Accella Instructions for Use Rev 6 May 2020

Hill-Rom S.A.S. ZI du Talhouët 56330 Pluvigner - France Tel: +33 (0) 2 97 50 92 12 Fax: +33 (0) 2 97 50 92 00 hillrom.com Edition 6: May 2020 First Printing: 2017 The information contained in this manual is confidential and may not be reproduced or transmitted in any form or by any means without the prior written permission of HillRom. Hillrom™, , ReFlex™ Progressa™, StayInPlace™ and Accella™ Therapy are trademarks of Hill-Rom Services, Inc. I-mmersion™ and MCM™ are trademarks of Hill-Rom SARL. 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 199253. © 2020 Hill-Rom Services, Inc. ALL RIGHTS RESERVED.

199253(6) - EN - Accella™ Therapy Mattress Instructions for Use

Section 1: Destination and Specifications

Page i

Compliance

199253(6) - EN - Accella™ Therapy Mattress Instructions for Use

Accessories

Understanding the Therapeutic Mode... 25 Selecting the Operation Mode... 25 Standalone version... 25 Locking... 26 Patient exit function... 26 MCM™*... 26

Disinfecting and Servicing

Section 3: Mobilizing and Securing the Patient

Moving the Device

Before Placing the Patient on the Device... 19 Checking the Compatibility of Bed Frames and Mattresses... 19 Installing the Device... 20 Standalone version... 20 Version combined with the Accella™ bed... 22 Version combined with the Progressa™ bed... 23

Mobilizing and Securing the Patient

Section 2: Installing the Patient

Installing the Patient

Structure of the Manual and Symbols Definition... 1 Safety and Usage Tips... 3 Intended Use... 3 Indications... 3 Contraindications... 3 Intended Users... 3 Identifying the models... 4 First Use... 4 Preventing Risks... 5 Complying with Electrical Safety Standards... 5 Complying with Conditions for Transport, Storage and Use... 6 Referring to Technical Specifications... 7 Essential performances of the device... 7 Control pendant*... 7 Therapeutic Mattress... 8 Understanding the Symbols on the Device... 10 Symbols on the Upper Cover... 10 Symbols on the Technical Box... 11 Symbols on the Control Pendant*... 12 Symbols on the labels... 13 Locating the Identification Labels of the Device... 14 On the technical box... 14 On the Control Pendant... 15 Accessing to the Upper and BottomCovers Identification Labels... 15 Checking the Model of the Device on the Packaging Label... 17

Destination and Specifications

Table of Contents

Combined mattress... 27 Activating the CPR... 27 Standalone version... 27 Combined mattress... 27 X-ray cassette pouch... 28 Understanding the Alarms... 29 Meaning of the alarms on the standalone mattress*... 29 Table of alerts... 30 Table of the error codes on the GCI screen (combined mattress*)... 30 Alarm silence... 30 Mains power fault... 31 Malfunction... 31

Section 4: Moving the Device Moving the Patient on the Bed in Transport Mode... 33 Transferring the Device from One Bed to Another... 34 Storing the Device... 35

Section 5: Disinfecting and Servicing Cleaning and Disinfecting the Device... 39 Complying with Safety Instructions... 39 Controlling Infection... 39 Complying with Hill-Rom Recommendations... 39 Cleaning and disinfection frequency of the various parts of the mattress 41 Cleaning and Disinfecting after the Departure of a Patient or when Changing the Sheets... 41 Cleaning and Disinfecting at Regular Intervals or in the Event of High Risk of Contamination... 42 Performing the Final Steps... 43 Servicing of the Device... 44 Complying with Safety Instructions... 44 Performing Preventive Maintenance... 44 Troubleshooting... 45 Complying with Warranty Conditions... 46 De-commissioning... 46

Section 6: Accessories and additional parts Reflex™ Seat Cushion (M04177)**... 47 Symbols on the upper cover... 47 Locate the seat cushion labels... 48 Installing the Seat Cushion... 49 Deflating and Packing the Seat Cushion... 50 Cleaning and Disinfecting the Seat Cushion... 50 Transport bag**... 50 Control pendant**... 51

Section 7: Compliance Page ii

199253(6) - EN - Accella™ Therapy Mattress Instructions for Use

Installing the Patient

Compliance... 53 CE conformity mark... 53 Standards... 53 Electromagnetic emissions compliance... 54 Compliance with electromagnetic immunity... 54 Recommended separation distances... 55

Destination and Specifications

Electromagnetic Compatibility

Mobilizing and Securing the Patient

Moving the Device Disinfecting and Servicing Accessories Compliance

199253(6) - EN - Accella™ Therapy Mattress Instructions for Use

Page iii

Page iv

199253(6) - EN - Accella™ Therapy Mattress Instructions for Use

Structure of the Manual and Symbols Definition

INSTALLATION

MOVEMENT

MOBILIZATION

EASE OF USE

COMFORT

PATIENT CAREGIVER

WELL BEING

INDEPENDENCE

HELP WITH CARE

SAFETY

For every type of use, Hillrom™ mattresses 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.

