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Healthniture HBB500, Instructions For Use Manual

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HBB500 BARIATRIC BED 

 

Instructions for Use

HBB500 BARIATRIC BED

Healthniture S.r.l. 

- Via della Vittoria 33, 20025 Legnano (MI) ITALY - email: [email protected]

IFU-HBB500-ENG-2021#ed02-May

1

Summary of Contents for HBB500

Page 1: ...HBB500 BARIATRIC BED Instructions for Use HBB500 BARIATRIC BED Healthniture S r l Via della Vittoria 33 20025 Legnano MI ITALY email bariatric healthniture com IFU HBB500 ENG 2021 ed02 May 1 ...

Page 2: ...rwise stated Healthniture S r l 2021 As our policy is one of continuous improvement we reserve the right to modify designs without prior notice The content of this publication may not be copied either wholly or in part without the consent of Healthniture S r l IFU HBB500 ENG 2021 ed02 May 2 ...

Page 3: ...ed could result in death injury or other serious adverse reactions Caution YOU WILL FIND THIS SYMBOL BOTH ON THIS IFU AND ON THE BED Indicates possible hazards in procedures or conditions which if not correctly followed could result in equipment damage or failure Explains or amplifies a procedure or condition Indicates an optional item or feature IFU HBB500 ENG 2021 ed02 May 3 ...

Page 4: ...14 Extendable Head board Foot board 14 Side Rails 14 Electric connection 16 Cable storage 17 Potential equalisation terminal 18 Mattress 19 4 Operation 21 Brakes and steering 21 Side Rails 22 Extendable Head board Foot board 27 Extendable Mattress Platform Sections 29 Electric and Mechanical CPR backrest release 31 Mattress support panels removal 32 Egress handle 32 Bed length adjustment 33 IFU HB...

Page 5: ...andset 40 Attendant Control Panel ACP 41 Function lockout 43 Backup emergency battery 45 Duty cycle lockout 47 5 Product Care 48 Decontamination 48 Preventive maintenance 49 Battery test 51 Troubleshooting 52 Product lifetime 52 6 Accessories 53 7 Technical Data 53 8 Warranty and Service 58 9 Electromagnetic Compatibility EMC 59 10 AFTER SALE SURVEILLANCE REPORTING FORM 61 IFU HBB500 ENG 2021 ed02...

Page 6: ...General Warnings Continued on next page IFU HBB500 ENG 2021 ed02 May 6 ...

Page 7: ...Continued on next page IFU HBB500 ENG 2021 ed02 May 7 ...

Page 8: ...IFU HBB500 ENG 2021 ed02 May 8 ...

Page 9: ...pport surface with removable HPL panels second section fixed Adjustable length mattress platform Electric CPR function and Mechanical CPR function Battery backup Linen tray Underbed light Full width brake bar at foot side steering swivelling full braked Patient Handset with backlight and Attendant Control Panel ACP with function locks I V pole sockets and oxygen bottle sockets at head end Corner r...

Page 10: ...the bed HBB500 Bariatric Bed and serial number of the bed X X X X can be found on the specification label located on the bed trolley frame Refer to the SN serial number to identify the bed for assistance purpose IFU HBB500 ENG 2021 ed02 May 10 ...

Page 11: ...ring pedal E Expandable Backrest section P Electric set control box battery F Expandable Seat section CPR handle Q Expandable sections operating knob G Expandable Thigh section R Extendable head board operating knob H Expandable Calf section S Adjustable length mattress platform I Side rails detachable T Mattress retainer mattress extension platform J Side rail operating knobs U Under bed light K ...

Page 12: ...riatric facilities Indications and intended patient group This bed is for adults UNI CEI EN 60601 2 52 2016 and it is appropriate for high dependency obese patients who pose a movement and handling risk and or whose clinical condition requires that they are positioned with minimal physical handling The use of this bed is reserved for medical personnel professionals and or people aware of the conte...

Page 13: ... Maximum patient weight Mattress Accessories including attached loads TOTAL 450kg 12kg 38kg 500kg The recommended patient height is between 146cm and 190cm At the discretion of the carer patients taller than 185 190cm may be accommodated by extending the bed refer to Bed length adjustment in Chapter 4 Ensure that patient s height does not exceed the In bed length shown in Chapter 7 IFU HBB500 ENG ...

Page 14: ... image below shows 1 the chrome tube of the side rails must always face the chrome tubes of the head and foot boards see image above 2 the blue plastic handles must always face each other on the same side of the bed see image above 3 the side rails must always have the ergonomic part see arrows in the image below facing the outside of the bed Only the side rails of the same diagonal pair can possi...

