Rehabed Leo Med Instructions For Use Manual Download Page 43 | Manualshive

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Rehabed Leo Med Instructions For Use Manual Download Page 43

43

14.

E

LECTROMAGNETIC COMPATIBILITY

(EMC)

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. Likewise, if the immunity limits of
the electrical system are exceeded the system may be seen to operate abnormally.

Interference can be received from fixed transmitters (e.g. commercial radio and
television towers) and portable / mobile RF communications equipment (e.g. mobile
phones). Due to the increasing number of mobile phones and other wireless devices
the possibilities of interference to the electrical system and other surrounding
equipment results in the need for special precautions to be taken regarding EMC.

If the bed or any alternative 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 supply and
contact your local distributor or importer.

▪

The bed should not be used adjacent to or stacked with other
medical  electrical  equipment,  where  viable.  If  adjacent  or
stacked  use  is  necessary,  the  bed  and  associated  medical
electrical  equipment  should  be  observed  to  verify  normal
operation - If not taken into account abnormal operation could
occur.

▪

The use of accessories and cables other than components
specified or provided by the manufacturer may increase the
electromagnetic emission of the bed and cause malfunction.

▪

Portable RF communications equipment (including peripheral
devices – such as antenna cables and external antennas) should
not be used closer than 30 cm from any part of the bed
(including cables). Otherwise, performance may be
deteriorated.

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Summary of Contents for Leo Med

Page 1: ......

Page 2: ...2 ...

Page 3: ...STORS 25 8 5 SIDE RAILS AND MATTRESSES 25 8 5 1 SIDE RAIL SAFETY 26 8 5 2 MATTRESS THICKNESS 26 8 5 3 OPERATING THE MEDICAL SIDE RAILS 27 8 6 EMERGENCY PULLING OUT OF THE BED END 28 8 7 ELECTRICAL OPERATION 28 8 7 1 HANDSET LOCATION 29 8 7 2 10 AND 9 BUTTON HANDSET OPERATION 30 8 7 3 HANDSET LOCKOUT 31 8 8 LEG SECTION 31 9 DISASSEMBLING THE BED FOR TRANSPORT 33 10 POWER FAILURES 34 10 1 EMERGENCY ...

Page 4: ...iuro 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 fram...

Page 5: ... 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 17 and a maxi...

Page 6: ... if 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 abov...

Page 7: ... 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 case of any doubt please...

Page 8: ... 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 power cable directly into a wall socket only the CE mark...

Page 9: ...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 Side rails may only be used with proper size mattresses intended for the bed o...

Page 10: ...amaged 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 under the bed to lower the bed to the lowest possible posi...

Page 11: ...ut 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 this is dependent on the situation and load on the bed If transporti...

Page 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...

Page 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...

Page 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...

Page 15: ...ctuator 5 Backrest section actuator and control box 6 Leg section actuator 7 Leg section frame 8 Side rail release button 9 Castor 10 Foot end 11 Handset not visible 12 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 ...

Page 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...

Page 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...

Page 18: ...able this situation may expose live conductors risk of electric shock Consider 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 MEDICAL BED END Place the bed end in the mounting sockets by inserting the tubes evenly It is recommended to hold the bed end...

Page 19: ...ould be placed evenly into both mounting bushes Note 1 Make sure that the side rails release button is positioned near the foot end Note 2 The medical side rails are available in the right and left version Ensure that the latches at the bottom of the mounting bushes lock the side rail in place If there is any doubt about the assembly contact the provider or manufacturer incorrectly fitted side rai...

Page 20: ...isk 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 secured to an auxiliary holder under the mattress platform Has the bed if necessary been cleaned and disinfected before use In ...

Page 21: ...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...

Page 22: ...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...

Page 23: ...ses may cause damage to the bed 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 init...

Page 24: ...e 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 MED bed can be equipped with a castors ...

Page 25: ...RAL LOCK OF THE CASTORS The central 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 T...

Page 26: ... of bed side rails should be aware of the 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 occ...