199253(6) - EN - Accella™ Therapy Mattress Instructions for Use

Page 1

Destination and Specifications

Destination and Specifications

Understanding the Symbols Symbol



Description Highlights special information or explains important instructions. 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

Biological danger

Page 2

199253(6) - EN - Accella™ Therapy Mattress Instructions for Use

Destination and Specifications

Safety and Usage Tips Intended Use This device benefits are phase I to phase IV pressure ulcers prevention and treatment help.

Indications It is suitable for low to very high-risk patients, within the recommended patient weight limits of 30 to 160 kg on the standalone mattress and between 40 and 160 kg on the version combined with the Accella™ bed or Progressa™ bed, in order to achieve valuated clinical performance in all the usual positions of the adjustable head section. It can be used as a mattress in the following environments, as defined in the standard IEC 60601-2-52: • application environment 1 (acute care); • application environment 2 (short-term care in hospitals or other medical establishments); • application environment 3 (long-term care in medical establishments); • application environment 5 (outpatients or ambulatory care). The device is not designed to come into direct contact with damaged skin and must to be used with a sheet between the patient’s skin and the surface of the mattress.

condition In accordance with the NPUAP/EPUAP directives , Hill-Rom recommends that the of each patient be regularly checked. For patients with special needs, Hill-Rom 1

recommends the use of the most suitable I-mmersion™ Therapy system. Caregivers are responsible for taking this decision, in accordance with modern care practices.

Contraindications This device must not be used with patients: • Suffering from an unstable fracture of the spine; for any other unstable fractures, a medical examination is necessary to determine whether the use of the device is appropriate. • with atypical anatomy; • suffering from cervical or trans-bone traction.

Intended Users The Accella™ Therapy mattresses are designed to be used by Qualified Staff for patient care from several care application environments.

1. NPUAP / EPUAP - Prevention and treatment of Pressure Ulcers - Quick Reference Guide, 2019

199253(6) - EN - Accella™ Therapy Mattress Instructions for Use

Page 3

Identifying the models Certain mattress models, 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 (**). Model

P006783A* P006790A* P006788A* P006791A* P006794A* P006789A* P006792A* P006793A*

Name

Accella™ Therapy mattress Accella™ Therapy MCM™ mattress

Accella™ Therapy MCM™ mattress combined with Hillrom™ 900 Accella™ bed Accella™ Therapy MCM™ mattress combined with Hillrom™ 900 Progressa™ bed

The mattress P006783A or P006788A or P006790A or P006791A is a standalone mattress controlled by a wired remote control,also available as an accessory (see page 51). The mattress P006789A or P006792A is combined with the Accella™ bed and is controlled using the bed interface. The mattress P006793A is combined with the Progressa™ bed (P7500A without StayInPlace™ function) and is controlled using the bed interface.

First Use Before using the mattress, 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. Caregivers must be informed of the risks that may be encountered in the use of electric devices. Product training can be provided on demand. When using the mattress with medical devices (accessories), the user must ensure that safety and conformity requirements are met. Before using the device for the first time or when removing from storage: • check the condition and conformity of the electrical system with the applicable safety standards; • Connect the device to the mains power supply (See “Complying with Electrical Safety Standards” on page 5); • Allow access to the wall outlet to disconnect the mattress when needed; • Make sure that all the functions of the device are in good conditions of operation; • make sure that the device and the care environment are in a good state of hygiene (See “Disinfecting” on page 41); • check the safe positioning of the device in its working environment (see “Before Placing the Patient on the Device” on page 19). Page 4

199253(6) - EN - Accella™ Therapy Mattress Instructions for Use

Improper use of the device can result in risks for the patient or the user. The following recommendations must be read and followed. In view of the multitude of models of frames and siderails, and for safety reasons, Hill-Rom advises that all necessary precautions must be taken, especially with regard to the height of the siderails and the dimensions of the mattress support platform. If this device is used on a bed with siderails that are less than 22cm above the mattress, patients must not be left unattended. For safety reasons, it is advisable to use the lock-out functions of the bed in the following situations: • During all interventions on the patient or the device (e.g.: examinations, transfers, maintenance); • when the patient is in an unusual condition or behaves abnormally (e.g.:excited, confused, disoriented, obsessive, old or of a weak constitution). Properly trained medical staff should determine how the device should be used and the required level of monitoring or constraint. It is imperative to observe the practices relating to the safety of caregivers. Special attention must be taken when redistributing the load application points, since there is a danger that the bed will tip when the chassis is moved. The impermeability of the surface and its therapeutic qualities may be compromised by holes made by needles or any other perforations in the cells of the mattress. Caregivers must be informed in order to avoid any tears in the cells of the mattress caused by needles. Avoid mechanical impacts.

