Rehabed Leo Med Instructions For Use Manual
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Rehabed Leo Med Instructions For Use Manual

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  • Page 3: Table Of Contents

    8.5.3. O CONTENTS PERATING THE MEDICAL SIDE ............27 RAILS 8.6. E MERGENCY PULLING OUT OF THE BED 1. INTRODUCTION ........4 .............. 28 1.1. C ........... 4 ONTACT 8.7. E ...... 28 LECTRICAL OPERATION 1.2. T ? ...... 4 O WHAT IT CONCERNS 8.7.1.

  • Page 4: Introduction

    1.2. T O WHAT IT CONCERNS This instruction manual applies to Leo MED beds consisting of 4-section mattress platform with metal slats and electrically operated backrest and knee break. All products are CE marked – in accordance with the EC Directive on medical devices (2017/745 (MDR)).

  • Page 5: Use

    1.4. U The Leo MED bed with scissor-pantograph mechanism has been designed to provide the user with optimal independence and freedom whilst aiding the manual handling requirements of the carer. The Leo bed with a 9-button handset (Trendelenburg position locked-off) is intended for use within hospitals, long-term care facilities or domestic environment.

  • Page 6: Contraindications

    Make sure the product is suitable for your condition or dysfunction. 1.5. C ONTRAINDICATIONS The contraindications for using the Leo MED bed include: ▪ Cervical or skeletal traction, ▪ Unstable fractures of the spine – if the bed’s functions remain unlocked, ▪...

  • Page 7: Warnings And Cautions

    2. W ARNINGS AND CAUTIONS Warnings in this instruction manual indicate potential hazards, disregard of which could lead to injury or death. Cautions in this instruction manual identify potential hazards, disregard of which could result in damage to the equipment. 2.1.
  • Page 8 particular attention should be paid to the risk of hand injury. ▪ Start and use of the defective device that could pose a risk to patients or others is forbidden. ▪ Actuators should not be used in the presence of flammable gases.
  • Page 9 unattended, in order to minimize the risk of injury caused by a fall. ▪ A handset must be locked if the patient should not change the height and/or tilt of the back and/or leg sections, or when there are doubts concerning the patient’s ability to safety control the functions of the bed.
  • Page 10 potentially hazardous section (movable: backrest section, leg section, high / low system, side rails) - risk of injury to the limbs! ▪ Particular attention should be paid to small children, the patient's limb or other items around the bed that could entrap in a space between mattress platform and the chassis and be damaged or injured.

  • Page 11: Transport And Storage

    3. T RANSPORT AND STORAGE The following conditions should be followed when transporting and storing the bed: ▪ Bed always to be stored on a flat and level floor. ▪ Bed ends set to minimum height. ▪ Wheel brakes should be applied. ▪...
  • Page 12 ▪ If the bed is removed from its place of use by the end user, before handing the bed over for storage, make sure that the bed has been cleaned and disinfected – in acceptance with your local infection control rules and/or rules that are specified in this instruction manual (see section 11).

  • Page 13: Symbol Definitions

    4. S YMBOL DEFINITIONS The following symbols are observed on the beds: Warning Beware of potential hazard Cautions Beware of potential hazard Refer to instructions for use – recommended Failure to read the instructions for use could introduce a hazard Refer to instructions for use –...
  • Page 14 Warning – dynamic mattress Dynamic mattresses must only be strapped to moving parts of bed frame Electrical specification Including storage and use conditions Warning – removable side rail Incompatible and improperly installed side rails may pose a risk of injury or death - see the instruction manual Total product weight in transport mode Heavy weight of the product - be careful when transporting on the transport stand and...

  • Page 15: Parts

    5. P ARTS 5.1. P ARTS SPECIFICATION (The figure shows the Leo MED bed with medical side rails) 1. Head end 2. Medical side rail 3. Backrest mattress platform 4. High / Low actuator 5. Backrest section actuator and control box 6.

  • Page 16: Bed Assembly And Preparing For Use

    6. B ED ASSEMBLY AND PREPARING FOR USE ▪ Before attempting to assemble the bed, ensure these instruction manual has been read and fully understood. ▪ Ensure a risk assessment in line with local health and safety policy is undertaken to ensure that staff are not put at risk when performing assembly activities.
  • Page 17 ▪ Check condition of power cable, handset cable and actuators' cables and make sure they are not damaged. ▪ Once all the cables are connected they are to be secured in place by attaching the retaining clip. Note: Actuator and handset cables are not shown (Image courtesy of DewertOkin GmbH) ▪...

  • Page 18: Power Cable

    6.1.1. H OLDER ARRANGEMENTS ON POWER CABLE Leo bed MED is equipped with 7 additional cable holders that allow the power cable suspension under the mattress platform. The figure below presents the arrangement. ▪ All cables must be suspended from the platform frame on dedicated brackets, to avoid rubbing and cannot touch the floor.

