Hill-Rom 900 Accella Bed LI900B4 Instructions for Use Rev 11

PROPRIETARY AND CONFIDENTIAL DRAFT: décembre 22, 2020 Hill-Rom S.A.S.  Z.I. du Talhouët 56330 PLUVIGNER - FRANCE Tel: + 33 (0)2 97 50 92 12 Fax: + 33 (0)2 97 50 92 03 hillrom.com Edition 11: December 2020 First printing 2017

The information contained in this manual is confidential and may not be reproduced or divulged in any form or by any means without the prior written permission of HillRom. The product images and labels are provided for information only. The actual product and labels may differ. Hill-Rom® 900, ClinActiv®  and Navicare® are registered trademarks of Hill-Rom Services, Inc. Duo® is a registered trademark of Hill-Rom Industries SA. Hillrom™, Accella™, Graphical Caregiver Interface (GCI)™, SmartCare™, Primo™, SmartSync™ and AutoContour™ are trademarks of Hill-Rom Services, Inc. MCM™ is a trademark of Hill-Rom SARL. Sabina™, Viking™, Golvo™ and LowBase™ are trademarks of Liko R&D AB. FUSION Hybrid is a registered trademark of Talley Group Limited. Hill-Rom reserves the right to make changes to the design, characteristics and models without prior notice. The only warranty Hill-Rom makes is the express written warranty extended on the sale or rental of its products. To order copies of this Instructions for Use, contact your national Hill-Rom representative go to hillrom.com and order the article with the part number 194412. © 2020 by Hill-Rom Services, Inc. ALL RIGHTS RESERVED.

194412(11) - Hill-Rom® 900 Accella™ Bed - Instructions For Use

Introduction, specifications

Table of Contents Introduction, specifications

Page i

Decontamination, Maintenance

194412(11) - Hill-Rom® 900 Accella™ Bed - Instructions For Use

Movements/Transfers

Electrical Functions Controls... 29 Caregiver half-siderail controls... 29 Patient half-siderail controls... 29 Control pendant*... 29 Bilateral HiLow pedal with caregiver mode*... 30 Raising/lowering the sleep surface... 30 Raising/lowering the head and thigh sections... 31 Trendelenburg/Reverse Trendelenburg... 32 Chair position... 34 Place sleep surface flat... 34 Bed exit aid... 34

Help with care

Mobilizing the patient

Patient safety

Before placing the patient on the bed... 21 Accessories and peripheral equipments... 22 Mattress**... 22 Recommended traction frame... 25 Recommended accessories**... 25 Recommended additional parts... 25 Recommended patient lifts... 26 Recommended bed dining tables... 26 Endboards... 26 Installing the endboards... 27 Footboard fastening system... 27 Bed frame extension*... 28

Mobilizing the patient

Installing the patient

Installing the patient

The structure of the Instructions for Use... 1 Symbol definitions... 2 Bed model and country of use... 3 Safety and Usage Tips... 4 Intended Use... 4 Contraindications... 4 Features... 4 Intended Users... 4 First use... 4 Risk prevention... 5 Electrical safety... 8 General precautions for the place of use... 9 Precautions for transport and storage... 10 Technical specifications... 11 Overview... 14 General Symbols... 15 Function Symbols... 16

Mechanical adjustable foot section... 35 Patient helpers**... 35 Graphical Caregiver Interface (GCI)™ controls... 38 Home screen... 38 Bed exit alerts*... 38 Backrest (Head) angle alert... 41 Alert suspension mode... 42 Scale (weigh system)*... 43 Weigh the patient... 46 Add/remove parts on the bed... 47 Weighed/unweighed parts... 47 combined Accella™ Therapy mattress*... 48 Description of the mattress screen (default mode)... 48 Installing the mattress... 48 Activating the mattress... 49 Therapeutic mode... 50 Maximum inflation mode (P-Max)... 50 MCM™*... 50 CPR... 51 Transport mode... 51 Deflating the mattress... 51 Stopping the mattress... 52 Disconnecting and storing the mattress... 52 Settings... 53 Wi-Fi connection... 55 SmartCare™ system*... 55 NaviCare® system*... 56 SmartSynch™ system*... 56 Wi-Fi Connection Module (WCM) - AD315A**... 57 Communication cable... 58

