Summary of Contents for Healthniture 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...
- Page 2 Design Policy and Copyright ® and ™ are trademarks belonging to Healthniture S.r.l. unless otherwise 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..
- Page 3 YOU WILL FIND THIS SYMBOL BOTH ON THIS IFU AND ON THE BED! Explains or amplifies a procedure or condition. Indicates an optional item or feature. IFU-HBB500-ENG-2021#ed02-May...
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Page 4: Table Of Contents
Electric connection Cable storage Potential equalisation terminal Mattress 4. Operation Brakes and steering Side Rails Extendable Head board/Foot board Extendable Mattress Platform Sections Electric and Mechanical CPR backrest release Mattress support panels removal Egress handle Bed length adjustment IFU-HBB500-ENG-2021#ed02-May... - Page 5 Attendant Control Panel (ACP) Function lockout Backup emergency battery Duty cycle lockout 5. Product Care Decontamination Preventive maintenance Battery test Troubleshooting Product lifetime 6. Accessories 7. Technical Data 8. Warranty and Service 9. Electromagnetic Compatibility (EMC) 10. AFTER SALE SURVEILLANCE REPORTING FORM IFU-HBB500-ENG-2021#ed02-May...
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Page 6: General Warnings
General Warnings Continued on next page IFU-HBB500-ENG-2021#ed02-May... - Page 7 Continued on next page IFU-HBB500-ENG-2021#ed02-May...
- Page 8 IFU-HBB500-ENG-2021#ed02-May...
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Page 9: Introduction
1. Introduction These instructions contain information for the installation, use and maintenance of the Bariatric Bed HBB500. This bed has multiple functions to provide the optimum nursing position for both patient and carer. Standard features Extendable mattress platform sections ... -
Page 10: Specification Labels
Specification labels The model number of 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. -
Page 11: Product Overview
Expandable Seat section (+CPR handle) Expandable sections operating knob Expandable Thigh section Extendable head board operating knob Expandable Calf section Adjustable length mattress platform Side rails (detachable) Mattress retainer/mattress extension platform Side rail operating knobs Under-bed light Linen tray Corner Roller buffer IFU-HBB500-ENG-2021#ed02-May... -
Page 12: Clinical Applications
The mattress platform can be positioned to assist with treatment of a patient as required within the clinical settings defined in Application Environments 1, 2 and 3. The correct use of this medical device, according to this IFU, represents a valid support to improve patient’s health. IFU-HBB500-ENG-2021#ed02-May... -
Page 13: Contra-Indications 1
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-2021#ed02-May... -
Page 14: Installation
(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 possibly be interchangeable in position. IFU-HBB500-ENG-2021#ed02-May... - Page 15 “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...
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Page 16: Electric Connection
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... -
Page 17: Cable Storage 1
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. IFU-HBB500-ENG-2021#ed02-May... -
Page 18: Potential Equalisation Terminal 1
A potential equalisation terminal is located at the head end of the bed. Potential When other electrical equipment is within reach of the patient or carer, equalisation potential differences between the equipment can be minimised by terminal connecting together their potential equalisation terminals. IFU-HBB500-ENG-2021#ed02-May... -
Page 19: Mattress 1
Recommended positioning from rear wall at least 8cm from the corner roller buffer Mattress Mattress size A label on the frame indicates the correct mattress size: (thickness measure must be read as the maximum value possible.) label IFU-HBB500-ENG-2021#ed02-May... - Page 20 To ensure compliance with EN 60601-2-52:2016, an approved mattress should be used. Compliance with this standard when using other mattresses must be validated by the user. For more information on suitable mattresses and mattress replacements, contact your local approved distributor. IFU-HBB500-ENG-2021#ed02-May...
- Page 21 Pulling or pushing the bed to its right height becomes essential to be able to transmit the right force for movement, taking advantage of your center of gravity, your weight and placing one leg before the other for the initial thrust. IFU-HBB500-ENG-2021#ed02-May...
- Page 22 The bed is fitted with n.4 drop split side rails, adjustable height and Side rails 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...
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Page 23: Operation
Operation Side rails are detachable. To lower Hold the top side rail handle (third level) and pull the UPPER blue operating knob: the side rail IFU-HBB500-ENG-2021#ed02-May... - Page 24 (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...
