag). Auf Anfrage können Sie eine gedruckte Gebrauchsanweisung kostenlos in der jeweiligen Landessprache unter der un­ ten angegebenen Anschrift bestellen. EN | INFORMATION In addition to the printed Instructions for Use, additional language versions are also included on CD (see back cover).
  • Page 3 TR | INFORMATION Basılmış olan kullanım kılavuzuna ilave olarak CD'de daha fazla alternatif diller bulunmaktadır (bakınız zarfın arka yüzü). İstek üzerine ilgili dilde basılmış kullanım kılavuzunu aşağıda belirtilmiş olan adresten temin edebilirsiniz. Ottobock Healthcare Products GmbH Brehmstraße 16 | 1110 Wien | Austria Service-admin.vienna@ottobock.com | Fax (+43-1) 526 79 85 1B1-2=* Meridium...

  • Page 4: Product Description

    Foreword English 1 Foreword INFORMATION Date of last update: 2019-07-26 ► Please read this document carefully before using the product. ► Instruct the user in the proper and safe use of the product. ► Please contact the manufacturer if you have questions about the product (e.g. regarding the start-up, use, maintenance, unexpected operating behaviour or circumstances).

  • Page 5: Intended Use

    Intended use In case of a product malfunction, safety mode makes restricted operation possible. Resistance parameters that are predefined by the product are configured for this purpose (see Page 29). Empty battery mode permits safe walking when the battery is drained. Resistance parameters that are predefined by the product are configured for this purpose (see Page 29).
  • Page 6 Safety 3.3 Service life 1B1-2 Meridium This product has been tested by the manufacturer with 2 million load cycles according to ISO 22675. Depending on the patient's activity level, this corresponds to a service life of 2 to 3 years.
  • Page 7 Safety CAUTION Independent manipulation of the product and the components Falling due to breakage of load-bearing components or malfunction of the product. ► Manipulations to the product other than the tasks described in these instructions for use are not permitted. ►...

  • Page 8: Information On The Power Supply/Battery Charging

    Safety CAUTION Signs of wear and tear on the product components Falling due to damage or malfunction of the product. ► Regular service inspections (maintenance) are mandatory in the interest of patient safety and in order to main­ tain operating reliability and protect the warranty. NOTICE Improper product care Damage to the product due to the use of incorrect cleaning agents.
  • Page 9 Safety 4.5 Battery charger information NOTICE Penetration of dirt and humidity into the product Lack of proper charging functionality due to malfunction. ► Ensure that neither solid particles nor liquids can penetrate into the product. NOTICE Mechanical stress on the power supply/battery charger Lack of proper charging functionality due to malfunction.

  • Page 10: Information On Proximity To Certain Areas

    Safety CAUTION Operator errors during the adjustment process with the adjustment software Falling due to unexpected behaviour of the product. ► Participation in an Ottobock product training course is mandatory prior to using the product. Additional product training courses may become necessary to qualify for software updates. ►...

  • Page 11: Notes On The Safety Modes

    Safety CAUTION Walking down stairs Falling due to foot being placed incorrectly on stair as a result of changed damping behaviour. ► Ensure that the patient uses the handrail when walking down stairs and places most of the sole of the foot on the stair surface.

  • Page 12: Information On The Use Of A Mobile Device With The Cockpit App

    Safety CAUTION Safety mode cannot be deactivated Falling due to unexpected product behaviour because of changed damping behaviour. ► If safety mode cannot be deactivated by recharging the battery, a permanent error has occurred. ► Using the product when it is defective is prohibited. ►...

  • Page 13: Scope Of Delivery And Accessories

    Scope of Delivery and Accessories 5 Scope of Delivery and Accessories 5.1 Scope of delivery • 1 pc. 1B1-2 Meridium • 1 pc. 757L16-4 power supply • 1 pc. 4E50-2 C-Leg battery charger • 1 pc. 646C107 Bluetooth PIN card • 1 pc. 647F542 prosthesis passport •...

  • Page 14: Charging The Prosthesis Battery

    Charging the battery 3) Connect the round, three-pin plug of the power supply to the 12 V receptacle on the battery charger so that the plug locks into place (see fig. 2). INFORMATION: Ensure correct polarity (guide lug). Do not use force when connecting the cable plug to the battery charger.

