Duo 2 User Manual Rev 002 Oct 2014

PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 23, 2014

Hill-Rom Industries S.A. 188, Rue du Caducée Parc Euromédecine 34195 MONTPELLIER Cedex 5 - FRANCE Tel: +33 (0)4 67 04 64 04 Fax: +33 (0)4 67 04 64 00 www.hill-rom.com Second Edition First Printing : May 2014 186662, Rev.002 / October 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. Hill-Rom® is a registered trademark of Hill-Rom Services, Inc. Deteq® is a registered trademark of Hill-Rom Services, Inc. Duo® is a registered trademark of Hill-Rom International BV. I-mmersion™ is a trademark of Hill-Rom Services, Inc Dismozon® is a registered trademark of Bode Chemie GmbH. Terralin® is a registered trademark of Schülke & Mayr GmbH. Velcro® is a registered trademark of Velcro Industries BV. 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, refer to the last page, identify your national Hill-Rom representative and order the part number 186662. © 2014 Hill-Rom Services, Inc. ALL RIGHTS RESERVED. Translation of the original instructions: Only the French version shall prevail in the event of a dispute.

186662(2) - EN - Duo® 2 User Manual

PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 23, 2014

Section 1: Destination and Specifications

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Appendix

186662(2) - EN - Duo®2 User Manual

Accessories

Understanding the Therapeutic Mode... 21 Selecting the Operation Mode... 21 Activating the CPR... 22 Understanding the Alarms... 23 Alarm Silence... 23 Mains Power Fault... 23 Malfunction... 24

Disinfecting Servicing

Section 3: Mobilizing and Securing the Patient

Moving the Device

Before Placing the Patient on the Device... 17 Checking the Compatibility of Bed Frames and Mattresses... 17 Installing the Device... 18

Mobilizing and Securing the Patient

Section 2: Installing the Patient

Installing the Patient

Structure of the Manual and Symbols Definition... 1 Knowing the Applications of the Device... 3 Indications... 3 Contraindications... 3 Complying with Safety and Usage Tips... 4 Commissioning... 4 Preventing Risks... 4 Complying with Electrical Safety Standards... 5 Complying with Conditions for Transport, Storage and Use... 6 Observing the Precautions for Use in Domestic Environment... 6 Referring to Technical Specifications... 7 Essential Performance of the Device... 7 Control Pendant... 7 Therapeutic Mattress... 8 Viewing the Whole Device... 9 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 Cover of the Air Filter Door in the Technical Box... 14 On the Control Pendant... 14 Accessing to the Upper and Bottom Covers Identification Labels... 15 Checking the Model of the Device on the Packaging Label... 16

Destination Specifications

Table of Contents

PROPRIETARY AND CONFIDENTIAL DRAFT: Section 4: Moving the Device Moving the Patient on the Bed in Transport Mode... 25 Transferring the Device from One Bed to Another... 26 Storing the Device... 27

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 Seat Cushion... 39 Installing the Seat Cushion... 39 Deflating and Packing the Seat Cushion... 40 Cleaning and Disinfecting the Seat Cushion... 40 Transport Bag... 40

Section 7: Manufacturer’s Declaration Electromagnetic Compatibility Electromagnetic Emissions Compliance... 41 Electromagnetic Immunity Compliance... 41 Recommended Separation Distances... 42

Section 8: EU Declaration of Conformity Directives... 43 Standards... 44 Device References... 44

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PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 23, 2014

Structure of the Manual and Symbols Definition

INSTALLATION

MOVEMENT

MOBILIZATION

EASE OF USE

COMFORT

PATIENT CAREGIVER

WELL BEING

HELP WITH CARE

INDEPENDENCE

SAFETY

For every type of use, Hill-Rom 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.