Patient safety Siderails... 59 Space filler panel (AD288A)**... 61 Fittings for the restraining strap handles... 63 Electrical function management... 64 Bed not in lowered position indicator... 65 Message indicator on GCI™... 65 Battery charge indicator... 65 Night light... 65 CPR... 66 Equipotential terminal... 67 Equipotential cable (AC968A)**... 67 Nurse call... 67

Help with care Fixed IV pole (AD294A)**... 69 Telescopic IV pole (AD298A-AD299A)... 69 Page ii

194412(11) - Hill-Rom® 900 Accella™ Bed - Instructions For Use

Decontamination, Maintenance

Appendix

Help with care

Warranty and after sales service conditions... 91 Compliance... 91 Electromagnetic conformance... 92 Electromagnetic emissions compliance... 92 Compliance with electromagnetic immunity... 94 Recommended separation distances... 97 Wireless Connectivity Specifications... 97

Patient safety

Decontaminating the bed... 83 Safety Recommendations... 83 Recommendations for cleaning and disinfection... 83 Servicing the bed... 87 Safety recommendations... 87 Preventive maintenance... 87 End-of-life equipment... 88 Decontaminating / servicing the combined Accella™ Therapy mattress*... 89

Mobilizing the patient

Brake and steer system... 79 Securing the power cable... 82 Removable frame (AD270B)**... 82

Installing the patient

Movements/Transfers

Introduction, specifications

Linen holder*... 70 Drainage bag holder pins... 71 Oxygen cylinder holder (AC959A-AD101A-AD102A)**... 71 Pivoting 3L Bottle Holder (AC962A)**... 72 Monitor stand (AD244B)**... 73 Syringe-driver holder (AC963A)**... 74 Traction frame... 74 IV line manager & support (AD286A)**... 75 X-ray-transparent adjustable head section (AD242A)**... 76 Chrome-plated IV hook (AC953A)**... 78 Label holder (AD325A)**... 78

Movements/Transfers Decontamination, Maintenance

194412(11) - Hill-Rom® 900 Accella™ Bed - Instructions For Use

Page iii

Page iv

194412(11) - Hill-Rom® 900 Accella™ Bed - Instructions For Use

The structure of the Instructions for Use

INSTALLATION

MOVEMENT

MOBILIZATION

EASE OF USE

COMFORT

PATIENT CAREGIVER

WELL BEING

INDEPENDENCE

HELP WITH CARE

SAFETY

For every type of use, Hillrom™ beds provide patients with optimal comfort and greater independence for a feeling of well-being that is conducive to a swift recovery. They are also easy to use for caregivers.

194412(11) - Hill-Rom® 900 Accella™ Bed - Instructions For Use

Page 1

Introduction, specifications

Introduction, specifications

Symbol definitions This Instructions for Use contains different typefaces and icons designed to improve readability and increase understanding of its content. Note the following examples: • standard text - normal character style used for “basic” information. • Boldface text- emphasizes a word or phrase. •

 highlights special information or explains very important instructions,

• The symbols below represent different risks or hazards:

Symbol

Description Warning • This symbol indicates that the failure to follow the associated recommendation can put the patient or the user in danger, or damage the equipment. Caution • This symbol indicates that the failure to follow the associated recommendation can result in damage to the equipment.

Tip

Risk of falling

Caught hazard warning

Risk of crushing an upper limb

Chemical Hazard Warning

Electric Shock Hazard

Page 2

194412(11) - Hill-Rom® 900 Accella™ Bed - Instructions For Use

Introduction, specifications

Bed model and country of use Certain features or accessories may be available or not, depending on the destination country. These features are identified with an asterisk (*) and the accessories or the additional parts are identified by two asterisks (**). To identify your bed model, its serial number SN (HRPXXXXXXXXX),its UDI and its date of manufacture, refer to the identification label (see “Overview” page 14). Your LI900B4 bed is made up of a chassis/sleep surface, with a REF reference starting with CS900B4 and two endboards (a headboard and a footboard)..

