P280 Mattress Instructions for Use Rev 010 Oct 2020

Hill-Rom S.A.S. Z.I. du Talhouet 56330 PLUVIGNER - FRANCE Tel: + 33 (0)2 97 50 92 12 Fax: + 33 (0)2 97 50 92 03 hillrom.com Edition 10 - October 2020 First Printing: August 2014 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 Hill-Rom. Hillrom™ is a trademark of Hill-Rom Services, Inc. Velcro® is a registered trademark of Velcro Industries BV. Terralin® is a registered trademark of Schülke & Mayr GmbH. Dismozon® is a registered trademark of Bode Chemie GmbH. Sanivap® is a registered trademark of Sanivap S.A. 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 part number 187692. © 2020 Hill-Rom Services, Inc. ALL RIGHTS RESERVED.

187692(10) - EN - P280 Mattress Instructions for Use

Section 1: Destination and Specifications

Installing the Patientt Mobilizing the Patient Moving the Device Disinfection Servicing

Structure of the Manual and Symbols Definition... 1 Safety and Usage Tips... 3 Intended Use... 3 Indications... 3 Contraindications... 3 Features... 4 Intended Users... 4 Identifying the Models of the Device... 5 First Use... 5 Preventing Risks... 6 Complying with Electrical Safety Standards... 6 Complying with Conditions for Transport, Storage and Use... 7 Referring to Technical Specifications... 8 Essential performances of the device... 8 Mattress Topper and Mattress... 8 Control Unit... 9 Viewing the Whole Device... 10 ... 11 Understanding the Symbols on the Device... 12 Symbols on the Upper Cover... 12 Symbols on the Control Unit... 13 Symbols on the Labels... 14 Locating the Labels on the Device... 15 Labels on the Control Unit... 15 Accessing to the Upper and Bottom Covers Identification Labels... 16 Serial number of the mattress... 17 Checking the Model of the Device on the Packaging Label... 18

Destination Specifications

Table of Contents

Section 2: Installing the Patient

Section 3: Mobilizing and Securing the Patient

187692(10) - EN - P280 Mattress Instructions for Use

Page i

Standards

Selecting the Operating Mode... 23 Activating the CPR... 25 Locking the User Interface... 26 Understanding the Audible Indicators... 26 Audible Indicator Silence... 26 Mains Power Fault Indicator... 26

Accesssories

Before Placing the Patient on the Device... 19 Checking the Compatibility of Bed Frame and Mattresses... 19 Installing the Device... 20

Low Pressure Indicator... 26 Malfunction Indicator... 26

Section 4: Moving the Device Moving the Patient on the Bed in Transport Mode... 27 Transferring the Device from One Bed to Another... 29 Storing the Device... 30

Section 5: Disinfecting and Servicing Cleaning and Disinfecting the Device... 31 Complying with Safety Instructions... 31 Controlling Infection... 31 Complying with Hill-Rom Recommendations... 32 Frequency of Cleaning and Disinfection of Different Parts of the Mattress. 33 Cleaning and Disinfecting after the Departure of a Patient or when Changing the Sheets... 33 Cleaning and Disinfecting at Regular Intervals or in the Event of High Risk of Contamination... 34 Performing the Final Steps... 35 Servicing of the Device... 36 Complying with Safety Recommendations... 36 Performing Preventive Maintenance... 36 Troubleshooting... 37 Complying with Warranty Conditions... 38 De-commissioning... 38

Section 6: Accessories and additional parts Recommended accessories**... 39 Recommended additional parts... 39 MRS Foam Base... 39 Reflex™ Seat Cushion (M04177)**... 39 Symbols on the upper cover... 40 Locate the seat cushion labels... 40 Installing the Seat Cushion... 41 Deflating and Packing the Seat Cushion... 42 Cleaning and Disinfecting the Seat Cushion... 42 Transport Bag... 42

Section 7: Compliance Electromagnetic Compatibility Compliance... 43 CE conformity mark... 43 Standards... 43 Electromagnetic Emissions Compliance... 44 Electromagnetic Immunity Compliance... 44 Page ii

187692(10) - EN - P280 Mattress Instructions for Use

Destination Specifications

Recommended Separation Distances... 46

Installing the Patientt Mobilizing the Patient Moving the Device Disinfection Servicing Accesssories Standards

187692(10) - EN - P280 Mattress Instructions for Use

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Page iv

187692(10) - EN - P280 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.

