agiliti NP Adjust User manual

NP Adjust™
User Manual
MFG-0021ZJ-0523
Doc. #: ____________ Rev. Date: ____________ Rev.: ______
IFU0000076
07/28/2023
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 Adjust™...................................................................................................... 12
Unpacking Instructions ............................................................................................................. 13
Set-Up Instructions .................................................................................................................... 13
Cleaning Instructions................................................................................................................. 15
Top Cover..............................................................................................................................15
Bottom Cover........................................................................................................................16
Preventive Maintenance ........................................................................................................... 17
Storage and Disposal................................................................................................................ 17
Limited Product Warranty......................................................................................................... 18

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Introduction
Product Description
The NP Adjust™ non-powered support surface can accommodate diverse patient body
types and patient weights. The system consists of a non-skid mattress base, a series of
foam-filled air cells encased in a foam cavity and a low friction, anti-shear top cover. The
surface and components are designed to eliminate harmful chemicals of concern in the
fabric, fire barrier and foam. A layer of CuPro™ copper- and gel-infused foam is laminated
to the top of the foam cavity and serves as the support surface underneath the patient.
The foam cavity also includes bolsters on the sides and ends of the support surface,
providing added patient stability and positioning. The sloped heel section aids in patient
comfort and pressure injury prevention.
Intended Use
The product is a non-powered, zoned pressure redistribution support surface intended to
prevent and treat pressure injuries. The product is 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.
— 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 Adjust™
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 Adjust™
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 should install the NP Adjust™ 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 NP Adjust 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 Max Patient Weight 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.