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burmeier Regia, Instruction Manual

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2.6

Safety information for disposal

WARNING

Risk of infection

Failure to heed this warning may result in infections.
Beds, bed components or accessories that have not been disinfected can become health
hazards for people.

•

The operator must ensure that all components of the bed that are to be disposed of are
not infectious or contaminated.

Safety Information

Part B: Operator and Technical Personnel

9

Summary of Contents for Regia

Page 1: ...Regia REF 287900 2021 12 14 Version 03 278569 Instruction Manual Part A General Information Part B Operator and Technical Personnel Part C Care staff and residents ...

Page 2: ...Part A General Information ...

Page 3: ...Regia Standard care bed Regia care bed DSG optional ...

Page 4: ...ver for operating castor brakes foot end both sides 8 Easy Click full length safety side DSG bars 4x 9 Full length safety side release but ton 4x 10 Side panel one piece only possi ble in conjunction with full length safety sides DSG 2x 11 Easy Switch split safety side TSG both sides telescopic 12 Release buttons for lower bar 13 Release buttons for upper bar Regia care bed with telescopic safety ...

Page 5: ...3 Icon information 4 Product Description 5 Use for the intended purpose 5 Contraindications 6 Components of the Bed 7 Mattress base frame 7 Safety side optional 7 Electrical adjustment system 7 Optional equipment 8 Mattress Base Sizes 9 Technical Data 9 Type plate 9 PID Number 11 Materials used 11 Dimensions and weights 12 Adjustment ranges 12 Ambient conditions 12 Classification 13 Electrical dat...

Page 6: ...II ...

Page 7: ...Stiegelmeyer Group company Industriestraße 53 32120 Hiddenhausen Germany Tel 49 0 5223 9769 0 Fax 49 0 5223 9769 090 Email info burmeier com Internet www burmeier com Market Information Customers outside Germany can contact our distribution companies in their particular coun try if they have any questions Contact details can be found on our website This product is not licenced for use on the North...

Page 8: ...m use Please therefore read and observe these instructions carefully They will help you to put the bed into service for the first time and to use it on a daily basis This instruction manual contains all the information you will need to control and handle this bed safely and easily for you as the operator and your specialist staff and carers It is a practical reference book and should be kept close...

Page 9: ...ty symbols used In this instruction manual safety information is displayed in the following way WARNING WARNING indicates a potentially hazardous situation that if not avoided could result in death or serious injury CAUTION CAUTION indicates a potentially hazardous situation that if not avoided could result in minor or moderate injury ATTENTION ATTENTION indicates a harmful situation that could re...

Page 10: ...read the safety information and follow the instructions exactly General information and cross references will be displayed in the following way Cross reference or active link Indicates the chapter of the instruction manual and the page number where you can find specific information Example Part A Safety information 3 Conventions of this Instruction Manual 4 Part A General Information ...

Page 11: ... a doctor and be used for diagnosis treatment or observation of the resident It is therefore equipped with a lock ing function of the electrical adjustment devices This bed has no special connectors for potential equalisation Please pay attention to this before connecting additional mains operated medical electrical equipment If necessary further advice on additional protective measures can be fou...

Page 12: ...he bed may be moved within the room even when the resident is lying in bed Adjust the mattress base to a flat home position at its lowest level This bed may only be used under the operating conditions described in this instruction manual Its use for any other type of application is deemed to be contrary to the inten ded purpose This bed must not be modified without authorisation by the manufacture...

Page 13: ... middle section a thigh rest and a lower leg rest All rests are adjustable The mattress base height can be adjusted horizontal ly A handset controls all electrical adjustments The entire mattress base and all parts of the bed that can be reached by a resident who is lying in the bed count as application parts At the customer s request the bed can be equipped with safety sides to protect the reside...

Page 14: ...hese ele ments are designed to mould themselves closely to the shape of the body and help to ventilate the mattress Their flexibility also ensures that the pressure is optimally distrib uted The comfort mattress base also significantly contributes to preventing pressure ulcers Bed extension adaptable extends the bed by approximately 20 cm If full length or combined safety sides are used longer saf...

Page 15: ...ard 101 x 211 cm 100 x 200 cm optional 111 x 211 cm 90 x 220 cm optional 101 x 231 cm 100 x 220 cm optional 111 x 231 cm You can find the type plate on the bed frame at the head end The type plate contains the following information Type plate example Type plate electrical data example Explanation of the graphical symbols used Model Bed model Material Material variant Version Variant if applicable ...

Page 16: ...roof Only for use in enclosed spaces do not use outdoors Dispose of electrical components in accordance with the WEEE Di rective Do not dispose of as household waste Attention Follow the operating instructions Total bed weight 130 kg maximum Protection of electrical equipment from water splashing from any di rection Conformity mark according to Medical Devices REGULATION EU 2017 745 MDR Safe worki...

Page 17: ... PID number ready any time you contact your specialist dealer You can find the PID no on the bed frame at the head end Part A Image1 PID number example For the most part the bed was manufactured from steel profiles whose surfaces were finish ed with a polyester powder coating or a metal coating of zinc or chromium The head and footboards safety side bars and sprung slats are made of wood or wood p...

Page 18: ...130 kg Safe working load 225 kg Disassembled bed Headboard and footboard 14 kg Chassis with motor 65 5 kg Mattress base frame without motors approx 38 kg Telescopic safety side TSG 6 kg each Patient lifting pole 5 kg Side panel 4 2 kg Electrical height adjustment range for mattress base approx 25 80 cm Electrical backrest adjustment from 0 to approx 66 Electrical thigh rest adjustment from 0 to ap...

Page 19: ...fulfils all the requirements of the Medical Device Regulation EU 2017 745 MDR This bed is classified as a Class I active medical product with type BF application parts EMDN Code V08060101 HOSPITAL HOME CARE ELECTRIC MEDICAL BEDS For use in the following application environments in accordance with IEC 60601 2 52 3 Long term care in a medical facility in which medical supervision is required and mon...

