SPAN PressureGuard PROTOCOL User manual

OWNER’SMANUAL
PressureGuard®
PROTOCOL™
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Span America Medical Systems, Inc.

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TABLEOFCONTENTS
DOCUMENT SYMBOLS.................................................................................................................................................................. 3
INTRODUCTION............................................................................................................................................................................... 4
Overview
Modes of Operation
Indications for Use
Intended Use
CONSTRUCTION AND DESIGN FEATURES ..........................................................................................................................6
Illustration Descriptions ..................................................................................................................................................... 6
The Science Behind the PressureGuard Protocol Microclimate Management Design ............................. 8
DIRECTIONS FOR SET-UP ........................................................................................................................................................... 9
CONTROL UNIT FUNCTIONS .................................................................................................................................................. 11
 On/Off
 Comfort Level
 Therapy Mode
 Low Pressure
 Auto Firm
 Audible Alarm On/Off
 Air Flow
GENERAL DIRECTIONS ............................................................................................................................................................. 12
 Head-of-Bed Elevation
 Bed Rails
 CPR
 Power Interruption
 Patient Transport
 Troubleshooting/Patient Complaints
 Bed Linens
 Service
 Environmental Conditions for Use
 Storage and Transportation
 Warranty
 Use in Wound Care
 Cleaning
 Waste Disposal
 Air Filter Preventive Maintenance
 Routine Inspection of Power Cords
 Mattress Preventative Maintenance
 Electromagnetic or Other Interference
SPECIFICATIONS.......................................................................................................................................................................... 20
ORDERING INFORMATION...................................................................................................................................................... 21
TROUBLE-SHOOTING GUIDE.................................................................................................................................................. 21
PRODUCT WARRANTY.............................................................................................................................................................. 23
MAINTENANCE AND REPAIR LOG....................................................................................................................................... 24

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Document Symbols
WARNING or CAUTION Direct Current
WARNING: Situations or actions that
may have an effect on patient or user
safety. Ignoring a warning could cause
patient or user injury.
IP21
Protection against the ingress of
fingers or similar objects and
dripping water
CAUTION: Points out special procedures
or precautions that persons must obey to
avoid equipment damage.
Authorized Representative in the
European Community
See the user manual for use instructions Potential trip hazards
Electrical shock hazard warning
Manufacturer
WEEE Double Insulated system
Type BF applied part EN 60601-1-2 Electromagnetic Emissions
European Conformity Marking IEC 60601-1 Electrical Safety
Foot End Keep Dry or Do Not Wet
Alternating current Not made with natural rubber latex
Serial number
Quantity
Non Sterile
Catalogue Number
Batch Code
Humidity limitation Temperature limitation

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INTRODUCTION
PressureGuardProtocol™
OVERVIEW: The system consists of a two-part microclimate management (often called “low air loss”) system
of cover and coverlet, a foam shell, air cylinder inflation system, and a control-unit. The foam shell has a high-
density foam topper, a patented Safety Edge™ contoured foam bolster on the perimeter of the mattress for
added patient stability and positioning, and graduated Heel Slope™ feature designed to further reduce
pressures on vulnerable heels. The air-cylinder inflation system is housed within the foam shell, and consists
of air-cylinders oriented lengthwise within the mattress. The control unit connects to the mattress at the
patient’s foot-end.
MODESOFOPERATION:. The Protocol provides the choice of two powered therapy modes of operation,
FLOAT or ALTERNATING.
WARNING–Thisproductisnotintendedforuseasanon‐poweredsupportsurface.Except
duringemergencypowerinterruption(seepage13)andduringoccasionalpatienttransport
(seepage14),patientsshouldbeonthesurfaceonlywhencontrolunitisconnected,
pluggedintowalloutlet,andpoweredON.

INDICATIONSFORUSE: The PressureGuard Protocol provides powered prevention and treatment of
pressure injuries through immersion and envelopment. Therapies provided include alternating pressure,
powered flotation, and microclimate management (management of excess moisture and heat). The system
may be indicated for use as a preventative tool against further complications associated with critically ill
patients or immobility. PressureGuard Protocol should always be used as part of a comprehensive medically
supervised care plan that includes appropriate repositioning, nutrition, and any necessary topical therapies
or incontinence management.
INTENDEDUSE: A pressure management system used for the prevention and treatment of pressure injuries.
Contraindication:ThePressureGuardProtocol™isnotforusebythosewithunstablespinal
cords.Patientinjurycouldoccur.


