Stiegelmeyer Sicuro pesa Instruction Manual Download Page 60

 

Instruction Manual for Sicurao pesa Hospital Bed 

Page 

60

 

Inspection Report following an inspection of electromedical equipment  
according to DIN EN 62353 (VDE 0751-1): 2015-10 - Page 2 of 2 

III.

 

Performance Check

 

Ok  Not 

Ok 

Description of 

Defect 

Performance Inspection of the Electrical Components (if installed)

 

Emergency operation using 
batteries; battery capacity; to 
check: connect bed to mains 
supply for 24 h, then run test. 

Minimum of 3 height adjustment 
cycles with a load of approx. 80 
kg on the bed. 

 

 

 

End of travel cut-out for motors  Automatic cut-out 

(not necessary 

when moving the ba leg rest, due 

to functional design; reason: friction 
clutch/providing protection against 
trapping)

 

 

 

 

Handset, foot pedal; operating 
elements, locking functions 

Test according to instruction 
manual 
No "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 firmly fastened 

 

 

 

Performance Inspection of the Mechanical Components (if installed)

 

Joints and pivots 

Smooth operation 

   

 

Gas  springs  (backrest,  mattress 
base tilting) 

Sufficient 

supporting 

force; 

reliable locking  

   

 

Height 

adjustment 

using 

hydraulic pump /foot pedal 

Sufficient lifting force 

   

 

Lower leg rest (Rastomat) 

Engage 

   

 

Grab handle with strap 

Secure position 

   

 

Castors 

Brakes, securely engaged brake 

   

 

safety sides 

Locking in place, release 

   

 

Accessories (e.g. patient lifting 
pole, grab handle) 

Fixing, damage, suitability 

   

 

Overall Inspection Result: 

Defects/remarks: 
 
 



No safety or functional defects were detected 



No direct risk, the defects detected can be rectified quickly 



Appliance must be taken out of circulation until the defects have been rectified! 



Appliance does not conform to requirements – modification/replacement of 

components/decommissioning recommended.

 

Test approval sticker applied:

 

 yes 

 no

 

 

 

Next inspection date:

 

Documents that form part of this inspection report: 

 

Checked  
 

Date:

 

Name:

 

Signature:

 

Test approval 
sticker 
applied: 
 

Date: 

Name: 

Signature: 
 

Address/stamp of responsible company. 
 
 

Summary of Contents for Sicuro pesa

Page 1: ...Instruction Manual Hospital bed for intensive care Sicuro pesa Date 2016 12 02 V4_211952...

Page 2: ...end 2 at each end 7 Linen holder with control box for extended electric locking and adjusting functions removable 8 Release buttons for extending the bed pull down on both sides 9 Foot pedal on both s...

Page 3: ...or the use of Additional Electromedical Equipment 22 4 2 3 Handset 23 4 2 4 Control Box 25 4 2 4 1 Battery Charge Indicator 28 4 2 4 2 Positioning Removing the Control Box 28 4 2 4 3 Enabling Locking...

Page 4: ...6 4 Service Address 61 6 5 Electrical Adjustment System 62 6 5 1 Safety Information 62 6 5 2 Control Unit 63 6 5 2 1 Terminal Assignments 63 6 5 2 2 Resetting Control Unit CB16 to Original Settings R...

Page 5: ...l the information you will need to make controlling and handling this bed as easy and safe as possible both for you as the operator and for your users It is a practical reference book and should be ke...

Page 6: ...10 functions with two stage backlight o CPR activation electrically but with additional operating lever on both long sides of the bed Control box for extended control of all electric adjustments by n...

Page 7: ...ctions that are important for him her Instructions for the Operator This hospital bed fulfils all the requirements of the 93 42 EEC Medical Device Directive It is classified as a Class 1 active medica...

Page 8: ...nual the 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 Risk of damage to property P...

Page 9: ...ety instructions are adhered 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...

Page 10: ...ns cable holder to ensure that it will not fall out or trail on the floor At regular intervals carry out a visual inspection of the mains cable to check for mechanical damage scuffing exposed wires ki...

Page 11: ...ese cases adjustments must only be performed by or in the presence of a trained person Lock the handset using the control box or locking box if The patient is unable to operate the bed safely or to fr...