Page 20: ...urrent input DC 8 A Internal device fuse 2 fold electronic automatic resetting overload protection Duty cycle Intermittent duty 2 min ON 18 min OFF Protection category IP X4 Classification Protection Class II Type B MDR classification Class I not for use in explosive atmospheres External switch mode power supply Type Linak SMPS 20 Input voltage AC 230 V 10 50 60 Hz Max current input AC 2 5 A Outpu...

Page 21: ...nal device fuse 10A safety fuse Protection category IP X6 Charger for external battery Possible with all aforementioned LINAK control units Handset with locking function Type Linak HL 7xx OpenBus Protection category IP X4 Additional handset for Trendelenburg reverse Trendelenburg position optional Type Linak HL 7xx OpenBus Protection category IP X4 Motors for mattress base height Type Linak LA 27 ...

Page 22: ...ty 2 min ON 18 min OFF Protection category IP X4 Thigh rest motor Type Linak LA 27 Force installation dimension lift 4000 N 272 mm 70 mm Input voltage Max DC 34 V Duty cycle Intermittent duty 2 min ON 18 min OFF Protection category IP X4 All plugs are connected to the control unit To prevent the plugs from being inadvertently dis connected they are secured with a plug cover Before replacing a plug...

Page 23: ...tre of bed low down F Foot end low down The letters in the following tables refer to the previous picture Location of the electrical components This indicates where the component is located in the bed A C B D E F Part A Image2 Location of the electrical components Product Description Part A General Information 17 ...

Page 24: ...r at head end E 3 Thigh rest motor B 4 Height adjustment motor at foot end E 5 Conventional handset B 6 Control unit A Components with an asterisk must be inserted into the correct connection socket only 04 06 05 01 02 03 Product Description 18 Part A General Information ...

Page 25: ...box MJB5 A 8 Under bed light B 9 Rechargeable battery A 10 Trendelenburg handset B 11 Reading lamp A 12 Distributor box MJB8 A 06 05 09 10 08 07 06 05 09 10 08 11 12 Product Description Part A General Information 19 ...

Page 26: ...es should be avoided as this could result in in correct operation If such use is nevertheless necessary this device and the other devices should be monitored to ensure that they are working properly Portable RF communication devices radio mobile phones etc including their accesso ries such as antenna cables and external antennas should not be used at a distance of less than 30 cm from the electric...

Page 27: ...the end of this chapter AC port for supply input Phenomenon EMC basic standard Immunity level test compli ance Home healthcare environment Electrical fast transient distur bances bursts IEC 61000 4 4 2 kV 100 kHz repetition frequen cy Electrical surges conductor to conductor IEC 61000 4 5 0 5 kV 1kV Conducted interference induced by high frequency fields IEC 61000 4 6 3 V 0 15 MHz to 80 MHz 6V in ...

Page 28: ...80MHz 80 AM at 1 kHz Table zz Test specifications for the immunity of sheathings to high frequency wire less communication equipment Test fre quency MHz Frequen cy band Radio serv ice Modulation Max power W Distance m Immunity test level v m 385 380 to 390 TETRA 400 Pulse modu lation 18 Hz 1 8 0 3 27 450 430 to 470 GMRS 460 FRS460 FM 5 deviation 1kHz sine wave 2 0 3 28 710 704 to 787 LTE band 13 1...

Page 29: ... Radio serv ice Modulation Max power W Distance m Immunity test level v m 1845 GSM 1900 DECT LTE band 1 3 4 25 UMTS 1970 2450 2400 to 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE band 7 Pulse modu lation 217 Hz 2 0 3 28 5240 5100 to 5800 WLAN 802 11 a n Pulse modu lation 217 Hz 2 0 3 9 5500 5785 Product Description Part A General Information 23 ...

Page 30: ...Part B Operator and Technical Per sonnel ...

Page 31: ...Regia Standard care bed Regia care bed DSG optional ...

Page 32: ...ver for operating castor brakes foot end both sides 8 Easy Click full length safety side DSG bars 4x 9 Full length safety side release but ton 4x 10 Side panel one piece only possi ble in conjunction with full length safety sides DSG 2x 11 Easy Switch split safety side TSG both sides telescopic 12 Release buttons for lower bar 13 Release buttons for upper bar Regia care bed with telescopic safety ...

Page 33: ...Operating the Bed 3 Electrical cables and connections 4 Operating time of electric drives 5 Handset 5 Bed adjustment 6 Special Hazards 7 Risk of fire 7 Safety Information for Attachments and Additional Equipment 8 Use of Resident Lifts 8 Safety information for accessories 8 Safety information for disposal 9 Assembling the Care Bed 10 Included in the package 10 Location requirements 11 Chassis and ...

Page 34: ...aning and Disinfection 42 Safety information on cleaning and disinfection 42 Cleaning and Disinfection Plan 43 Instruction of Care Staff and Technical Personnel 43 Cleaning agents and disinfectants 44 Handling Cleaning and Disinfection Agents 46 Maintenance 47 Legal principles 47 Inspections and Function Checks 48 Operating Current Test Procedure 49 Inspection report 50 Replacement parts 55 Replac...

Page 35: ... rectification 63 Decommissioning 64 Dismantling the Care Bed 65 Disposal 66 Disposal of the Bed 66 Disposal of Packaging 66 Disposal of Electrical Components 66 Appendix 67 Accessories 67 Mattress requirements 67 Safety Side Requirements 68 Translation of EC Declaration of Conformity 68 III ...

Page 36: ...IV ...

Page 37: ...ational regulations must be complied with Using this instruction manual which is provided with this care bed ensure that care staff is instructed in the safe operation of this bed before using it for the first time Draw every user s attention to the possible hazards that can arise if the bed is improp erly used This applies in particular to the use of electrical drives and safety sides Make sure t...