• REF: CS900B4XXXXXX; CS900 = Hill-Rom® 900 Accella™; B = Version; 4XXXXXX = a unique 7-figure numerical code matching various criteria, such as the voltage, the electrical functions, the language, etc. • SN: HRPXXXXXXX: HRP = Hill-Rom Pluvigner; XXXXXXX = incremental code. • UDI; Unique Device Indification.

194412(11) - Hill-Rom® 900 Accella™ Bed - Instructions For Use

Page 3

Safety and Usage Tips Intended Use The Hill-Rom® 900 Accella™ LI900B4 medical beds, with CPR, are intended for intensive (the CPR function remains operational in the event of an electric power outage), acute and ambulatory care for adult patients (EN60601-2-52 application environments 1, 2 and 5). The design benefits are the application of the advanced techniques used in specialized units, with the needs of the whole medical team in mind, and facilitate the use of monitoring equipment and the transfer of patients to examination wards.

Contraindications • children (aged less than 12 or under 1.46 m tall), • persons over 1.85 m tall, • persons with BMI below 17, • persons weighing less than 40 kg,

Features The Hill-Rom® 900 Accella™ LI900B4 beds are equipped with: • an emergency CPR function (Cardio Pulmonary Resuscitation), • a Trendelenburg/reverse Trendelenburg function, • batteries providing protection against power outages, The Hill-Rom® 900 Accella™ LI900B4 beds can be equipped with: • a patient position detection system, • a nurse call function*, • a built-in weigh system (compliant with the directive 2014/31/EEC) indicating the weight and BMI of the patient. • a Wi-Fi communication system* (compliant with Directive 2014/53/EEC) • a system to power and control the Accella™ Therapy* mattress that helps to prevent and treat phase I, II, III and IV pressure ulcers in low to very high-risk adult patients

Intended Users The Hill-Rom® 900 Accella™ beds are designed to be used by Qualified Staff. Patients and Visitors can also use the Hill-Rom® 900 Accella™medical beds depending on authorization given by Qualified Staff.

First use Before using the bed, it is essential to have a thorough understanding of this Instructions for Use. This Instructions for Use contains instructions for general use and maintenance and guarantees improved safety. Caregivers must have access to this Instructions for Use. Page 4

194412(11) - Hill-Rom® 900 Accella™ Bed - Instructions For Use

Caregivers must be informed of the risks that may be encountered in the use of electric beds. The many sources and types of accessories, hardware, or medical devices that may be used together with this bed do not enable Hill-Rom to guarantee both the safety and conformity of all the combinations thus created. The operator who creates these device combinations must therefore ensure that security and conformity requirements are met. Use of accessories, transducers and cables other than those specified or provided by Hill-Rom could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

Waste packaging (plastic, cardboard, metal, wood, etc.) must follow suitable recovery circuits with a view to being recycled. Before installing the bed for the first time or after bringing the bed and its accessories out of storage: • ensure that the bed and its various parts are at room temperature. • only connect the bed to a mains electric power supply with earth protection (see “Electrical safety” page 8), • the power plug must be accessible to disconnect the bed, • wait 12 hours until the battery is fully charged before using the bed without the mains power supply, • make sure that all the moving parts are in good working order, • check the time and language settings, • make sure that the bed has been cleaned and disinfected (see “Decontaminating the bed” page 85).

Risk prevention General recommendations In general: • check that nothing (e.g. objects, accessories, power cable, maintenance cable or nurse call cable) or any persons (e.g. children, limbs) will interfere with the movement of the mobile parts of the bed before actuating them. An intermittent beep sounds when one of the bed’s movements is hindered. • during a movement or combination of movements of a mobile part of the bed (eg, backrest, sleep surface, siderail), be vigilant (for oneself, the patient or any other person) on the risks of pinching or crushing between moving parts or with a fixed part.

194412(11) - Hill-Rom® 900 Accella™ Bed - Instructions For Use

Page 5

Introduction, specifications

Training can be provided on demand.

