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Страница 3: ...F THE CASTORS 27 8 4 3 CENTRAL LOCK OF THE CASTORS 27 8 5 SIDE RAILS AND MATTRESSES 27 8 5 1 SIDE RAIL SAFETY 28 8 5 2 MATTRESS THICKNESS 28 8 5 3 OPERATING THE WOODEN FULL LENGTH SIDE RAILS 29 8 5 4 OPERATING THE LIGHT SIDE RAILS 29 8 5 5 OPERATING THE SPLIT SIDE RAILS 29 8 6 ELECTRICAL OPERATION 30 8 6 1 HANDSET LOCATION 31 8 6 2 10 AND 9 BUTTON HANDSET OPERATION 32 8 6 3 HANDSET LOCKOUT 33 8 7 ...
Страница 4: ...biuro rehabed com pl phone 48 608 727 090 Each serious incident connected with the device should be reported to Reha Bed Sp z o o and the competent authority of the Member State where the device is used Please provide the product serial number LOT in all correspondence You can find it on the identification labels which are located on the inside of the backrest section frame and the leg section fra...
Страница 5: ...cilities where medical care and health monitoring are required e g nursing homes rehabilitations centres geriatric wards The bed significantly relieves a caregiver thanks to a fully electrically profiled platform that enables to adjust the position to the user s needs The bed is designed for users with a minimum height from 146 to 185 cm when the bed length extension is not fitted BMI greater than...
Страница 6: ...f the bed s selected functions remain unlocked Level of mental development that makes it impossible to safely operate the bed s functions if the bed functions remain unlocked Confusion agitation or unstable emotional state of the patient if side rails are installed and or they are in the highest position Exceeding the maximum patient s weight Inadequate height of the patient below 146 cm or above ...
Страница 7: ...ild s proportions and the dimensions of thebed s frame The bed is not suitable for users with a height less than 146 cm incase of doubt please contact the local distributor importer or manufacturer The bed is not suitable for users weighting less than 40 kg in case of any doubt please contact thelocal distributor importer or manufacturer The bed is not suitable for users with a BMI less than 17 in...
Страница 8: ... device for the means of isolating the bed from the mains supply the plug must be accessible at all times Pulling the plug out of the socket is permissible only for holding the body of the plug adapter not the cord Inappropriate handling positioning of the mains cable could cause kinking or shearing of the cable which may lead to exposed live wires risk of electrocution If you cannot plug the main...
Страница 9: ...he power supply before transporting the bed The transportation should take place in the lowest position of the mattress platform while maintaining the patient in the horizontal lying position Side rails must be installed on both sides of the bed on the side of the wall as well Standard height side rails enable to use mattresses with a maximum height of 150 mm The height extension of the side rails...
Страница 10: ...d to ensure that they do not become squeezed trapped or damaged risk of electric shock and or fire All electrical components that are a part of the bed and or related accessories which are damaged must be immediately withdrawn from service and replaced damaged electrical components may present a risk of electric shock fire If the bed will be used with a hoist make sure that there is enough space u...
Страница 11: ... bed is not intended for patient transport it is not to be moved out of the room it is located in with a patient occupying the bed Risk of patient carer injury If the bed is to be moved within the room with an occupant in the bed a risk assessment in line with local health and safety policy is to be undertaken in order to ensure that neither staff or patients are put at risk when moving the bed th...
Страница 12: ...moisture may damage the electrical system and or have a detrimental effect on parts of the bed s frame Do not use side rails to transport the bed risk of damage Do not transport the bed over threshold risk of damage When using the bed s functions make sure that no furniture or other things such as a bedside table are not an obstacle Make sure that the bed is positioned in an appropriate distance f...
Страница 13: ...se it to perform its assigned functions see section 15 4 Type BF application parts that are electrically isolated from earth and other parts of medical equipment they comply with the specific requirements for protection against electric shock in acceptance with IEC 60601 1 Class II electrical appliance The user is protected by at least two insulation layers against conductive elements e g power ca...
Страница 14: ...erly 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 assembly Certification mark Product meets the requirements of the EC Directive on medical devices 2017 745 MDR Manufacturer data DOM Date of manufacturing LOT Serial number Reference number...