WARNING‐Toreducetheriskofburns,electrocution,fireorinjurytopersons:READALL
INSTRUCTIONSBEFOREUSINGTHISUNIT.

1. Always unplug this unit immediately after using.
2. Do not operate near water.
3. Do not place or store product where it can fall or be pulled into a tub or sink.
4. Do not place in or drop into water or other liquid.
5. Do not reach for a product that has fallen into water. Unplug immediately.
6. Use this unit only for its intended use as described in the operating instructions.
7. Never operate this product if it has a damaged cord or plug, if it is not working properly, if it has been
dropped or damaged, or dropped into water. Return the unit to Span-America Medical Systems, Inc. for
examination and repair.
8. Keep the cord away from heated surfaces.
9. Never drop or insert any object into any opening or hose.
10. Do not use outdoors.
CONSTRUCTIONANDDESIGNFEATURES

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Span-America’s proprietary use of non-collapsible “Air Diffusion Matrix” fabric in both the inner air delivery
cover and the outer removable coverlet creates an open pathway beneath the user, helping eliminate
excess moisture from the microclimate. Because neither the inner air delivery cover nor the outer
removable coverlet allow fluids to penetrate the surface, maintenance is minimal. The air-cylinder inflation
system and the foam shell work in concert to maintain low interface pressures throughout the surface,
making the Protocol effective for treatment of pressure injuries by preventing further tissue breakdown.
Close‐upillustrationsoftheOuterRemovableCoverletandtheInnerAir‐DeliveryCover,andanexplanationof
theSciencebehindthedesignarefoundonpage7.

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IllustrationofindividualcomponentsofthePressureGuardProtocol:

1. Outer Removable Coverlet
2. Inner Air Delivery Cover
3. Air Cylinders
4. Foam Shell with Geo-Matt®
segmented topper and
Safety-Edge™ bolsters system.
5. Control Unit
ILLUSTRATIONDESCRIPTIONS

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1. Outer Removable Coverlet:

The blue-colored coverlet is fluid resistant, cleanable and flame resistant. It
can be replaced if damaged or worn. Its smooth outer fabric is highly vapor
permeable and its crush-resistant Air Diffusion Matrix fabric provides a
pathway for efficient movement of moisture vapor away from the patient.
Coverlet can be routinely wiped clean and disinfected in place, or can be
removed and machine laundered according to directions in this manual.
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2. Inner Air Delivery Cover:

The gray, multi-layered inner cover serves as a barrier, protecting the inside
of the mattress from both fluids and vapors, while supplying air to the
microenvironment between the cover and coverlet. Unlike the blue
removable coverlet, it is intended to remain on the mattress at all times. It
can be cleaned and disinfected in place using standard hospital, medical
grade products. The air delivery cover consists of two layers of urethane
fabric with a welded pattern. Sandwiched between these layers is a layer of
crush-resistant Air Diffusion Matrix fabric. A series of air holes designed to
deliver air flow to the top of the mattress to flow underneath the patient in
the removal of moisture from the patient’s skin.
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3. Air Cylinders:

The inflation system consists of air cylinders that run lengthwise underneath
the body. Unlike typical roll-up systems, the cylinder inflation system does
not lose air from the inflation system for "low air loss", and can be
programmed to perform either Flotation or Alternating Pressure. The cycles
and inflation levels are designed to provide and maintain low interface
pressures throughout the mattress, and to redistribute peak interface
pressures during both therapy modes.

4. Foam Shell: The segmented Geo-Matt® style foam topper is cut from a high density,
medical grade foam. The unique geometric design consists of over 800
individual cells, each of which acts individually to customize patient comfort,
support, and pressure reduction and redistribution. This foam topper
includes the unique Heel Slope™ feature, designed to further reduce
pressure for the sensitive heel area. The proprietary Safety Edge™ consists
of contoured foam bolsters on the perimeter of the mattress for added
patient stability and positioning.
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5. Control Unit: 
The quiet, energy efficient control unit houses two separate air compressors:
a high-volume compressor provides air for the microclimate management
function through the cover/coverlet, while a low-volume compressor
provides air to the air cylinder inflation system.