Page 38: ...eir training or briefing are qualified to deliver the care bed assemble or dismantle it and to transport the bed Furthermore this personnel is briefed in the cleaning and disinfection instructions Target Groups Qualifications and Duties 2 Part B Operator and Technical Personnel ...

Page 39: ...al device in accordance with the classification rules The safety of this care bed has been tested by an independent testing institute Any item of technical electrical equipment can prove hazardous if not used properly Please observe your obligations as the operator in accordance with the Medical Devices Op erator Ordinance Medizinprodukte Betreiberverordnung German abbreviation MPBe treibV to ensu...

Page 40: ... the floor At weekly intervals when the bed is being used carry out a visual inspection of the mains cable to check for damage scuffing exposed wires kinks pressure points etc A check should also be performed whenever the cable has been subjected to any mechanical load e g has been driven over by the bed itself or by an equipment trolley or whenever the cable has been bent stretched or violently p...

Page 41: ...the cable cannot be damaged by moving parts of the care bed Risk of injury Failure to heed this warning may result in physical injury due to unintentional incorrect oper ation Lock the operating functions for the resident on the handset if The resident is unable to operate the bed safely or to free himself herself from potentially dangerous situations the resident is exposed to an increased risk o...

Page 42: ...stment Do not leave children unsupervised in the room with the bed Adjustments may then be made only by or in the presence of a person who has received appropriate instruction Material damage Failure to heed this warning may result in the care bed being damaged which could have an adverse effect on the loading capacity of the care bed or the adjusting functions Ensure that No obstacles such as bed...

Page 43: ...ith DIN EN 597 1 and 2 Only use additional devices e g electric blankets and other electrical devices e g lamps radios that are in perfect working order and ensure that their connection cables cannot be damaged by moving parts of the bed Ensure that this equipment is used only for the purpose intended Ensure that this equipment is not inadvertently placed on or under the bedding danger of overheat...

Page 44: ...heeling the resident lift un der the care bed Material damage Failure to heed this warning may result in incorrect use or use of unsuitable accessories When using external electrical components such as resident lifts reading lamps or com pressors for positioning systems ensure that their power cables will not become entan gled or damaged by moving parts of the bed Efficient and safe operation comb...

Page 45: ...ult in infections Beds bed components or accessories that have not been disinfected can become health hazards for people The operator must ensure that all components of the bed that are to be disposed of are not infectious or contaminated Safety Information Part B Operator and Technical Personnel 9 ...

Page 46: ...le device The bed is delivered unassembled Two people are required to assemble the bed The bed is supplied in the following packaging units Package Contents Box 1 Chassis with height adjustment motor handset switch mode power supply Box 2 Mattress base Box 3 Headboard and footboard Box 4 and 5 Side panels and or safety side split or full length Remove all packaging materials and cable ties before ...

Page 47: ...operly installed 230 volt mains socket must be available as close as possible to the bed If any other additional equipment is attached to the bed e g compressors for position ing systems etc ensure that this is securely fastened and functions properly Pay par ticular attention here to the safe routing of all loose connector cables tubing etc If you have any questions or concerns consult the manufa...

Page 48: ...emove the locking pin on the housing Cut through the cable tie on the drive tube Note Pay attention to the cable routing Place the motors with their locking pins on the floor 3 Connect the switch mode power supply see Part A Electrical connection dia gram 16 4 Move the chassis to the highest position Assembling the Care Bed 12 Part B Operator and Technical Personnel ...

Page 49: ...to the signs indicating the head and foot end 6 Insert the location pins 1 into the holes on both sides 7 Connect the mattress base and the chassis 2 with the handwheel bolts 2 x 2 bolts Assembling the Care Bed Part B Operator and Technical Personnel 13 ...

Page 50: ... pin 3 on the housing side Note Observe the following installation position The housing assembly must be loca ted over the lift motor 10 Guide the lifting bar for the backrest motor into the take up 11 Secure the lifting bar with the locking pin 4 Assembling the Care Bed 14 Part B Operator and Technical Personnel ...

Page 51: ...ng pin 6 As an optional feature the headboard and footboard can be quickly fitted removed without tools to provide easier access to the resident The headboard and footboard are fitted removed by operating a locking lever that is attached to the cross tubing Risk of injury Failing to heed this warning may result in physical injuries due to entrapment or falling caused by incorrect assembly storage ...

Page 52: ...suffer severe knocks during disassembly or storage Never use Easy Switch systems that are damaged 1 Standing behind the headboard foot board firmly grip the uppermost cor ners of the headboard footboard with both hands 2 Insert the locking hooks 1 of the adapters as far as they will go into the slits of the cross tube 2 and make sure the headboard footboard is fitted securely Assembling the Care B...

Page 53: ...ing levers 3 left and right side upwards and press until they audibly click into place 4 Check that the headboard footboard is firmly in place by pulling the top edge of the board to and fro Assembling the Care Bed Part B Operator and Technical Personnel 17 ...

Page 54: ...be as evenly as possible The bed can optionally be fitted with side panels A total of four side panels are needed 2 x long 110 cm and 2 x short 90 cm 1x short and 1x long side panel are mounted on each side of the bed When fitting a bed extension at a later date the short side panels must be replaced with longer ones Risk of injury Failure to heed this warning may result in entrapment or falls due...

Page 55: ...long tube 1 First swivel the locking levers left and right for the side panel 1 downwards To do so pull the orange safety lock 2 outwards with your finger and hold it in this position while swivelling the locking lever downwards 2 Attach the side panel for the head end to the long tube head end as shown 3 Insert the locking hooks for the adapters 1 into the slits in the long tube as far as they wi...

Page 56: ...in place by jiggling the top edge of the panel to and fro 6 Repeat steps 1 to 5 with the remaining three side panel sections Loosen the locking levers to release the side panels 1 Use a finger to pull the orange safety lock of the locking lever 1 outwards and keep holding it in this position Assembling the Care Bed 20 Part B Operator and Technical Personnel ...