Страница 15: ...t mattress platform 6 Backrest section actuator and control box 7 Leg section frame 8 Leg section actuator 9 Castor 10 Side rail release button 11 Foot end 12 Handset not visible 13 Lifting pole optional not visible During assembly disassembly and regular operation particular attention should be paid to the risk of hand injury The bed cannot be used in case a screw is missing ...
Страница 16: ...the bed will not be obstructed Apply the brakes to the castors 6 1 FITTING ELECTRICAL SYSTEM The bed is designed to be connected to a constant power supply at all times during use An auxiliary emergency power supply is available as an accessory to maintain the bed s basic functions for a specified period of time if mains power is not available see section 10 The bed is delivered with fitted electr...
Страница 17: ...ed and are not under excessive tension and check that cables are not tight especially the main power cable when lifting the bed up and down and or backrest section control cable to avoid possible damages Damaged cables pose a risk of electric shock and or fire Make sure that both actuators high low are plugged into the correct ports If the Trendelenburg or reverse Trendelenburg function does not w...
Страница 18: ...onsider the adequate placement of actuator and or handset cables in order to minimize the risk of accidental suffocation as a result of the entanglement of the user and or other people 6 2 ASSEMBLING THE WOODEN BED ENDS Note If this action is being undertaken the manufacturer recommend that the castors are braked before assembly commences Fit bed end sliding the spigot into the platform end and de...
Страница 19: ...hannels at the head end of the bed Carefully rest the unattached ends on the floor taking care to ensure that the other ends are sufficiently far into the fingers so that they will not fall out Take the previously removed finger assembly place the lift wire over the top finger set as shown in the picture below and insert into the other end of the top side rail Slide the finger assembly inside the ...
Страница 20: ...pful when you need to replace the side rails or their components To fit the Light side rails fix it to the bed according to the below picture setting it evenly on both mounting sleeves Pay attention that the side rails release button is closer to the foot bed end Note the side rails are the same for the right and left sides of the mattress platform and they may be installed interchangeably 6 5 FIT...
Страница 21: ...low is closer to the center of the mattress platform Use the dome screws and fix the side rail to the bed Repeat the above steps for the other side rails If there is any doubt about the assembly contact the provider or manufacturer incorrectly fitted side rails can lead to death Side rails must be installed on both sides of the bed on the side of the wall as well With standard side rails the maxim...
Страница 22: ... the bed clear of obstructions Do the side rails raise lower smoothly and lock automatically in the raised position Has a risk assessment been performed on the suitability of the bed and any ancillary equipment for the user Has the control box cable retaining clip been attached Are plugs of actuators and power cable in the power box secured with the provided cover cap Has the mains cable been secu...
Страница 23: ...ined person as soon as possible preferably before the use of this product It is the responsibility of the end user to ensure they have received sufficient training to use the bed and any associated accessories safely and correctly It is the responsibility of the trained person to ensure that users are able to use this bed and any additional accessories in a safe and proper way If the above mention...
Страница 24: ...rior to each operating the bed ensure the brakes on all the castors have been applied It is forbidden to start and use the product with defects that may pose a risk to users or other persons If children adults with reduced cognitive learning abilities or even pets pose a potential risk of intentional or unintentional manipulating the bed consider its suitability for use during the initial risk ass...
Страница 25: ...8 3 PREPARING FOR START Prior to using the bed for the first time Ensure the bed and all accessories are at room temperature Ensure the bed has been cleaned and disinfected see section 11 Ensure the mains cable is plugged appropriately After plugging the bed into the mains supply it was not attempted to operate at least 10 seconds to allow the control system to initialise itself Ensure the brakes ...
Страница 26: ... be left in the Trendelenburg or reverse Trendelenburg position Only medical mattresses are allowed Using other types of mattresses may cause damage to the bed Ensure the bed is positioned an appropriate distance from walls other furniture to prevent damage or patient injury when operating the bed particularly when operating it in tilt 8 4 BRAKE SYSTEM The LEO bed can be equipped with a castors wi...
Страница 27: ...l lock allows to lock all 4 wheels simultaneously Optionally the central wheel lock can be equipped with a direction lock To apply the brakes for all castors press the one chosen brake pedal down from the bed ends side outer side of the bed To appl the direction lock press the one chosen brake pedal down from the center of the mattress platform inside of the bed To release the brakes for all casto...
