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
1
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.
2
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
3
IFU0000072 Pulsate User Manual

Product at a Glance
Mattress
1. Mattress 1. Serial number location
4
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.
5
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.
6
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.
7
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.
8
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.
9
IFU0000072 Pulsate User Manual

Safety Instructions
Warnings
WARNING:
Medical equipment should not be used, stacked, or located on or around
equipment that may create electromagnetic inferences.
WARNING:
Using other manufacturer’s cables and accessories may affect EMC
performance. Unauthorized use of these items will void warranty and could result in
patient and/or user injury as well as damage to equipment or other property.
WARNING: The use of cables or accessories other than those for which the control unit
was designed or tested can significantly degrade emissions and immunity
performance.
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.
WARNING:
It is recommended that gloves and protective clothing be worn at all times
during cleaning and disinfecting.
WARNING:
DO NOT autoclave.
WARNING:
(120V unit) Make sure the power cord is plugged into a properly grounded
hospital grade 120V A/C outlet.
10
IFU0000072 Pulsate User Manual

Safety Instructions
Cautions
CAUTION: Only authorized personnel should engage in the troubleshooting process.
Troubleshooting by unauthorized persons could result in personal injury or equipment
damage.
CAUTION:
It is recommended that gloves and protective clothing be worn at all times
during cleaning and disinfecting.
CAUTION:
Keep out of direct sunlight.
CAUTION:
DO NOT expose to temperatures below 0°F (-18°C) or above 95°F (35°C).
CAUTION:
DO NOT expose to moisture or areas of humidity greater than 95%.
CAUTION: Beware of Electromagnetic Interference from Radio Wave Sources such as:
Hand-held portable transceivers with the antenna mounted directly to the transmitting
unit including citizen band
(CB) radios, “walkie-talkies, security, fire and police transceivers, cellular telephones
and other personal communication devices.
CAUTION:
The mattress requires regular maintenance to ensure performance and
avoid premature wear, damage and injury.
11
IFU0000072 Pulsate User Manual

Specifications
Control Unit
Mode of Use For Indoor Use Only
Duty Cycle Continuous
Control Unit Dimensions
(LxWxH)
7.5” (19cm) x 18.5” (47cm) x 12” (30.5cm)
Control Unit Weight 16 lb. (7.26kg)
Operating Temperature -18°C to 35°C (0°F to 95°F)
Functions
Pulsating Low Air Loss 3,5, or 10 minutes
Liters of Air Per Minute 1,740 LPM
Alarms
Power Failure
Low Pressure
CPR
Electrical
Power Requirements 120V AC 60 Hz 6.3A Maximum
Electric Shock Protection Class I
Degree of Shock Protection Type B
Maximum Relative Humidity 95%
Storage Temperature -18°C to 35°C (0°F to 95°F)
Environmental Conditions Product must be stored and transported in
packaging free of moisture and dust.
User Serviceable Parts Hooks, hook brackets, absorber pad, power cord,
fuses, and filters.
Power Cord 16’ (5m) detachable with hospital grade plug.
Fuses T 6.3A 250V AC (5mm x 20mm)
12
IFU0000072 Pulsate User Manual