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THESCIENCEBEHINDTHEPRESSUREGUARDPROTOCOL
MICROCLIMATEMANAGEMENTDESIGN

Protocol’s proprietary “Air Diffusion Matrix” design maximizes removal of excess moisture (i.e.,
perspiration) from the user’s skin. Moisture passes in vapor form down through the cover, where a
continuous air current takes it away before it can re-form as liquid.
The Air Diffusion Matrix fabric is not collapsible, ensuring a pathway for a constant flow of air beneath the
patient. Compare to typical low air loss designs that cause the patient’s body to press the cover directly onto
the air holes, closing off the flow of air beneath the patient.

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DIRECTIONSFORSET‐UP

1. Confirm that the bed frame is appropriate for use with the mattress, and that the length and
width of the mattress are appropriate for the frame. Place directly on a healthcare
bedframe only, never on top of another mattress.
WARNING:Thefitofthemattresstothebedframeisimportant.Minimizing
spacesorgapsbetweenthemattressandframewillhelppreventpatient
entrapmentissues.

2. The mattress should be placed so that the blue coverlet is facing up toward the patient. The
air line should be located at the foot end of the bed, to the patient’s right hand side when
laying on the mattress. The white screenprinting on the cover should be located at the foot
end of the bed, and it should read correctly when being viewed by a person facing the frame
from the foot end of the bed. The black bottom of the cover should face down onto the bed
frame. The foot end is clearly marked on the mattress cover.
3. The surface is designed to be used with appropriate linens in place. See page 14.
Connectingcontrolunit:

4. Hang the air-control unit on the foot-end of the bed. Avoid blocking vent holes for
filter on the back of the control unit housing.
5. Plug the power cable into the connector module at
lower left on the back side of the air-control unit.
Plug the opposite end into the wall outlet.
Alwaysplugthepowercablesecurelyinto
thewalloutlet.Makesuretheoutletisin
goodworkingorder.Theplugofthepower
cordshouldfittightlyintothewalloutlet.
Theplugbody,thewalloutlet,andthewall
plateshouldnotbecrackedorchipped.The
plugbladesshouldbesecurelyretainedin
theplugbody.
Donotconnectthepowercordtoanextensioncordortoamultipleoutletstrip.Iftheuseof
extensioncordsormultipleoutletstripscannotbeavoided,useonlyconnectorsthatareapproved
bythefacilityengineeringdepartment.Multipleoutletstripsshouldbemountedonafixedobject
toreducetheriskofliquidspillsandphysicaldamage.Inaddition,ifmultiple‐receptacleoutlet
boxesareused,theyalsoshouldbeprotectedfromtheriskofliquidspillsandphysicaldamage.
Allextensioncordsandmultipleoutletstripsshouldbetaggedandinspectedroutinely.
Donotcoverthepowercordwitharugorcarpet.Rugsorcarpetscanpreventnormalairflow,
whichcanleadtogreaterheatbuilt‐up.Placethecordinalowornotrafficarea.Checktobesure
themotionofthebeddoesnotinterferewiththebed’spowercordorplug.
Neverthreadpowercordsthroughmechanicalpartsofthebedorbedrailswhere
normalbedmovementmaydamageorcutthecord.

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6. Ensure that the three air lines that extend from the mattress are protruding through the
opening in the lower right corner of the blue coverlet. If necessary, the zipper at the
underside of the coverlet can be unfastened in order to retrieve air lines. Once the air lines
are protruding through the coverlet opening and the zipper is refastened, the air lines from
the mattress can be connected to the air lines that extend from the control unit.
7. Bring the three air lines from the control around to the meet air lines extending from the
mattress. Ensure that the airlines are not kinked or twisted.
CAUTION:Neverthreadairlinethroughmechanicalpartsofthebedorbedrails
wherenormalbedmovementmaydamagetheairlinesortheaircontrolunititself.
Checktobesuretheroutingoftheairlinesorthemotionofthebeddoesnot
impedeairflowbycrimpingtheairlines.

8. Identify correct male/female pairs, which match by both color and size. Press
corresponding fittings together until hearing an audible click, which confirms that the
connection is complete.
The surface is now ready for use by patients who are within the 400 lbs (181.4 kg) weight
limit for the product.
Attemptingtoforceaconnectionbetweenfittingsthatarenotproperlymatedbysizeand
colorwillcausedamagetotheconnectorsandwillnotallowsystemtofunctionproperly.