Page 27: ...igned to support the patient Side rails are not designed to be used as a patient s lifting aid When operating the side rails ensure they are free from obstructions to prevent injury or entrapment When leaving the bed do not hold the side rails risk of trapping crushing finger s when the weight of the patient s legs causes side rail s bending and closing the gap between side rails In the absence of...

Page 28: ...e attached to moving parts of the bed s frame This enables to change their position with the use of the handset Pressing the appropriate button activates the selected function and releasing completes the operation and stops all movements The caregiver has the option of blocking the bed s functions if necessary in order to reduce the risk of accidental and or unintentional operation of the bed The ...

Page 29: ... domestic environment it is recommended to use a 9 button handset without the function of tilting head down If the bed is continuously used for an extended period of time and it exceeds the duty cycle the control box and or lift actuators may become temporarily disabled or irreparably damage If this occurs remove the power supply from the wall and allow system to rest for 20 30 minutes before atte...

Page 30: ...out function on the handset is to be used at the discretion of the carer The bed is not fitted with a battery backup facility so it must always be plugged into the mains supply during normal use Consideration is to be taken in the storage of the handset lockout key to minimise the risk of it being swallowed by a baby child or the bed occupant and creating a choking hazard Consideration is to be ta...

Page 31: ... 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 place indicated in the picture on the right Note Functions of the handset should be disabled when the bed is put into service Engage the lockout function if a patient could be injured due to inadvertent motion of the mattress platform 8 8 LEG SECTION Note The operation of the leg s...

Page 32: ...s 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 use handles to lift the thigh section to the maximum position Before a...

Page 33: ...ide rail s pivots out of the mounting bushes Place the side rail on the floor Repeat for the other side of the bed Electrics Flatten and lower the bed and the wholemattress platform to its minimum height Unplug the mains cable from the mains socket With cable ties or similar secure themoving parts of the backrest and leg section to the bed frame With cable ties or similar secure all cabling and en...

Page 34: ... 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...

Page 35: ...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 ...

Page 36: ... 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...

Page 37: ...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...

Page 38: ...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...

Page 39: ...e 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 the lock on the side rails automatically engages when raised Check if the castors lock function works correctly and that when locked castors do not move Check if the bed s frame does not show signs of excessive wear in particular whether ther...

Page 40: ...ructions 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 ...

Page 41: ...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...

Page 42: ...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...

Page 43: ...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...

Page 44: ...d 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 Trendelenburg functionality is deemed ...

Page 45: ...rds 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 potential risk regarding entrapment and or suffocation when the bed is in use When positioning and adjusting the side rails make sure that all spaces between side rails mattress and bed fr...

Page 46: ...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...

Page 47: ... correctly and ensuring that the product combination is compatible In the case of doubts please contact the supplier or the manufacturer It is forbidden to use accessories that have not been approved or are not intended for use with the bed the risk of danger due to incompatibility regarding the combination of products The manufacturer is not responsible for any injuries or incidents connected wit...

Page 48: ... 780x2000x120 850x2000x120 900x2000x120 900x2000x150 35 Foam Mattress 780x2000x120 800x2000x120 850x2000x120 900x2000x100 900x2000x120 900x2000x150 900x2000x200 25 Foam Mattress 900x2000x120 900x2000x150 35 Foam Mattress with HR filling 900x2000x150 35 Mattress extension 780x200x120 900x200x120 900x200x140 900x200x150 25 The values refer to the density of individual layers of mattress Other mattre...

Page 49: ... be placed between mattress holders on sides of the mattress platform sections an incorrect mattress may pose a risk of entrapment and or fall of the patient Make sure that side rails and mattress are correctly selected incorrect selection of products may pose a risk of entrapment Make sure that the control box of the dynamic mattress is not placed on side rails risk of damage by falling when afte...

Page 50: ...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...

Page 51: ... 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...

Page 52: ...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...

Page 53: ...19 REPAIRS AND MAINTENANCE TREATMENTS DATE DESCRIPTION SIGNATURE AND STAMP OF THE SERVICE ...

Page 54: ...20 NOTES ...

Page 55: ......

Page 56: ...INSTRUC LEO MED EN 2021 04 REV2 ...

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