ARJO HUNTLEIGH Skin IQ Microclimate Manager Bedienungsanleitung

Skin IQ

Microclimate Manager

Instructions for Use

...with people in mind

408204-AH Rev E • 12/2017

Gebrauchsanweisung • Gebruiksaanwijzing • Mode d’emploi

Istruzioni per l’uso • Instrucciones de uso • Brugervejledning

Bruksanvisning • Bruksanvisning

iii

ENGLISH

DEUTSCH

NEDERLANDS

FRANÇAIS

ITALIANO

ESPAÑOL

DANSK

SVENSKA

NORSK

DISCLAIMER OF WARRANTY AND LIMITATION OF LIABILITY

ARJOHUNTLEIGH HEREBY DISCLAIMS ALL EXPRESS OR IMPLIED WARRANTIES, INCLUDING WITHOUT

LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR

PURPOSE, ON THE ARJOHUNTLEIGH PRODUCT AS DESCRIBED IN THIS PUBLICATION. ANY WRITTEN

WARRANTY OFFERED BY ARJOHUNTLEIGH SHALL BE EXPRESSLY SET FORTH IN THIS PUBLICATION

OR INCLUDED WITH THE PRODUCT. UNDER NO CIRCUMSTANCES SHALL ARJOHUNTLEIGH BE LIABLE

FOR ANY INDIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES AND EXPENSES, INCLUDING

DAMAGES OR INJURY TO PERSON OR PROPERTY, DUE IN WHOLE OR IN PART TO THE USE OF THE

PRODUCT OTHER THAN THOSE FOR WHICH DISCLAIMER OF WARRANTY OR LIMITATION OF LIABILITY

IS EXPRESSLY PROHIBITED BY SPECIFIC, APPLICABLE LAW. NO PERSON HAS THE AUTHORITY TO BIND

ARJOHUNTLEIGH TO ANY REPRESENTATION OR WARRANTY EXCEPT AS SPECIFICALLY SET FORTH IN

THIS PARAGRAPH.

Descriptions or speciﬁcations in ArjoHuntleigh printed matter, including this publication, are meant

solely to generally describe the product at the time of manufacture and do not constitute any

express warranties, except as set forth in the written limited warranty included with this product.

Information in this publication may be subject to change at any time. Contact ArjoHuntleigh for

updates.

IMPORTANT INFORMATION FOR USERS

In order for ArjoHuntleigh products to perform properly, ArjoHuntleigh recommends the following

conditions. Failure to comply with these conditions will void any applicable warranties.

• Use this product only in accordance with these instructions and applicable product

labeling.

• WARNING: Assembly, operations, adjustments, extensions, modiﬁcations, technical

maintenance or repairs must be performed only by qualiﬁed personnel authorized by

ArjoHuntleigh. Contact ArjoHuntleigh for information regarding maintenance and repair.

• Ensure the electrical installation of the room complies with the appropriate national

electrical wiring standards. To avoid the risk of electric shock, this product must be

connected to a grounded power receptacle.

Speciﬁc indications, contraindications, warnings, precautions and safety information exist

for ArjoHuntleigh’s therapeutic support systems. It is important for users to read and

familiarize themselves with these instructions and to consult the treating physician prior to

patient placement and product use. Individual patient conditions may vary.

NOTICE

This product has been conﬁgured from the manufacturer to meet speciﬁc voltage requirements.

Refer to the power supply label for speciﬁc voltage.

Table Of Contents

Quick Reference ............................................................................................... 2

Introduction...................................................................................................... 4

Indications .................................................................................................................... 4

Contraindications......................................................................................................... 4

Intended Care Setting.................................................................................................. 4

Compatibility ............................................................................................................... 5

Risks and Precautions................................................................................................... 5

Safety Information....................................................................................................... 6

Unpacking and Inspection .............................................................................. 6

Installation........................................................................................................ 7

Care and Cleaning............................................................................................ 8

Disposal ............................................................................................................ 8

Specifications ................................................................................................... 9

Electromagnetic Compatibility...................................................................... 10

Warranty......................................................................................................... 13

Symbols Used................................................................................................. 14

Customer Contact Information ..................................................................... 15

Consult

Instructions for use

Smooth out wrinkles.

Pull coverlet tightly over corners.

Connect power supply to fan.

Move hand to end of bed and feel fan

vibration, listen for humming sound.

Quick Reference

Consult

Instructions for use

Secure coverlet to bed frame.

Connect power supply to power cord

and move power supply under bed.

Connect power cord to wall outlet.

Introduction

This document should be saved in an easily accessible place for quick reference.

It is recommended that all sections of these instructions be read prior to product use. Carefully

review the Indications, Contraindications, Risks and Precautions and Safety Information prior

to placing a patient on the Skin IQ™ Microclimate Manager (MCM).

These instructions do not provide speciﬁc safety or operational information

for the pressure redistribution surface and / or bed frame provided by

the facility for use with the Skin IQ MCM. Consult product labeling for

information.