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
CONTROLUNITFUNCTIONS

ON/OFF:Plug power cord into wall outlet. Press ON/OFF switch to “ON”. Indicator light
will change to green, along with additional lights on control panel, indicating that the unit
is powered up. Unit will resume the settings it was in when last powered down.
COMFORTLEVEL:For best possible pressure management, maximize immersion and
envelopment by initially setting the “COMFORT LEVEL” on the control panel to the softest
selection appropriate for the patient, in accordance with the stated weight limits:
 Forpatientsupto120lbs,begin with Level 1 (“Max.
Immerse”).
 Forpatientsweighingmorethan120lbs(upto400
lbs.)begin with Level 2.
Adjust for user comfort as desired, using “SOFTER” and
“FIRMER” buttons.
NOTE:Elevating the head of bed may require adjusting COMFORT LEVEL to ensure
appropriate support, especially if elevated beyond 30 degrees (see “Head of Bed
Elevation”, below).
THERAPYMODE:Toggle between “ALTERNATING” and “FLOAT” mode as desired.

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LOWPRESSURE:The “LOW PRESSURE” indicator light indicates that the air system is
not reaching or maintaining its appropriate minimum setting. If light comes on, first check
that all airlines are properly and securely connected and that they are not kinked. If light
remains on 30 minutes after making these adjustments, call for service.
NOTE:Tofacilitateinstallation,systemincludesabuilt‐indelay(upto5minutesinfloat
mode,upto10minutesinalternatingpressure]beforealarmwillsoundafteralowpressure
situationoccurs.


AUTOFIRM:Select the AUTO FIRM mode to stop the alternating movement of the
mattress. The AUTO FIRM indicator light will illuminate and the mattress will achieve
uniform support that may be desired for egress and exit, . The mattress will remain in the
AUTO FIRM mode for 30 minutes.
During this time, all of the COMFORT LEVEL indicator lights will be illuminated in amber,
and the THERAPY MODE indicator will turn off. The COMFORT LEVEL, THERAPY MODE
and ON/OFF selectors will be inactive. The Audible alarm is not affected.
After 30 minutes, the system will automatically resume the comfort and therapy mode
settings that had been previously selected.
Pressing the AUTO FIRM selector at any time prior to the elapsing of 30 minutes will
immediately return the system to the comfort and therapy mode settings it was in prior to
the pressing of AUTO FIRM, and will re-active all selectors including ON/OFF.
AUDIBLEALARMON/OFF:When this light is on, alarm will sound if “LOW PRESSURE”
indicator light comes on. Press AUDIBLE ALARM ON/OFF button to silence.
AIRFLOW(LOWAIRLOSS):This function operates continuously whenever the control
unit is powered on, regardless of therapy mode selected. Indicator light provides visual
confirmation that air is being provided to air delivery cover.

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GENERALDIRECTIONS

ELEVATINGHEADOFBED(HOB):All support surfaces using air as a support medium are designed for
distributing pressures over the body in a flat, horizontal position. Bending the support surface and the body
at the midpoint when elevating the HOB concentrates the body weight over the center of the surface,
stressing that small area. This extreme change in dynamics creates a challenge for all air support surfaces.
Maximum pressure management benefits are realized between zero and 30 degrees HOB elevation. Beyond
30 degrees, the amplitude of the changes in the air cylinders begins to decrease in proportion to the increased
elevation of the HOB. Although the Protocol will maintain its support and therapeutic capabilities up to and
including 70 degrees HOB, for maximum benefit we recommend that any pressure management surface be
used with the head of the bed elevated as little as possible, and for limited periods at a time. If HOB is elevated
at 30 degrees or beyond, a regular pattern of pressure relief in the form of a return to non-elevated position is
warranted. Adjustment of comfort level setting may also be required. See “Comfort Setting”, above.
BEDRAILS: Due to concerns over the possibility of patient entrapment, Span-America recognizes that the use
of rails of any length is a matter currently addressed by federal and state laws/guidelines, and by individual
facility protocol. It is the responsibility of the facility to be in compliance with these laws, which typically
require that decisions on the use of bed rails of any type are based on assessment of the physical and mental
status of each patient individually. If bedrails are needed by the patient to prevent fall-related injury, as
determined by this facility assessment, we recommend that the bedrails be locked in the up position at all
times. We do not require use of bedrails with the Protocol mattress unless the patient is deemed to be safer
with them than without them.
CPR(CardiopulmonaryResuscitation):. The standard for life support recommended by the American Heart
Association recommends a hard level surface such as a crash board, or moving the person to the floor. If that
is not possible, do the following for performing CPR:
1.) Select AUTO FIRM
2.) Place a crash board underneath the patient
3.) Follow CPR procedures.
POWERINTERUPTION:As a safety feature, in the event of a power interruption the system will maintain at
least a minimum level of support for up to 8 hours— depending on factors including mode, comfort setting,
and patient weight —by automatically locking in whatever air is present in the system at the time of power
interruption.
However,tomaximizepatientsupportforpowerinterruptionsofanextendedorpotentially
extendedduration,thefollowingisrecommended:

