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Instruction Manual for Vertica-Homecare Bed    

 

Page 

81

 

11

 

EC Declaration of Conformity 

 

EC Declaration of Conformity

 

 

We,

 

Stiegelmeyer GmbH & CO. KG

 

Ackerstraße 42

 

D - 32051 Herford, 
 

hereby declare under sole responsibility as the manufacturer that the product named 
below:

 

Care beds with stand-up function 

Vertica Care;  Vertica Homecare  

in the version submitted complies with the regulations of the EC Directive 93/42/EEC 
Appendix VII for Medical Devices, last amended by Directive 2007/47/EC dated 5 
September 2007.  
It is categorised as a Class I active medical device. 
The relevant technical documentation is kept by the manufacturer’s safety 
representative. 
To evaluate the conformity to the Directives, all applicable parts of the following 
standards were referred to: 

Harmonised Standards

:    

 

EN 14971: 2013-04 

 

Application of Risk Management to Medical 
Devices 

EN 60601-1: 2007-07

 

Safety for Medical Electrical Equipment 

EN 60601-1-2: 2007-12

 

Electromagnetic Compatibility       

DIN EN 60601-1-6: 2010-10

 

Medical Electrical Equipment -  
Usability 

 

 

DIN EN 60601-2-52: 2016-04 

 

Particular requirements for basic safety and 
essential performance of medical beds 

 

 

International Standards: 

 

IEC 60601-2-52: 2009-12 
+AMD 1: 2015-03 

Medical electrical equipment:  
Particular requirements for the basic safety and 
essential performance of medical beds 

IEC 62366:2007 

Medical equipment: Usability 

 

 

 

 

Herford, 2016-11-22  

 

 

Georgios Kampisiulis Kemmler 

(Management) 

 

Hans-Peter Löw 
(Management) 

Notes 

 

Содержание Vertica-Homecare

Страница 1: ...Instruction Manual Care bed with stand up function Vertica Homecare Date 2018 05 25 241335 v3...

Страница 2: ...emergency lowering of backrest CPR both sides 14 Foot lever both sides for operating castor brakes or for steering 15 NURSE handset Stand up function 16 Support rollers automatically retracting for se...

Страница 3: ...Moving and Braking the Bed 19 4 2 Electric Drive System 20 4 2 1 Special Safety Information on the Electrical Actuator System 20 4 2 2 Patient Handset 22 Sleep position 22 4 2 3 NURSE Handset Stand Up...

Страница 4: ...ents 53 6 MAINTENANCE 54 6 1 Servicing 54 6 1 1 Service Interval 54 6 1 2 Servicing Plan 55 6 2 Regular Safety Inspections on Care Beds 57 6 3 Replacement Parts 60 6 4 Service Address 60 6 5 Replaceme...

Страница 5: ...o service for the first time and to use it on a daily basis This instruction manual contains all the information you will need to make it as easy and safe as possible to control and handle this bed bo...

Страница 6: ...linical condition of the patient Patient A patient is defined as a person who is in need of care ill infirm or disabled and occupies this bed It is strongly recommended that the operator or user instr...

Страница 7: ...following safety symbols are used Risk of injury to persons Dangerous electrical voltage There is danger to life General danger There is danger to life and health Warning of damage to property Possib...

Страница 8: ...hered to Ensure that users know where this instruction manual is kept in accordance with the Medical Devices Operator Ordinance MPBetreibV 9 If the hospital bed is in long term use test the functions...

Страница 9: ...be avoided in this way Before moving the bed always make sure that you have unplugged it from the mains supply Hang the mains cable in the mains cable holder to ensure that it will not fall out or tra...

Страница 10: ...intentional electrical adjustments place the handset out of their reach e g at the foot end of the bed In these cases adjustments must only be performed by or in the presence of a trained person Lock...

Страница 11: ...es owners the instruction manual must be handed over with the bed The use of this bed in hospitals is only permitted in rooms designed for medical treatment of the application group 0 in accordance wi...

Страница 12: ...ation with high frequency surgical equipment Before using the safety sides assess and take into consideration the clinical condition and particular physical build of the patient For example if the pat...

Страница 13: ...ions mattress base dimensions 200 x 90 cm external dimensions approx 104 x 214 cm Mattress base height adjustment range from approx 40 5 to 81 cm via two lifting columns Adjustment of backrest from 0...