Page 12: ...with the operating instructions If the hospital bed changes owners the instruction manual must be handed over with the bed The bed with its stable smooth running castors is designed for being moved wi...

Page 13: ...reducing the distance between the bars on the safety sides may be necessary In these cases use protective covers accessory posey belts etc 2 3 3 Contraindications This bed is only suitable for occupan...

Page 14: ...nsions approx 99 x 215 cm Rail for universal holders on safety sides on both sides Mattress base height adjustment range from approx 45 to 80 cm Adjustment of the backrest from 0 to approx 70 Adjustme...

Page 15: ...lex 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 control unit installed underneath...

Page 16: ...wn on the electrical type plate on the bed The type plate is located under the backrest beside the mains cable entry The mains cable is connected and routed in such a way that it cannot be damaged and...

Page 17: ...eformations Mattress base covers Damage deformation Performance Check of the Electrical Components if installed Handset Functional test Foot pedal Functional test Control box Function test locking fun...

Page 18: ...ng systems etc is attached ensure that all items of equipment are fixed securely and function properly Pay special attention here to the safe routing of all loose connector cables tubing etc If you ha...

Page 19: ...r driven over Such damage could lead to electrical hazards and malfunctions When the bed is moved ensure that objects hanging in the sliding rails 10 do not cause any damage e g to door frames Risk of...

Page 20: ...in medical rooms which meet the electrical requirements of the VDE 0100 Part 710 standard Please also refer to the Chapter Specifications for the use of Additional Electromedical Equipment on page 61...

Page 21: ...compatibility EMC For this reason observe the following instructions when installing and operating the bed o Portable and mobile high frequency communication devices e g cordless telephones mobile tel...

Page 22: ...section In addition observe the information given in the instruction manuals of the additional devices as well as the requirements stipulated in the relevant standard EN 60601 1 1 Use of ECG EEG Equi...

Page 23: ...ly one button can be pressed at a time otherwise all adjustments stop The handset can be hung at any position on the bed The coiled cable provides plenty of flexibility Illustration of handset Standar...

Page 24: ...position when it reaches the highest or lowest setting Thigh rest The thigh rest can be raised to approx 80 Reverse Trendelenburg position The mattress base can be tilted by up to approx 18 default s...

Page 25: ...user must immediately lock the respective function s using the control box The bed remains in the position that it was in at the moment when the functions were switched off A sticker on the linen hold...

Page 26: ...base sections quickly to a low position N Normal position S Shock position button Trendelenburg position RL Backrest UP DOWN lock enable OL Thigh rest UP DOWN lock enable H Height adjustment UP DOWN...

Page 27: ...ly to a low position N Normal position button S Shock position button Trendelenburg position R Raise button for backrest O Raise button for thigh rest H Raise button for height adjustments AT Reverse...

Page 28: ...e foot section This makes it easier and more ergonomic to use Place the control box back in the linen holder when it is no longer needed and slide the linen holder back under the footboard Ensure that...

Page 29: ...fter re connecting to the mains Using the foot pedal Generally for safety reasons activation is only possible with a double click like on a computer mouse Always press the desired button with your foo...

Page 30: ...ts up orange while not in use This prevents inadvertent adjustments from being made and the patient from falling out of bed Enabling the function By pressing the or the button and a release button the...

Page 31: ...tandard horizontal position Bringing the bed into a horizontal position Press the release button F and the AT button at the same time The mattress base automatically moves to the horizontal position a...

Page 32: ...adjustment range of the backrest and thigh rest remain unrestricted Programming and changing the maximum mattress base height 1 Set the mattress base to the desired maximum height 2 Press the memory...

Page 33: ...ments to the rests and mattress base The adjustment sequence and the position are preset 1 Backrest and thigh rest horizontal and 2 Mattress base horizontal and at a height of approx 60 cm The normal...

Page 34: ...plugged into a mains electricity socket avoid attempting repeated motorized adjustments that would discharge the battery even more Charging the batteries charging time The batteries are fully charged...

Page 35: ...ain functions or features are described which are not incorporated in your bed 4 3 1 Safety Information When making any adjustments always ensure that there are no limbs in the way that could be trapp...