  • Page 15: Preparation For Use

    Preparation for use 38% – Charge level of battery for currently connected component 7 Preparation for use 7.1 Applying/removing footshell For applying/removing the footshell, please consult the instructions for use included with the footshell. CAUTION Incorrect assembly/disassembly and improper use of footshell >...
  • Page 16 Preparation for use Use the alignment recommendations of the manufacturer (TF modular lower limb prostheses: 646F219,TT • modular lower limb prostheses: 646F336). 7.2.3 Dynamic alignment optimisation Make sure the heel height is correctly set before beginning the dynamic alignment optimisation! •...

  • Page 17: Cockpit App

    Cockpit app 8 Cockpit app The cockpit app enables switching from basic mode into the pre-configured MyModes. In addition, information about the product (step counter, battery charge level, etc.) can be called up. The behaviour of the product can be changed to a certain extent on a day-to-day basis using the app (e.g.

  • Page 18: Control Elements For Cockpit App

    Cockpit app 4) Tap the Add component button. → The Connection Wizard opens and guides you through the process of establishing a connection. 5) Follow the subsequent instructions on the screen. 6) After the Bluetooth PIN is entered, a connection to the component is established. →...

  • Page 19: Cockpit App Navigation Menu

    Cockpit app 8.3.1 Cockpit app navigation menu Tap the symbol in the menus to display the navigation menu. Additional settings for the connected component can be configured in this menu. Product Name of the connected component change Product MyModes Return to the main menu to switch MyModes MyModes 2.
  • Page 20 INFORMATION If establishing a connection to a component is not possible, perform the following steps: ► Delete the component from the Cockpit app if applicable (see the section "Deleting a component") ► Add the component again in the Cockpit app (see the section "Adding a component") INFORMATION After activating the "visibility"...
  • Page 21 9.1.2 Setting the heel height with the cockpit app 1) Once the component is connected and in the desired mode, tap the  symbol in the main menu. → The navigation menu opens. 2) Tap the "Heel Height" menu option. change Product 3) Follow the on-screen instructions.

  • Page 22: Walking Up Stairs

    9.2.3 Sitting down/sitting Sitting down 1) Place both feet side by side at the same level. 2) While sitting down, distribute weight evenly between both legs and use armrests, if avail­ able. 3) Move the buttocks in the direction of the backrest and lean the upper body forward. Sitting The relief function can be used when sitting;...
  • Page 23 9.2.7 Walking up a ramp With the first step, the foot is already adjusted to the inclination of the ramp, making a rollover possible if the step is on the heel or middle of the foot. In order to do so, the lower leg should positioned almost perpendicular to the surface of the ramp and the full area of the foot should be placed on the surface.
  • Page 24 9.2.11 Kneeling If the leg with the joint is tilted backwards, plantar flexion damping is reduced, making it possible for the foot to bend so the lower leg can lie flatter to the ground surface. 9.2.12 Relief function When weight is evenly placed on the heel without movement for more than 2 seconds, the tip of the foot lowers to reach a more natural foot position.
  • Page 25 1) Tap the symbol of the MyMode (1) you want in the main menu of the app. → A security question for changing the MyMode appears. Product change 2) If you want to change the mode, tap the "OK" button. →...

  • Page 26: Changing Prosthesis Settings

    2) Using the heel of the prosthetic foot, knock on a solid obstacle behind you (e.g. a wall) according to the num­ ber of the configured MyMode (MyMode 1 = 3 times, MyMode 2 = 4 times, MyMode 3 = 5 times). It is also pos­ sible to knock against the tip of the shoe of the contralateral leg.

  • Page 27: Changing The Prosthesis Setting Using The Cockpit App

    • The O&P professional's setting is located in the middle of the scale. After making adjustments, this setting can be restored by tapping the "Standard" button in the Cockpit app. • Prosthesis settings should be optimised using the adjustment software. The Cockpit app is not intended for use by the O&P professional to set up the prosthesis.