Page 57: ...t side downwards 3 Grasp the lower edge of the side panel with both hands 4 Pull the side panel as smoothly as possible straight up and then outwards out of the slits in the tube Assembling the Care Bed Part B Operator and Technical Personnel 21 ...

Page 58: ... panels are fixed to the longitudinal tube of the mattress base using screws 1 Adjust the bed to its highest position to make the assembly process easier 2 Raise the thigh rest and the backrest 3 Position the side panel as shown along the longitudinal tube of the mattress base 1 4 Fasten the side panel to the inner side of the mattress base 2 with the through bolts and the washers 4x 5 Repeat step...

Page 59: ...resident from falling out of bed The safety sides can be raised from the lowered position beside the mattress base to protect the resident Should it later be necessary to use a safety side the bed can easily be fitted with this at a later date There are two versions of safety side to choose from Split safety side TSG Full length safety sides DSG Type of safety side Type of mat tress base Height of...

Page 60: ...The safety side bars can be attached to the holding devices quickly and with little effort thanks to the simple click on system Risk of injury Failure to heed this warning may result in injury and damage to property due to improperly assembled falling safety side bars After installing each safety side bar check that it is correctly locked into the holding devi ces Test the function to check that t...

Page 61: ...er holding fixture at the foot end The bar must firmly click into place with the aid of the release button 2 Make sure that the bar is properly engaged by moving it up and down by hand 4 Repeat the last few steps to attach the second third and fourth bars Assembling the Care Bed Part B Operator and Technical Personnel 25 ...

Page 62: ...ition the safety side bars diagonally as shown 2 Press the release button 2 on the holding device down with your index finger and re move one end of the bar Assembling the Care Bed 26 Part B Operator and Technical Personnel ...

Page 63: ...rs This care bed can also be fitted with optional Easy Switch split safety sides Risk of injury Failure to heed these warnings may result in injuries due to entrapment or falls as well as material damage Please carefully follow the assembly steps described below Assembling the Care Bed Part B Operator and Technical Personnel 27 ...

Page 64: ...long sides of the bed to attach them The safety sides are available in two sizes 2x long 110 cm and 2x short 90 cm One long and one short safety side is fitted to each side of the bed Start with the long safety side at the head end on the left hand side 1 First swivel the locking levers left and right of the safety sides 2 downwards To do so pull the orange safety lock 1 out wards with your finger...

Page 65: ...ng levers left and right hand side upwards and press them until they audibly click into place 5 Check that the safety side is firmly attach ed by holding it at the lower edge with both hands and trying to move it up and down 6 Repeat steps 1 to 3 with the remaining three sections of the split safety side Assembling the Care Bed Part B Operator and Technical Personnel 29 ...

Page 66: ...is only permitted as a mobilisation aid to facilitate the entry and exit of residents who do not require increased protection in the form of safety sides to prevent them from accidentally falling out of bed Figures B C and D More extensive standard compliant protection against accidentally falling out of bed can only be achieved with these variants 1 Split safety side 90 cm wide 2 Side panel 110 c...

Page 67: ...des to one side of the bed Doing so creates a gap between the two safety sides which leads to a risk of entrapment of limbs Only attach the permitted sizes of split safety sides per bed side more on this on the next page Observe the following table when installing split safety sides Assembly on beds without a bed extension Assembly on beds with a bed extension approx 20 cm Per bed side 1x size 110...

Page 68: ...With a bed extension The following is permitted A 2x size 110 cm split safety sides B Bed extension approx 20 cm Without bed extension Assembling the Care Bed 32 Part B Operator and Technical Personnel ...

Page 69: ...se to accommodate split safety sides or side panels Two slits are left open when the large safety side side panel is mounted at the head end and the small one at the foot end and vice versa For hygienic reasons these must be closed with a cover clip 1 The cover clips are placed over one of the slits before the bed leaves the factory Assembling the Care Bed Part B Operator and Technical Personnel 3...

Page 70: ...move or replace the cover cap grasp it from below push it down and remove it from the slit Fitting the cover clip Proceed in reverse order to the removal proc ess Assembling the Care Bed 34 Part B Operator and Technical Personnel ...

Page 71: ...ever outwards and keep holding it in this position 2 Tilt the locking levers on the left and right hand side downwards 3 Hold the safety side by grasping the housing sections at either side with both hands as shown Assembling the Care Bed Part B Operator and Technical Personnel 35 ...

Page 72: ...d must be immobilised with the brake The side panel at the foot end must be removed and replaced with a longer one see Part B Side panels 18 The split safety sides TSG at the foot end if fitted must be dismantled and replaced with longer ones see Part B Split safety sides 27 The bars of the full length safety sides DSG 8 if fitted must be dismantled and re placed with longer ones see Part B Full l...

Page 73: ...d press them in until they audibly click into place 6 Install the footboard see Part B Headboard and footboard 15 7 Install the longer side panel and or longer safety side see Part B Side panels 18 and or Part B Full length safety sides DSG 24 Part B Split safety sides 27 Proceed in reverse order to the installation process with the only difference Pull the orange safety lock C outwards with your ...

Page 74: ...100 cm wide mattress base Included in the package 1 Wings of the black elements face out wards 1 2 Turn the mounting clips 2 180 until they are 144 mm in length 3 3 Fit the mounting clips onto the struts of the mattress base 4 and 5 white ele ments in the middle and black elements outside Assembling the Care Bed 38 Part B Operator and Technical Personnel ...

Page 75: ...r the switch mode power supply must NOT be under the bed Otherwise the moving mattress base frame may rip the switch mode power sup ply out of the mains socket during horizontal adjustments Before moving the bed always hang the switch mode power supply on the head end chassis using the cable holder The cable holder is attached to the mains cable Before moving the bed remember the length of the ele...

Page 76: ...into a mains socket The cable outlet must hang downwards see picture 2 Insert the plug of the low voltage cable into the connection socket found underneath the head end of the mattress base Assembling the Care Bed 40 Part B Operator and Technical Personnel ...