Страница 14: ...d with an integrated Multiflex safety side system to protect the occupant from accidentally falling out of bed Electric drive system The electric drive system for this bed consists of A central contro...

Страница 15: ...ng key out of the range of patients or other parties such as key ring users carers see also chapter 4 2 2 Each time before putting the bed into service the user must check that The bed has been cleane...

Страница 16: ...Components Grab handle with strap No damage Mattress base covers No damage cracks deformation Performance Check of the Electrical Components if installed Patient handset Stand up handset Press all bu...

Страница 17: ...and function properly Pay special attention here to the safe routing of all loose connector cables tubing etc If you have any queries or concerns consult the manufacturer of the equipment or the Burm...

Страница 18: ...ed Otherwise the mains cable could sustain damage as a result of being torn off crushed or driven over Such damage could lead to electrical hazards and malfunctions When the stretcher is moved ensure...

Страница 19: ...ang the handset on the hook or holder provided within the protected bed area This helps to protect patients from hazards arising from functional defects and unintentional movements Ensure that no obst...

Страница 20: ...bed o Portable and mobile high frequency communication devices e g cordless telephones mobile telephones baby monitors WLAN WIFI wireless equipment etc can influence the operation of electro medical e...

Страница 21: ...The handset can be hung at any position on the bed with an elastic hook The coiled cable provides ample freedom of motion The following basic rule applies to the keys Raise Lower 4 2 2 1 Adjustment Fu...

Страница 22: ...each intermediate position To continue adjusting the bed let go of the button and then press it again Position 1 Position 2 Position 3 Reverse Trendelenburg The mattress base can be tilted by up to a...

Страница 23: ...e of the bed and put the patient at risk or cause damage to equipment The patient is exposed to an increased risk of entrapment during backrest and thigh rest adjustments when the safety sides are rai...

Страница 24: ...e locked position using the locking key The colour of the respective display changes from green to yellow Actuator released Lock is vertical Colour of display green Keys can be operated clicking sound...

Страница 25: ...inutes if the battery is new and fully charged Under emergency conditions if the remaining battery capacity is 30 depleted a signal tone will sound as an alert during the adjustment If the battery cha...

Страница 26: ...tion Manual for Vertica Homecare Bed Page 27 In this case contact Burmeier s customer service We will replace the rechargeable batteries and dispose of the old batteries properly see page 60 for the a...

Страница 27: ...d health of the patient Operating and controlling the stand up function is done exclusively by the care staff or those carers who have been trained using a separate NURSE handset and may not be done b...

Страница 28: ...p function by the care staff The general operation takes place the same as described earlier for the patient handset The NURSE handset is generally locked when in standard operation and must be first...

Страница 29: ...lectronically limited The CPR position allows all parts of the mattress base to be lowered quickly particularly for resuscitation purposes It is also suitable for moving the bed to a specific low posi...

Страница 30: ...able To remove Stand in front of the headboard Grasp each upper corner of the headboard with both hands Standard wood head footboard 7 20 Pull the headboard or footboard smoothly up and out Avoid jamm...

Страница 31: ...own The fold down footboard optional has pushbuttons in the upper plastic corners and can be folded down Note that the sticker on the outside of the bed indicates the foot end important because of the...

Страница 32: ...el slightly upwards as a mobilisation support do not allow it to fall 2 Let go of the release lever and continue to swing the side panel up as far as engagement position 1 Check that the mobilisation...

Страница 33: ...eleased Patient handset 3 and control panel 13 are locked Hold down the buttons again for at least 3 seconds to relock this function 3 Stand up function display active by Orange blinking light on NURS...

Страница 34: ...dividual capabilities and health of the patient Here is how to go for example from a slightly raised backrest cardiac position sitting position all the way to a complete standing up position 1 Slight...

Страница 35: ...out as far as engagement position 1 in order to avoid trapping the patient see Chapter 4 3 5 1 For obese patients check whether it is possible to use the table function with the larger body mass witho...

Страница 36: ...ith a horizontal table top for example for eating writing or supporting a book 4 3 9 Ending the Stand Up Function Requirement The mattress base must be moved back until the thigh rest and lower leg re...

