agiliti Pulsate User manual

Pulsate™
User Manual
MFG-0021J-1022
Doc. #: ____________ Rev. Date: ____________ Rev.: ______
IFU0000072
12/28/2022
A

Table of Contents
Introduction ................................................................... 2
Product at a Glance .................................................. 3
Symbols ........................................................................... 5
Labels ................................................................................ 6
Safety Instructions ..................................................... 8
Specifications ................................................................ 12
EMC Information ......................................................... 14
Unpacking Instructions ............................................ 18
Setup Instructions ...................................................... 19
Operating Instructions ............................................. 20
Cleaning Instructions ................................................ 23
Maintenance .................................................................. 26
Troubleshooting .......................................................... 28
Frequently Ordered Parts ...................................... 29
Storage and Disposal ................................................ 30
Warranty Information ............................................... 31
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IFU0000072 Pulsate User Manual

Introduction
Intended Use
Pulsate™ is indicated for the prevention and treatment of pressure injuries, the treatment of severe or
extensive burns, and to aid in circulation.
Purpose of the Device
Pulsate™ is a therapeutic support surface that provides immersion for pressure redistribution. It offers
two therapy modes: pulsation and static (immersion), both with low air loss.
Pulsate can be used for patients with spinal cord injury once the acute injury has been stabilized and
these patients have been accessed and cleared by the appropriate physician. Pulsate is not
recommended for use by patients with unstable spinal fractures.
The selection of a pressure redistribution surface should be based on each individual patient’s clinical
condition, diagnosis and/or co-morbidities. The choice and use of a support surface is one factor in a
holistic program of wound prevention and treatment.
Device Information
Pulsate™ Low Air Loss Mattress System is comprised of a specialized inflatable air bladder (air
mattress) and an electrically powered control unit.
Pulsate is a specialized, multi-cell air mattress sized to fit a standard hospital bed frame. The air
mattress serves as a replacement to the original mattress and is equipped with 6 air tubes with
connectors that connect to the control unit. The control unit is a self-contained, totally enclosed
module that hangs by hinged hooks on the footboard of the bed.
If the footboard is too wide, hang a control unit hanger bar on the footboard. If no hanger bar is
available, use best judgment on control unit placement. Do not place control unit under the bed.
The control unit is provided with a detachable hospital grade electrical cord and has a control panel
with selector switches and indicator lights. The switches and indicators are protected under a flexible
membrane to keep liquids out spills and make cleaning easier. Inside the control unit is a variable
output blower and manifold that allow the air mattress to operate in a static (immersion) mode or
provide pulsation pressure variations within the mattress. There is also a printed circuit board which
operates the electrical controls.
General Information
— 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 accessories that are specific to Pulsate.
— 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 operate the
Pulsate safely 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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IFU0000072 Pulsate User Manual

Product at a Glance
Control Unit
1. Control unit keypad
2. CPR button
3. Quick Reference instructions
1. Control unit keypad
1. Mounting hooks
2. Foam filter/HEPA filter
3. Carrying handle
1. Power switch
2. Alarm switch
3. Fuses
4. Power cord receptacle
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IFU0000072 Pulsate User Manual

Product at a Glance
Mattress
1. Mattress 1. Serial number location
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IFU0000072 Pulsate User Manual

Symbols
Symbol Description
Certification:
Indicates device has been independently tested and meets the
published safety standard(s).
Device Type:
Indicates a Type B device properly protected from electrical shock.
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 Pulsate™
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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IFU0000072 Pulsate User Manual

Labels
Manufacturer’s Label
Label Description
Label indicates the location of the leakage
test point screw.
Label indicates the location and specifications
of fuses.
Label on power cord explaining the
requirement for the power cord to be
connected to hospital grade outlets only.
Label indicates mains power switch and alarm
power switch locations.
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IFU0000072 Pulsate User Manual

Labels
Label Description
Label relaying information on hazards related
to environmental requirements for transport
and storage.
Label located on packaging.
Label relays important warning for hazards
related to electrical shock and bodily harm.
Do not open control unit case.
Label indicates and explains legal entity
relationship.
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IFU0000072 Pulsate User Manual

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 an Air Therapy system the care provider is
responsible for ensuring the mattress 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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IFU0000072 Pulsate User Manual

Safety Instructions
Only authorized users should operate Pulsate™. A thorough understanding of the Pulsate user manual is
required prior to use. Follow the instructions contained in this manual carefully. Use Pulsate only if it is
in proper working order. 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.
Electrical Shock Hazards
ELECTRICAL SHOCK HAZARD WARNING:
To avoid risk of electric shock or Injury,
only use manufacturer’s approved power cord.
ELECTRICAL SHOCK HAZARD WARNING:
Inappropriate handling of the power
supply cord, (e.g. by kinking, shearing, other mechanical damages) is hazardous.
ELECTRICAL SHOCK HAZARD WARNING: Before any cleaning and disinfection
procedures are performed, unplug power cord from outlet to eliminate possibility of
electrical shock.
ELECTRICAL SHOCK HAZARD WARNING: Electrical shock may occur when plugging
the Pulsate™ optional air pump into the wall outlet. Use ONLY grounded or hospital-
grade outlets.
ELECTRICAL SHOCK HAZARD WARNING:
To avoid electrical shock, DO NOT open
the control unit. Refer servicing to qualified personnel only.
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IFU0000072 Pulsate User Manual