• always check (e.g. to and fro movements) that the various locking mechanisms are in good working order (e.g. siderails, extensions, brakes). • sufficiently qualified nursing staff determines the usage condition suitable for the various functions and the degree of supervision to ensure that the patient uses the bed safely. When the patient is left unattended: • apply the brakes to prevent any risks of falling, especially if the patient leans on the bed when getting in or out, • leave the sleep surface in the lowest position to avoid serious consequences in the event of falling, • use the siderails to secure the patient and reduce the risk of falling accidentally, • lock any function that, if misused, could worsen existing injuries or pathologies, or even result in bodily injury, • never leave the bed in the Trendelenburg position. Never modify the bed without Hill-Rom's prior written consent. Alterations could result in injury to the patient or damage to the bed. Only use manufacturer's parts and accessories. Never place objects or equipment on the chassis or use it to support a person. Do not use of the bed with loads in excess of the safe working load. Notice to Users and/or Patients: Any serious incident that has occurred in relation to the device, should be reported to the manufacturer and the Competent Authority of the Member State in which the user and/or patient is established.

Recommendations for the siderails In the case of patients suffering from particular behavioral difficulties (e.g., agitation, mental confusion, loss of sense of direction, obsessive behavior, old patients, weakness, etc.), properly trained medical staff should ascertain how the siderails should be used (irrespective of the model or type), whether the patient should be monitored closely or immobilized and whether the patient helpers should be left in position, in order to ensure that patients use the bed in complete safety. Certain national health authorities have issued guidelines risks to patients and the reduction of these hazards, as indicated below. It is recommended that patients at risk be identified in each establishment or ward so that the safety measures most appropriate to their particular needs can be implemented.

Page 6

194412(11) - Hill-Rom® 900 Accella™ Bed - Instructions For Use

specifying: 1. situations and conditions for siderail use and authorized mattress type or model, 2. for all patient monitoring procedures, both for restrained and unrestrained patients, including during intervals, 3. circumstances under which patients must be restrained according to the instructions and recommendations of the manufacturer of the said restraining devices. The siderails are designed to help reduce the risk of patients falling out of bed accidentally. They are not designed to restrain or immobilize the patient. Restraining straps or other devices must not be fastened to them.

Recommendations for the mattresses Hill-Rom shall not be held liable for any problems occurring if the mattress used is not included in the list of equipment recommended by Hill-Rom (see “References of recommended mattresses” page 24). Despite the protective height above the mattress and the top of the siderail, patients can still potentially fall or become trapped in the spaces around the mattress. Use of a mattress thicker than the thickness recommended in “References of recommended mattresses” page 24 may reduce the effectiveness of the siderails. Thicker mattresses can increase the risk of falling and shorter or narrower mattresses can increase the risk of patients becoming trapped. In such cases, the patient must be monitored closely. As assessed by the “Hospital Bed Safety Workgroup” guide and the standard EN 60601-2-52, the mattress label on page 22 lists the mattresses recommended for use on the Hill-Rom® 900 Accella™ to offer the safest conditions. The therapeutic benefits of the other therapeutic mattresses listed in page 22 outweigh the residual risk of entrapment or fall incurred by their use. Other mattresses may be used, but the manufacturer must always be consulted to make sure that the bed/mattress/siderail combination does not affect the bed's performance, its suitability for use or its safety characteristics. If the bed is fitted with an electrically powered air mattress, the power cord must be routed so as to prevent it from being cut by the moving parts of the bed. Users must check the compatibility of the patient's weight and the accessories placed on the bed and the mattress system in view of the specifications of the medical bed and the mattress system. If the mattress power cord is unplugged, it is advisable to store it on the support provided by the mattress supplier.

194412(11) - Hill-Rom® 900 Accella™ Bed - Instructions For Use

Page 7

Introduction, specifications

One measure which has already proved effective is to draw up a protocol

Recommendations for the function lockouts The electrical function management control prevents any unintended bed movements that might cause injury to the patient.

It is highly recommended that functional lock out should be used whenever a patient is undergoing examination or treatment or when the bed is being serviced or moved. Functions should also be locked out when the patient is left unattended and if the nursing staff believes that the patient is not capable of operating the controls independently in safety. It is thus the responsibility of the nursing staff to authorize the patient to use certain bed functions, including the HiLow.

The Trendelenburg / Reverse Trendelenburg, Boost™*, chair* and CPR* functions must only be accessible to caregivers.

