Centuris Pro Bed LI900B1 Instructions for Use Rev 7 May 2021

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 7: May 2021 First printing 2015

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. ClinActiv® is a registered trademarks of Hill-Rom Services, Inc. Hillrom™ and AutoContour™ are trademarks of Hill-Rom Services, Inc. Centuris™ is a trademark of Hill-Rom Services PTE Ltd. MCM™ is a trademark of Hill-Rom SARL. Sabina™, Viking™, Golvo™ et LowBase™ are trademarks of Liko R&D AB. FUSION Hybrid is a 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 manual, contact your national Hill-Rom representative or go to hillrom.com and order the article with the part number 194568. © 2021 by Hill-Rom Services, Inc. ALL RIGHTS RESERVED.

194568(7) - Instructions for Use Electric Bed Centuris™ Pro

PROPRIETARY AND CONFIDENTIAL DRAFT: 28 mai 2021 Introduction Specifications

Table of Contents Introduction, specifications

Page i

Decontamination, Maintenance

194568(7) - Instructions for Use Electric Bed Centuris™ Pro

Moving the bed

Electrical Functions... 29 Control pendant*... 29 Caregiver half-siderails* controls... 29 Patient half-siderails* controls... 30 Raising/lowering the sleep surface... 30 Raising/lowering the head and thigh sections... 31 Trendelenburg/Reverse Trendelenburg... 32 Mechanical adjustable foot section... 32 Patient helpers**... 33

Help with care

Mobilizing the patient

Securing the patient

Before placing the patient on the bed... 21 Accessories and peripheral equipments... 21 Mattress**... 22 Recommended accessories**... 25 Recommended additional parts... 25 Recommended patient lifts... 26 Recommended bed dining tables... 26 Endboards... 26 Installing the endboards... 26 Bed frame extension*... 27 Wall stop AD277A*... 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 Intented 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... 10 Precautions for transport and storage... 11 Technical specifications... 12 Overview... 13 General Symbols... 16 Function Symbols... 17 Electrical controls... 19

PROPRIETARY AND CONFIDENTIAL DRAFT: 28 mai 2021 Egress handles*... 36

Securing the patient Siderails... 37 AD271B** siderails... 37 Removing the long siderails... 38 Installing the the long siderails... 38 Siderail safety net (AD312A)**... 39 Half-siderails*... 39 Foot gap panels (AD288A)... 40 Fittings for the restraining strap handles... 42 Electrical function management... 44 Bed not in lowered position indicator*... 45 CPR... 45 Equipotential terminal... 45 Equipotential cable (AC968A)... 46

Help with care Fixed IV pole (AD294A)... 47 Telescopic IV pole (AD298A-AD299A)... 47 Linen holder*... 48 Drainage bag holder pins... 49 Oxygen Cylinder Holder (AC959A-AD101A-AD102A)... 49 Pivoting 3L Bottle Holder (AC962A)**... 50 Monitor stand (AD244B)... 51 Syringe-driver holder (AC963A)... 51 IV line manager & support (AD286A)**... 52 X-ray-transparent adjustable head section (AD242A)**... 52 Chrome-plated IV hook (AC953A)**... 55 Label holder (AC325A)**... 55

Movement/Transfer Braking/steering... 57 Securing the power cable... 59 Removable frame (AD270B)... 59

Decontamination, Maintenance Decontamination... 61 Safety recommendations... 61 Recommendations... 61 Recommendations for cleaning and disinfection... 61 Maintenance... 65 Safety recommendations... 65 Preventive maintenance... 65 De-commissioning... 66

Appendix Warranty and after sales service conditions... 67 Page ii

194568(7) - Instructions for Use Electric Bed Centuris™ Pro

PROPRIETARY AND CONFIDENTIAL DRAFT: 28 mai 2021 Introduction Specifications Installing the patient

Compliance... 67 Electromagnetic conformance... 68 Complies with electromagnetic emission standards... 68 Electromagnetic conformance... 69 Complies with electromagnetic emission standards... 69 Compliance with electromagnetic immunity... 70 Recommended separation distances... 72

Mobilizing the patient Securing the patient Help with care Moving the bed Decontamination, Maintenance

194568(7) - Instructions for Use Electric Bed Centuris™ Pro

Page iii

PROPRIETARY AND CONFIDENTIAL DRAFT: 28 mai 2021

Page iv

194568(7) - Instructions for Use Electric Bed Centuris™ Pro

PROPRIETARY AND CONFIDENTIAL DRAFT: mai 28, 2021

The structure of the Instructions for Use

INSTALLATION

MOVEMENT

MOBILIZATION

EASE OF USE

COMFORT

PATIENT CAREGIVER

WELL BEING

HELP WITH CARE

INDEPENDENCE

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.

