Primo User Manual Rev 004 Edition 4 Oct 2016

PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 26, 2016

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 00 www.hill-rom.com Edition: 4 / October 2016 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. Hill-Rom® is a registered trademark of Hill-Rom Services, Inc. I-mmersion™ is a trademark of Hill-Rom Services, Inc. Primo™ is a trademark of Hill-Rom Services, Inc. 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 article with the part number 186826. © 2016 Hill-Rom Services, Inc. ALL RIGHTS RESERVED. Translation of the original instructions: Only the french version shall prevail in the event of a dispute.

186826(4) - EN - Primo™ User Manual

PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 26, 2016 Destination Specifications

Table of Contents Section 1: Destination and Specifications

Moving the Device Disinfecting Sservicing

Before Placing the Patient on the Device... 15 Checking the Compatibility of Bed Frame and Mattresses... 15 Installing the Device... 16

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 Description 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 Therapeutic Mattress... 7 Control Unit... 8 Viewing the Whole Device... 9 Understanding the Symbols on the Device... 10 Symbols on the Upper Cover... 10 Symbols on the Control Unit... 10 Buttons and Indicator Lights... 11 Symbols on the Labels... 12 Locating the device identification labels... 13 On the Rear of the Control unit... 13 Checking the Model of the Device on the Packaging Label... 13 Accessing to the Upper and Bottom Covers Identification Labels... 14

Section 3: Mobilizing and Securing the Patient

Accessories

Understanding the Operation Mode... 19 Continuous Low Pressure Mode... 19 Maximum Inflation Mode... 19 Activating the CPR... 20 Understanding the Alarms... 21 Alarm Silence... 21 Mains Power Fault... 21 Malfunction... 22

Section 4: Moving the Device

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Appendix

Moving the Patient on the Bed in Transport Mode... 23 Transferring the Device from One Bed to Another... 23 Storing the Device... 24

PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 26, 2016 Section 5: Disinfecting and Servicing Cleaning and Disinfecting the Device... 25 Complying with Safety Instructions... 25 Controlling Infection... 25 Complying with Hill-Rom Recommendations... 26 Frequency of Cleaning and Disinfection of Different Parts of the Mattress... 27 Cleaning and Disinfecting after the Departure of a Patient or when Changing the Sheets... 27 Cleaning and Disinfecting at Regular Intervals or in the Event of High Risk of Contamination... 28 Performing the Final Steps... 29 Servicing of the Device... 30 Complying with Safety Instructions... 30 Performing Preventive Maintenance... 30 Troubleshooting... 31 Complying with Warranty Conditions... 32 De-commissioning... 32

Section 6: Accessories and Spare Parts Seat Cushion (M04177)... 33 Installing the Seat Cushion... 33 Deflating and Packing the Seat Cushion... 33 Cleaning and Disinfecting the Seat Cushion... 34 Upper Covers... 34 Quick Inflate/Deflate Kit... 34 Transport Bag (163176)... 34

Section 7: Compliance Electromagnetic Compatibility Compliance... 35 Directives... 35 Standards... 35 Electromagnetic Emissions Compliance... 36 Electromagnetic Immunity Compliance... 36 Recommended Separation Distances... 37

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PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 26, 2016

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.

186826(4) - EN - Primo™ User manual

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Destination Specifications

Destination and Specifications

PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 26, 2016 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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186826(4) - EN - Primo™ User manual

PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 26, 2016 Destination Specifications

Knowing the Applications of the Device Description of the Device The Primo™ is a therapeutic mattress equipped with a pressure control system designed to operate in continuous (or static) low-pressure mode. The Primo™ is a therapeutic solution by I-mmersion™ that distributes pressure and reduces the shearing effects on the surface of the patient's skin. The Primo™ comprises a mattress and an external control unit. It offers the following functionality: • A CPR valve to facilitate external cardiac massages; • A maximum inflation mode for greater patient mobility.

Indications The device helps to prevent and treat pressure ulcers in low to 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 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 (outpatient or ambulatory care). This 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 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 - 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 26, 2016

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 control unit of the device to the mains power supply (See “Complying with Electrical Safety Standards” page 5); • Make sure that all the functions of the device are in good conditions of operation (See “Installing the Device” page 16); • Make sure that the device and the care environment are in a good state of hygiene (See “Cleaning and Disinfecting the Device” page 25); • Check the safe positioning of the device in its working environment (see “Before Placing the Patient on the Device” page 15).