Page 77: ... and Disinfection 42 The bed is ready for operation if all the steps described in the chapter Part B Assem bling the Care Bed 10 have been read and carried out successfully Before putting the bed into service each time the user must check that The bed has been cleaned and disinfected The castors are braked The power supply is compatible with the bed AC 230 V 50 60 Hz 15 10 The switch mode power su...

Page 78: ... by wiping Material damage Failure to heed this warning may result in severe damage to the bed and its electrical equip ment and lead to subsequent faults This bed is not suitable for machine washing or for cleaning in a decontamination unit The bed is only suitable for manual cleaning and disinfection Unplug the power plug and store it so that it does not come into excessive contact with water or...

Page 79: ...ntally friendly cleaning agent This also applies for the handset If the bed has been visibly contaminated with infectious or potentially infectious materi als the bed should be subsequently disinfected by wiping with one of the disinfection media approved by the DGHM Deutsche Gesellschaft für Hygiene und Mikrobiologie German Society for Hygiene and Microbiology which is suitable for the correspond...

Page 80: ...completed technical staff must disinfect their hands before carrying out other tasks Staff should be equipped with a suitable pump dispenser containing a disinfectant for hands The immediate cleaning of the bed on site has the advantage that no dirty beds or bed components are transported together with clean beds The transfer of potentially infectious germs that may be on the used bed frame is pre...

Page 81: ...table repair substance to prevent moisture from penetrating For further information consult BURMEIER or a specialist dealer of your choice Disinfectants based on compounds that could potentially release chlorine may be corro sive for metals synthetics rubbers and other materials over longer contact periods or when concentrations are too high Use these agents sparingly and only if expressly re quir...

Page 82: ...mucous membrane irritants Wear gloves in order to avoid direct skin contact Do not keep ready prepared surface disinfection solutions in open containers with float ing cleaning cloths Be sure to cover all containers Use sealable bottles with pump dispensers for moistening the cleaning cloths Ventilate the room after the disinfection has been completed Disinfect by wiping do not disinfect by sprayi...

Page 83: ...of a patient user or another person c a seri ous risk for public health source MDR Article 2 65 Operators of medical beds in Europe are obliged in accordance with the new Medical Device Regulation EU 2017 745 MDR and existing relevant national laws regulations e g in Ger many currently the German Medical Devices Operator Ordinance 4 Maintenance Berufsgenossenschafts Vorschrift DGUV regulation 3 Di...

Page 84: ...o instruct care staff about the maintenance work that they must perform Maintenance work that must be carried out by care staff is described in the chapter Part C Maintenance 35 The operator of this care bed is obliged according to MPBetreibV Medical Devices Operator Ordinance Section 4 to conduct regular inspections after each renewed assembly after each maintenance and during regular operation t...

Page 85: ...e bed is ready for operation immedi ately after the switch mode power supply has been replaced with an intact switch mode power supply Burmeier offers leakage current testing of switch mode power supply units as a service To take advantage of this the power supply units must be sent to Burmeier You will receive tested switch mode power supply units in return Contact us for further details about th...

Page 86: ... inspection report template for inspecting electro medical equipment in ac cordance with DIN EN 62353 latest issue Inspection report Customer Medical facility Practice Address Carried out Repeat inspection Inspection prior to initial operation reference value Inspection following repairs maintenance Equipment type Hospital bed x Care bed Protection class I x II Bed type Regia Inventory number Loca...

Page 87: ...t housing and keypad film Motor and handset cables Damage routing of cable Cable harness switch mode power supply sockets Available correct po sition Visual inspection of the mechanical components Stickers and type plates Present legible Patient lifting pole adapter sleeves Damage deformation Bed frame Damage deformation Sprung slats Damage splinters Castors Damage Mattress base Damage deformation...

Page 88: ...he test socket of the measuring instrument 2 Connect the probe at the common measuring point of all applied parts bare screw of the backrest swivel joint underneath the backrest on the mattress base frame 3 Start the measuring procedure on the measuring instrument measuring voltage 500 V DC Limit val ue Measured value Result Bed prot class II type BF 70 MΩ MΩ Leakage current direct or differential...

Page 89: ...unction lock ing function Perform the test acc to Part C Handset 8 Motors Abnormal noise develop ment rattling uneven run ning Strain Relief of mains cable if mains cable available Mains cable firmly fas tened Functional check of the mechanical components Joints and pivots Smooth operation Grab handle with strap Securely fixed when load tested under approx 75 kg load hang from it brief ly with two...

Page 90: ...ce must be taken out of circulation until the defects have been rectified Device does not conform to requirements modification replacement of components decommis sioning recommended All values within permissible range yes no Next inspection date If inspection was not passed Defective do not use bed Repair Defective do not use bed Take out of service Bed does not meet the safety standards Test appr...

Page 91: ...For more information please refer to the chapter Part A Type plate 9 and to the chapter Part A PID Number 11 In order to maintain operational reliability and the right to claim under warranty only original Burmeier replacement parts may be used To order replacement parts or make customer service requests or other queries please contact Burmeier GmbH Co KG A Stiegelmeyer Group company Industriestra...

Page 92: ...ised electricians in compliance with all the relevant VDE and safety regulations On no account should the user attempt to rectify malfunctions in the electrical system Crushing hazard due to falling mattress base parts Failure to heed this warning may result in physical injury due to crushing The bed must be in the home position with the mattress base horizontal in order to re move the motors Othe...

Page 93: ...d must not be opened In the event of a malfunction the corresponding components should always be replaced in full When replacing individual components make sure that the plugs have undamaged O rings for sealing and are inserted into the control unit as far as they will go This is the only way to ensure proper sealing and faultless operation Ensure the polarity is correct when inserting plugs and d...

Page 94: ...not damaged It seals the plug into the control unit 4 When routing the handset cable ensure that it cannot be damaged by any moving parts of the bed 5 Put the plug cover back in place This prevents all the plugs from being pulled out of the control unit For additional features with under bed light or handset extension For additional features with under bed light or handset extension the handset ma...

