ClinActiv Therapy Mattress User Manual Rev 001 Sept 2009

PROPRIETARY AND CONFIDENTIAL DRAFT: November 18, 2009 Manufacturer: Hill-Rom Industries S.A. 188, Rue du Caducée Parc Euro médecine 34195 MONTPELLIER cedex 5 FRANCE

www.hill-rom.com First edition, first printing 2009 Printed in Europe 159968 Rev.001/September 2009

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 Hill-Rom. Hill-Rom®, ClinActiv®, ClinActiv® ⊕ and Clinitron® are registered trademarks of Hill-Rom Services, Inc. VarioTM Advanced, ReFlexTM and MCMTM-MicroClimate Management are deposited trademarks of Hill-Rom Services, Inc. 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 HillRom 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 article with the part number 159968(1). © 2009 by Hill-Rom Services, Inc. ALL RIGHTS RESERVED

ClinActiv® ⊕ User Manual - 159968(1)

PROPRIETARY AND CONFIDENTIAL DRAFT: November 18, 2009

Chapter 1: Introduction Symbol definitions... 1 - 1 Intended purpose... 1 - 2 Putting into service... 1 - 2 Recap of symbols... 1 - 4

Chapter 5: Accessories Installing the seat cushion... 5 - 1 Deflating the seat cushion... 5 - 2 MCMTM... 5 - 3

Safety tips/general precautions for use

Chapter 7: Specifications and warranty Specifications... 7 - 1 Technical data... 7 - 1 Compliance... 7 - 4 Manufacturer's responsibility... 7 - 4

Accessories

Chapter 6: Safety/General precautions for use Electrical safety precautions... 6 - 3 End-of-life equipment... 6 - 3 Transport, storage... 6 - 4

Cleaning, care and replacement parts

Chapter 4: Cleaning, maintenance and spare parts Troubleshooting... 4 - 1 Maintenance... 4 - 1 Maintenance calls... 4 - 2 Infection Control... 4 - 2 Cleaning... 4 - 2

Instructions for use

Chapter 3: Instructions for use Installation... 3 - 1 Functions... 3 - 4 Packing instructions... 3 - 9

Product overview

Chapter 2: Product overview About the ClinActiv® ⊕ therapy mattress... 2 - 1 Product Overview... 2 - 3 Functional description... 2 - 5

Introduction

Table of Contents

Specifications and warranty

ClinActiv® ⊕ User Manual - 159968(1)

Page i

PROPRIETARY AND CONFIDENTIAL DRAFT: November 18, 2009

Symbol definitions This manual contains different typefaces and icons designed to improve readability and increase understanding of its content. Note the following examples: • Standard text - used for regular information. • Boldface text- emphasizes a word or phrase. • NOTE: sets apart special information or important instruction clarification.

The symbols below represent different risks or hazards: Symbol

Description

Warning/Caution • WARNING: identifies situations or actions that may affect patient or user safety. Disregarding a warning could result in patient or user injury. • CAUTION: points out special procedures or precautions that personnel must follow to avoid equipment damage. Caught Hazard Warning

Chemical Hazard Warning

Electric Shock Hazard

ClinActiv® ⊕ User Manual - 159968(1)

Page 1 - 1

Introduction

Chapter 1 Introduction

PROPRIETARY AND CONFIDENTIAL DRAFT: November 18, 2009

Intended purpose The ClinActiv® ⊕ is a multizone therapy mattress incorporating ImmersionTM Therapy designed by Hill-Rom to adress the following needs: – Automatic efficient interface pressure re-distribution to prevent and treat pressure ulcers, with dedicated zones in the sacrum and in the heel; – greater patient safety; – effective patient's micro-climate management by the MCMTM system. The ClinActiv® ⊕ therapy mattress is a genuine therapy solution from both economic and medical perspectives. The ClinActiv® ⊕ therapy mattress can be used as a replacement mattress in hospitals, long-term care institutions and at home. Indication The ClinActiv® ⊕ assists in the prevention and treatment of pressure ulcers and is suitable for all patients, including those at the highest-risk, in a recommended range of weight between 30 kg (67 lb) and 160 kg (353 lb). Contraindication The ClinActiv® ⊕ must not be used in the cases of patients with: • an unstable fracture of the spinal column. For any other unstable fracture, a medical evaluation is necessary to determine if the use of the ClinActiv® ⊕ is appropriate. • a cervical or skeletal traction.