Page 36: ...nder the mattress base near the backrest upwards and guide the backrest down to the desired position using the grab handle 5 4 The backrest is not held in position until the operating lever 11 is rele...

Page 37: ...on using the grab handle 5 4 The lower leg rest is not held in position until the operating lever 11 is released This procedure can be carried out from either of the long sides of the bed If there is...

Page 38: ...mm at the foot end 1 With both hands grasp the grey plastic levers 8 located on the left and right side under the foot section 2 Press both of the plastic levers 8 down with the thumb of each hand and...

Page 39: ...a list of accessories in Chapter 8 showing the different versions of mattress foam insert that are available Restoring the Mattress Base to its Normal Size Remove the mattress foam insert 1 The fixing...

Page 40: ...age 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 movin...

Page 41: ...five years Please also refer to the detailed instruction manual supplied with every grab handle Attachment The grab handle must be fitted to the patient lifting pole using the fixing loop Ensure that...

Page 42: ...ot be set to the Trendelenburg position o The mattress base must be in the horizontal home position o The bed may not be moved and must be braked Lowering The bed must be braked Using the handle swing...

Page 43: ...he hand rail slightly raise the head section smoothly and evenly and then lower it outwards away from the bed Raising the headboard Swing the head section up to the vertical position The headboard wil...

Page 44: ...tal tubes from above into the sleeves at the foot end of the mattress base Do not tilt it Only for Classic footboard Removing the footboard Raise the footboard slightly and remove it towards the insid...

Page 45: ...red 4 Tighten the adjusting screws S again by hand 4 4 6 Mains Cable Holder A mains cable holder is located on the outside of the head section Before moving the bed always hang the mains cable in this...

Page 46: ...re that patients or third parties are not exposed to risks risk of crushing Ensure that attached objects do not cause damage e g to door frames when moving the bed Ensure when adjusting the mattress b...

Page 47: ...ve protection and reduce the risk of the patient getting trapped or slipping through the gaps Only use suitable mattresses not too soft to DIN 13014 with a volume weight of at least 40 kg m and dimens...

Page 48: ...the bed or o Lock the handset from the control box refer to Chapter 4 2 4 Otherwise there is a danger of limbs being crushed or trapped between the safety sides if the patient inadvertently activates...

Page 49: ...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 post with your...

Page 50: ...lease 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 P...

Page 51: ...ns cable Store the mains plug so that it does not come into excessive contact with cleaning solutions Ensure that none of the electrical components show any signs of external damage If these instructi...

Page 52: ...ountry if they have any questions Contact details can be found on our website Do not use scouring agents abrasive cleaning agents or scouring pads These substances can damage the surfaces Do not use o...

Page 53: ...dle tubes The cleaning agent wash water used for the decontaminating process must have a pH value of between 5 and 8 The hardness of the washing water must not exceed 5 dH The total salt content shoul...

Page 54: ...d 70 C Washing temperatures that are too low must also be avoided as this will result in poor drying Max wash water temperature 65 C Do not cool suddenly using cold water After completing the washing...

Page 55: ...SERVICING 6 1 1 Service Interval As a guideline we recommend that annual maintenance is carried out by our qualified service engineers Please consult our service centre see page 61 for the address Da...

Page 56: ...fter 5 years wear and tear part If the plugs have been disconnected e g when drives have been replaced or during troubleshooting always check to see if the O rings sealing rings of the electrical plug...

Page 57: ...r securing bolts R up as far as they will go 2 Insert 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 ha...

Page 58: ...sponding knowledge training and experience Such persons must also verify that they have knowledge of the beds that are to be inspected and of the relevant provisions medical products act operator ordi...

Page 59: ...ble 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 installed Stickers and...

Page 60: ...tion manual Strain relief of mains cable Mains cable firmly fastened Performance Inspection of the Mechanical Components if installed Joints and pivots Smooth operation Gas springs backrest mattress b...

Page 61: ...on the cross tubing at the head end of the bed Required information Model Product name Item number Order number Date of manufacture week year 6 4 SERVICE ADDRESS To order replacement parts or make cus...

Page 62: ...anger of crushing due to parts of the mattress base falling The components control unit drives handset control box locking box of the electrical system are maintenance free and must not be opened If a...