Page 95: ...n cable connection on the motor 4 Fit the new motor in the same way 5 To prevent the motor bolts from working loose and causing potentially hazardous sud den changes in the position of the bed always ensure that you fit new safety caps Starlock available from Stiegelmeyer s service department and do not refit the old safety caps that you removed 6 Applies only for height adjustment motors Perform ...

Page 96: ...t and undamaged These seal the plugs into the control unit 7 When routing the handset cable ensure that it cannot be damaged by any moving parts of the bed 8 Put the plug cover back in place This prevents all the plugs from being pulled out of the control unit 9 Perform a new initialisation of the control unit see Part B Initialising the control unit 60 10 Check the motorised bed adjustment functi...

Page 97: ...with the Height UP button to the highest horizontal position until both motors switch off automati cally at the highest position and keep the button pressed for a fur ther 2 seconds When the button is released the intermittent sound signal stops End of initialisation If no adjustments are possible and intermittent sound signals sound instead this means that the control unit has detected a fault an...

Page 98: ...le or a fault in the position detection in the end position switch An internal fault in the control unit If the module emits intermittent sound signals when making motorised adjustments and or no adjustments are possible or adjustments are only possible on one side Effect Deletes any existing saved errors RESET The last error is retained and can still be read out displayed Proceed as follows Press...

Page 99: ... to the Part C Troubleshooting 31 In all other cases the operator and or the technical personnel for maintenance and repairs are re sponsible for rectifying malfunctions and faulty components Please ask care staff to initially try to solve faults and problems with the aid of the trou bleshooting table before contacting the operator or technical personnel Part B Operator and Technical Personnel 63 ...

Page 100: ...e to a flat home position at its lowest level Lock the electric adjustment functions to prevent them from being activated accidental ly or by unauthorised persons If the optional rechargeable battery is fitted Charge the integrated rechargeable battery by connecting the bed to the mains electricity supply for about 8 hours and then un plug the switch mode power supply from the socket and hang it o...

Page 101: ... bolts for the thigh rest motor and place the thigh rest motor on the floor Undo the connection screws on the mattress base at the head and foot end Take the mattress base off Reinsert the plug of the switch mode power supply into the mains socket Move the chassis to the lowest position Disconnect the switch mode power supply plug from the mains socket Insert the backrest motor and thigh rest moto...

Page 102: ...ive 2008 98 EC This bed since it is electrically adjustable is classified as type b2b industrial electrical equipment in accordance with the WEEE Directive 2012 19 EC implemented in Germany in the law governing electrical equipment The electrical components used are free from prohibited hazardous substances in compli ance with the RoHS II Directive 2011 65 EU Replaced electrical components drives ...

Page 103: ...t when the back or leg rest is adjusted If this cannot be guaranteed care staff must safely prevent the resident from adjusting the back and leg rests Lock the handset adjustment options in such cases Up to date lists of accessories can be obtained from Burmeier and their sales partners Please quote the bed model Here are some examples of accessories Mattresses various dimensions see Part B Mattre...

Page 104: ...de and footboard 318 mm Permissible accessory safety sides Type model Split safety side TSG Full length safety sides DSG Item no right hand side Item no left hand side We Burmeier GmbH Co KG in our sole responsibility as the manufacturer hereby de clare that this product complies with the provisions of REGULATION EU 2017 745 OF THE EUROPEAN PARLIAMENT AND THE COUNCIL of 5 April 2017 MDR The full l...

Page 105: ...Appendix Part B Operator and Technical Personnel 69 ...

Page 106: ...Part C Care staff and residents ...

Page 107: ...Regia Standard care bed Regia care bed DSG optional ...

Page 108: ...ver for operating castor brakes foot end both sides 8 Easy Click full length safety side DSG bars 4x 9 Full length safety side release but ton 4x 10 Side panel one piece only possi ble in conjunction with full length safety sides DSG 2x 11 Easy Switch split safety side TSG both sides telescopic 12 Release buttons for lower bar 13 Release buttons for upper bar Regia care bed with telescopic safety ...

Page 109: ...t 4 Bed adjustment 5 Safety Information for Attachments and Additional Equipment 6 Use of Resident Lifts 6 Safety information for accessories 7 Safety information for users and residents 7 Operation 8 Handset 8 Operation 8 Special functions 10 Saving a new intermediate stop position 11 Resetting the intermediate stop position to the factory default setting 11 Trendelenburg handset optional equipme...

Page 110: ...e Grab Handle 20 Safety sides 20 Split safety side TSG optional equipment 22 Full length safety sides DSG 25 Lower leg rest 27 Raising by Hand 27 Lowering by hand 28 Lowering using the handset 28 Raising using the handset 28 Emergency release of the backrest 29 Troubleshooting 31 Maintenance 35 Cleaning and Disinfection 38 Cleaning Private Use 38 Cleaning agents and disinfectants 38 II ...

Page 111: ...working order and must observe the instruc tions in the instruction manual particularly the safety information during operation and maintenance in accordance with 2 of the Medical Devices Operator Ordinance MPBetreibV Only by doing so can operating errors be prevented and correct handling ensured in order to prevent injuries and damage from occurring In other countries the relevant national regula...

Page 112: ...he bed is OUT OF ORDER Report this immediately to the operator responsible A checklist for assessing the proper condition of the bed is given in the chapter Part C Maintenance 35 In this instruction manual the term resident is defined as a person who is infirm or in need of care and occupies this care bed It is a requirement that the operator or care staff instructs each new resident in the bed fu...

Page 113: ...re moving the bed always make sure that you have unplugged it from the mains socket Hang the mains cable in the mains cable holder provided on the headboard to ensure that it will not fall off or trail on the floor At weekly intervals when the bed is being used carry out a visual inspection of the mains cable to check for damage scuffing exposed wires kinks pressure points etc A check should also ...