Страница 28: ...he potential risk of entrapment and asphyxiation when a bed is occupied Care must be taken when positioning and adjusting bed side rails to ensure that any spaces between the bed side rails mattress or bed frame will not allow entrapment of the occupant s head or body In addition consideration should be given to the size and physiological condition of the occupant and an assessment undertaken to e...
Страница 29: ...de rail until it is heard to latch into position at the top height 8 5 5 OPERATING THE SPLIT SIDE RAILS To lower side rails Pull the side rail s release button Gently move the side rail until the lock disengages Gently lower the side rails the release button can be let depressed when lowering side rails To raise the side rails Lift the side rail until it is heard to latch into position at the top ...
Страница 30: ...t 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 Thanks to the use of the handset it is possible to control the electronic linear system of actuators which are controlled by the central control box Actuators are attached to moving parts of the bed s frame T...
Страница 31: ...burning objects candles cigarettes etc in the bed s area the risk of damage to the electrical system leading to a fire It is forbidden to use actuators in the presence of flammable gases and or in oxygen rich environments due to the risk of explosion fire For safety reasons in a domestic environment it is recommended to use a 9 button handset without the function of tilting head down If the bed is...
Страница 32: ...r lowering down maximum value until the mattress platform is levelled Engage the lockout function if a patient could be injured due to inadvertent motion of the mattress platform If children adults with learning difficulties or even pets pose a potential risk of intentional or unintentional tampering with the bed the lockout function on the handset is to be used at the discretion of the carer The ...
Страница 33: ...function depends on the caregiver s decision To lock unlock the handset turn the handset over put the key in the recess on the back of the handset turn the key fully clockwise to lock or counter clockwise to unlock functions To lock unlock the Trendelenburg function only in the case of 10 button handset turn the handset over put the key in the recess on the back of the handset turn the lock to the...
Страница 34: ...etting the bed so that the leg section angle adjustment operates Press the leg section button on the handset and raise the leg section height not important Lift the foot section manually so that the ratchet disengages if in doubt lift the leg section to the ratchet s maximum extent Gently lower the leg section down The leg section angle adjustment will now be set Note To unlock reset the ratchet u...
Страница 35: ...ly remove all side rails Relocate the finger assemblies into the channel see section 6 3 Re fit the retaining screw into the channel Repeat for the other side of the bed Note Do not disassemble the Light side rails or the split side rails For transport these side rails should be lowered to the lowest position Bed Ends Unfasten the grub and dome screws from both end of the bed Remove both bed ends ...
Страница 36: ...sure that moving parts were secured with cable ties stretch foil etc the risk of uncontrolled movements of individual sections during transport During transport hold only the constant parts of bed construction ...
Страница 37: ... The bed will operate normally while charging There is not audible or visual signal which would indicate that the system is charging or used Make sure that the backup power system is not exposed to direct sunlight or other heat source direct heating of the battery by an external heat source may result in a risk of fire or explosion Do not use the emergency power system during normal use i e when t...
Страница 38: ...er to determine if it is possible to levelled the section with the load in a safe way When the pins are removed there is nothing supporting the section the person holding the frame must be ready to support the section weight It is recommended that 2 persons perform the operation Beware of objects and body parts crushed between the bed headrest and platform frameworks ...
Страница 39: ... to the bed These instructions apply to all accessories with the exception of mattresses General cleaning The bed should be cleaned by starting with the cleanest parts of the bed and systematically moving to the dirtiest parts Extra care should be taken around areas where excess dirt or dust may gather The cloth should be changed during the cleaning process if it becomes soiled Wipe down with a cl...
Страница 40: ...contact of these measures with the skin Always check what neutralizing agent is recommended by the manufacturer Decontamination procedure performed by an unauthorized person pose a threat to the person as well as the environment The bed manufacturer assumes no responsibility for any loss or damage caused by improperly conducted decontamination Pay special attention to the decontaminator does not g...
Страница 41: ...ame is mechanically operational The bed operates as per its intended purpose The bed is cleaned following the guidelines in this Instruction Manual All accessories and additional equipment are fitted in a right way 12 1 GENERAL MAINTENANCE The manufacturer recommends that the beds are serviced once yearly as a minimum Please act accordingly with the following instructions Failure to perform inspec...
Страница 42: ...anically operational Check if the leg section including the knee break functions work correctly Check if all labels and stickers are present and legible Raise and lower the side rails check if they move smoothly Check if aluminum channels at the bed ends operate correctly Check if the lock on the side rails automatically engages when raised Check if the castors lock function works correctly and th...