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.

Complying with Electrical Safety Standards The mains power supply must comply with following standards: • NF C15-100 and NF C15-211 (France); • International Electrotechnical Commission (IEC) 60364 for other countries. Check that the supply voltage of the device shown on the identification label matches the voltage of the establishment’s mains power system (See “Locating the Identification Labels of the Device” on page 14). The device should be connected to a power system equipped with a maximum 30 mA earth leakage circuit breaker, in compliance with IEC 60364-5-53. Connect the device to the nearest wall plug in order to leave the shortest possible length of cable on the floor to avoid any risk of crushing. 199253(6) - EN - Accella™ Therapy Mattress Instructions for Use

Page 5

Destination and Specifications

Preventing Risks

For the mattress P006789A* or P006792A* (combined with the Accella™ bed)

and P006793A* (combined with the Progressa™ bed), refer to the bed’s manual for the recommendations on connections. In compliance with standards relating to electromagnetic interference for medical devices, this product does not interfere with other medical devices nor is it susceptible to interference when combined with other medical devices that also comply with the electromagnetic standards in place. However, some devices, particularly older ones that do not comply with the electromagnetic compatibility standards, may undergo interference or may themselves interfere with the functionality of this device. Using accessories or cables other than those specified, with the exception of cables sold by the device manufacturer, as replacement parts for internal components, may result in an increase of emissions or a reduction of the device's immunity. The users of such devices are responsible for ensuring that any malfunctions will not endanger the patient or any other person. When intravascular or intracardiac connections are in use, the electric potentials of all the unprotected metal parts of the appliance and the bed need to be equalized. This label indicates that oxygen tents must never be used and that only the use of nasal tubes and oxygen masks is authorized. For reasons of safety, masks and tubes should always be kept at a higher level than the mattress support platform.

Complying with Conditions for Transport, Storage and Use Symbol

Features

Use

Transport/storage

Temperature

+10°C to +40°C

-30°C to +50°C

Hygrometry

30% - 85%

20% - 85%

Atmospheric pressure

700 mbar - 1060 mbar 700 mbar - 1060 mbar

a

a. Applicable only if the device is stored in its original packaging.

The device is designed for indoor use only. When used at 40°C, the temperature of the applied part can reach 43°C. The electrical medical device must be used at an altitude of 3000 m or lower.

The device must be stored in its original packaging: • protected against light and damp; • At least 10 cm above floor level to prevent fluid ingress; • protected against dust; • outside passageways. Never stack more than 5 mattresses.

Page 6

199253(6) - EN - Accella™ Therapy Mattress Instructions for Use

Destination and Specifications

Referring to Technical Specifications

Specifications are subject to change.

Essential performances of the device The Accella™ Therapy is a therapeutic mattress. It has two operating modes: continuous low pressure (CLP) and alternating low pressure (ALP), with permanent regulation of the pressure by the I-mmersion™ sensor in both modes.

Control pendant* Front View of the Control Pendant

Control panel

Characteristics

Description

Dimensions Weight Protection index offered by the covers (IEC 60529)

12x17x9 cm / 4.8x6.77x3.54’’ 0.445 kg / 0.98 lb IP21: Protected against access to dangerous parts with fingers and splashes of water

Only the original connector should be connected to the device.

199253(6) - EN - Accella™ Therapy Mattress Instructions for Use

Page 7

Therapeutic Mattress Characteristics Model Dimension (inflated)

Description P006783AP006790AP006788AP006791AP006789A P006792A

215x96x21.5 cm / 84.6x37.8x8.5’’ ~ 17.5 kg / ~ 37.5 lb 120V 220-240V

203x92x21.5 cm / 80x35.5x8.5’’

Weight Voltage

220-240V

Frequency Apparent power ALP & CLP modes Initial inflation Maximum energy consumption Operation of the device Upper cover (applied part of the device)

50 Hz

60 Hz

50 Hz

32 VA 146 VA 13 Wh

32 VA 146 VA 13 Wh

32 VA 146 VA 13 Wh

Continuous Polyurethane coating on Polyamide material, lowfriction, stretchable in both directions, breathing, bacteriostatic; fungistatic and antimicrobial; can be wiped and washed.