194568(7) - Instructions for Use Electric Bed Centuris™ Pro

Page 1

Introduction Specifications

Introduction, specifications

PROPRIETARY AND CONFIDENTIAL DRAFT: mai 28, 2021

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

194568(7) - Instructions for Use Electric Bed Centuris™ Pro

PROPRIETARY AND CONFIDENTIAL DRAFT: mai 28, 2021

Certain bed 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 “Electrical characteristics” page 13). Your bed model, LI900B1, is composed of a chassis/sleep surface whose reference REF starts with CS900B1 and two endboards (a headboard and a footboard).

• REF: CS900B1XXXXXX: CS900 = Centuris™ Pro; B = Version; 1XXXXXX = unique 7figure numerical code according to different criteria, such as the voltage, the electrical functions, the language, etc. • SN: HRPXXXXXXXXX: HRP = Hill-Rom Pluvigner; XXXXXXXXX = incremental code. • UDI; Unique Device Identification.

194568(7) - Instructions for Use Electric Bed Centuris™ Pro

Page 3

Introduction Specifications

Bed model and country of use

PROPRIETARY AND CONFIDENTIAL DRAFT: mai 28, 2021

Safety and Usage Tips Intented Use The Centuris™ Pro beds LI900B1 with electric comfort Trendelenburg / Reverse Trendelenburg are variable-height beds designed for acute, general and ambulatory care or care during long hospital stays for adult patients (EN 60601-2-52, application environments 2, 3 and 5). They are designed with the needs of the whole medical team in mind and the benefits are to facilitate the use of monitoring equipment and the transfer of patients to examination wards, etc.

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

Features The Centuris™ Pro beds: • are fitted with batteries providing protection against power outages. The electric Trendelenburg is not an emergency function. • fitted with Ø 150mm casters can be used to transfer patients.

Intended Users The Centuris™ Pro beds are designed to be used by Qualified Staff. Patients and Visitors can also use the Centuris™ Pro 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 manual. This manual contains instructions for general use and maintenance and guarantees improved safety. Caregivers must have access to this manual. Training can be provided on demand. 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.

Page 4

194568(7) - Instructions for Use Electric Bed Centuris™ Pro

PROPRIETARY AND CONFIDENTIAL DRAFT: mai 28, 2021

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, • make sure that the bed has been cleaned and disinfected (see “Decontamination” page 61).

Risk prevention General recommendations In general: • check that nothing (e.g. objects, accessories or power 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. • always check (e.g. to and fro movements) that the various locking mechanisms are in good working order (e.g. siderails, extensions, grip handles, brakes). • sufficiently qualified nursing staff determine the usage condition suitable for the various functions and the degree of supervision to ensure that the patient uses the bed safely.

194568(7) - Instructions for Use Electric Bed Centuris™ Pro

Page 5

Introduction Specifications

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.

PROPRIETARY AND CONFIDENTIAL DRAFT: mai 28, 2021 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.

One measure which has already proved effective is to draw up a protocol specifying: 1. 2.

situations and conditions for siderail use and authorized mattress type or model, 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 the half-length siderails (e.g., straps). Page 6

194568(7) - Instructions for Use Electric Bed Centuris™ Pro

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 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 606012-52, the mattress label on page 22 lists the mattresses recommended for use on the Centuris™ Pro 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 (refer to the instructions of the mattress). 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.

194568(7) - Instructions for Use Electric Bed Centuris™ Pro

Page 7

Introduction Specifications

PROPRIETARY AND CONFIDENTIAL DRAFT: mai 28, 2021 Recommendations for the mattresses

PROPRIETARY AND CONFIDENTIAL DRAFT: mai 28, 2021 Recommendations for the function lockouts The electrical function management control prevents any unintended bed movements that might cause injury to the patient.

For safety reasons, it is advisable to use the lock-out functions when treating the patient or working on the bed (e.g., examinations, transfers, maintenance), when the patient is left unattended and when caregivers believe that the patient is not in a fit state of health to operate the controls 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 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 the electrostatic discharges are prevalent, we recommend using an antistatic caster. The mains power supply for the bed must comply with relevant 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 “Electrical characteristics” page 13) 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 that are within the patient's reach, even if they are under the frame, are applied parts. 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. Page 8

194568(7) - Instructions for Use Electric Bed Centuris™ Pro

PROPRIETARY AND CONFIDENTIAL DRAFT: mai 28, 2021

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 59). 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 “Decommissioning” page 66. 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 sleep surface. Always lock out the HiLow function before any cleaning or maintenance operations. 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.