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Destination Specifications

Destination and Specifications

PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 23, 2014 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 of Upper Limb

Chemical Hazard Warning

Electric Shock Hazard

Biological Danger

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PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 23, 2014 Destinationn Specifications

Knowing the Applications of the Device Indications This device helps to prevent and treat pressure ulcers stage I to IV in low to very high risk adult patients, within the recommended patient weight limits of 30 to 150 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 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 4 (care administered at home); • Application environment 5 (outpatients or ambulatory care). The device is intended 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 the 1

condition of each patient be regularly checked. For patients with special needs, Hill-Rom recommends the use of the most suitable I-mmersion™ Therapy system. Caregivers are responsible for making 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 anatomies. • Suffering from cervical or trans-bone traction.

1. NPUAP / EPUAP - Pressure Ulcer Prevention - Quick Reference Guide, January 2010 NPUAP / EPUAP - Pressure Ulcer Treatment - Quick Reference Guide, December 2009

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PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 23, 2014

Complying with Safety and Usage Tips Commissioning 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 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 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 (see “Installing the Device” on page 18) 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 33); • Check the safe positioning of the device in its working environment (see “Before Placing the Patient on the Device” page 17).

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.

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PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 23, 2014

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.

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. 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 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.

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Destinationn Specifications

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.

PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 23, 2014

Complying with Conditions for Transport, Storage and Use Symbol

Features

Use

Temperature

+5°C - +40°C

-25°C - +70°C

Hygrometry

15% - 93%

0% - 93 %

Atmospheric Pressure

700 mbar - 1060 mbar 700 mbar - 1060 mbar 0 to 2,000 meters 0 to 2,000 meters

Transport, Storage

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.

Observing the Precautions for Use in Domestic Environment Strangulation warning: Never leave children aged under 3 or animals alone in the vicinity of the device; they may become caught up in the power cord and be strangled. Suffocation warning: Never leave the electric connection accessories supplied with the device within the reach of children or animals.

Do not use the device in dusty environments and avoid the presence of soft toys and ash (cigarettes, etc.). Do not expose the device to excessive light, including sunlight. Do not install the device close to a source of intense heat (fireplace, heaters, etc.) nor excessive humidity (sprayers, kettles, etc.). Do not install the device close to pets, insects or pests. Protect the device against misuse by children.

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PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 23, 2014 Destinationn Specifications

Referring to Technical Specifications

Specifications are subject to change.

Essential Performance of the Device Percentile Angle of the Adjustable Head Section CLP ALP

P5-P30* Woman

P75-P95* Man

0°

45°

0°

45°

1.8 2.1

1.8 2.1

2.9 3.4

3.6 4.3

* Data source : IFTH 2006 National Body Measurement Campain in France (target population: men and women aged between 18 and 70).

Values in kPa +/- 20%. Control Pendant

Front View of the Control Pendant of the Duo® 2

Control Panel

Characteristics Dimension Weight Degree of Protection Provided by the Cover (IEC 60529)

Description 12x17x9 cm / 4.8x6.77x3.54’’ 0,445 kg / 0.98 lb IP24 : Protected against access to dangerous parts with fingers and splashes of water

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PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 23, 2014

Therapeutic Mattress Characteristics Model Dimension (inflated) Weight Power Supply Apparent Power ALP & CLP Mode Initial Inflation Maximum Energy Consumption Operation of the Device Upper Cover Device in Inflation or Quick Deflate Mode : Sound Pressure / Power (ISO 3744) Device in ALP or CLP Regulation Modes: Sound Pressure / Power (ISO 3744) Alarm: Sound Pressure / Power (IEC60601-1-8) Maximum Compressor Pressure Maximum Compressor Flow Rate IEC 60601-1 Classification

Description P02039B P02049B 200x85x23 cm / 79x33.5x9’’ ~ 19.4 kg / ~ 43 lb 220-240V 220-240V 50/60 HZ 50/60 HZ 24 VA 131 VA 17 Wh

24 VA 131 VA 17 Wh

Continuous Polyurethane coating on Polyamide material, low-friction, stretchable in both directions, breathing, bacteriostatic; fungistatic and antimicrobial; can be wiped and washed. 68 dB(A) / 77 dB(A) 39 dB(A) / 54 dB(A) 66 dB(A) / 74 dB(A) 0 - 10.5 kPa

Degree of Protection Against Electric Shock

12 l/mn Class II Type BF applied parts protected against defibrillation shocks (labeled 1 and 8 on page 9).