187692(10) - EN - P280 Mattress Instructions for Use

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Destination 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

Entrapment Hazard Warning

Risk of Crushing an Upper Limb

Chemical Hazard Warning

Electric Shock Hazard

Biological Danger

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187692(10) - EN - P280 Mattress Instructions for Use

Destination Specifications

Safety and Usage Tips Intended Use The P280, MRS (Mattress Replacement System) model with foam base or Overlay model and P280 Air, is a therapeutic mattress designed by Hill-Rom.Its benefits are an efficient automatic redistribution of pressure, especially in the sacrum and heel zones, as part of a protocol for prevention and appropriate treatment of pressure ulcers.

Indications This device helps to prevent and treat pressure ulcers in low to high risk adult patients, within the recommended patient weight limits of 30 to 140 kg, in order to achieve validated clinical performance in all the typical head of bed positions. It can be used as a mattress in the following environments, as defined in the standard IEC 60601-2-52: • Application Environment 2 (short-term care in hospitals or other medical establishments); • Application Environment 3 (long-term care in medical establishments); • Application Environment 5 (outpatient or ambulatory care). This 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.

In accordance with the NPUAP/EPUAP directives , Hill-Rom recommends that 1

the condition of each patient be regularly checked. For patients with special needs, Hill-Rom recommends the use of the more 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 decide whether the use of the device is appropriate. • With atypical anatomies. • Suffering from cervical or trans-bone traction.

1. NPUAP / EPUAP - Prevention and treatment of Pressure Ulcers - Quick Reference Guide, 2014

187692(10) - EN - P280 Mattress Instructions for Use

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Features This device offers : • Two therapeutic modes with manual adjustment of the parameters of comfort: Continuous Low Pressure (CLP) and Alternating Low Pressure (ALP). • Two functions: Over-Inflation and Maximum Inflation (Pmax). The P280 Overlay model must be installed on a standard foam mattress, or on the MRS foam base. The MRS foam base can be ordered separately; See “MRS Foam Base” on page 39 to upgrade P280 Overlay into P280 MRS. Configuration of the P280 MRS

P280 Overlay (Mattress Topper)

MRS Foam Base

Intended Users The P280 mattresses are designed to be used by Qualified Staff for patient care and from several care application environments.

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187692(10) - EN - P280 Mattress Instructions for Use

Destination Specifications

Identifying the Models of the Device Model

P005858A P005987A P006052A

Description P280 Overlay 220V - 240 V ~, 50/60Hz P280 Overlay 120V ~, 50/60Hz P280 MRS 220V - 240 V ~, 50/60Hz P280 MRS 120V ~, 50/60Hz

Mattress Topper Mattress - Height: 17 cm Mattress - Height: 17 cm

P006172A P006173A

P280 Air 220-240V ~, 50/60Hz P280 Air 120V ~, 50/60Hz

Mattress - Height: 17 cm Mattress - Height: 17 cm

P005856A

Configuration Mattress Topper

See “Locating the Labels on the Device” on page 15. 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 (**).

First Use Before using the device, it is essential to have a thorough understanding of this manual. This manual contains instructions for general use and maintenance and guarantees improved safety. Access to this manual should be made available to caregivers. Caregivers must be informed of the risks that may be encountered in the use of electric devices. Product training is available upon request.

When using the mattress with medical devices (accessories), the user must ensure that safety and conformity requirements are met.

Before using the mattress 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 control unit of the device to the mains power supply (See “Complying with Electrical Safety Standards” on page 6); • 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 (See “Installing the Device” on page 20); • Make sure that the device and the care environment are in a good state of hygiene (See “Disinfecting and Servicing” on page 31). • Check the safe positioning of the device in its working environment (See “Before Placing the Patient on the Device” page 19).

187692(10) - EN - P280 Mattress Instructions for Use

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Preventing Risks 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); • 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 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 frame is moved. Surface impermeability and therapy capabilities could be affected by needle sticks or other mattress bladder punctures. Caregivers should be instructed to prevent mattress bladder punctures caused by needle sticks. 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 Labels on the Device” on page 15). 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.

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187692(10) - EN - P280 Mattress Instructions for Use

In compliance with standards relating to electromagnetic interference for medical devices, this device 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 product. 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 hPa - 1,060 hPa

700 hPa - 1,060 hPa

a

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

The device is designed for indoor use only. 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.

187692(10) - EN - P280 Mattress Instructions for Use

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Destination Specifications

Connect the device to the nearest wall plug in order to leave the shortest possible length of cable on the floor.

Referring to Technical Specifications

Specifications are subject to change. Essential performances of the device The P280 is a therapeutic mattress. It has two operating modes: continuous low pressure (CLP) and alternating low pressure (ALP). The mattress firmness is adjustable from the control unit.