Page 114: ...the mains cable could be damaged When the handset is not in use position it on the bed using its elastic hook so that it cannot fall off accidentally or be otherwise damaged When routing the handset cable ensure that it cannot be damaged by any moving parts of the bed Hang the handset up with the keypad facing inwards towards the bed in order to pre vent adjustments from being made accidentally Ma...

Page 115: ... in the room with the care bed Risk of injury Failure to heed this warning may result in physical injury due to entrapment or crushing When making any adjustments always ensure that no limbs belonging to the resident care staff or other persons especially playing children could become trapped underneath the mattress sections or the mattress base during the adjustment This bed is only intended for ...

Page 116: ...or the resident when the bed sections are adjusted If this cannot be ensured you must lock those particular adjustment controls Use the locking functions on the handset for this purpose Material damage Failure to heed this warning may result in incorrect use or use of unsuitable accessories When using external electrical components such as resident lifts reading lamps or com pressors for positioni...

Page 117: ...rotection of residents can only be guaranteed if original Burmeier accessories designed for the relevant model of bed are used Ensure that the operator your medical supply store instructs you in the safe operation of this bed Ask a healthcare professional for advice if you are uncertain about a possible application of safety sides or about the necessity of activating the locking functions of the e...

Page 118: ...ing functions Adjustments can be locked on the handset in order to protect residents whose clinical condition is deemed by the doctor treating them to necessitate this The handset can be hung at any position on the bed with its elastic hook The spiral cable allows maximum freedom of movement The handset is water protected and can be wiped clean with a damp cloth Explain the handset functions to th...

Page 119: ...t the same time Lower The thigh rest follows the backrest after a five second delay This prevents the resident from sliding towards the foot end of the bed Backrest The backrest can be raised to approx 66 Please also refer to the chapter Part C Emergency release of the backrest 29 Thigh rest The thigh rest can be raised to approx 40 Operation Part C Care staff and residents 9 ...

Page 120: ... Initially the backrest and thigh rest are raised to an auto contour position The mattress base is then tilted to a reverse Trendelenburg position Sleep position If this button is kept pressed the mattress base is adjusted to the following positions in turn in the following order 1 to a horizontal position 2 the backrest is lowered immediately the thigh rest follows after a delay of 9 seconds 3 To...

Page 121: ...A buttons at once on the handset briefly three times Then immediately press button B As soon as the new position has been saved a short signal tone sounds to confirm the change Press both A buttons at once on the handset briefly three times Then press button C immediately and hold for approxi mately 5 seconds until the pulsating signal tone stops Tilting the mattress base can help to bring the res...

Page 122: ...s button will move the mattress base into the Trendelenburg position If the bed is in a Trendelenburg position this function will automatically cause the mattress base to move into a horizontal position when it is moved into its lowest or high est position 2 Indicator 3 Reverse Trendelenburg position Pressing this button will move the mat tress base into the reverse Trendelen burg position If the ...

Page 123: ... switched off Material damage Failure to heed this warning may result in damage to the handset Do not forcibly turn the locking key beyond the limit stop of the lock The lock or the entire handset can be damaged Risk of injury Failure to heed this warning may result in physical injury due to incorrect use of the hand set The bed is delivered with a locking key which is attached to the handset with...

Page 124: ...hanges from green to yellow Operation enabled The lock is in a vertical position Colour of display green Keys can be operated click sound Drive locked Lock turned approx 15 clockwise Colour of display yellow Keys are locked On the Trendelenburg handset there is a choice of 2 levels that can be set with the locking key Symbol Function Explanation All adjustment options are locked All functions are ...

Page 125: ...t is sufficiently subtle however to not disturb the resident of the adjacent bed The light goes on automatically if the bed is connected to the mains power supply Press the two buttons Backrest UP and Backrest DOWN at the same time for about 3 seconds to manually switch the under bed light on or off The cable for the switch mode power supply is fitted with a mains cable holder The holder is locate...

Page 126: ...ay when getting into out of bed as well as to crushing To avoid toe injuries wear closed shoes when operating the bed Ensure that the brakes of the bed are always adequately applied at least three castors when a resident is left unattended If the bed is standing on a sloping floor e g on a ramp then the brakes must be applied on all castors A safe and secure bed position must always be ensured Mat...

Page 127: ...ng marks on the floor Make sure that the cable of the switch mode power supply cannot be stretched rolled over or otherwise damaged when moving the bed Check that all cables tubes or leads belonging to any accessory devices that are attach ed to the bed are safely secured and cannot be damaged Brake Move Lift the brake pedal with your foot Press the brake pedal down with your foot Risk of injury F...

Page 128: ... of bed Part C Image1 Lifting Pole Adapter Sleeves There are two lifting pole adapter sleeves at each corner of the head end of the mattress base There is a notch A on the surface of the lifting pole adapter that together with the pin B restricts the slewing range C of the patient lifting pole The lifting pole should be fitted to the side of the bed that the resident gets in and out of bed To inse...

Page 129: ...r that the bed will tip up when weight is applied to the pole A triangular grab handle can be attached to the lifting pole The resident can use this grab handle to sit up and readjust his her position more easily Check the grab handle and belt regularly for damage see Part C Maintenance 35 Replace damaged grab handles or straps immediately A date is printed on the grab handle In normal use the gra...

Page 130: ... of the grab handle by tugging hard on it The height of the triangular grab handle can be adjusted using the strap Make sure that the strap is correctly threaded through the buckle Make sure that the end of the strap projects at least 3 cm from the buckle f Safety sides provide suitable protection for residents against falling out of bed They are not intended as a device to prevent the resident fr...

Page 131: ...sey belts etc This is the only way to ensure effective protection and reduce the risk of the patient getting trapped or slipping through the gaps To prevent putting residents at risk of entrapment or suffocation only use suitable mat tresses not too soft complying with DIN 13014 with a volume weight of at least 38 kg m and dimensions complying with the specifications in the instruction manual The ...