Electrical safety When direct intravascular or intracardiac connections are in use, the electric potentials of all the unprotected metal parts need to be equalized. The bed must be connected to a mains electric power supply with earth protection. In an environment where electrostatic discharges are prevalent, we recommend the use of an antistatic caster. The mains power supply for the bed must comply with following standards: • NF C 15-100 and NF C 15-211 (France), • International Electrotechnical Commission (IEC) 364 for other locations. Check that the bed’s power requirements on the identification label (see “Overview” page 14) correspond to the power supply voltage of the hospital. The power supply should be equipped with a maximum 30 mA earth leakage circuit breaker, in compliance with IEC 364-5-53.

All the parts of the bed within the patient's reach are applied parts, even if they are under the bed frame. If the integrity of the protective conductor is in doubt, the beds fitted with batteries must be used in battery mode. In compliance with standards relating to electromagnetic interference for medical equipment, this product does not interfere with other medical devices or is not susceptible to interference when combined with other medical devices that also comply with the electromagnetic standards in force. Some devices, particularly older ones that do not comply with the electromagnetic compatibility standards, may however undergo interference or may themselves interfere with the working of this product. The users of such devices are responsible for ensuring that any malfunctions will not endanger the patient or any other person.

Page 8

194412(11) - Hill-Rom® 900 Accella™ Bed - Instructions For Use

If the bed is equipped with a battery, and the bed is stored for long periods of time, the battery must be charged every 3 months. Failure to do so could result in damage to the battery.

General precautions for the place of use It is advisable not to use the bed under the following conditions: - in hospital wards other than the intended ward (see “Intended Use” page 4), - climatic conditions outside the corresponding ranges recommended by HillRom, - in hyperbaric chambers, - in explosive atmospheres, - in the presence of flammable gases or vapors, - with oxygen tent type respiration devices or devices that extend below the sleep surface, - outdoors or to transport a patient in a vehicle, - moving the bed over soft ground or inappropriate surfaces, - moving the bed along slopes of over 10° (with or without a patient).

194412(11) - Hill-Rom® 900 Accella™ Bed - Instructions For Use

Page 9

Introduction, specifications

Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Ensure that the power cord is unplugged and hooked to the bed before moving the bed (see “Securing the power cable” page 84). Only duly qualified and authorized staff should carry out electrical maintenance. Never clean or service the bed without unplugging it from the mains power supply and disconnecting the battery. The battery backup must never be left in direct contact with fire, placed in liquid, or discarded in a refuse bin. In the event of the battery being damaged, see “End-of-life equipment” page 90. This label indicates that the bed must never be used with an oxygen tent or in explosive atmospheres (presence of inflammable gases or vapors). Use only nasal tubes and oxygen masks. For reasons of safety, masks and tubes should always be kept at a higher level than the mattress support platform. Always lock out the HiLow function before any cleaning or maintenance operations.

Climatic restrictions Service temperature Service humidity Working atmospheric pressure

+10° to +40° C 30% - 85% 700 hPa to 1,060 hPa

Precautions for transport and storage The following conditions must be met to ensure that the bed and its accessories are shipped and stored in complete safety. a

During shipment , the bed must be: - in the low position - in “function lock out” mode - covered, brakes applied, strapped - protected from fluid ingress

When stored, the bed must be: - in the low position - in “function lock out” mode - covered, brakes applied - protected from fluid ingress

a. Transport does not include the transfer of the bed between wards with or without patients.

Climatic restrictions on transport and storage Transport/storage temperature Transport/storage hygrometry Transport/storage atmospheric pressure

-30° to +50° C 20% - 85% 700 hPa to 1,060 hPa

During shipment or storage, beds should not be stacked one on top the other.