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. Page 4

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PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 26, 2016

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 device identification labels” page 13). 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 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.

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Destination Specifications

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.

PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 26, 2016

Complying with Conditions for Transport, Storage and Use Symbol

a

Features

Use

Temperature

+5°C - +40°C

-25°C - +70°C

Hygrometry

15% - 93%

0% - 93 %

Atmospheric Pressure

700 mbar - 1,060 mbar

700 mbar - 1,060 mbar

Transport, Storage

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 26, 2016 Destination Specifications

Referring to Technical Specifications

Specifications are subject to change.

Essential Performance of the Device Percentile Angle of the Adjustable Head Section I-mmersion™ setting

P5-P30* Woman

P75-P95* Man

0°

45°

0°

45°

22 mbar

26 mbar

35 mbar

40 mbar

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

Values in mbar +/- 8%. Therapeutic Mattress Characteristics Model

Description P02033A

Length (inflated) Width (inflated) Height (inflated) Weight Autonomy in Transport Mode Upper Cover Bladders

250

250

Maximum Pressure of Relief Valve Degree of Protection Against Electric Shock Degree of Protection Provided by the Cover (IEC 60529)

P02047A

P02034A

P02044A

200 cm / 79’’ 200 cm / 79’’ 90 cm ± 0.25 cm 77 cm ± 0.25 cm 35.4’’ ± 1’’ 30.3’’ ± 1’’ 16 cm / 6’’ 16 cm / 6’’ 8.4 kg / 18.5 lb 2 hours Polyurethane coating on polyester material, low-friction, stretchable in both directions, breathing, bacteriostatic, fungistatic and antimicrobial; can be wiped and washed. 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 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. 1psi / 69 mbar Type BF applied parts protected against defibrillation shocks (labeled 1 and 6 on page 9). IP24: Protected against access to dangerous parts with fingers and splashes of water.

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PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 26, 2016

Control Unit Front view of the Control Unit of the Primo™

Control Panel

Characteristics Model Dimensions Weight Power Supply Apparent Power Maximum Energy Consumption Operation of the Device Enclosure Material Device : Sound Pressure Level / Sound Power (ISO 3744) Alarm : Sound Pressure Level / Sound Power (IEC60601-1-8) Fuses Compression Compressor Flow Rate IEC 60601-1 Classification Degree of Protection Provided by the Cover (IEC 60529) Protection Against Inflammable Anesthetic Mixtures Battery Life

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Description P02033A

220-240V 50/60 HZ 20 VA 16.4 Wh

P02047A P02034A P02044A 15x29x12 cm / 6x11.5x5’’ 3.5 kg / 8 lb 220-240V 220-240V 120V 60HZ 50/60HZ 50/60HZ 20 VA 32 VA 20 VA 16.4 Wh

16.4 Wh

16.4 Wh

Continuous ABS PC V0 41 dB(A) / 52 dB(A)

56 dB(A) / 67 dB(A) T160 mA T160 mA T 200mA T160 mA 0 - 180 mbar 0 - 180 mbar 0 - 215 mbar 0 - 180 mbar 10 l/min 10 l/min 12 l/min 10 l/min Class II IP21: protected against access to dangerous parts with finger and vertically dripping water. Not for use with flammable anesthetics. 1 hour

186826(4) - EN - Primo™ User manual

PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 26, 2016 Destination Specifications

Viewing the Whole Device 1

2

5

9

3

8

6

4 7

Item 1 2 3 4

8

Name Upper Cover Air Mattress Control Unit Sensor

186826(4) - EN - Primo™ User manual

Item 5 6 7 8 9

Name Foam Sub-Mattress Bottom Cover CPR Valve Straps Sensor Box

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PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 26, 2016

Understanding the Symbols on the Device Symbols on the Upper Cover CPR Symbol

Do not walk on or run over the power cord

Adjust the head and foot end straps

Foot End

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

Symbols on the Control Unit A

B A

Connection for Inflation of the Seat Cushion Fuse 220-240 VAC

B Fuse 120 VAC

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186826(4) - EN - Primo™ User manual

PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 26, 2016 Destination Specifications

Buttons and Indicator Lights

1

A

B

2

3

C

D

The control unit is very easy to use and, thanks to the automatic pressure regulation, no manual adjustments are necessary.

