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INSTRUCTION FOR USE MOBI PRO FLEXI / MOVER – FLEXI – PRO: 11992146 Mover – Flexi – PRO is a mobile device designed to help a patient with a disability to be moved by a caregiver over short distances and to facilitate moving the patient from one sitting area to another.
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WARNING To avoid injuries always read this Instruction for Use and accompanied documents before using the product. Read Instruction for Use.
Contents Foreword ..........................1 Intended Use ......................... 2 Safety Instructions ......................... 3 Assembly of Mover – Flexi – PRO ..................4 Preparation ..........................4 Before First Use (9 Steps) ....................4 Before Every Use (5 Steps) ....................4 Mover – Flexi – PRO driving directions .................. 5 Parts designation ........................
Reporting Unexpected Operations or Events. In case of unexpected operations or events contact Koval or your local Koval representative. The Koval contact information is printed on the last page of this IFU. Serious Incident In case of a serious incident in relation to this medical device involving the user or the patient;...
This product should be used according to the intended purpose and these safety instructions. Everyone using this equipment should read and understand these instructions, which are included in this Instruction for Use (IFU). In case of doubts feel free to contact Koval or your Koval representative at any time.
Some product parts, such as casters, as well as seat and knee upholstery, which are subjected to wear, may need to be replaced during the device lifetime according to information in the Instruction for Use (IFU). Transport damage Upon delivery check the product and the packaging for damages. Observe the delivery date: visible damages should be reported within 2 days after delivery and hidden damages within 7 days after delivery.
Assembly of Mover – Flexi – PRO Follow these steps: Cut the straps securing the cardboard box to the pallet. Unpack the Mover. Remove all protective foil and foam from casters, seat upholstery and handles. The Mover is now ready for use – no further installation is required. Preparation Before First Use (9 Steps) Visually inspect the Mover for transport damages.
In case of missing or damaged parts do NOT use the product! WARNING To prevent cross-contamination always follow the disinfection instructions from this IFU. Mover – Flexi – PRO driving directions The driving direction during transport, as well as the left and right side are illustrated below (sides are marked pursuant to patient position).
Parts designation 1 Mover frame 7 Double-wheel caster 2 Flexible base 8 Double-wheel caster with brake 3 Plastic footrest 9 Maneuvering handle 4 Knee upholstery 10 Lever for adjusting flexible base 5 Right seat upholstery 11 Crossbar 6 Left seat upholstery Product Description / Functions Mover is a mobile (wheeled), non-self-propelled device designed to help a caregiver to safely move a patient with a disability (e.g., geriatric, injured, with disabilities) across short distances,...
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homes, rehabilitation units and other health care settings. The equipment is intended for indoor use. Rotating padded seats and a knee support with 50 mm of seamless padding provides maximum comfort and is easy to clean. Plastic foot plate can be equipped with anti-slip tape to provide more grip. Four swivel double-wheel casters with 75 mm of diameter for improved maneuverability.
Adjusting the flexible base width The width of the flexible base of the Mover can be adjusted by means of a hand lever. It has three positions: narrow, middle and wide. Inner caster distance: 830 mm 1 Left position (wide) - Outer caster distance: 970 mm Inner caster distance: 640 mm 2 Middle position -...
Rotating the padded seats Rotate one part of the two-part seat in either direction from the open position to position underneath the patient. WARNING To avoid damages to the equipment always move the padded seats in the closed position. WARNING To prevent injuries the patient must never be left unattended.
Adjusting the height of the knee support The position of the knee support is height adjustable by 9 cm. 1. Unscrew the two PVC screws and adjust the height of the knee support. 2. Hold the knee support with one hand and tighten the PVC screws with the other hand.
7 Rotate both parts of the seat down. (See Fig. 3.) Fig. 3 8 Ask the patient to sit down. (See Fig. 4.) Fig. 4 9 Release the brakes and proceed with the transfer. (See Fig. 5.) Fig. 5 To a Chair, Wheelchair, Bed or Toilet (8 steps) 1 Approach the chair and adjust the flexible base of the Mover, if needed.
5 Ask the patient to sit down by holding the crossbar. 6 When seated, ask the patient to remove the feet from the footrest. 7 Release both caster brakes and move the Mover away. 8 Rotate the both parts of the seat down. WARNING When accommodating the patient all the brakes must always be applied to prevent patient falls.
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5 Use a clean cloth to wipe all surfaces especially handles, the crossbar and knee upholstery. 6 Use a new cloth soaked in water to remove all traces of disinfectant. When removing disinfectant periodically rinse the cloth under running water. 7 If the traces of disinfectant cannot be removed, spray water with a temperature of approx.
The Mover is subject to normal wear and tear; therefore, the following actions should be performed as specified to make sure that the product retains its original manufacturing specification. Koval or your local Koval representative shall carry out a regular yearly checkup by prior agreement. WARNING To avoid malfunction resulting in injury make sure to carry out regular inspections and follow the recommended maintenance schedule.
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Responsibilities of the Caregiver Responsibilities of the caregiver shall be carried out by personnel with sufficient Mover knowledge following the instructions in this IFU. Daily Disinfection • Disinfect the Mover immediately after every use. Use recommended concentrations of standard disinfectants and cleaning agents. For additional cleaning/disinfecting instructions see Cleaning and Disinfection Instructions section.
The operating temperature must range from +5°C to +40°C. Humidity must range from 20% to 80% and atmospheric pressure must range from 700 to 1060hPa. Technical Specifications 11992146 - MOVER – FLEXI – PRO/Mobi Pro Flexi Rotating padded seats Seamless padding (50 mm)
End of Life Disposal • Upholstery and any other polymers or plastic materials etc. should be sorted as combustible waste. • Components that are primarily made up of different kinds of metal (containing more than 90% metal by weight), should be recycled as metals.
Troubleshooting Troubleshooting for Mover – Flexi – PRO NOTE: If the product does not work as intended, immediately contact Koval or your local Koval representative for support. PROBLEM ACTION Manually adjustable flexible base cannot be 1 Check flexible base mechanism for opened or closed.
Labels Label explanation Manufacturer Catalogue number, Catalogue number Serial number, Batch Identification code, Model name, Serial number Data Label Manufacturing date, Manufacturer, Safe Batch code working load. Warning Warnings about European Conformity Label improper use Mark Warning: pinching of Symbol explanation hands Safe working load Apply the brake...
Approvals and List of Standards Product complies with the European Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices: - Classified as Class I medical devices as set out in Annex VIII of Regulation (EU) 2017/745 - Complies with the provisions of Regulation (EU) 2017/745 “Medical Devices”...
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