Страница 37: ...are described which are not incorporated in your bed 4 4 1 Safety Information When making any adjustments always ensure that there are no patient limbs in the way that could be trapped in the process...

Страница 38: ...sition until the operating lever 12 is released As soon as the drive system is connected to the mains supply again the backrest can be adjusted using the handset or control panel The red operating lev...

Страница 39: ...ootboard 20 out towards the outside Max load 15 kg Do not sit on it Fold in Fold the footboard 20 up as far as the holding bars S and then using both hands simultaneously slide both release sliders 1...

Страница 40: ...and pull the footboard completely out until it hits the stop 4 The footboard must securely engage on both sides with a click Check that it is properly engaged by pushing it back and forth Insert matt...

Страница 41: ...he space for the extension To shorten the mattress base follow the steps for extending the base in the reverse order 1 Grasp left and right with both hands under the outer edges of the footboard 2 Pre...

Страница 42: ...e The maximum loading capacity at the front end of the patient lifting pole is 75 kg The patient lifting pole is not suitable for rehabilitation exercises Pay attention to door clearances when moving...

Страница 43: ...s Please also refer to the detailed instruction manual supplied with every grab handle Attachment Attach the grab handle with the hand loop to the trapeze bars patient lifting pole Ensure that the int...

Страница 44: ...ric shock fire and other hazards as well as malfunctions A damaged mains cable must be replaced immediately see Chapter 6 5 4 4 5 4 Universal Holder Optional Two sliding universal holders 11 are attac...

Страница 45: ...attress sliding uncontrollably and minimises possible patient risks of injury through trapping falling suffocating Approved mattresses See requirements in Chapter 8 Accessories If elevated resident po...

Страница 46: ...y sides 1 Raise both posts as shown by the arrows until they are in a vertical position Tip Hold on to the plastic section of the left hand post with your left hand and at the same time the right hand...

Страница 47: ...se buttons with the thumb of each hand 3 Lower the safety side evenly Do not let it drop Lowering the safety side posts 4 Hold onto the plastic section of the left hand post with your left hand 5 Pull...

Страница 48: ...tions Make sure that all plugs are properly inserted There must be no external damages visible on any of the elec trical components Non compliance with this advice could lead to malfunctions or damage...

Страница 49: ...Hygiene und Mikrobiologie German Society for Hygiene and Microbiology which is suitable for the corresponding surfaces The same applies for all beds with patients who have notifiable diseases accordin...

Страница 50: ...uitable for the relevant surface For this activity the expert should be provided with disposable aprons and gloves which are impermeable to fluids For the cleaning treatment only fresh clean cloths ma...

Страница 51: ...scratches markings etc which permeate the entire coating should be resealed using a suitable repair medium to prevent the penetration of moisture For further information consult Burmeier company or a...

Страница 52: ...ibutors in their particular country if they have any questions Contact details can be found on our website 5 5 HANDLING CLEANING AND DISINFECTION AGENTS Pay attention to the exact dosage We recommend...

Страница 53: ...y or the EU the relevant national regulations must be complied with 6 1 SERVICING 6 1 1 Service Interval As a guideline we recommend that annual maintenance is carried out by our qualified service eng...

Страница 54: ...ct the Burmeier service personnel Rechargeable batteries must be charged and fully functional Connect bed to mains supply Recommendation We recommend that rechargeable batteries be replaced after 5 ye...

Страница 55: ...the spray tube of the lubricant applicator as far as possible into the hole B on the inside surface of the safety side and spray once for about half a second 3 Jiggle the locking bolt up and down 3 4...

Страница 56: ...ent III Performance inspection Visual and functional check The visual inspection and function testing as well as the assessment and docu mentation of the test results must be conducted exclusively by...

Страница 57: ...ndset cable mains cable Damage routing Mains cable holder Fixed position Plug and plug cover on control unit Available correct position Visual inspection of the mechanical components if applicable Sti...

Страница 58: ...rattling when shaken Motors Abnormal noise level Emergency release backrest motor Control unit transformer and motors Test according to instruction manual Strain relief of mains cable Mains cable firm...

Страница 59: ...on the cross tubing of the mattress base frame Model Name of product Item number Order number Date of manufacture week year 6 4 SERVICE ADDRESS To order replacement parts in Germany and for any custom...