Page 15: ...o the nylon blue central parts Pull the upper blue operating knob and slide the central chrome plated rail into its socket and release the operating knob until it will make an audible click to be securely fastened To remove the upper part of the side rail pull the upper operating knob and holding the top side rail handle pull out the side rail IFU HBB500 ENG 2021 ed02 May 15 ...

Page 16: ...ug is easily accessible so it can be disconnected quickly in an emergency When the bed is connected to the electricity supply a GREEN indicator will light on the control box The electric set is located underneath the mattress platform covered with a plastic laminated panel unscrew the panel to reach the set if needed IFU HBB500 ENG 2021 ed02 May 16 ...

Page 17: ...h the mattress platform will flash too when the battery is on charge see OPERATIONS at page 45 To keep the battery in stock not mounted on the bed as a spare part switch it OFF When not in use or before moving the bed take the power supply cord coil it up around the rectractable linen tray at foot side To isolate the bed from the electricity supply disconnect the mains plug from the socket outlet ...

Page 18: ...l is located at the head end of the bed When other electrical equipment is within reach of the patient or carer potential differences between the equipment can be minimised by connecting together their potential equalisation terminals IFU HBB500 ENG 2021 ed02 May 18 ...

Page 19: ...rear wall at least 8cm from the corner roller buffer Mattress Mattress size label A label on the frame indicates the correct mattress size thickness measure must be read as the maximum value possible IFU HBB500 ENG 2021 ed02 May 19 ...

Page 20: ...height when used with a foam mattress up to 19cm thick Specialist powered air foam replacement mattresses will typically envelop the patient when loaded and can generally be deeper than a foam mattress without compromising safety Other makes of specialist mattress replacement must be assessed individually prior to use to verify sufficient clearance is maintained Mattress overlays are not recommend...

Page 21: ...s Using the steering castor Position the bed so that all the castors line up in the direction of travel Raise the pedals to lock the steering castor and move the bed by pushing it from the opposite end The steering castor is at right head side The steering castor is conductive too Pulling or pushing the bed to its right height becomes essential to be able to transmit the right force for movement t...

Page 22: ...tted with n 4 drop split side rails adjustable height and detachable They can be adjusted on three different height levels First level all down mattress level Second level mid Third level all up IFU HBB500 ENG 2021 ed02 May 22 ...

Page 23: ...Operation Side rails are detachable To lower the side rail Hold the top side rail handle third level and pull the UPPER blue operating knob IFU HBB500 ENG 2021 ed02 May 23 ...

Page 24: ...n the side rail which will slide at the second level mid of height then pull the LOWER blue operating knob and push down the side rail at the first level all down mattress level IFU HBB500 ENG 2021 ed02 May 24 ...

Page 25: ...so that the side rail folds down below the mattress platform To raise the side rail Grab the top side rail handle and pull it up IFU HBB500 ENG 2021 ed02 May 25 ...

Page 26: ...n third level with an audible click When the side rail is raised at its maximum top height third level then you can adjust it at the second level of height see how to lower the side rail at page 23 or leave it at the third level maximum top height IFU HBB500 ENG 2021 ed02 May 26 ...

Page 27: ...EXTENSION Head foot boards are extendable This is needed whenever the mattress platform sections are extended The gap between the head foot board and the safety side rail must be less than 6 cm Head foot boards can be easily lifted off and removed from the bed for closer access to the patient To extend the head foot boards grab the chrome plated extension tube at right left side pull the blue oper...

Page 28: ...ht left side and push them inside until the lower tube locks with an audible click To remove the head foot board grab the upper frame and lift the board up To put them back in place grab the upper frame and place the two tapered inserts inside their sockets Head Foot boards are detachable IFU HBB500 ENG 2021 ed02 May 28 ...

Page 29: ...s are identified by this symbol Keep hands and fingers away from these areas Extendable mattress platform sections The bariatric bed is supplied with extendable mattress platform sections from 90cm to 105cm and to 120cm IFU HBB500 ENG 2021 ed02 May 29 ...

Page 30: ...knob underneath that section and pull out the section with your hand pull out the extension frame release the operating knob until it locks with an audible click The first extension is at 105cm and the second extension is at 120cm To shorten the sections just reverse the procedure grab each section frame pull the BLUE operating knob underneath that section push the extension frame release the BLUE...

Page 31: ...atform sections plus levelling and lowering the bed This enables cardio pulmonary resuscitation procedure to be carried out MECHANICAL CPR quick release of the backrest The bilateral levers to activate the quick release of the backrest are located on the second extendable sections of the mattress platform Pull one of the two levers upwards to quickly lower the backrest IFU HBB500 ENG 2021 ed02 May...