 Disconnect the two smaller, white paired fittings that connect the mattress airlines to the control unit
air lines.
 Once disconnected from the control unit air lines, connect the white male and female fittings
together. This will cross-connect all four mattress air cylinders, equalizing them and sealing the
entire system closed.
 If head of bed is elevated, it should be returned to flat position if possible.

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When power is restored, control unit will resume the settings it was in when power was interrupted.
Mattress air lines that have been cross connected should be disconnected from each other and re-connected
to their corresponding control unit air lines. Allow approximately 5 minutes after power is restored to
achieve normal therapy mode functions.
PATIENTTRANSPORT:The patient can remain on the mattress while the mattress and bed frame are being
moved, with proper safety precautions taken. Prior to unplugging the power connector from the wall
receptacle, mattress should be left in FLOAT Mode for a minimum of two minutes.
The inflation of the mattress will be maintained and the air will equalize in the air cylinders.
CAUTION:DONOTMOVEPATIENTONMATTRESSWITHOUTBED.
Mattressshouldnotbeusedaloneforpatienttransport.


TROUBLESHOOTING/PATIENTCOMPLAINTS: Occasionally a patient may complain of feeling as if he/she
is “sinking into a hole”.
1) Sometimes this occurs when the head of the bed is elevated and the mattress is in alternating pressure.
This sensation may be a combination of the deflation of the cylinders during their cycle and the increased
weight of the patient on the sacrum and pelvis when the head of the bed is elevated. This may
demonstrates the need to minimize elevation of the head of the bed.
2) A patient may complain when he/she is supine or side-lying and are not used to the changing pressures
within the air system. Reassure the patient that this is normal functioning, as the cylinders alternately inflate
and vent. The vented tubes are not fully deflated. Some air is always maintained in them to prevent bottoming
out. After reassurance, patients typically become acclimated to the changing pressures.
BEDLINENS:Seven-inch deep fitted sheets are recommended, though flat (non-fitted) sheets may be used.
Multiple layering of linens or incontinence underpads beneath the patient should be avoided where possible
for maximum pressure redistribution.
SERVICE:Return the control unit for repair or service to Span-America Medical Systems. Repairs to be
performed by manufacturer only. Call 800-888-6752, 8 am – 5 pm EST M-F.
ENVIRONMENTALCONDITIONSFORUSE:
• Indoor Use
 Altitude up to 2000 meters
• Temperature 5 degrees C to 40 degrees C
• Maximum relative humidity 80% for temperatures up to 31 degrees C, decreasing linearly by 50 per
cent relative humidity at 40 degrees C
• Mains Supply Voltage Fluctuation up to 10 +/-% of the nominal voltage
• Overvoltage Category II
• Pollution Degree 2