Страница 43: ...sories are serviced and maintained 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 see section 15 4 ...
Страница 44: ...nd contact the approved service department Work cycle of the control box has been exceeded possible permanent damage If the control box has exceeded its duty cycle permanent damage may have occurred Allow power supply to cool for 20 30 minutes before attempting to re operate If electrical functions still do not work a replacement power supply and or control box will be required Electrical function...
Страница 45: ...t to be disposed of in general municipal waste Some of the electrical components could be harmful to the environment and where viable the components can be recovered and reused recycled The steel plastic and wooden components are also to be separated and disposed of following the local recycling policy as these can also be recovered and recycled The bed is to be decontaminated before disposal to a...
Страница 46: ...tive equipment is found to be operating abnormally turn off the piece of equipment that is believed to be causing the interference if possible to identify the source of the RF energy Once identified mitigation measures are to be taken such as the separation distances being increased and or the device s being re orientated If the bed continues to operate abnormally disconnect it from the mains supp...
Страница 47: ...ry depending on the version of the bed and accessories The bed data identify the maximum angles which can be achieved in normal use by each part of the mattress support platform with reference to horizontal Mattress platform height is defined as the maximum and minimum height from the floor which can be achieved by the mattress support platform in normal use If patient requirements are such that T...
Страница 48: ...esponsible for ensuring the suitability for use Despite the fact that the manufacturer made every effort to ensure that the design of side rails meets the appropriate safety standards side rails may still pose a potential risk of death resulting from entrapment and or suffocation Persons responsiblefor the sale purchase selection for use and adjustment of side rails should be aware of the potentia...
Страница 49: ...rarily disabled or irreparably damaged No more than two drives may be operated at rated load simultaneously Safety standards IEC 60601 1 2005 IEC 60601 2 52 2009 IEC 60601 1 11 2010 Applied part electrical shock protection Type BF Applied parts Mattress platform Profiling sections Bed ends Handset Side rails Liquid ingress protection IPX4 Splash resistant Noise level 67dB A Service life 5 years En...
Страница 50: ... of using the selected accessory with your version of the bed Characteristics of the accessories can be found in the relevant accessory s instructions for use The manufacturer cannot be held responsible for any injury or incident which relates to the use of any product combinations not approved by the manufacturer It is the carer s responsibility for selecting and fitting the products correctly an...
Страница 51: ... and approved with side rails characterized by specific dimensions dedicated to the Leo bed see section 15 3 Dimensions mm width x length x thickness Density kg m3 Foam Mattresses Hyper Foam Plus 800x2000x140 850x2000x140 900x2000x140 1100x2000x140 35 38 Hyper Foam 2 800x2000x150 900x2000x150 1100x2000x150 35 45 50 Hyper Foam Maxx 250 900x2000x140 1100x2000x180 35 50 50 Hyper Air Hybrid 900x2000x1...
Страница 52: ...e the gap introduced by cell compression at the mattress edge and the side rail is to be considered A patient risk assessment must be performed to ensure an asphyxiation risk is not introduced Make sure that the applied mattress is characterized by the correct size and type and that it is positioned in a right way on the bed The mattress should be placed between mattress holders on sides of the ma...
Страница 53: ...ifting pole in the selected lifting pole socket Note Make sure that the positioning pin is placed in the positioning groove Place an adjustable belt with a triangle handle on the lifting pole Make sure that the grip belt is located between positioning pins Installation of the lifting pole in a place that is not intended for this purpose poses a risk of damage to health or an accident In order to e...
Страница 54: ... caused by inadequate use or use inconsistent with the instructions for use e g storage maintenance broken seals mechanical damages 6 The concept of repair does not include actions determined in this instruction manual which should be carried out by the user on his own 7 The warranty is extended for the period during which the product is under repair If a defect as a defect covered by the warranty...
Страница 55: ...hit breaking the railings by leaning or sitting on the product etc e The product was damaged as a result of external factors e g through contamination flooding of actuators or the control box use of the bed in inadequate conditions and if the product was damaged due to the user s fault e g during the use of a damaged product or inappropriate equipment overloading the bed etc f The product was used...
Страница 56: ...INSTRUC LEO EN 2021 04 REV2 ...