Putting into service 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 beds. The many sources and types of accessories, hardware, or medical devices that may be used together with this mattress do not enable Hill-Rom to guarantee both the safety and conformity of all the combinations thus created. The health care personnel who creates these device combinations must therefore ensure that security and conformity requirements are met. Page 1 - 2

ClinActiv® ⊕ User Manual - 159968(1)

• check the condition and conformity of the electrical system with the applicable safety standards, • connect the ClinActiv® ⊕ system to the mains power supply (See “Connection to the mains mower supply” page 1-3), • check that all the functions of the ClinActiv® ⊕ (See “Installation” page 31) are in good working order, • check the hygiene and cleanliness (See “Cleaning” page 4-2), • check the safe positioning of the product in its working environment (See “Instructions for use” page 3-1).

List of compatible bed chassis The ClinActiv® ⊕ therapy mattress is designed to be installed on the following bed models: • Hill-Rom Evolution, • Hill-Rom AvantGuard 1200, • Hill-Rom AvantGuard 1600. WARNING: To use any other bed, check that the dimensions and the type of sleep surface of the bed are compatible with the ClinActiv® ⊕ therapy mattress. Do not use spring bed frames, as they may affect the performance of the mattress. NOTE: To check dimensions of the mattress, see page 7 - 2.

Connection to the mains mower supply The mains power supply for the bed must comply with the following standards: • NF C 15-100 and NF C 15-211 (France), • International Electrotechnical Commission (IEC) 364 for other countries. Check that the supply voltage of the ClinActiv® ⊕ mattress shown on the identification label matches the voltage of the mains power of the health care facility (See “Product identification labels” page 2-8). The ClinActiv® ⊕ mattress should be connected to a power supply network protected by a maximum 30 mA earth leakage circuit breaker, in compliance with IEC 364-5-53.

ClinActiv® ⊕ User Manual - 159968(1)

Page 1 - 3

Introduction

PROPRIETARY AND CONFIDENTIAL DRAFT: November 18, 2009 Before using the mattress for the first time or when removing from storage:

PROPRIETARY AND CONFIDENTIAL DRAFT: November 18, 2009

Recap of symbols Immediate visual indicators

Immediate activation

Internal pressure

Alarm silence

Inflation of the seat cushion

P-Max

Activation of CPR Safety lock-out

Bed exit alarm

On/Off

Power failure MCMTM

Mattress malfunction

Page 1 - 4

ClinActiv® ⊕ User Manual - 159968(1)

PROPRIETARY AND CONFIDENTIAL DRAFT: November 18, 2009

Chapter 2 Product overview About the ClinActiv® ⊕ therapy mattress

In addition to I-mmersionTM Therapy, the new ClinActiv® ⊕ therapy mattress is now made up of 5 zones: • a multi-zone air therapy surface made up of 30 bladders: •

11 flat welded bladders in two layers in the heel zone,

•

2 flat welded bladders the thigh zone,

•

8 individual bladders in the sacrum zone,

•

6 flat welded bladders the back zone,

•

3 flat welded bladders the head zone,

• 1 intermediate mattress for patient comfort and safety, • 1 air mattress underlay including the last generation of the VarioTM advanced sensor system. The ClinActiv® ⊕ therapy mattress has 4 different configurations: • ClinActiv® ⊕ Alternating (ALP/Alternating Low Pressure), • ClinActiv® ⊕ Continuous (CLP/ Continuous Low Pressure), • ClinActiv® ⊕ MCMTM (MicroClimate Management) Alternating, • ClinActiv® ⊕ MCMTM (MicroClimate Management) Continuous. The change from ClinActiv® ⊕ Alternating to ClinActiv® ⊕ Continuous is performed by replacing the detachable module of the control unit (see procedure for the replacement of the detachable module in the ClinActiv® ⊕ Therapy Mattress Service Manual 159970(1)).

ClinActiv® ⊕ User Manual - 159968(1)

Page 2 - 1

Product overview

The ClinActiv® ⊕ is an intelligent system offering a variety of functions and accessories to meet user requirements and therapeutic indications.

PROPRIETARY AND CONFIDENTIAL DRAFT: November 18, 2009

Product Overview The ClinActiv® ⊕ therapy mattress is made up of: C

D

A

E

J

B F

G

K

I

H

Item

Page 2 - 2

Name

A B C D E F G H I J

Control unit with retractable carry handle Technical box Detachable upper cover Therapy surface Intermediate mattress Mattress Underlay Lower cover VarioTM Advanced sensor system Foam heel zone extension

K

Double supply hose

230 V

power cord

ClinActiv® ⊕ User Manual - 159968(1)

PROPRIETARY AND CONFIDENTIAL DRAFT: November 18, 2009 The ClinActiv® ⊕ therapy mattress is delivered in transport bags designed specially for the mattress (A) and the control unit (B). It is recommended to keep these transport bags for easy transport and storage at a later date. They protect the system against mechanical shocks and dirt. B

ClinActiv® ⊕ User Manual - 159968(1)