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STORAGEANDTRANSPORTATION
Store the mattresses in a clean, dry place. Once the mattress is removed from the box, store in a flat position
if possible. Protect from damage. Avoid temperature extremes (below freezing or above 120oF). Allow to
acclimate to room temperature before use. Do no stack more than 10 high. Do not stack other equipment on
top of the mattresses.
Store the control unit in a clean, dry place, protected from accidental damage or falls. Avoid temperature
extremes (below freezing or above 120oF).
Do not stack other equipment on top of the controller. For
transportation, secure to prevent damage or falls. For shipment, use box and packaging as provided by the
manufacturer.
WARRANTY: The Protocol is unconditionally guaranteed against failure due to manufacturing defects under
normal use for 18 months. See page 23.
USEINWOUNDCARE: Use of PressureGuard® Protocol™ 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. As there are many factors that may influence the development of a pressure injury for each
individual, the ultimate responsibility in the prevention and treatment of pressure injuries is with the health
care professional.
CLEANING:Cleananddisinfectmattresscoversfollowing contamination with bodily fluids and between
patients. Both the inner cover and the removable coverlet can be cleaned in place by wiping with neutral suds
and lukewarm water. Rinse and allow to air dry for approximately 20-30 minutes before use. For hard to
clean spots, use liquid cleaner with soft sponge in the concentration recommended by the manufacturer. DO
NOT USE HARSH CLEANERS OR SOLVENTS.
If desired, removable coverlet can be machine-laundered using cold or warm water and a cold rinse cycle.
Begin wash cycle, add detergent, allow to agitate for two minutes, then place coverlet in washer. Tumble dry
using low heat or no heat, or allow to air dry.
CAUTION:USEOFHIGHHEATINWASHINGORDRYINGWILLDESTROYTHE
COVERLET.

For long-term incontinent applications, clean and disinfect cover daily. A scented cleaner/disinfectant is
recommended. Iodophor type disinfectants (e.g. Betadine) will stain the fabric.
For disinfection, phenolic or quaternary type disinfectants are recommended. Disinfectants should be
hospital grade (tuberculocidal). Follow manufacturer’s instructions for use concentrations, contact times and
rinsing.
Contamination with blood on the fabric can be disinfected with a 1:10 dilution of household bleach (5.25%
sodium hypochlorite) as recommended by the CDC. The use of bleach at improper dilutions may result in
fabric discoloration and fluid pass-through.
Where surveillance and epidemiology indicate ongoing transmission of C.difficile,an EPA registered
hypochlorite-based disinfectant is recommended. Follow the manufacturer’s instructions for use
concentrations, contact times and rinsing. Generic sources of hypochlorite (e.g. household chlorine bleach)
may also be used. Prepare the disinfection solution fresh daily at a 1:10 dilution. Improper dilutions may
result in ineffectiveness and higher than recommended concentrations will damage the fabric.

16
P10452R6CO#2648
Note:alcohol-based disinfectants are not effective against C.difficileand should not be used to disinfect
environmental services. For further information relative to this organism and infection control in the
healthcare setting, please refer to www.cdc.gov/ncidod/hip.
Do not puncture the mattress with needles or sharp instruments. This may result in loss of integrity of the
mattress air system or top surface low air loss bladder and will void the warranty. Inspect the covers and
zipper area for signs of damage, puncture, or wear that could result in fluid pass-through. If the cover is
stained, soiled, or torn, inspect the internal components for signs of contamination. If contamination is
evident, quarantine the mattress and remove from service following infection control procedures.
Ifrequired,thecontrolunitcanbecleanedanddisinfected.

Turnunitoffandunplugfromwallbeforecleaning.[Note: The mattress will maintain air with
the unit unplugged. The unit will resume previous setting when powered back up].
Wipedownwithusingdampspongeorcloththathasbeenthoroughlywrungouttoremove
excessliquid.Donotallowliquidstopenetratetheuserpanel.

For cleaning, use neutral suds and lukewarm water. For disinfection, phenolic or quaternary type
disinfectants are recommended. Disinfectants should be hospital grade (tuberculocidal). Follow
manufacturer’s instructions for concentrations and contact times.
WASTEDISPOSAL:This Product has been supplied from an environmentally aware manufacturer that
complies with the WEEE.
This product may contain substances that could be harmful to the environment if disposed of in
locations (landfills) that are not appropriate according to legislation. Please be environmentally
responsible and recycle this product through your recycling facility at its end of life.
AIRFILTERPREVENTIVEMAINTENANCE:The air filter for the control unit should be checked routinely for
signs of dirt or contamination. The frequency for cleaning depends on the air quality. The air filter is
accessible from the backside of the control unit. As the filter is white, the need to clean is obvious. Simply
turn off the control unit and remove the plastic filter cover, remove the filter, and hand wash using warm
water and mild detergent. Rinse thoroughly and allow to air dry. Replace the filter and the plastic cover.
ROUTINEINSPECTIONOFPOWERCORDSANDSAFETYTIPSTOPREVENTFIRES

1. Assure that the electrical resistance of the safety ground conductor and the level of leakage current
(line conductor-to-safety ground and neutral conductor-to-safety ground) meet applicable standards
for resistivity and leakage current. Protection afforded by the ground pin is negated if the receptacle
is not properly grounded. If you have questions about the adequacy of your facility’s building wiring,
contact qualified electrician or consult the code authority in your jurisdiction.
2. Check all electrical outlets, including accessory outlets for cleanliness, physical integrity and
functionality.
3. Check the power cord to assure that contact pins are straight and secure.

