agiliti NP Duo User manual

NP Duo™
User Manual
MFG-0021ZK-0523
Doc. #: ____________ Rev. Date: ____________ Rev.: ______
IFU0000075 05/29/2023 1.0

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Table of Contents
Introduction ...................................................................................................................................3
Product Description...............................................................................................................3
Intended Use...........................................................................................................................3
General Information...............................................................................................................3
Product at a Glance......................................................................................................................4
Symbols ..........................................................................................................................................5
Labels..............................................................................................................................................6
Safety Instructions.........................................................................................................................8
Seven Zones of Bed Rail Entrapment .................................................................................8
Electrical Shock Hazards .....................................................................................................10
Warnings................................................................................................................................10
Cautions.................................................................................................................................10
General Notes.......................................................................................................................11
Specifications: NP Duo™ ..........................................................................................................12
Unpacking Instructions ..............................................................................................................13
Set-Up Instructions .....................................................................................................................13
Cleaning Instructions..................................................................................................................14
Top Cover..............................................................................................................................14
Bottom Cover........................................................................................................................15
Preventive Maintenance ............................................................................................................16
Storage and Disposal.................................................................................................................16
Limited Product Warranty..........................................................................................................17

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Introduction
Product Description
The NP Duo™ non-powered support surface can accommodate diverse patient body
types and patient weights. The multi-layered design ensures proper weight dispersal and
maximizes pressure redistribution. The surface and components are designed to
eliminate harmful chemicals of concern in the fabric, fire barrier and foam. All versions use
a laminated high-density foam core. The sloped heel section aids in patient comfort and
pressure ulcer prevention.
Intended Use
The 2-layered foam support surface will provide pressure redistribution to prevent and
treat pressure injuries. The product is intended for use on a Medical Bed Frame in a
medical facility by trained personnel.
General Information
— An authorized user is defined as an adult.
— Read and completely understand the manual before use.
— DO NOT modify this equipment without authorization from the manufacturer.
— Only use Agiliti replacement covers that are specific to this product.
— At certain intervals, maintenance of this product is required and must be performed by authorized
personnel only.
— Retain this manual for future use and maintenance.
— Patients, or users, should be risk assessed to ensure they are able to understand this manual and
make use of this product without risk to themselves or others.
Symbols, definitions, and fonts are used throughout this manual to aid user readability and
understanding of content.
— Standard Text: Used for regular information.
— Bold Text: Emphasizes a word or phrase.
— NOTE: Sets apart special information or important instruction clarification.

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Product at a Glance
NP Duo™
Support Surface Size (W x L) 7” Height

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Symbols
Symbol Description
Follow User Manual:
Indicates mandatory action to read and fully understand these instructions
prior to use.
Accompanying Documents:
Read and fully understand all accompanying documents for NP Duo™
before use.
Electrical Shock Hazard Warning:
Symbol alerts user to the presence of electrical shock hazards. It is
important to follow all instructions and special procedures to avoid
electrical shock to the operator, caregiver, and/or patient.
Contraindication:
Symbol alerts user to possible condition or circumstance which makes a
particular treatment or procedure potentially inadvisable. Disregarding a
contraindication could result in patient and/or user injury, as well as
damage to equipment.
Warning/Caution:
Symbol alerts user to the presence of important operating, maintenance,
or servicing instructions. Disregarding a warning could result in patient
and/or user injury, as well as damage to equipment.

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Labels
Label Description
Top Cover Screen Print
Cleaning and Care Label
Law Label
Flammability Standard Compliance Label
16 CFR Part 1632
16 CFR Part 1633
Technical Bulletin 117-2013 Compliance Label
TB117

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UDI Label
Part Number / Lot # Label

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Safety Instructions
WARNING: Bed rail entrapment is a serious health risk that can result in serious
injury or even death. Agiliti recommends the care provider be mindful of the FDA
guidelines relevant to bed rail entrapment, as serious injury can result. These
guidelines can be found on the FDA website. When using a foam or air therapy
system the care provider is responsible for ensuring the support surface properly
fits the bed frame. It is also the care provider’s ultimate decision whether or not to
use bed rails with the patient.
Seven Zones of Bed Rail Entrapment
If the patient would have any clinical conditions that could result in risk of falling or
improperly lying-in bed, the bed should be left at its lowest setting and in flat position
when not attended. Agiliti recommends the use of bed rails if they are available. There are
seven zones of bed rail entrapment.

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Safety Instructions
Only authorized users install the NP Duo™ support surface on bed frames. A thorough
understanding of the bed frame user manual is required prior to use. Follow the instructions
contained in this manual carefully. Use the NP Duo only if it is in proper working order and free
from tears or punctures. The terms Warning and Caution are used frequently throughout this
manual. A clear and concise understanding is required of these two terms.
CONTRAINDICATION: Indicates important information that may be contradictory
to the product instructions, which if not understood, could cause serious injury.
ELECTRICAL SHOCK HAZARD WARNING: This symbol is intended to alert the
user to the presence of electrical shock hazards. It is important to follow all
instructions and special procedures to avoid electrical shock to the operator, care
provider, and/or patient.
WARNING: Indicates a potentially dangerous situation, which if not avoided, could
result in injury ranging from moderate to serious severity up to and including death.
CAUTION: Indicates a potentially dangerous situation, which if not avoided, could
result in injury ranging from minor to moderate severity.

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Electrical Shock Hazards
ELECTRICAL SHOCK HAZARD WARNING: To avoid risk of electric shock or Injury,
ensure all cords on bed frame are away from bed deck prior to installing product.
ELECTRICAL SHOCK HAZARD WARNING: Before any cleaning and disinfection
procedures are performed, unplug all power cords in proximity to product to
eliminate possibility of electrical shock.
Warnings
WARNING: To avoid serious injury or death, ensure product is used with
compatible bed frame sizes.
WARNING: To avoid serious injury or death, ensure product is properly retained
on bed frame to avoid slippage or unintended movement.
WARNING: Product is to be used in accordance with each facility’s policies and
procedures.
WARNING: Do not exceed safe working load listed in the specifications. Can lead
to injury or damage
WARNING:
Bed rail entrapment can result in serious injury or even death. Agiliti
recommends caregivers be mindful of the FDA guidelines relevant to bed rail
entrapment. These guidelines can be found on the FDA website as referenced
below. When using a replacement support surface, the caregiver is responsible for
ensuring the product properly fits the bed frame. It is also the caregiver’s decision
whether or not to use bed rails with the patient.
Cautions
CAUTION: Use only approved replacement parts or covers.
CAUTION: Use of product is only one element of care in the prevention and
treatment of pressure injuries. Frequent repositioning, proper care, routine skin
assessment, wound treatment and proper nutrition are but a few of the elements
required in the prevention and treatment of pressure injuries. The responsibility of
prevention and treatment of pressure injuries lies with the health care professional.
CAUTION: Ensure that product covers are free from tears, rips or damage from
shipping and handling prior to installing on bed frame.
CAUTION: It is recommended that gloves and protective clothing be worn at all
times during cleaning and disinfecting.
CAUTION: Product requires regular maintenance to ensure performance and avoid
premature wear, damage and injury.