Страница 60: ...locking box of the electrical system are maintenance free and must not be opened If a malfunction occurs the relevant component must be replaced in its entirety When replacing individual components ma...

Страница 61: ...boxes handsets brake alarm 3 Under bed light further handsets junction box Do not plug in here ES Brake alert Connection Device 1 M1 Lifting columns for mattress base height head end 2 M2 Thigh rest...

Страница 62: ...on move the mattress base to the highest position Unplug the mains cable At the head end of the chassis release the strain relief of the mains cable Remove the mains cable from the holders Pull the IE...

Страница 63: ...mpartment has its own fan This must not be obstructed or covered as otherwise pressure could build up and an explosion could occur For easy installation move the mattress base to the highest position...

Страница 64: ...nt During the alignment the current start positions of the actuators are transmitted to the control unit through a reference run to 0 and then the existing tolerances in ongoing operation are aligned...

Страница 65: ...s Adjust the thigh rest using the Thigh rest DOWN button to the lowest horizontal position as far as the automatic switch off At the same time the lower leg rest moves to the horizontal position and s...

Страница 66: ...g rest is too high Adjust the thigh rest until it is parallel to the horizontal flat mattress base using the Thigh rest UP button a b Save the calibrated lower leg rest position On the patient handset...

Страница 67: ...powered operation not possible Battery not charged There is no rechargeable battery Connect the bed to the mains supply for approx 8 hours Constant alarm sounds during adjustment Battery capacity depl...

Страница 68: ...bed retest Remove obstructions move bed away from obstructions e g window sills sloping roofs Control unit partly not functioning One or more motors are not connected electrical plug connections are d...

Страница 69: ...ries only while these are required and only at the positions intended for them in such a way as to avoid damaging the surfaces of the bed and accessories Avoid for example chafing or unprotected attac...

Страница 70: ...ides 415 mm above the mattress base 9 2 ADJUSTMENT OPTIONS Height adjustment range Approx 40 5 to 81 cm Thigh rest to approx 30 Backrest for stand up function to approx 70 to approx 85 Extended leg po...

Страница 71: ...d with a battery not for use in explosive atmospheres Protection category IP X6 Rechargeable battery integrated Type 2 sealed maintenance free lead acid rechargeable batteries Capacity 1 3 Ah Voltage...

Страница 72: ...on category IP X6 Actuator M4 Electric motor lower leg rest Type LINAK LA31 machine washable Path feedback HALL sensor Force installation dimension lift 6000 N 288mm 105 mm End position cut out Micro...

Страница 73: ...th the Medical Devices Directive 93 42 EEC Appendix VII 11 Safe working load max permissible weight of patient mattress and all accessories attached 9 1 Max weight of patient max permissible weight of...

Страница 74: ...e equipment may not be used directly next to or on top of other equipment If it is necessary to use the equipment in this way you must check to ensure that it functions properly in the required config...

Страница 75: ...utput cables Not applicable Surges according to IEC 61000 4 5 1 kV transversal voltage 1 kV transversal voltage The quality of the supply voltage should be equivalent to that of a typical business or...

Страница 76: ...stance in metres m b According to an in situ test c the field strength of stationary radio transmitters should be lower for all frequencies than the compliance level d Interference is possible when in...

Страница 77: ...where P is the maximum power rating of the transmitter in watts W as stated by the manufacturer of the transmitter Note 1 The higher frequency range applies for 80 MHz and 800 MHz Note 2 These guideli...

Страница 78: ...e 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 pro...

Страница 79: ...e oil and dispose of it properly Please note in this connection The release mechanism must not be activated if gas springs are removed These devices are under pressure Careless release could cause inj...

Страница 80: ...r s safety representative To evaluate the conformity to the Directives all applicable parts of the following standards were referred to Harmonised Standards EN 14971 2013 04 Application of Risk Manage...

Страница 81: ...Instruction Manual for Vertica Homecare Bed Page 82 Notes...

Страница 82: ...Instruction Manual for Vertica Homecare Bed Page 83 Notes...

Страница 83: ...Instruction Manual for Vertica Homecare Bed Page 84...

Страница 84: ...eider Stra e 270 D 32791 Lage Lippe Tel 49 0 52 32 98 41 0 Fax 49 0 52 32 98 41 41 Email info burmeier com Internet www burmeier de No part of this manual may be reproduced without the prior written p...

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