17
P10452R6CO#2648
4. Routinely inspect the power cord for damage sustained from crushing, pinching, shearing, cutting, or
from being worn through. They can be damaged by bed movement, deterioration from use or aging,
or human or equipment traffic. The cord’s insulation should be intact and there should be no
evidence of bulging, stretching, crimping, cracking, or discoloration, especially at the ends, there the
cord is attached to the plug body and the control unit.
5. Regularly inspect as parts of the bed frame, motor, mattress and controller, and the floor beneath and
near the bed for build-up of dust and lint.
6. Inspect the cover of the control panel to assure that the covering is not cracked or damaged, allowing
liquids or other conductive material to penetrate to the switches.
7. Report any unusual sounds, burning odors, or anything unusual to maintenance personnel.
Discontinue use of the power cord immediately and contact Span-America Medical Systems for
replacement.
MATTRESSPREVENTATIVEMAINTENANCE
Inspect the covers and zipper area for signs of damage, puncture, or wear that could result in fluid pass-
through. If the cover is stained, soiled, or torn, inspect the internal components for signs of contamination. If
contamination is evident, quarantine the mattress and remove from service following infection control
procedures.
You may use the Preventive Maintenance Log provided on the last page of this manual to monitor and
document regular inspection and maintenance of your PressureGuard Protocol Surfaces.
ELECTROMAGNETICOROTHERINTERFERENCE:This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance with the instructions, may cause harmful
interference to other devices in the vicinity. However, there is no guarantee that interference will not occur
in a particular installation.
If this equipment does cause harmful interference to other devices, which can be determined by turning the
equipment off and on, the user is encouraged to try to correct the interference by one or more of the
following measures:
- Reorient or relocate the receiving device.
- Increase the separation between the equipment.
- Connect the equipment into an outlet on a circuit different from that to which the other device(s)
are connected.
- Consult the manufacturer for help.
EMC:Electric devices may interact due to electro-magnetic radiation. We recommend a safety distance of at
least one –meter, especially for sensitive equipment. Upon request, we will provide you with a table for more
detailed information.

18
P10452R6CO#2648
Guidance and manufacturer’s declaration – electromagnetic emissions
The 3400 is intended for use in the electromagnetic environment specified below. The customer or the user of the 3400 should assure
that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1 The 3400 uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B The 3400 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.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
Guidance and manufacturer’s declaration – electromagnetic immunity
The 3400 is intended for use in the electromagnetic environment specified below. The customer or the user of the 3400 should assure that it is used in such
an environment.
Immunity test IEC 60601
test level
Compliance level Electromagnetic environment – guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
6 kV contact
8 kV air
6 kV contact
8 kV air
Floors should be wood, concrete or ceramic tile. If floors are covered
with synthetic material, the relative humidity should be at least 30 %.
Electrical fast
transient/burst
2 kV for power
supply lines
2 kV for power
supply lines
Mains power quality should be that of a typical commercial or hospital
environment.
IEC 61000-4-4 1 kV for input/output 1 kV for input/output
lines lines
Surge
IEC 61000-4-5
1 kV line(s) to line(s)
2 kV line(s) to earth
1 kV line(s) to line(s)
2 kV line(s) to earth
Mains power quality should be that of a typical commercial or hospital
environment.
interruptions and <5 % UT <5 % UT Mains power quality should be that of a typical commercial or hospital
voltage variations
on power supply
input lines
(>95 % dip in UT)
for 0,5 cycle
(>95 % dip in UT)
for 0,5 cycle
environment. If the user of the3400 requires continued operation during
power mains interruptions, it is recommended that the 3400 be
powered from an uninterruptible power supply or a battery.
40 % UT 40 % UT
IEC 61000-4-11 (60 % dip in UT) (60 % dip in UT)
for 5 cycles for 5 cycles
70 % UT 70 % UT
(30 % dip in UT) (30 % dip in UT)
for 25 cycles for 25 cycles
<5 % UT <5 % UT
(>95 % dip in UT) (>95 % dip in UT)
fo
r
5 sec fo
r
5 sec
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields should be at levels characteristic of a
typical location in a typical commercial or hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.