- Page 25 To raise Grab the top side rail handle and pull it up: the side rail IFU-HBB500-ENG-2021#ed02-May...
- Page 26 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...
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Page 27: Extendable Head Board/Foot Board 2
To extend the head/foot boards, grab the chrome plated extension tube at EXTENSION right/left side, pull the blue operating knob, pull out the chrome plated extension tube (while releasing the blue operating knob) until it locks with an audible “click”. IFU-HBB500-ENG-2021#ed02-May... - Page 28 “click”. REMOVAL To remove the head/foot board grab the upper frame and lift the board 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...
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Page 29: Extendable Mattress Platform Sections 2
Mattress platform sections potential contact points are identified by this symbol. Keep hands and fingers away from these areas!!! The bariatric bed is supplied with extendable mattress platform sections, Extendable from 90cm to 105cm and to 120cm. mattress platform sections IFU-HBB500-ENG-2021#ed02-May... - Page 30 TO SHORTEN the To shorten the sections, just reverse the procedure: grab each section frame, pull the BLUE operating knob underneath that section, push the sections extension frame, release the BLUE operating knob until it locks with an audible “click”. IFU-HBB500-ENG-2021#ed02-May...
- Page 31 The bilateral levers to activate the quick release of the backrest are located MECHANICAL CPR on the second extendable sections of the mattress platform. Pull one of quick release of the two levers upwards to quickly lower the backrest. the backrest IFU-HBB500-ENG-2021#ed02-May...
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Page 32: Egress Handle 3
It was not designed to have the same function of the safety side rail the bed is originally equipped with. Its adjustment operation is the same of standard side rail at page 20. IFU-HBB500-ENG-2021#ed02-May... -
Page 33: Bed Length Adjustment 3
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-ENG-2021#ed02-May... - 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...
- Page 35 The linen tray is used for supporting clean linen when the bed sheets need Linen tray a change. Pull out the linen tray from its closed position below the foot board. After use, push the linen tray back to its closed position. IFU-HBB500-ENG-2021#ed02-May...
- Page 36 IV hooks safe working load is 4kg overall. Lifting pole socket is located at head end, behind the extendable head Lifting pole board. socket Operation 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...
- Page 37 Oxygen bottle holder is designed to accommodate AD, CD, DD, PD, RD, ZD, Oxygen bottle D cylinders (according to Medical Gas Cylinder Data Chart). holder Oxygen bottle holder dimension is 370×140mm. Use the black hand-wheel to lock the tank. Safe working load is 10kg. IFU-HBB500-ENG-2021#ed02-May...
- Page 38 Oxygen bottle holder sockets are located at head end, behind the head Oxygen bottle board. holder sockets Place the oxygen bottle holder in one of the two sockets until the metal insert is completely inside the socket. Operation IFU-HBB500-ENG-2021#ed02-May...
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Page 39: Adjusting The Mattress Platform 3
Movement will continue until the button is released or the limit of actuator stroke is reached. The bed is supplied with under bed light on a side, underneath the trolley Under-bed light frame. See next paragraph for operation. (night-light) IFU-HBB500-ENG-2021#ed02-May... -
Page 40: Under-Bed Light 3
Minimum height: 43cm Maximum height: 79cm UNDER-BED LIGHT: this button switches ON the under bed light, located at a side of the bed, under the trolley frame. To switch the light OFF, just push the button again. IFU-HBB500-ENG-2021#ed02-May... - Page 41 The patient handset is supplied with green background lighting for easy usage in dark surroundings The Under-Bed Light is not working whenever the emergency battery is running out of charge. The ACP is located on the foot board through its clip. Attendant Control Panel (ACP – Nurse handset) IFU-HBB500-ENG-2021#ed02-May...
- Page 42 This button lowers the head end of the mattress platform (maximum 12°). AUTO-CHAIR (cardiac-chair): The Auto-Chair button simultaneously raises the backrest (50°) and thigh sections (22°), then lower the foot end of the mattress platform into a chair position. IFU-HBB500-ENG-2021#ed02-May...