Caregivers should discuss Safety Information, Risks and Precautions and Contraindications

with the patient (or the patient’s legal guardians) and the patient’s family.

The Skin IQ MCM is a single patient use, disposable device that provides Negative Airﬂow

Technology (NAT) to manage the microclimate of the skin at the patient surface when ﬁtted over a

customer-provided pressure redistribution surface.

It is also designed to reduce friction and improve patient comfort.

The Skin IQ MCM is suitable for use in acute and post acute facilities, is vapor permeable, and has a

ﬂuid-resistant nylon taffeta cover.

Indications

The Skin IQ MCM is indicated for use in conjunction with a pressure redistribution surface in order

to aid in the prevention and treatment of skin breakdown and pressure ulcers (Stages I-IV) for

patients who require microclimate management of the skin.

Contraindications

Although Skin IQ MCM has no associated direct contraindications the caregiver should refer to and

follow any contraindications in the product labeling for the pressure redistribution surface and / or

bed frame being used with the Skin IQ MCM.

Intended Care Setting

• Acute Care

• Post Acute Care

Compatibility

The Skin IQ MCM is designed to ﬁt on a pressure redistribution surface that is 203.2 cm - 213.4 cm

(80 - 84 in) long by 88.9 cm - 91.4 cm (35 - 36 in) wide by 17.8 cm (7 in) high.

Consult product labeling for the pressure redistribution surface and / or bed frame for compatibility.

Risks and Precautions

Transfer

This product is not intended for use as a transfer device.

Duration of Use

Recommended duration of use for single patient is not more than 60 days for patients

< 172.37 kg (380 lb).

Duration of use for patients weighing 172.37 kg (380 lb) - 227 kg (500 lb) is not to exceed more

than 30 days.

However, patient speciﬁc duration of use may vary. Clinical conditions such as, but not limited to,

incontinence, skin condition, nutrition status, medications, mobility, weight, or etiology need to be

considered when assessing duration of use for the Skin IQ MCM.

Height

The Skin IQ MCM will increase the height of the pressure redistribution surface it is applied to by

approximately 6.35 mm (0.25 in).

Use With Other Devices

All Skin IQ MCM components are designed to be used as a single system device.

The included power supply should only be used with the Skin IQ MCM. The coverlet should only

be powered by the Skin IQ Power Supply ArjoHuntleigh part number 4103832.

Any attempt to connect and use the power supply with any other device,

or use any other brand or model of power supply other than ArjoHuntleigh

part number 4103832 will result in improper operation of equipment,

possibly leading to increased risk of patient injury.

Patient Migration

Specialty surfaces have different shear and support characteristics than conventional surfaces and

may increase the risk of patient movement, sinking and / or migration into hazardous positions

of entrapment and / or inadvertent bed exit. Monitor patients frequently to guard against patient

entrapment.

Safety Information

Please refer to and follow any safety information in the product labeling for

the pressure redistribution surface and / or bed frame being used with the

Skin IQ MCM.

Power Cord

Only use a grounded power outlet and the power cord supplied with the Skin IQ Power Supply. The

power cord should be positioned to avoid a tripping hazard and / or damage to the cord. The Skin

IQ MCM should never be operated with a worn or damaged power cord. Should the power cord

become worn or damaged, contact ArjoHuntleigh or a ArjoHuntleigh authorized representative to

order a replacement.

Coverlet

Use care when handling or transporting. Dropping or other sudden impacts may result in damage to

the device.

Skin Care

Monitor skin conditions regularly and consider adjunct or alternative therapies for high acuity

patients. Give extra attention to any possible pressure points and locations where moisture or

incontinence may occur or collect. Early intervention may be essential to preventing skin breakdown.

The Skin IQ Microclimate Manager (MCM) Product Family has an

antimicrobial agent formulated into the patient contact layer. Although

rare, there is a potential that some patients may experience sensitivity

or a reaction during use. Regularly monitor the patient’s skin condition.

Discontinue use and seek medical treatment if any signs of a reaction are

observed.

For more information about the Skin IQ MCM Product Family, contact

ArjoHuntleigh at 1-800-343-0974.

Patient Weight

The maximum patient weight for this device is 227 kg (500 lb). In addition, consult the speciﬁcations

for the pressure redistribution surface and / or bed frame being used. Additional weight limitations

may apply.

Disposal

The coverlet contains electrical components that may be removed and disposed of separately.

See Disposal on page 8 for removal.

General Protocols

• Avoid contact of sharp instruments with the Skin IQ MCM. Punctures, cuts and tears will

prevent proper operation.

• Follow all applicable safety rules and institution protocols concerning patient and

caregiver safety.

Unpacking and Inspection

Unpack the Skin IQ MCM from the shipping box and locate items as listed.

• coverlet with instructions for use booklet (included in complete kit or coverlet only)

• power supply (included in complete kit or available as a separate item)

• power cord (included in complete kit or power supply only)

Inspect all items carefully. If any items are damaged or missing, contact ArjoHuntleigh or a

ArjoHuntleigh authorized representative.

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