Protection against Inflammable Anesthetic Mixtures

Not for use with flammable anesthetics.

250

250

Pressure Relief Valve Threshold Degree of Protection Provided by the Cover (IEC 60529) Battery : Minimum Battery Life Time to Fully Charge Operation in Transport Mode

Page 8

12 l/mn

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. 1,5 psi / 10.3 kPa IP24 : Protected against access to dangerous parts with fingers and splashes of water. 2 hours 8 hours 2 hours

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PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 23, 2014 Destinationn Specifications

Viewing the Whole Device

1 2

5

9

3 4

7 8

6 Item 1

Name

4

Upper Cover Therapeutic Mattress with 3 Zones : Head Zone (1 bladder) Sacrum Zone (12 bladders) Heel Zone (8 bladders with reduced volume) Sensor Enclosure I-mmersion™ Therapy Mattress

5 6 7 8 9

Sensor Straps Technical Box Bottom Cover Control Pendant

2 3

The characteristics of the mattress parts labeled 1 through 8 are described on page 8. The characteristics of the mattress parts labeled 9 are described on page 7.

186662(2) - EN - Duo®2 User Manual

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PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 23, 2014

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

Adjust the head and foot end straps

Foot End

Folding the Mattress Zone for Notes Always install the mattress so that the I-mmersion™ Therapy text is visible

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PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 23, 2014 Destinationn Specifications

Symbols on the Technical Box

Sensor Connecti on

Control Pendant Connection

Deflate Position Normal Position Vacuum Mode Lever

Fuse

220-240 VAC fuse 1A FAST BLOW, Icu: 35A, 5*20

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PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 23, 2014

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

2

3

1

C

B

E

D A

Indicator lights

Buttons

a

Symbol

Description

Symbol

Description

A

Rapid CPR - Stop Device (after unplugging the power cord)

1

On/Off indicator Green : On (Mains Connection) Yellow : Off (Mains Disconnection)

B

Continuous Low Pressure Mode (CLP)

2

Malfunction Visual Alarm : Yellow (green : no malfunction)

C

Alternating Low Pressure Mode (ALP)

3

Mains Power Fault visual Alarm : Yellow

D

Alarm Silence (15 minutes)

E

Maximum Inflation Mode (15 minutes) a. All buttons : Indicator light green: function enable Indicator light off: function disable

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PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 23, 2014

Manufacturer

IP24

Device Reference

a

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

Compliant with Directive 93/42/EEC

CAUTION Read the Safety Instructions Carefully

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

a.The device part number contains the following information: - P+5 figures = Model, - B = Device Revision Letter.

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

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Destinationn Specifications

Symbols on the Labels

PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 23, 2014

Locating the Identification Labels of the Device On the Cover of the Air Filter Door in the Technical Box To identify your device model and serial number:.

On the Control Pendant The label showing the conditions of use and specifications of the device is located on the rear of the control pendant.

See “Symbols on the Labels” on page 13

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PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 23, 2014

Open the zip fastener on the mattress.

Upper Cover P02049B

P02039B

Bottom Cover P02049B

P02039B

See details of the symbols for cleaning and disinfection in the chapter: “Disinfecting and Servicing” on page 31.

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Destinationn Specifications

Accessing to the Upper and Bottom Covers Identification Labels

PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 23, 2014

Checking the Model of the Device on the Packaging Label P02039B

P02049B

See symbols in paragraph “Observing the Precautions for Use in Domestic Environment” on page 6.

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186662(2) - EN - Duo®2 User Manual