Page 32: ...g and maintenance except the second section panel which is fixed Push towards head side of the bed the plastic laminate panel to release it it will slide for 1 cm and then remove it Egress handle This accessory can be used in place of the standard side rail ONLY to make the egress of the patient from the bed easier and more comfortable It was not designed to have the same function of the safety si...

Page 33: ...t end of the bed underneath the mattress platform Turn the two black hand wheel knobs placed at right side and left side of the foot frame below the foot section to unlock the foot extension now the foot extension is free to move Pull the foot extension frame out and then turn back the two hand wheel knobs until securely fastened to lock them the foot extension now is securely fastened IFU HBB500 ...

Page 34: ...Pull out the mattress retainer panel at foot end item T at page 11 turn it over and position it flat with the metal insert in its socket IFU HBB500 ENG 2021 ed02 May 34 ...

Page 35: ...e two hand wheel knobs to unlock the extension now the foot extension is free to move push it back to its original closed position turn the two hand wheels knobs back until securely fastened and locked see page 32 now the foot extension is securely fastened Linen tray The linen tray is used for supporting clean linen when the bed sheets need a change Pull out the linen tray from its closed positio...

Page 36: ...f get off the bed Lifting pole is supplied with IV hooks on top IV hooks safe working load is 4kg overall Lifting pole socket Operation Lifting pole socket is located at head end behind the extendable head board Place the lifting pole in its socket until the plastic covers of the double tubes is inside the socket IFU HBB500 ENG 2021 ed02 May 36 ...

Page 37: ...til the tube is completely inside the socket The two black nylon sockets placed at head end behind the head board can be used for I V pole fixed height and or for oxygen bottle holder Oxygen bottle holder Oxygen bottle holder is designed to accommodate AD CD DD PD RD ZD D cylinders according to Medical Gas Cylinder Data Chart Oxygen bottle holder dimension is 370 140mm Use the black hand wheel to ...

Page 38: ... Operation Oxygen bottle holder sockets are located at head end behind the head board Place the oxygen bottle holder in one of the two sockets until the metal insert is completely inside the socket IFU HBB500 ENG 2021 ed02 May 38 ...

Page 39: ... on both handsets are described separately over the next few pages To adjust the mattress platform press and hold the appropriate button until the required position is achieved Movement will continue until the button is released or the limit of actuator stroke is reached Under bed light night light The bed is supplied with under bed light on a side underneath the trolley frame See next paragraph f...

Page 40: ...led downwards AUTO CONTOUR The Auto Contour up button simultaneously raises the backrest and thigh sections to provide upright patient profiling the raised thigh section prevents the patient sliding down the bed The Auto Contour down button returns the mattress platform to a flat position MATTRESS PLATFORM HEIGHT these buttons raise and lower the mattress platform Minimum height 43cm Maximum heigh...

Page 41: ...ting for easy usage in dark surroundings The Under Bed Light is not working whenever the emergency battery is running out of charge Attendant Control Panel ACP Nurse handset The ACP is located on the foot board through its clip IFU HBB500 ENG 2021 ed02 May 41 ...

Page 42: ...ion upper button to raise lower button to lower When the thigh section is raised from the flat position 32 the calf section will be in the Fowler position 7 angled downwards MATTRESS PLATFORM HEIGHT these buttons raise and lower the mattress platform upper button to raise lower button to lower Minimum height 43cm Maximum height 79cm AUTO CONTOUR The Auto Contour upper button simultaneously raises ...

Page 43: ...et ORANGE light movement OFF function locked on ACP as well as on patient Handset To selectively lock prevent movements press the Function Lockout button and for 3 seconds the corresponding movement to lock The light of that movement will turn from green to ORANGE To lock all the movements press the Function Lockout button and for three seconds the auto chair button When all movements are locked C...

Page 44: ...m height lock will lock Reverse Trendelenburg Trendelenburg and Auto Chair too When total lock of the movements press Function Lockout Auto Chair is activated CPR and TRENDELENBURG movements will work for Emergencies Under bed light will work as well IFU HBB500 ENG 2021 ed02 May 44 ...

Page 45: ... level is displayed on the ACP On the top of the battery there are the ON and OFF switches Button Operation Action ON Press 1sec Turned ON and discharging operative bed OFF Press 3sec Turned OFF STOP discharging storage of bed or battery The battery of a new bed supplied is turned OFF It will turn ON AUTOMATICALLY when the bed will be connected to the mains otherwise turn it ON before making the b...

Page 46: ...letely discharged While the battery is recharging the ACP battery indicator will flash ORANGE The ACP indicator will be steady ORANGE when the battery will be fully charged The product should be charged continuously at least 24hrs under following circumstances Before long period without AC in First operation after long period storage Period including shipping Capacity Status 3 months 79 usable 6 m...