Page 132: ... following instruction if the bed is only equipped with side panels on one side and safety side s on the other side An inserted mattress can slip if the mattress retainers are not raised The resident can get stuck in the resulting free space between the mattress base and the safety side Only use mattresses with suitable dimensions as described in the chapter entitled Ac cessories Always use the ma...

Page 133: ...nd pull the safety side up as far as it will go Repeat this procedure with the middle bar 2 Various position options The split safety sides can be positioned as follows Fully lowered safety side Top bar raised Operation Part C Care staff and residents 23 ...

Page 134: ...to entrapment and crushing Be careful with fingers when adjusting and lowering the safety side These can be crush ed between the bed frame and the safety side Proceed as follows First relieve the load on the safety side by lifting it slightly Then press both release buttons for the upper bar 1 and lower the safety side Repeat this procedure for the middle bar release buttons 2 Operation 24 Part C ...

Page 135: ...es DSG Requirements for operation The full length safety side DSG has been fitted to the bed at the fixing points provided for this purpose in accordance with the assembly instructions Operation Part C Care staff and residents 25 ...

Page 136: ... injured underneath the rests and mattress sections or between the mattress retainer and the safety sides during the adjustment 1 Raise the safety side bars one after the other at one end until they click into place at both ends It should not be possible to push the bars up or down 2 Check that the safety side bars are securely locked in place by pressing down on them 1 Lift the safety side bars s...

Page 137: ...purpose an adjustable fitting that locks the lower leg rest in position is located under the lower leg rest The thigh rest must be raised in order to raise the lower leg rest 1 Raise the lower leg rest at the foot end not using the mattress retainer bars until the desired position is reached The lower leg rest engages automatically Operation Part C Care staff and residents 27 ...

Page 138: ...ower the lower leg rest carefully There is a risk of injury occurring if the lower leg rest falls unchecked 1 Raise the lower leg rest to its full extent 2 Then lower the lower leg rest slowly If the thigh rest is lowered using the handset the lower leg rest is automatically lowered as well If the raised thigh rest is lowered using the handset the lower leg rest locks into place in sev eral interm...

Page 139: ... to react quickly and correctly If the backrest falls unchecked the resident and or the second member of staff could be injured In the event of power supply outages or electrical drive system failures the raised backrest can be lowered by hand Two carers are absolutely necessary to carry this out 1 Release the load on the backrest 1 before carrying out the CPR release procedure 2 To do so the firs...

Page 140: ...t firmly when lowering it as it could otherwise fall uncontrollably To return the bed to its original state 1 Swing the lifting pipe up again use the pin to secure it in place in the motor connector mount and fold the curved clip back over 2 Insert the pin again from the side of the thigh rest motor Operation 30 Part C Care staff and residents ...

Page 141: ...o the electrical drive system may only be carried out by service engineers the drive manufacturer or by qualified and authorised electricians in compli ance with all the relevant VDE and safety regulations Problem Possible causes Solution Handset drive sys tem not working bed is connected to the mains power supply Switch mode power supply not inserted No power supply to mains socket The switch mod...

Page 142: ... it cool down for at least 30 minutes Then reconnect the device to the power supply If the device still does not function Device is faulty re place the device LED on external switch mode pow er supply lights up green constantly LED does not light up yellow when but tons are pressed on the handset Handset faulty The cable from the switch mode power sup ply 24 volt is not plug ged in properly Functi...

Page 143: ...unit Inform your oper ator if repairs are necessary Replace the handset with a new one Replace connecting cable Manual CPR re lease of backrest optional accesso ry is not possible Bowden cable is too loose or not attached Bowden cable is kinked Readjust at the release lever or attach properly Install new Bowden cable Inform your operator if repairs are neces sary drive runs for a brief time only t...

Page 144: ...tion signal tone sounds during adjustment Control unit has forgot ten the drive positions Connecting cable defec tive Perform initialisation see Part B Initialis ing the control unit 60 Replace connecting cable Height adjustment and tilting do not work signal tone sounds during ad justment Drive s defective Connecting cable defec tive Perform RESET see Part B Control unit Reset 62 then test each f...

Page 145: ...handset every time they have been sub jected to mechanical stress and after the bed has been moved Use the following check list to help you As well as the extensive routine inspections performed by technical personnel the bed must also be checked at shorter regular intervals by non technical users care staff family carers etc and be briefly visually inspected and have its functions tested before b...

Page 146: ...amage splinters Locking levers of TSG headboard footboard side pan els Clamping function Functional check of the electrical components Handset Function test locking function Functional check of the mechanical components Emergency release of the backrest Test according to in struction manual Castors Moving and braking Screws and bolts Fixed securely Safety sides Safe locking unlock ing Motor bolt F...

Page 147: ...Check OK Not OK Description of Fault Inspector s signa ture Inspection result Date Maintenance Part C Care staff and residents 37 ...

Page 148: ...esult in malfunctions or damage to the electrical components The electrical components must not be cleaned with a water jet a high pressure cleaner or any other similar device Clean only with a moist cloth If you suspect that water or any other form of moisture has penetrated into the electrical components unplug the power pack immediately and do not plug it back into the socket Label the bed clea...

Page 149: ...e sealed using a suitable repair substance to prevent moisture from penetrating For fur ther information consult BURMEIER or a specialist dealer of your choice Disinfectants based on compounds that could potentially release chlorine may be cor rosive for metals synthetics rubbers and other materials over longer contact periods or when concentrations are too high Use these agents sparingly and only...

Page 150: ...tside Germany can contact our distribution companies in their particular coun try if they have any questions Contact details can be found on our website Cleaning and Disinfection 40 Part C Care staff and residents ...

Page 151: ...Cleaning and Disinfection Part C Care staff and residents 41 ...

Page 152: ...Burmeier GmbH Co KG Industriestraße 53 D 32120 Hiddenhausen Telephone 49 0 5223 9769 0 Fax 49 0 5223 9769 090 E mail info burmeier com www burmeier de ...

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