A continuous beep when activating a movement sounds to indicate that the battery needs recharging.

194568(7) - Instructions for Use Electric Bed Centuris™ Pro

Page 9

Introduction Specifications

The users of such devices are responsible for ensuring that any malfunctions will not endanger the patient or any other person.

PROPRIETARY AND CONFIDENTIAL DRAFT: mai 28, 2021

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 “Bed model and country of use” page 3), • 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). Climatic restrictions Service temperature Service humidity Working atmospheric pressure

Page 10

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

194568(7) - Instructions for Use Electric Bed Centuris™ Pro

PROPRIETARY AND CONFIDENTIAL DRAFT: mai 28, 2021

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 lowered position - all functions locked out - covered, brakes applied and all moving parts secured - protected from fluid ingress

When stored, the bed must be: - in the lowered position - all functions locked out - 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° and +50° 20% - 85% 700 hPa to 1,060 hPa

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

194568(7) - Instructions for Use Electric Bed Centuris™ Pro

Page 11

Introduction Specifications

Precautions for transport and storage

PROPRIETARY AND CONFIDENTIAL DRAFT: mai 28, 2021

Technical specifications

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

W

L B

S 65° 28° H h

C

B1

B2

S1

Features

Value

Maximum width (W) Maximum length (without extension) (L) Maximum length (with extension closed) (L) Maximum length (with extension open) (L+) Length of long siderail protection (B) Height of long siderail protection (without mattress) (S) Length of the head half-siderail protection (B1) Length of the foot half-siderail protection (B2) Height of long siderail protection (without mattress) (S1) Low position (150 diameter casters ) (h) High position (150 diameter casters ) (H) Chassis clearance (150 diameter casters ) (C) Head section incline Thigh section incline Foot section incline Trendelenburg/Reverse Trendelenburg d

cd

d

cd

d

e

e

e

Page 12

cd

a

995 mm 2162 mm 2162 mm 2362 mm 1421 mm 385 mm 499 mm 631 mm 393 mm 397 mm 768 mm 203 mm + 65° + 28° - 3° to -22° - 17°/+ 17° a a a

b

ab a a a a a a

a a

a a

194568(7) - Instructions for Use Electric Bed Centuris™ Pro

PROPRIETARY AND CONFIDENTIAL DRAFT: mai 28, 2021 Value

Maximum patient weight 220 kg SWL version g

Maximum tare of long siderails Maximum tare of half-siderails without an extension Maximum tare of half-siderails with an extension Maximum temperature of applied parts at 40° C Unweighted peak acoustic pressure levels Maximum measured level of weighted acoustic pressure g

g

155-185 kg 125 kg 133 kg 137 kg 56,5° C <120 dB 42 dBA

Introduction Specifications

Features

f

a. These are average values, which may vary according to manufacturing tolerances. b. Bed fitted with AD271B siderails c. Dimensions in mm. d. An antistatic version is also available. e. Maximum inclination in relation to sleep surface f. SWL 220 kg / the maximum patient weight varies according to the mattress and accessories - 155 kg as per EN60601-2-52 (acute care) - 185 kg as per EN60601-2-52 (other environments). g. Without mattress or accessories.

Electrical characteristics Characteristic Voltage Frequency Power supply unit maximum power load Power supply unit fuse rating Electric shock protection Class according to IEC 60601-1 Protection against harmful ingress of water (according to IEC 60529) Duty cycle

100-240V*

230V*

100-240V AC 230V AC 50/60 Hz 50/60 Hz 500 VA 300 VA 2 x 4.0 A T 2 x 1.25 A T Class I Type B a

IPX4 / IPX6 10% (2min/18min)

b

a. Option b. 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.

Overview

194568(7) - Instructions for Use Electric Bed Centuris™ Pro

Page 13

PROPRIETARY AND CONFIDENTIAL DRAFT: mai 28, 2021 Bed with half-siderails D

N

B

A

M C G

E

H I

L

F

Item

J

K

Name

Item

Name

H

B C

Half siderails Headboard 2 sockets for I.V. pole and patient helper

Extension + linen holder Bumper (4) Central brake and steer bar control

D

Control pendant

a

K

E

Head section “CPR” control General lock-out unit of the electrical functions Footboard

A

a

a

F G

I J

a

L

150 mm diameter single band casters HRP and identification labels

M

Caregiver half-siderails controls

N

Patient half-siderails controls

a

a

a. Equipment varies depending on bed model

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194568(7) - Instructions for Use Electric Bed Centuris™ Pro