Volume of the device: in ALP or CLP regulation mode / in MCM™ mode only (ISO 3744) Alarm: Sound pressure (ISO 3744)

<55dB(A) / <30dB(A) 44.6 dB(A)

Maximum compressor pressure Maximum compressor flow rate Electric shock protection Class according to IEC 60601-1 Protection against inflammable anesthetic mixtures

250

P006793AP006794A

250

0 - 24.5 kPa 27.4 l/mn

30.1 l/mn 27.4 l/mn Class II Type BF applied parts protected against defibrillation shocks (labeled 1 and 8 page 11) Not for use with flammable anesthetics. Safe working load including the total weight of the patient, accessories (if they are supported by the support system of the medical bed) and the load supported by these accessories (excluding the weight of the patient). Safe Working Load is the technical limit of patient weight that can be applied after which a damage may occur on the mattress.

Maximum pressure of the safety 104 mBar valve Degree of protection provided by the IP24: protection against splashes of water. cover (CEI 60529) Battery: 2 hours Minimum battery life 24 hours Time to fully charge Battery life with CPR/patient exit 2 hours alarm/low pressure alarm 8 hours Patient support battery life

Page 8

199253(6) - EN - Accella™ Therapy Mattress Instructions for Use

Destination and Specifications

Viewing the Whole Device

1

2 3

9 8 4

6

7

5 Item 1

2

3 4 5 6 7 8 9

Name Upper cover Therapeutic Mattress with 5 Zones: Head zone (3 bladders) Back zone (6 bladders) Sacrum zone (8 bladders) Thigh zone (2 bladders) Heel Zone (11 bladders) Bottom Cover I-mmersion™ sensor Straps (Accella™ Therapy) or knobs (Progressa™) Technical box Bottom cover Control pendant* X-ray bag

199253(6) - EN - Accella™ Therapy Mattress Instructions for Use

Page 9

Understanding the Symbols on the Device Symbols on the Upper Cover Do not walk on or run over the power cord

Adjust the straps

Foot end

Zone for notes Always install the mattress so that the (I-mmersion™ ) Therapy text is visible

Seat cushion

X-ray bag

MCM™

Safe Working Load

Page 10

199253(6) - EN - Accella™ Therapy Mattress Instructions for Use

Destination and Specifications

Symbols on the Technical Box

fuse

220-240VAC: 5*20 time delayed 1.6A fuse-Icu=1,500A

120VAC: 5*20 time delayed 2A fuse-Icu=1500A

199253(6) - EN - Accella™ Therapy Mattress Instructions for Use

Page 11

Symbols on the Control Pendant* All commands are centralized and are activated by simply pressing a button.

10

6 8

5

7 3 2

4

9 1

Buttons and indicator lights Symbol

Description

Symbol

Description

1

CPR activated: Green 6

On/Off Button

2

Continuous low pressure (CLP) mode 7 activated: Green

Malfunction/service alarm: yellow and intermittent audible alarm

3

Alternating low pressure (ALP) mode 8 activated: Green

4

Inhibit/suspend the alarms activated for 10 minutes: Green

9

5

Maximum inflation activated for 20 minutes (P-Max): Green

10

Page 12

Mains power present after pressing the On/Off button: Green Mains Power Fault Alarm: yellow and intermittent audible alarm Bed exit monitor activated: Green Bed exit alert: Green flashing and continuous audible signal MicroClimate Management (MCM™)* activated: Green

199253(6) - EN - Accella™ Therapy Mattress Instructions for Use

Manufacturer

IP24

Device reference

a

Cover protected against access to dangerous parts with fingers and splashes of water Type BF applied parts protected against defibrillation shocks

Serial number

Class II device

Alternating Current

Medical Device conformity mark

General safety sign

Temperature limits

Refer to the user manual.

Atmospheric pressure limits

DO NOT DISCARD Obey local recycling rules

Hygrometry limits

Interior use

Fuse

No Oxygen Tent

Date of manufacture

Unique Device Identification

Medical Device

a.The device part number contains the following information: P+6 figures = model, - A = device version letter

See “Locating the Identification Labels of the Device” page 14

199253(6) - EN - Accella™ Therapy Mattress Instructions for Use

Page 13

Destination and Specifications

Symbols on the labels

Locating the Identification Labels of the Device On the technical box To identify the device model REF and its serial number SN:

P006783A

P006788A

P006789A

P006790A

P006791A

P006792A

P006793A

Page 14

P006794A

199253(6) - EN - Accella™ Therapy Mattress Instructions for Use