Mattress Topper and Mattress Characteristics Model

Values P280 Overlay P005856A/ P005858A/

P280 MRS P005987A/ P006052A a

P280 Air P006172A/ P006173A

Length (inflated) 200 cm / ~ 80’’ Width (inflated) 90 cm / ~ 36’’ Height (inflated) 10 cm / 4" 17 cm / 7" Weight 6,1 kg / 13,4 lb 12 kg / 26,5 lb 7,5 kg / 16,5 Ib Range in transport mode 2 hours Polyurethane coating on polyester material, low-fricUpper cover (applied tion, stretchable in both directions, breathing, bactepart of the device) riostatic, fungistatic and antimicrobial; can be wiped and washed. Bladders Polyurethane 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 250 250 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. Pressure relief valve 1.5 psi / 10,3 kPa threshold Degree of protection Type BF applied part against electric shock Cushions pressure. from 8"H2O to 30"H2O Adjustable range a. See “Identifying the Models of the Device” on page 5.

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187692(10) - EN - P280 Mattress Instructions for Use

Characteristics

Values

Model

M04566 M04584 29 x 20 x 12 cm / 11.4" x 8" x 4.6" 2.2 kg / 5 lb 220-240 V~, 50/60 Hz 120 V~, 50/60 Hz 0.07 A @ 220-240 Vac 0.17 A @ 120 Vac 5.2 Wh Continuous ABS PC

Dimensions Weight Power supply Rated power Maximum energy consumed Operation of the device Sleeve material Device: sound pressure level / sound power (ISO 3744) Fuses Compression Compressor flow rate IEC 60601-1 Classification

45 dB(A) / 61 dB(A)

Degree of protection provided by the cover (IEC 60529)

T1AL, 250V 0-10,5 kPa 10 l/min Classe II IP41: Protected against access to hazardous parts with a wire and against vertically falling water drops

Protection against inflammable anesthetic mixtures

Not for use with flammable anesthetics.

Front and Back Views of the P280 Control Unit Control Panel

Hose Connector

Fuses

Handle Attachment

Main Switch Power Socket Filter

The control unit may generate noise and vibration that can cause discomfort to the patient.

187692(10) - EN - P280 Mattress Instructions for Use

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Destination Specifications

Control Unit

Viewing the Whole Device B

C

E D F

A

H I

G

Item

Name: P280 MRS

A B C D E F G H I

Control Unit Detachable Upper Cover Pneumatic Mattress Heel Zone Foam Bottom Cover Power Cord Hose MRS Foam Base (P280 MRS Mattress Configuration only) Mattress (P280 MRS) or Mattress Topper (P280 Overlay) Bottom Cover

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187692(10) - EN - P280 Mattress Instructions for Use

Destination Specifications

Item A B C D E F

Name: P280 Air Control Unit Detachable Upper Cover Pneumatic Upper Mattress Pneumatic Lower Mattress Bottom Cover Power Cord

187692(10) - EN - P280 Mattress Instructions for Use

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Understanding the Symbols on the Device Symbols on the Upper Cover

Do not walk on or run over the power cord

Foot End

Zone for Notes

Top of the Mattress

Install on a standard foam type mattress (P280 Overlay only)

Adjust the head and foot end straps

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187692(10) - EN - P280 Mattress Instructions for Use

Destination Specifications

Symbols on the Control Unit Buttons and Indicator Lights A

1

3

2

4

B

C

D

E

F

G

5

Buttons Symbol

6

7 Indicator Lights

Description

Symbol

Description

A

Alternating Pressure Cycles (every 5 minutes)

1

Maximum Inflation (P-max)

B

Comfort Setting: Reduce the Pressure

2

Alternating Low Pressure Mode

3

Continuous Low Pressure Mode

4

Over-Inflation

C

D

Comfort Setting: Increase the Pressure Selection of the Operating Mode

E

Security Lock

5

Mains Power Fault Indicator

F

On/Off

6

Low Pressure Indicator

G

Audible Indicator Silence

7

Malfunction Indicator

187692(10) - EN - P280 Mattress Instructions for Use

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Symbols on the Labels Manufacturer

IP41

IP24

Device Reference

a

Control unit protected against access to hazardous parts with a wire and against vertically falling water drops. Cover protected against access to hazardous parts with a finger and against splashing water.

Serial Number

Type BF Applied Part

Fuse

Class II Device

CAUTION read the Safety Instructions Carefully

Medical Device conformity mark

Refer to the User Manual

Alternating Current

DO NOT DISCARD Obey Local Recycling Rules

Temperature Limits

Interior Use

Atmospheric Pressure Limits

WARNING High Voltage (Label on the Power Supply Card in the Control Unit)

Hygrometry Limits

Unique Device Identification

Medical Device

Date of manufacture a.The device part number contains the following information: - P+6 Figures = Model, - A = Device Version Letter.

See “Locating the Labels on the Device” on page 15. Page 14

187692(10) - EN - P280 Mattress Instructions for Use