Page 10

194412(11) - Hill-Rom® 900 Accella™ Bed - Instructions For Use

Introduction, specifications

Technical specifications

Hill-Rom has an ongoing continuous improvement policy. Therefore specifications are liable to be altered without notice. L+ W

L

28° 65° -22° H

C B1

B2

S1

h

Features Maximum width (W) Maximum length (without extension) (L) Maximum length (with extension closed) (L) Maximum length (with extension open) (L+) Length of the head half-siderail protection (B1) Length of the foot half-siderail protection (B2) Siderail protection height (without mattress) (S1) Low position (double-band 125 diameter casters) (h) Low position (double band 150 diameter casters) (h) Low position (150 diameter casters) (h) High position (double-band 125 diameter casters) (H) High position (double band 150 diameter casters) (H) High position (150 diameter casters) (H) b

b

b

b

b

b

194412(11) - Hill-Rom® 900 Accella™ Bed - Instructions For Use

Value a

995 mm 2158 mm 2158 mm 2358 mm 499 mm 631 mm 393 mm 386 mm 431 mm 439 mm 747 mm 800 mm 808 mm

a a a

a a a a a a a a a

Page 11

Features b

Chassis clearance (double-band 125 diameter casters) (C) Chassis clearance (double band 150 diameter casters) (C) Chassis clearance (150 diameter casters) (C) Head section incline Thigh section incline Foot section incline Trendelenburg/Reverse Trendelenburg Boost™ patient position mechanism Electric CPR - return adjustable head section (T1)  and sleep surface (T2) to flat position Safe working load (SWL) Maximum patient weight LI900B4 bed weight (no mattress or accessories) Total weight authorized during moving Maximum temperature of the applied parts at 40°C Unweighted peak acoustic pressure levels Weighted maximum measured acoustic pressure b

b

c

c

c

c

Value a

150 mm 195 mm 203 mm + 65° + 28° - 3° to -22° + 17°/- 17° - 7 °/30 sec T1 < 5 s T2 < 30 s 250 kg a a

a a

a a

185-215 kg 170 kg 420 kg 56.5° C <120 dB 42 dBA

d

a. These are average values, which may vary according to manufacturing tolerances. b. Dimensions in mm. c. Maximum incline in relation to the sleep surface d. SWL 250 kg / the maximum patient weight varies according to the mattress and accessories used - 185 kg as per EN60601-2-52 (intensive and acute care) - 215 kg as per EN60601-2-52 (ambulatory care)

Electrical characteristics Features Voltage Frequency: Maximum absorbed power Electric shock protection Class according to IEC 60601-1 Protection against harmful ingress of water (according to IEC 60529) Duty cycle

120V* 120V AC 60 Hz 500 VA

230V* 230V AC 50/60 Hz 500 VA Class I Type B IPX4 a

10% (2 min/18 min)

a. Do not operate electrical functions continuously for more than 2 minutes in any 18 minute period when the bed is loaded at the safe working load value as this may damage electrical components. The power supply of the actuator is temporarily cut off if the load factor is exceeded when using the HiLow.

Page 12

194412(11) - Hill-Rom® 900 Accella™ Bed - Instructions For Use

The weigh system of the Hill-Rom® 900 Accella™ bed uses four weighing cells installed in the bearing structure of the bed. The bed is made up of a mobile structure (the weigh system) and a fixed structure (the frame).

Features

Value a

Class of the weigh system (2014/31/EEC) NAWI Maximum range of the weigh system Minimum range of the weigh system Range

Class III 250 kg 10 kg 0.5 kg

a. Non-Automatic Weigh Instrument

Conditions required to connect the nurse call system For more information about the connections required to use the nurse call function, please refer to the SideCom® Communication System Design and Application Manual (DS059).

194412(11) - Hill-Rom® 900 Accella™ Bed - Instructions For Use

Page 13

Introduction, specifications

Characteristics of the weigh system (scale)

Overview B

G

F

A

Q D H

C

O

I J K

P E

L M

Item

Name

Item

A B C

Half-siderails Headboard 2 sockets for I.V. pole and patient helper Caregiver half-siderail controls Head section “CPR” control

I J K

D E F G H

Page 14

Patient half-siderail controls Graphical Caregiver Interface (GCI)® controls Footboard

Name

O P

Extension + linen holder* Bumper (4) Central brake and steer bar control 150 mm diameter casters Bilateral HiLow pedal with caregiver mode* Control pendant* Identification label

Q

Wi-Fi module AD315A**

L M

194412(11) - Hill-Rom® 900 Accella™ Bed - Instructions For Use