Arjo Skin IQ 365 Instructions For Use Manual

INSTRUCTIONS FOR USE
Skin IQ 365
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· Návod k použití · Brugsvejledning · Bedienungsanleitung ·
· Instrucciones de uso · Mode d'emploi · Használati útmutató · Istruzioni per l'uso ·
· Gebruiksaanwijzing · Bruksanvisning · Instrukcja obs ug · Instruções de utilização ·
Instruc iuni de Utilizare · · Instructions for use · Bruksanvisning ·
Kullan m Talimatlar · H ng d n s d ng ·
414479 Rev 9 • 12/2022
IMPORTANT INFORMATION FOR USERS
In order for Arjo products to perform properly, Arjo 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, modi cations, technical maintenance
or repairs must be performed only by quali ed personnel authorized by Arjo. Contact Arjo 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.
Speci c indications, contraindications, warnings, precautions and safety information exist for
Arjo'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 con gured from the manufacturer to meet speci c voltage requirements. Refer to
the power supply label for speci c voltage.
If a serious incident occurs in relation to this medical device, a ecting the user, or the patient then the
user or patient should report the serious incident to the medical device manufacturer or the distributor. In
the European Union, the user should also report the serious incident to the Competent Authority in the
member state where they are located.
Introduction
This document should be saved in an easily accessible place for quick reference.
EN
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™ 365.
These instructions do not provide speci c safety or operational information for the pressure
redistribution surface and / or bed frame provided by the facility for use with the Skin IQ 365. 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 365 is a multi-patient, reusable device that provides Negative Air ow Technology (NAT) to manage
the microclimate when tted over a customer-provided pressure redistribution surface.
It is also designed to reduce friction and shear and improve patient comfort.
The Skin IQ 365 is suitable for use in acute and post acute facilities, is vapor permeable, and has a uid-resistant
nylon ta eta cover.
Indications
The Skin IQ 365 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 365 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 365.
Intended Care Setting
• Acute Care
• Post Acute Care
Compatibility
The Skin IQ 365 is designed to t on a pressure redistribution surface that is 80 - 84 in
(203.2 - 213.4 cm) long by 35 - 36 in (88.9 - 91.4 cm) wide by 7 - 8 in (17.8 - 20.3 cm) high.
Consult product labeling for the pressure redistribution surface and / or bed frame for compatibility.
Risks and Precautions
To avoid serious injury or death, the CPR rapid de ation unit must be visible and accessible at
all times. (See Fig. 1)
Transfer
This product is not intended for use as a transfer device.
Duration of Use
Useful life of this product is one year or 35 laundry cycles, whichever comes rst.
Patient speci c duration of use may vary. 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 365.
Height
The Skin IQ 365 will increase the height of the pressure redistribution surface it is applied to by approximately
0.375 in (9.53 mm).
Use With Other Devices
All Skin IQ 365 components are designed to be used as a single system device, in combination with a pressure
redistribution surface.
The included power supply should only be used with the Skin IQ 365. The coverlet should only be powered by
the Skin IQ 365 Power Supply part number MENB1010A1203B02 (Arjo P/N 44001211).
Any attempt to connect and use the power supply with any other device, or use any other brand
or model of power supply will result in improper operation of equipment, possibly leading to
increased risk of patient injury.
Patient Migration
Specialty surfaces have di erent friction 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 365.
Power Supply
Only use the Skin IQ 365 Power Supply with attached power cord. The power supply cord should be
positioned to avoid a tripping hazard and / or damage to the cord. The Skin IQ 365 should never be operated
with a worn or damaged power supply cord. Routinely inspect the power supply and cord and should the
power supply cord become worn or damaged, contact Arjo or an Arjo 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
Skin care monitoring should be conducted as per institutional guidelines. This product is not a replacement for
proper skin care management and overall nursing care.
The Skin IQ 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 treatment if any signs
of a reaction are observed.
For more information about the Skin IQ product family, contact Arjo at 1-800-343-0974.
Patient Weight
The maximum patient weight for this device is 500 lb (227 kg). Additional weight limitations may apply, consult
the speci cations for the pressure redistribution surface and / or bed frame being used.
General Protocols
• Avoid contact of sharp instruments with the Skin IQ 365. Punctures, cuts and tears will prevent proper
operation.
• Follow all applicable safety rules and institution protocols concerning patient and caregiver safety.
• The Skin IQ 365 can be removed or placed on a bed while the bed is occupied. This can be
accomplished by clinical personnel using a common method usually referred to as the "Log Roll", in order
to change soiled linens of immobile patients. At least two clinical attendants can roll the patient to one
side of the bed and then placed, folded or rolled, directly behind the patient's back. The patient is then
rolled over to the Skin IQ 365 applied side. The remainder of the Skin IQ 365 can now be applied to the
newly unoccupied side of the bed. When nished, the patient can be rolled back on to the center of the
bed.
Unpacking and Inspection
Unpack the Skin IQ 365 from the shipping box and locate items as listed.
• Coverlet with instructions for use (included in complete kit or coverlet only)
• Power supply (included in complete kit or available as a separate item)
• Fan assembly (included in complete kit or available as a separate item)
Inspect all items carefully. If any items are damaged or missing, contact Arjo or an Arjo authorized
representative.
Installation
Failure to properly secure the coverlet to the existing surface may lead to patient or user
injury or equipment damage.
1. Remove coverlet, fan assembly and power supply from shipping bag.
2. Remove all covers and sheets from the existing pressure redistribution surface.
3. Place the coverlet on top of the existing surface, ensuring the foot tag on the coverlet is at the foot
end of the bed. The blue colored layer is the patient contact surface and should be the visible outside
layer when the coverlet is placed on the mattress. For pressure redistribution surfaces with a CPR
feature, make sure the CPR is visible. (See Fig. 1)
4. The power supply should come connected to the fan assembly. If not, plug power supply into fan
assembly.
5. The power supply comes with adapters speci c to the type of plug used in the country. Identify the
proper adapter and then insert adapter into the power supply and rotate clockwise until adapter
clicks. To remove adapter, depress button on adapter and rotate counterclockwise.
6. Locate fan assembly port underneath the foot end of the coverlet. Snap fan assembly into round red
fan port on coverlet. Rotate fan as necessary to achieve the correct nal fan positioning. (See Fig. 2)
Vents should be aligned so that fan exhaust is vented down and to the sides of the coverlet.
The location of CPR
may vary by product.
Fig. 1 Fig. 2