Page 47: ...Duty Cycle Lockout Duty cycle is 10 MAX 2min ON 18min OFF IFU HBB500 ENG 2021 ed02 May 47 ...

Page 48: ...are Decontamination Remove the side rails from the bed to allow better decontamination on beds The bed should be cleaned and disinfected weekly and before a new patient uses the bed IFU HBB500 ENG 2021 ed02 May 48 ...

Page 49: ...cyanurate NaDCC at a concentration of 1 000 parts per million 0 1 of available chlorine In the case of pooling body fluids e g blood the concentration of NaDCC should be increased to 10 000 parts per million 1 of available chlorine The manufacturer recommends sodium dichloroisocyanurate NaDCC as a disinfectant because it is effective stable and has a fairly neutral pH Many other disinfectants are ...

Page 50: ...se to the descent of the backrest Actions to be done by qualified personnel Yearly By carer keep in mind also during daily use the occurrence of signs of malfunction and or suspected degradation of the original conditions of the device reported by these tests so that a preventive intervention would be possible Carry out a full test of all electrical bed positioning functions backrest height tilt e...

Page 51: ...carrying out the following test 1 Disconnect the bed from the electricity supply 2 Raise the mattress platform to maximum height 3 Raise the backrest and thigh sections as far as they will go 4 Press and hold the CPR button and lower the mattress platform to minimum height 5 Apply maximum head down tilt Trendelenburg 6 Return the mattress platform to the level position 7 Apply maximum foot down ti...

Page 52: ...height actuators under heavy load The height operation at once under heavy extreme load 500kg could not allow the progressive fluidity of the grease around the piston of the actuator and the control box is cutting power to height actuators When control box is cutting the power just release the push button and press it again release and press until the height operation will go without interruptions...

Page 53: ...nsing Atmospheric pressure 700hPa to 1060hPa Electrical Safety data Input Voltage 100V 240V AC 50 60 Hz Transformer SMPS Max 4A Output Voltage 32V 8A 10A Duty cycle 10 Max 2 min ON 18 min OFF Safety Standards Medical device class I classified in accordance to IEC 60601 1 2005 IEC 60601 2 52 2016 Other Safety standards Requirements of Regulation EU 2017 745 MDR of the European Parliament and of the...

Page 54: ...ion 1 Short 230cm Position 2 Extended 246cm In bed length Position 1 Short 200cm Position 2 Extended 220cm Overall width Position 1 Short 106cm Position 2 Extended 136cm In bed width Position 1 Short 90cm Position 2 Medium 105cm Position 3 Extended 120cm Height of mattress platform centre of seat section to floor Height adjustment 43cm to 79cm Head down tilt angle TR 12 Foot down tilt angle RTR 12...

Page 55: ...hese hazards contact the seller for information on correct disposal Transportation and storage Handle with care Do not drop Avoid shock or violent impact This equipment should be stored in a clean dry and well ventilated area which meets the following conditions Operation temperature 5 C to 40 C Stock temperature 10 C to 50 C Relative humidity 20 to 90 at 30 C non condensing Atmospheric pressure 7...

Page 56: ... be Upper frame section Bed controls Side Rails Head and Foot Boards Manufacturer date of manufacture Complies with the European Medical Device Directive Waste Electrical and Electronic Equipment WEEE do not dispose of this product in general household or commercial waste Serial number Model number Potential equalisation terminal IFU HBB500 ENG 2021 ed02 May 56 ...

Page 57: ...Protective earth ground Recommended mattress size Recommended patient height IFU HBB500 ENG 2021 ed02 May 57 ...

Page 58: ...ade without the written consent of the manufacturer or non original components and or non original accessories have been mounted on the bed The manufacturer also declines any responsibility for Civil Liability arising from improper use of the bed and or not complying with the operating and maintenance rules of this IFU All costs for any damage suffered during transport will be charged to the recip...

Page 59: ...9 Electromagnetic Compatibility EMC EMC Test report The full version of the EMC Test is available under request Please send an email request to the seller IFU HBB500 ENG 2021 ed02 May 59 ...

Page 60: ...facture or use of this medical device in order to enhance patient and users safety The aim of this after sale surveillance system is to actively and systematically gather record and analyse relevant data on the quality performance and safety of this device throughout its entire lifetime This allows the manufacturer to continuously update the risk benefit assessment and to initiate necessary measur...

Page 61: ...cisions made for treatment No action Further surveillance actions Share informations with users IFU amendment Corrective action on future production Corrective action on devices already on the market Product recall action manager to be performed by date action verifier checked on date result detected POSITIVE NEGATIVE for the following reasons Notes see new action N of date AFTER SALE SURVEILLANCE...

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