  • Page 28: Switching Off The Product

    Parameter Adjustment soft­ Setting range, Meaning ware range order to do so, this function needs to be enabled in the adjustment software. 9.4.3 Overview of adjustment parameters in MyModes The parameters in the MyModes describe the static behaviour of the prosthesis for a specific motion pattern such as golf.

  • Page 29: Additional Operating States (Modes)

    Additional operating states (modes) → The navigation menu opens. 2) In the navigation menu, tap the entry "Functions". 3) Tap the entry "Deactivate Bluetooth". 4) Follow the on-screen instructions. Switching on Bluetooth 1) Rotate the component or connect/disconnect the battery charger. →...

  • Page 30: Maintenance

    Maintenance 12 Maintenance INFORMATION The foot shell for the prosthetic foot has an expected working life of approx. one year when professionally moun­ ted and properly used. Damaged foot shells must be replaced immediately, before the prosthetic foot is used again.

  • Page 31: Local Legal Information

    Caution: Exposure to Radio Frequency Radiation. This device must not be co-located or operating in conjunction with any other antenna or transmitter. Responsible party: Otto Bock Health Care, LP 3820 West Great Lakes Drive Salt Lake City, Utah 84120-7205 USA...

  • Page 32: Technical Data

    Technical data Caution: Federal law (USA) restricts this device to sale by or on the order of a practitioner licensed by law of the State in which he/she practices to use or order the use of the device. 14 Technical data Environmental conditions Storage transport...

  • Page 33: Symbols Used

    Appendices Battery charger Reference number 4E50-2 Storage and transport in original packaging -25 °C/-13 °F to +70 °C/+158 °F Storage and transport without packaging -25 °C/-13 °F to +70 °C/+158 °F Max. 93% relative humidity, non-condensing Operation 0 °C/+32 °F to +40 °C/+104 °F Max. 93% relative humidity, non-condensing Input voltage 12 V Power supply Reference number 757L16-4...

  • Page 34: Warnings/Error Signals

    Appendices Lot number Article number Please note the instructions for use Check product settings using corresponding adjustment software Ottobock Data Station. 15.2 Operating states/error signals The prosthesis indicates operating states and error messages through beeps and vibration signals. 15.2.1 Signals for operating states Battery charger connected/disconnected Beep signal Vibration signal...
  • Page 35 Appendices Beep signal Vibration signal Event Required action – 5 x long Battery charge level Charge battery immediately; under 15% the product will be switched off after the next warning sig­ nal. 10 x short 10 x long Charge level 0% Charge the battery. After the beep and vibra­...

  • Page 36: Error Messages While Establishing A Connection With The Cockpit App

    Appendices LED on LED on Error Resolution power sup­ battery charger Battery is fully charged (or connection heard. with product is interrupted). If no signal is emitted, the connection to the product is interrupted. If the connection to the product is inter­ rupted, an authorised Ottobock Service Centre must inspect the product, battery charger and power supply.
  • Page 37 Appendices Beep sig­ Vibration Result signal – – Conduct the self-test again by connecting/disconnecting the battery charger. If no beep/vibration signal is emitted after connecting/disconnecting the battery charger again, the product must be inspected by an authorised Ottobock Service Center. Battery charge level Battery charger...
  • Page 38 Appendices immediate vicinity of wire­ less communication devices Magnetic fields with rated IEC 61000-4-8 30 A/m power frequencies 50 Hz or 60 Hz Table 5 – alternating current gate for the supply input Phenomenon EMC basic standard or Interference immunity test level test procedure Professional healthcare Environments in areas of facility...
  • Page 39 Appendices Test fre­ Frequency Radio service Modulation Maximum Distance [m] Interference quency band power [W] immunity test [MHz] [MHz] level [V/m] DECT; Pulse modula­ tion LTE Band  1, 217 Hz 3, 4, 25; UMTS 2450 2400 to 2570 Bluetooth Pulse modula­ tion WLAN 802.11­...
  • Page 40 EP 1 962 735 in DE, GB, FR, IT, NL, TR, PL, SE Patents pending in Brazil, EPA, Germany, USA. Otto Bock Healthcare Products GmbH Brehmstraße 16 · 1110 Wien · Austria T +43-1 523 37 86 · F +43-1 523 22 64...

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