Buttons 1 - Alarm Silence Button : Inhibits the audible alarms (see “Alarm Silence” page 21). 2 - On/Off Button: To switch off the control unit: Press to silence the battery, in this case no mains power fault alarm will be reported; Unplug the control unit from the mains. 3 - Maximum Inflation Button: Increases the pressure inside the mattress to the maximum value for 5 minutes. See “Maximum Inflation Mode” page 19. Is also used to inflate the seat cushion (see “Seat Cushion (M04177)” page 33).

Indicator Lights / Alarms A - Malfunction Alarm: In case of malfunction, the audible alarm sounds and the visual alarm yellow comes on (see “Malfunction” page 22). B - Mains Power Fault Alarm: In case of power failure, the audible alarm sounds and the visual alarm yellow comes on (see “Mains Power Fault” page 21). C - On/Off Indicator: The green indicator light at the bottom comes on when the control unit is on. D - Inflation Indicator : The green indicator light flashes for 5 minutes while the inflation. 186826(4) - EN - Primo™ User manual

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PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 26, 2016

Symbols on the Labels Manufacturer

Control unit protected against access to dangerous parts with finger and vertically dripping water. Cover protected against access to dangerous parts with fingers and splashes of water. Type BF applied parts protected against defibrillation shocks (mattress).

IP21

a

Device Reference

IP24

Serial Number

Alternating Current

Class II Device

CAUTION Read the Safety Instructions Carefully

Compliant with Directive 93/42/EEC

Refer to the User Manual

Temperature Limits

DO NOT DISCARD Obey local recycling rules

Atmospheric Pressure Limits

Interior Use

Hygrometry Limits

WARNING High Voltage (label on the power supply card in the control unit)

Width of the Mattress (model P02044A only)

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

See “Locating the device identification labels” page 13.

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PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 26, 2016 Destination Specifications

Locating the device identification labels On the Rear of the Control unit To identify your device model and serial number.

The label showing the conditions of use and specifications of the device is also located on the rear of the control unit (right-hand side). See “Symbols on the Labels” page 12.



Checking the Model of the Device on the Packaging Label

See symbols in paragraph “Complying with Conditions for Transport, Storage and Use” page 6.

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PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 26, 2016

Accessing to the Upper and Bottom Covers Identification Labels Open the zip fastener on the mattress. Upper Cover P02033A/P02034A

P02044A

P02047A

Bottom Cover P02033/P02034A

P02044A

P02047A

See details of the symbols for cleaning and disinfection in section: “Disinfecting and Servicing” page 25.

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186826(4) - EN - Primo™ User manual

PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 26, 2016

Installing the Patient Before Placing the Patient on the Device

Install and use for the first time must be done in accordance with these instructions.

Checking the Compatibility of Bed Frame and Mattresses The bed / mattress / siderails combination (and in particular their respective dimensions) must be examined in order to make sure that it meets the requirements of the IEC 60601-2-52 standard and the ’’Hospital Bed Safety Workgroup’’ guide, and that the resulting combination does not alter the performance of the devices, their safety nor their usability.

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Installing the Patient

Assess the various risks, including but not limited to the following (incomplete list containing risks related to reasonably foreseeable misuse): • Risk of entrapment; • Potential falls from the bed; • Patient in state of confusion; • Patient's learning ability; • Children (aged less than 12 or under 1.46 m tall); • Persons lacking the mental capacity to recognize unsafe actions; • Unauthorized persons.

PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 26, 2016

Installing the Device 1. Unpack the control unit and the device. 2. Check that all the components are present and correct, and that the power cord is not damaged. 3. Place the rolled up mattress on the top of the bed at the foot end and unroll it.

The CPR valve must be positioned at the foot end of the bed. The CPR valve must remain accessible for use in the event of emergency deflation.

4. Check that the symbol is at the foot of the bed.

on the cover

Keep the 2 elastic bands. 5. Attach the mattress using the straps at the head and foot ends.

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

straps

7. Make sure that the device is correctly installed, securely attached, centered on the mattress support platform and pushed tightly against the footboard to avoid the danger of entrapment. 8. Make sure that the attachments do not become entangled in the moving parts of the mattress support platform, such as actuators, CPR handles, etc. With articulated frames, make sure that the straps of the device are only attached to the mobile head and foot sections and NOT to the main frame. Page 16

186826(4) - EN - Primo™ User Manual