Page 63: ...nputs outputs MJB special Plug assignment for junction box MJB art no 195681 Sockets Possible connections 1 2 4 5 Further MJB junction boxes foot pedals handsets brake alarm 3 Under bed light further...

Page 64: ...see also Chapter 7 2 Error codes Effect Deletes any errors in CB16 reset Deletes any lifting limits programmed Where On the control box 13 at the foot end Version EM4 Version EM5 1 Press and hold both...

Page 65: ...ir end position reference position o Only necessary for Drives M1 M3 mattress base height M4 lateral tilting Manual mode is exited automatically if o No button is pressed for 20 seconds or o All drive...

Page 66: ...when a button is pressed stops All functions on the control box are locked please enable them The control unit has now reverted to normal operating mode To check this move all adjusting functions to t...

Page 67: ...ional feature 3x Re adjust the required horizontal mid position reference position Press the memory button briefly three times and then only the button shown A beep is emitted Drive M4 is re adjusted...

Page 68: ...O ring on the plug is not damaged This ring ensures that the plug is tightly sealed Re attach the locking device When routing the handset cable ensure that it cannot be damaged by any moving parts of...

Page 69: ...compartment 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 positi...

Page 70: ...ssary repairs Operation using battery 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 B...

Page 71: ...onnected There is a serious problem with the control unit For safety reasons all functions are locked Connect all motors reset the control unit RESET see Chapter 6 5 2 2 If problem recurs have drive s...

Page 72: ...easier to rectify the fault Flashing locking LEDs on Control Box Possible Faults Solution A B C D E 2 1 2 1 2 1 2 1 2 Position switch for mattress base height motor M1 head end socket 1 Check cable pl...

Page 73: ...hich are designed for the relevant model of bed Accessory lists can be obtained from us quoting the bed model Here is a small sample of the accessories available Description Item Number Patient liftin...

Page 74: ...ght adjustment approx 16 s Tilting range of mattress base to Trendelenburg position to approx 19 Backrest Length compensation acc to DbfK to approx 70 approx 80 mm Tilting range of mattress base to Re...

Page 75: ...voltage 24 V DC Output current Max 10 A electronic monitoring and cut out Duty cycle Intermittent duty 2 min ON 18 min OFF Classification Protection class I type B device with internal power supply i...

Page 76: ...sion 320mm 100 mm End position cut out Micro switch Input voltage 24 V DC Duty cycle Intermittent duty 2 min ON 18 min OFF Type of enclosure IP X6 suitable for automatic cleaning Drive M3 Height of ma...

Page 77: ...IP X6 suitable for automatic cleaning Drive M5 Backrest Type LINAK LA34Q Path feedback Potentiometer Force installation dimension lift 5000 N 477 mm 217 mm End position cut out Micro switch Input volt...

Page 78: ...tient this is dependent on the total weight of all the accessories attached to the bed and is always less than the safe working load 2 3 1 9 1 Minimum patient measurements weight height 146 cm weight...

Page 79: ...The 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 con...

Page 80: ...output 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...

Page 81: ...distance 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...

Page 82: ...d below Power rating of the transmitter W Protection distance d dependent on the transmission frequency m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 P 1 2 d 1 2 P 1 2 d 2 3 P 1 2 0 0...

Page 83: ...portant for the support of the patient s vital functions 2 Acute care in a hospital or in other medical establishments in which medical supervision and monitoring are required A medical electrical ME...

Page 84: ...dustrial electrical equipment in accordance with the WEEE Directive 2012 19 EC law governing electrical equipment The electrical components used are free from prohibited hazardous substances in compli...

Page 85: ...the 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 i...

Page 86: ...mity to the Directives all applicable parts of the following standards were referred to Harmonised standards EN 14971 2013 04 Risk analysis for medical devices EN 60601 1 2007 07 Medical electrical eq...

Page 87: ...Instruction Manual for Sicuro pesa Hospital Bed Page 87 Notes...

Page 88: ...a e 42 D 32051 Herford Germany Tel 49 0 5221 185 0 Fax 49 0 5221 185 252 Email info stiegelmeyer com www stiegelmeyer com No part of this manual may be reproduced without the prior written permission...

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