Product overview

A

Page 2 - 3

PROPRIETARY AND CONFIDENTIAL DRAFT: November 18, 2009

Functional description Description of the detachable module controls There are 2 types of detachable module for the ClinActiv® ⊕ therapy mattress: • one module for the “ClinActiv Continuous” mode, • one module for the “ClinActiv Alternating” mode. H

G

F

I J K

E

L D

A

C

B

CLP module

G

I

F I J E

K L

D

A

C B

ALP module

Page 2 - 4

ClinActiv® ⊕ User Manual - 159968(1)

PROPRIETARY AND CONFIDENTIAL DRAFT: November 18, 2009

N° Symbol

Name Maximum inflation (P-max)

Action / Audible alarm

When inflating for the first time, maximum inflation is automatically activated. The mattress then returns to therapy mode after about 10 minutes. When connected to the mains power for the first time, the mattress will automatically inflate to maximum inflation (P-max) to fully expand the air cells. It then automatically reverts to therapy mode.

Press the P-max key at any time to activate maximum inflation. Press again to immediately return to therapy mode.

On/Off

Press the On/Off button to switch on the unit. The green light comes on.

B Bed exit alarm

Moderately loud noise. Beeps for a few seconds every 30 seconds.

This alarms indicates that the patient has left the bed.

C

Press the Bed exit alarm button to switch on patient egress surveillance. The light indicator next to the control then remains on permanently. Press the Bed exit alarm button again to switch off patient egress surveillance. Very loud noise. Beeps every second during a short time.

Alarm silence

This control disables the P-max (A), CPR (L), mains power failure (F) and mattress malfunction alarms (E).

Press this key to silence the alarms. They will sound again after about 10 seconds. To silence the alarms permanently, press the Silence alarm key (D) until the light flashes.

Mattress malfunction

This light comes on in the event of a pressure fault.

To disable the alarm. See Silence alarm (D). See “Troubleshooting” page 41 for more details.

D

E

Loud and permanent noise

ClinActiv® ⊕ User Manual - 159968(1)

Page 2 - 5

Product overview

A

Description

PROPRIETARY AND CONFIDENTIAL DRAFT: November 18, 2009 N° Symbol

Name

Description

Action / Audible alarm

Power failure

This light comes on if the unit is disconnected from the mains or in the event of a power failure. It also comes on during transport. The On/Off switch remains active.

Reconnect the control unit to the mains power supply, stop the box or disable the alarm. See Alarm silence (D). Moderately loud and permanent noise.

Internal pressure indicator

This indicator gives an indication The green segments light up to of the variation in pressure in the show the variation in pressure. therapy mattress. This is just an indication and not a measurement. The ALP module has two indicators corresponding to each of the two alternate zones.

F

G

H

Continuous low This symbol shows that the CLP therapy is in use. pressure therapy

I

Alternating low This symbol shows that the ALP therapy is in use. pressure therapy Seat cushion inflation

This green light comes on when Press the P-max key to stop the the optional seat cushion is being inflation of the seat cushion. inflated and will go off after 5 minutes, once the seat cushion is completely inflated. Maximum inflation is automatically activated, without any audible indication, when the seat cushion is being inflated.

MCMTM

This light comes on when the micro climate management system is activated.

Press the micro climate management system module key to activate the ventilation.

CPR

This yellow light flashes when the CPR function is activated.

Disable the alarm. See Silence Alarm (D). See “CPR valve” page 3-4 for more details.

J

K

L

Moderately loud noise. Beeps for a few seconds every 30 seconds.

Page 2 - 6

ClinActiv® ⊕ User Manual - 159968(1)

PROPRIETARY AND CONFIDENTIAL DRAFT: November 18, 2009

Symbols on the control unit

Product overview

A D

C

B

E F G

H I

N° Symbol

Name Safety lock/unlock

A B

Protective ground

Seat cushion inflation port and key

C Fuse

D Caution: refer to accompanying documents

E F G

Consult instructions for use

Type B applied parts protected against defibrillation shocks

Hazardous voltage

H I

Apply local regulations on how to dispose wastes of electrical and electronic equipment

ClinActiv® ⊕ User Manual - 159968(1)

Page 2 - 7

PROPRIETARY AND CONFIDENTIAL DRAFT: November 18, 2009

Product identification labels There are 3 serial numbers on the ClinActiv® ⊕ system: (A) the serial number of the control unit is on the label on the back of the control unit; (B) the serial number of the detachable module is on the label on the back of the detachable module; (C) the serial number of the technical box is on the label on the top of the box inside the mattress (foot end).