Specifications
Surfaces
Air Cells (qty.) 20
Air Cell Zones (qty.) 1
Top Cover Polycarbonate 4-Way Stretch
Standard 35”
Surface Weight 19 lb. (8.62kg)
Safe Working Load 600 lb. (272.35kg)
Maximum Patient Weight
550 lb. (249.48kg)
Air Cell Height Base (foam) Overall Height Width Length
6” (15.24cm) 2” (5.08cm) 8” (20.32cm) 35” (88.9cm) 82” (208.3cm)
Bariatric 39”
Surface Weight 25 lb. (11.33kg)
Safe Working Load 1000 lb. (453.59kg)
Maximum Patient Weight 950 lb. (430.92kg)
Air Cell Height Base (foam) Overall Height Width Length
8” (20.32cm) 1” (2.54cm) 9” (22.86cm) 39” (99cm) 82” (208.3cm)
Bariatric 42”
Surface Weight 31 lb. (14.06kg)
Safe Working Load 1000 lb. (453.59kg)
Maximum Patient Weight 950 lb. (430.92kg)
Air Cell Height Base (foam) Overall Height Width Length
8” (20.32cm) 1” (2.54cm) 9” (22.86cm) 42” (106.7cm) 82” (208.3cm)
Bariatric 48”
Surface Weight 37 lb. (16.8kg)
Safe Working Load 1000 lb. (453.59kg)
Maximum Patient Weight 950 lb. (430.92kg)
Air Cell Height Base (foam) Overall Height Width Length
8” (20.32cm) 1” (2.54cm) 9” (22.86cm) 48” (121.9cm) 82” (208.3cm)
13
IFU0000072 Pulsate User Manual

EMC Information
WARNING:
Medical equipment should not be used, stacked, or located on or around
equipment that may create electromagnetic inferences.
WARNING:
Using other manufacturer’s cables and accessories may affect EMC
performance. Unauthorized use of these items will void warranty and could result in
patient and/or user injury as well as damage to equipment or other property.
WARNING: The use of cables or accessories other than those for which the control unit
was designed or tested can significantly degrade emissions and immunity
performance.
Pulsate™ has been tested for compliance with the EMC requirements. The guidelines in this section will
help to ensure the medical equipment will meet the requirements of the standard.
Emissions
This control unit has been type tested and has passed the requirements of CISPR 11. Observe the
following recommendations to minimize radio frequency emissions in this section and the
Electromagnetic Interference section.
The control unit is intended for use in the electromagnetic environment specified below. The customer or
user of this control unit should ensure that it is used in such an environment.
Table 201 Guidance and Manufacturer’s Declaration – Emissions All Equipment and Systems
Emissions Test Compliance Electromagnetic Environment Guidance
RF Emissions
CISPR 11 Group 2
The control unit must emit electromagnetic energy in order to
perform its intended function. Nearby electronic equipment may
be affected.
RF Emissions
CISPR 11 Class A
The control unit is suitable for use in all establishments, including
domestic establishments and those directly connected to the
public low-voltage power supply network that supplies buildings
used for domestic purposes.
Harmonics
IEC 61000-3-2 Class A
Flicker
IEC 61000-3-3 Complies
All pins of connectors have passed ESD testing.
List of Cables & Accessories
Replacement parts, such as cables and accessories, must be purchased through Agiliti to ensure proper
compliance requirements.
14
IFU0000072 Pulsate User Manual

EMC Information
Immunity
This control unit has been stringently tested for susceptibility to electromagnetic radiation over the
frequency range 80 MHz to 2.5 GHz. The test was conducted on this control unit and passed the
requirements of IEC 60601-1-2:2007.
The control unit is intended for use in the electromagnetic environment specified below. The customer or
user of the control unit should ensure that it is used in such an environment.
Table 202 Guidance and Manufacturer's Declaration - Immunity All Equipment and Systems
Immunity
Test
IEC 60601 Test
Level
Compliance
Level Electromagnetic Environment Guidance
ESD
IEC 61000-4-
2
±6kV Contact
±8kV Air A
Floors should be wood, concrete or
ceramic tile. If floors are synthetic, the r/h
should be at least 30%
EFT
IEC 61000-4-
4
±2kV Mains
±1kV I/Os A
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-
5
±1kV Differential
±2kV Common A
Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage
Dips/Dropout
IEC 61000-4-
11
>95% Dip for
0.5 Cycle
60% Dip for
5 Cycles
30% Dip for
25 Cycles
>95% Dip for
5 Seconds
A
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the control unit
requires continued operation during power
mains interruptions, it is recommended that
the control unit be powered from an
uninterruptible power supply or battery.
Power
Frequency
50/60Hz
Magnetic
Field
IEC 61000-4-
8
3A/m A
Power frequency magnetic fields should be
that of a typical commercial or hospital
environment.
15
IFU0000072 Pulsate User Manual