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Page 43: Function Lockout 4
CPR and TRENDELENBURG movements will work for Emergencies (Under bed light will work too). To unlock (allow) previously locked movements: press the Function Lock button and the corresponding movement to unlock. Thigh section lock, will lock Auto-Contour and Auto-Chair too. IFU-HBB500-ENG-2021#ed02-May... - Page 44 Mattress platform 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...
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Page 45: Backup Emergency Battery 4
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 bed fully operative. IFU-HBB500-ENG-2021#ed02-May... - Page 46 *Be sure to charge 24hrs every 6 Remarks months least From Hi charging status (around 80%) to fully charged (in warranty period > 90% max capacity), it needs around additional 10hrs charging. When seeing the failure status indication, please liaise with the seller. IFU-HBB500-ENG-2021#ed02-May...
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Page 47: Duty Cycle Lockout 4
Duty Cycle Lockout Duty cycle is 10%, MAX 2min ON, 18min OFF. IFU-HBB500-ENG-2021#ed02-May... -
Page 48: Product Care
5. Product Care 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... -
Page 49: Preventive Maintenance 4
This product is subject to wear and tear during use. Preventive To ensure that it continues to perform within its original specification, maintenance preventive maintenance procedures should be carried out at the intervals shown. IFU-HBB500-ENG-2021#ed02-May... - Page 50 foot down tilt is applied. Check that the bed operates correctly using the backup battery as described in the next section Battery test. Check operation the of castors, paying special attention to braking and steering functions IFU-HBB500-ENG-2021#ed02-May...
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Page 51: Battery Test 5
If the bed fails a second time, contact the seller. To maintain best performance see: - chapter 7. Technical data / Electrical & Safety data / backup battery. - chapter 7. Technical data / Transportation and storage / Caution. IFU-HBB500-ENG-2021#ed02-May... -
Page 52: Troubleshooting 5
Product Lifetime “Lifetime” is defined as the period during which the product will maintain the specified performance and safety, provided it has been maintained and operated in conditions of normal use in accordance with the requirements in these instructions. IFU-HBB500-ENG-2021#ed02-May... -
Page 53: Accessories
Requirements of Regulation (EU) 2017/745 MDR of the European Parliament and of the Council of April, 5th 2017 Electric shock protection Class I Complies with EN 60601-1-2 (2014/30/EU) Potential equalisation terminal Complies with EN 60601-1 (DIN 42801) Ingress protection IPX4 (Electric set is IP66) IFU-HBB500-ENG-2021#ed02-May... - Page 54 12° Mattress size (refer to Chapter 3 for details) Position 1 (Short) 200cm x 90cm, 12.5 to 19cm thick Position 2 (Medium) 200cm x 105cm, 12.5 to 19cm thick Position 3 (Extended) 200cm x 120cm, 12.5 to 19cm thick IFU-HBB500-ENG-2021#ed02-May...
- Page 55 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 700hPa to 1060hPa IFU-HBB500-ENG-2021#ed02-May...
- Page 56 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...
- Page 57 Protective earth (ground) Recommended mattress size Recommended patient height IFU-HBB500-ENG-2021#ed02-May...
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Page 58: Warranty And Service
For each request for spare parts, the code of the bed (RF) and its Serial Number (SN) must be specified. For service, maintenance and any questions regarding this product, please contact the manufacturer (bariatric@healthniture.com) or your own local distributor. IFU-HBB500-ENG-2021#ed02-May... -
Page 59: Electromagnetic Compatibility (Emc)
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... - Page 60 MANUFACTURER of any issue or reportable event spotted regarding the use of HBB500 Bariatric Bed, in order to let the manufacturer take corrective and/or preventive actions in accordance with information on this medical device and its performance. This process allows the identification of problems with the design, manufacture or use of this medical device in order to enhance patient and users safety.
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Page 61: After Sale Surveillance Reporting Form
(date) action verifier: checked on: (date) result detected: POSITIVE NEGATIVE for the following reasons: Notes: see new action N° … of (date)... AFTER SALE SURVEILLANCE REPORTING FORM Rev. 0 – November 1st, 2020 - Healthniture S.r.l. IFU-HBB500-ENG-2021#ed02-May...
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