  • Page 19: Fitting The Medical Side Rails

    6.3. F ITTING THE MEDICAL SIDE RAILS Leo MED is delivered with fitted medical side rails. The following instructions may be helpful when you need to replace the side rails or their components. ▪ Insert the side rail’s pivots into the mounting bush in the mattress platform (as shown on the right).

  • Page 20: Checking The Bed

    6.4. C HECKING THE BED The bed is now fully assembled. Before the bed is put into use ensure the bed is correctly assembled: ▪ Has all packaging been removed, e.g. cable ties securing the platform sections? ▪ Are the cables free of all moving parts and is there sufficient slack in the cables to allow for movement? ▪...

  • Page 21: Training

    7. T RAINING Professional personnel should be appropriately familiarized with the functionality of the bed, its limitations and the target user group before use. The user’s ability to operate the handset in an independent manner should be determined in acceptance with the risk assessment.

  • Page 22: First Use

    8. F IRST USE Prior to using the bed for the first time the following risk assessment must be performed based on the status of the patient and their body. This assessment should include, but is not limited to: ▪ The possibility of patient entrapment ▪...

  • Page 23: General Safety

    8.2. G ENERAL SAFETY ▪ When the bed is operated, make sure that objects such as a bedside table or other furniture are not an obstacle. ▪ Before exploiting the bed, make sure that the patient has been positioned correctly. ▪...

  • Page 24: Brake System

    8.4. B RAKE SYSTEM The Leo MED bed can be equipped with a castors with individual lock, axle lock or central lock (optionally with a direction lock). For safety reasons, wheels should be blocked with the foot (not with the use of a hand), and the manufacturer recommends wearing adequate footwear.

  • Page 25: Castors With Individual Lock

    8.5. S IDE RAILS AND MATTRESSES Leo MED bed comes as a standard with a medical side rails. Medical rails extend over the ¾ length of the bed. Characteristics of the mattresses and the side rails tested and approved by the...

  • Page 26: Side Rail Safety

    ▪ Ensure that any mattresses used are of the correct size and type and have been fitted correctly – Incorrect mattress specification could lead to an entrapment and / or falls hazard. ▪ Ensure the mattress fitted is used with a compatible side rail. 8.5.1.

  • Page 27: Operating The Medical Side

    8.5.3. O PERATING THE MEDICAL SIDE RAILS To lower side rails: ▪ Pull the side rails gently towards head bed end. ▪ Pull the release button for side rails. ▪ Gently lower the side rails (the release button can be let when lowering side rails). To raise the side rails: ▪...

  • Page 28: Emergency Pulling - Out Of The Bed End

    8.7. E LECTRICAL OPERATION Leo MED bed has been equipped with a 9-button or 10-button easy-to-use handset. It is intended for use by both the patient and the caregiver. However the handset should be operated by the care person. During the operation of the bed position by the caregiver, make sure that the user is informed about the change in the position of the mattress platform.

  • Page 29: Handset Location

    ▪ Before lowering the bed ensure nobody is in close proximity to the underside of the bedframe – risk of crushing. ▪ Before lowering the bed ensure feet / limbs are kept away from the castor pedals / corner posts (long wooden ends of the bed ends) - risk of crushing.

  • Page 30: And 9- Button Handset Operation

    8.7.2. 10 BUTTON HANDSET OPERATION Note: when the bed is in the tilt position (even if the Trendelenburg function is locked), levelling the mattress platform is carried out through the adjustment of the mattress platform high, by lifting the platform upwards (maximum value) or lowering down (maximum value) –...

  • Page 31: Handset Lockout

    8.7.3. H ANDSET LOCKOUT The handset is supplied with a lockout function which enables the care person to disable the handset with a mechanic key (functions or the Trendelenburg function - only in the case of 10-button handset) until the light is on/off. The key is attached to the bag with the Instruction For Use.
  • Page 32 ▪ Lift the leg section manually with the use of handles so that the ratchet engages (once engaged the leg section will be supported by the ratchet). ▪ The leg section will now move parallel to the bed frame as it is driven up / down with the use of the adequate function on the handset.

  • Page 33: Disassembling The Bed For Transport

    9. D ISASSEMBLING THE BED FOR TRANSPORT ▪ Before attempting to disassemble the bed ensure these instructions have been read and fully understood. ▪ Ensure a risk assessment in line with local health and safety policy is undertaken to ensure that staff are not put at risk when performing disassembly activities.

  • Page 34: Power Failures

    10. P OWER FAILURES The bed can be equipped (optionally) with additional emergency power supply – Backup System, that enable to lower the backrest and leg sections in the event of a power failure. If the bed is not equipped with an auxiliary power supply, in the event of a power failure, the electrical functions will not work.
  • Page 35 ▪ If the section should be lowered while the patient is in the bed, a risk assessment consistent with local health and safety regulations ought to be carried out in order to determine if it is possible to levelled the section with the load in a safe way. ▪...