EMC Information
Table 204 Guidance and Manufacturer's Declaration - Immunity Equipment and Systems which are
NOT Life-supporting
Immunity
Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic Environment Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC
61000-4-3
3 VRMS
.15 MHz to 80 MHz
3 V/m
80 MHz to 2.5
GHz
(V1) VRMS = 3
(E1) V/m = 3
Portable and mobile communications
equipment should be separated from the
control unit by no less than the distances
calculated/listed below:
D = (3.5/V1) (SQRT P)
D = (3.5/E1) (SQRT P)
80 to 800 MHz
D = (7/E1) (SQRT P)
800 MHz to 2.5 GHz
Where P is the max power in watts and D is the
recommended separation distance in meters.
Field strengths from fixed transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance levels (V1
and E1).
Interference may occur in the vicinity of
equipment containing a transmitter.
16
IFU0000072 Pulsate User Manual

EMC Information
Equipment and Systems which are NOT Life-supporting
Recommended Separation Distances for the control unit
The control unit is intended for use in the electromagnetic environment in which radiated disturbances
are controlled. The customer or user of the control unit can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF Communications Equipment and the
control unit as recommended below, according to the maximum output power of the communications
equipment.
D = (3.5/V1) (SQRT P)
D = (3.5/E1) (SQRT P)
80 to 800 MHz
D = (7/E1) (SQRT P)
800 MHz to 2.5 GHz
Table 206 Recommended Separation Distances between portable and mobile RF
Communications equipment and the control unit.
Compliance Level Cond RF
3
Rad RF-800MHz
3
Rad RF - 2.5GHz
3
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.67 23.33
17
IFU0000072 Pulsate User Manual

Unpacking Instructions
WARNING:
(120V unit) Make sure the power cord is plugged into a properly grounded
hospital grade 120V A/C outlet.
CAUTION:
Keep out of direct sunlight.
CAUTION:
DO NOT expose to temperatures below 0°F (-18°C) or above 95°F (35°C).
CAUTION:
DO NOT expose to moisture or areas of humidity greater than 95%.
CAUTION:
Beware of Electromagnetic Interference from Radio Wave Sources such as:
Hand-held portable transceivers with the antenna mounted directly to the transmitting
unit including citizen band (CB) radios, “walkie-talkies, security, fire and police
transceivers, cellular telephones and other personal communication devices.
NOTE :
Some cellular telephones and similar devices transmit signals while they are ON, even
when not being used.
General
The two principal components of the Pulsate™ system are a specialized air inflatable bladder (Air
Mattress) and an electrically powered control unit.
Instructions
Remove product from packing material and examine for shipping damage. If damage is detected,
contact the freight company and file a damage complaint immediately.
Parts:
— Control Unit
— Detachable power cord
— Low Air Loss Mattress Replacement with Mattress Cover
18
IFU0000072 Pulsate User Manual

Setup Instructions
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.
Pulsate™ can be placed on any conventional medical bed, including those used in hospitals, nursing
homes or a homecare. The original mattress should be removed and stored in an appropriate place. The
following steps should be completed in installing the system:
1. Remove standard mattress from bed.
2. Replace with Pulsate™ mattress. (Be sure air hoses are at the foot end of the bed).
3. Strap Pulsate air mattress to bed frame on all four sides with straps provided.
4. Place control unit on the footboard using the two hinged hooks located on the back of the unit.
5. Use power cord to connect the control unit and medical grade power outlet.
6. Align master shape on mattress quick connector to same shape on control unit.
7. Apply upward pressure and twist counterclockwise until all three tabs are seated in slots.
8. Visually inspect connection to ensure connector will not leak air.
19
IFU0000072 Pulsate User Manual