A

Label of the control unit

Page 2 - 8

C

B

Label of the detachable module

Label of the technical box

ClinActiv® ⊕ User Manual - 159968(1)

PROPRIETARY AND CONFIDENTIAL DRAFT: November 18, 2009

Chapter 3 Instructions for use Installation 1.

Unpack the control unit.

2.

Unpack the mattress.

NOTE: Take care not to damage the mattress and the control unit when unpacking. Check that all the components are present and appropriate.

4.

Place the rolled up mattress on the top of the bed and unroll it.

5.

Check that the symbol on the cover is at the foot of the bed.

Instructions for use

3.

NOTE: The CPR valve must be positioned at the foot end of the bed. 6.

Keep the 2 elastic bands.

7.

Attach the mattress using the straps at the head and foot ends.

8.

Adjust the length of the straps to safely secure the mattress.

ClinActiv® ⊕ User Manual - 159968(1)

Page 3 - 1

PROPRIETARY AND CONFIDENTIAL DRAFT: November 18, 2009 CAUTION: Make sure that the attachments do not become entangled in the drive mechanisms of the moving parts of the bed, such as actuators, CPR handles, etc. With articulated beds, make sure that the straps of the mattress are only attached to the moving head and foot sections and NOT to the fixed frame. Failure to follow this recommendation could result in damage to the equipment. 9.

Hang the control unit to the foot board of the bed using the hanging bracket.

10. Connect the double hose to the control unit. The connector will double-click when correctly in position.

CLICK

NOTE: The control unit is also fitted with rubber feet so that it can be placed on a hard surface. 11. Check that the power cord is not damaged. 12. Connect it to the control unit and secure using the safety clip. 13. Route an adequate length of power cord inside the flap along the lefthand side of the mattress. Use also Velcro(R) straps in order to the power cord to the frame.

14. Connect the power cord to the outlet.

Page 3 - 2

ClinActiv® ⊕ User Manual - 159968(1)

PROPRIETARY AND CONFIDENTIAL DRAFT: November 18, 2009 WARNING: Take care with articulating frames that the power cord is not attached to moving parts such as the head or foot sections. Also ensure that it will not become trapped or trail on the floor. Failure to do so could result in damage to the equipment or patient or user injury. WARNING: Take care not to drive over the power cord when moving the bed chassis. Failure to follow this recommendation could result in injury or equipment damage. 15. Check that the CPR valve is closed.

17. Press the On/Off system.

Instructions for use

16. Set the mains switch on the left side of the control unit to position 1.

key on the detachable module to switch on the

18. When connected to the mains power for the first time, the mattress will automatically inflate to maximum inflation (P-max) to fully expand the air bladders. The mattress then returns to therapy mode after about 10 minutes. NOTE: After the unit has been switched on, the functional alarms are disabled for 15 minutes. The mattress malfunction alarm will be activated if, after 15 minutes, the mattress has not automatically reverted to therapy mode. 19. The mattress is now ready for use. 20. Place the patient on the mattress. The ClinActiv® ⊕ system automatically adjusts the pressure in each zone of the mattress. NOTE: Make sure the patient's sacrum is well positioned above the I-mmersion Therapy symbols on either side of the mattress.

ClinActiv® ⊕ User Manual - 159968(1)

Page 3 - 3

PROPRIETARY AND CONFIDENTIAL DRAFT: November 18, 2009

Functions CPR valve The CPR valve (A) is at the foot end of the mattress. It can be easily identified by its yellow plug and the symbol on the mattress cover. A

WARNING: Locate the position of the CPR valve before placing the bed sheet. Failure to follow this recommendation could result in injury or equipment damage. 1.

To activate the CPR, turn the yellow CPR valve clockwise as shown by the arrow.

2.

The mattress will quickly deflate to provide a hard surface for cardiac massages.

3.

To return to the normal operating mode, turn the yellow CPR valve back to its original position as shown by the arrow.

Page 3 - 4

ClinActiv® ⊕ User Manual - 159968(1)

PROPRIETARY AND CONFIDENTIAL DRAFT: November 18, 2009

Safety lock-out This function locks the user interface to prevent the operating mode from being changed unintentionally. It can be found on the rear of the detachable module of the control unit. 1.

Turn off the power (press on the detachable module, then set the mains switch on the left side of the control unit to position 0) before attempting to extract the detachable module.

WARNING: If an electronic module is disconnected when the system is switched on, the module may be damaged. 2.

Instructions for use

To extract the detachable module, unlatch the lever (A) at the rear of the control unit. A

3.

Set the switch (B) to "lock position" (1 up and 2 down). The user interface is locked out.

B

NOTE: To unlock the user interface set the switch (B) to the unlock position (1 and 2 down).

ClinActiv® ⊕ User Manual - 159968(1)

Page 3 - 5