  • Page 36: Decontamination

    11. D ECONTAMINATION Infection control and routine cleaning must be carried out in accordance with the Infection Control Policy, the local infection control schedule or recommendations from the local regulatory authorities. ▪ Always disconnect the bed from the main power supply prior to cleaning.
  • Page 37 Note: If any of the stages stated above are omitted or combined it will reduce the effectiveness of the clean. Note: The use of neat bleach or similar surface cleaners is not recommended as damage may be caused to the cleaned surfaces. ▪...

  • Page 38: Maintenance

    12. M AINTENANCE Only authorised service personnel or Reha-Bed sp. z o.o. service engineers should carry out repairs or service activities. The manufacturer is not liable for unauthorised repairs. Failure to observe the rule may result in the manufacturer’s warranty becoming void.

  • Page 39: Service Life

    Contact details can be found in section 1.1 of the booklet. 12.2. S ERVICE LIFE The service life of the Leo MED bed is 10 years*, with the exception of the mattresses. On the basis that the bed and its associated accessories are serviced and maintained...
  • Page 40 in acceptance with the information detailed in these instructions for use and the individual instructions provided with the accessory in question. At the end of service life, the bed should be withdrawn from use in accordance with local waste management policy. *Not applicable to the electrical components –...

  • Page 41: Faulty Finding

    12.3. F AULTY FINDING Listed below are a set of electrical faults that may occur within the service life of the bed. If a fault does occur please try the following suggestions, as these may help in diagnosing the fault, or contact the service department. Fault Possible cause Remedy...

  • Page 42: Disposal Of Parts

    13. D ISPOSAL OF PARTS When the bed frame / electrical system has come to the end of its useful life follow local recycling and W.E.E.E. (Waste Electrical and Electronic Equipment) policies. The electrical system on the bed frame is not to be disposed of in general municipal waste.

  • Page 43: Electromagnetic Compatibility (Emc)

    14. E (EMC) LECTROMAGNETIC COMPATIBILITY The electrical system has been designed to meet the necessary EMC requirements (IEC 60601-1-2 standard) however it may still be affected by or emit harmful radio frequency (RF) energy. The RF emissions from the electrical system are very low and are not likely to cause any interference to nearby electronic equipment, however interference to sensitive equipment is still possible.

  • Page 44: Specification

    15. S PECIFICATION 15.1. B ED DATA Leo Med Leo Med Leo Med Overall length 2150 mm 2150 mm 2150 mm Overall width 1010 mm 960 mm 890 mm Mattress platform height range 315 – 785 mm Under bed clearance (up to the metal frame)

  • Page 45: Technical Data Of Side Rails

    15.3. T ECHNICAL DATA OF SIDE RAILS Leo MED bed has been tested and approved with the medical side rails along the ¾ length of the mattress platform. The table below presents the basic dimensions of side rails that can be used with the bed.

  • Page 46: Electrical Data

    15.4. E LECTRICAL DATA MCL II control box Voltage in: 100 – 240V, 50/60 Hz Current in: Max. 3,15A Electric shock protection: Class II Duty cycle:* 2 mins of continuous use followed by 18 mins not in use 5 switching cycles per minute *Electrically operated beds are intended to be operated intermittently rather than continuously.

  • Page 47: Accessories

    16. A CCESSORIES The Leo MED bed has been tested and approved with the following accessories: ▪ Lifting pole with plastic handgrip ▪ Drip holder ▪ Urological bag holder ▪ Grab rail (holder that supports standing)* ▪ Grab rail external (holder that supports standing)* ▪...

  • Page 48: Mattress And Side Rails

    16.1. M ATTRESS AND SIDE RAILS Leo MED bed has been tested and approved with listed below mattresses. The mattresses listed below are mattresses recommended by the manufacturer. Contact your distributor, importer or manufacturer to select a mattress suitable for your bed.
  • Page 49 ensure the gap between the top of the mattress and top of the side rail when raised is acceptable and will not introduce a hazard to the patient. ▪ If the dynamic mattresses are set to a low pressure the gap introduced by cell compression at the mattress edge and the side rail is to be considered.

  • Page 50: Lifting Pole

    17. L IFTING POLE Optionally, the bed can be equipped with a lifting pole with a triangular handle with an adjustable length of the belt. In order to install the lifting pole: ▪ Lock all 4 wheels. ▪ Select one of the two lifting pole sockets located at the corners of the mattress platform (on the head bed end).

  • Page 51: Warranty

    18. W ARRANTY The warranty period is 24 months from the date of purchase of the bed. The warranty does not cover mechanical damage and interference with the bed’s structure, actuators or the bed’s control box. In the absence of regular inspections, the guarantor is not responsible for any damage resulting from this fact.
  • Page 52 a) It is not possible to identify the product from the serial number and production date on the bed. b) The product has been used in a manner inconsistent with the manner described in the instruction manual. The product has been used for other purposes or in conditions other than the intended ones.

  • Page 53: Repairs And Maintenance Treatments

    19. R EPAIRS AND MAINTENANCE TREATMENTS SIGNATURE AND STAMP OF DATE DESCRIPTION THE SERVICE...

  • Page 54: Notes

    20. N OTES...
  • Page 56 INSTRUC/LEO-MED/EN, 2021/04 REV2...

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