19
P10452R6CO#2648
Portable and mobile RF communications equipment should be used no
closer to any part of the 3400, including cables, than the recommended
separation distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
d = 1,2
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
d = 1,2 80 MHz to 800 MHz
d = 2,3 800 MHz to 2,5 GHz
Radiated RF 3 V/m
3 V/m
where P is the maximum output power rating of the transmitter in watts
(W) according to the transmitter manufacturer and d is the
recommended separation distance in metres (m).
IEC 61000-4-3 80 MHz to 2,5 GHz Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey,a should be less than the compliance level
in each frequency range.b
Interference may occur in the vicinity of equipment marked with the
following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM
radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the 3400 is used exceeds the
applicable RF compliance level above, the 3400 should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the 3400.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between
portable and mobile RF communications equipment and the 3400
The 3400 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the
user of the 3400 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the 3400 as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum output
power of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d = 1,2
80 MHz to 800 MHz
d = 1,2
800 MHz to 2,5 GHz
d = 2,3
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be
estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
UseofmainpowercordsotherthanthatsuppliedwithproductbySpan‐America(P10509)may
affectEMCcompliancewithULregulations.Powercordsotherthanrecommendedby
manufactureroratlengthsotherthansuppliedlengthmayincreaseremissionsordecrease
immunity.

20
P10452R6CO#2648
SPECIFICATIONS

COVER: Bacteriostatic, flame resistant, fluid-proof, tear resistant
FOAM: High-density open-cell polyurethane. “THIS PRODUCT MEETS THE
REQUIREMENTS OF BUREAU OF ELECTRONIC AND APPLIANCE REPAIR, HOME
FURNISHINGS AND THERMAL INSULATION TECHNICAL BULLETIN 117-2013.”
AIR CYLINDERS: Urethane (main cylinders ), and urethane-coated nylon
CONTROL UNIT: Model No.: 3400
Dimensions: 14 x 9.5 x 6.5 inches
Weight: 11.5 lbs plus weight of added airlines
Rated Spec: AC 110-120V / 60Hz / 0.6A MAX
Fuse Rating: 1A 250VAC
Classification: Type BF/ Class I
Not AP or APG equipment
Leakage Current: N/A (floating earth ground)
Listing: Conforms to CAN/CSA-C22.2 No. 60601-1-14 and AAMI ES60601-1:2005
STANDARD
SURFACE SIZES: 80”L X 36”W
84”L X 36”W
75”L X 36”W
MATTRESS HEIGHT: 7” for all models
WEIGHT LIMIT 400 lbs.
CYCLE TIME: 10 minutes

21
P10452R6CO#2648
ORDERINGINFORMATION


ProductName

Catalog
Number

Description

Re-order#
Mattress Only
Re-order #
Outer Removable
Coverlet (blue)
Re-order #
Inner Air Delivery
Cover (gray)









PressureGuard®
Protocol™
P7535-29 With control unit
75”L x 35”W x 7”H PM7535-29 CLT-PM7535 C1-PM7535
P8035-29 With control unit
80”L X 35”W X 7”H PM8035-29 CLT-PM8035 C1-PM8035
P8435-29 With control unit
84”L X 35”W X 7”H PM8435-29 CLT-PM8435 C1-PM8435
23173 With control unit
80”L X 42”W X 7”H M23173 CLT-23173 C1-23173
17108 With control unit
84”L X 42”W X 7”H M17108 CLT-17108 C1-17108

69212
With control unit
80”L X 35”W X 7”H
w/Raised Perimeter

M69212

CLT-69212

C1-69212

33905
With control unit
84”L X 35”W X 7”H
w/Raised Perimeter

M33905

CLT-33905

C1-33905

72235
With control unit
80”L X 42”W X 7”H
w/Raised Perimeter

M72235

CLT-72235

C1-72235

81990
With control unit
84”L X 42”W X 7”H
w/Raised Perimeter

M81990

CLT-81990

C1-81990
PressureGuard
Protocol Control Unit 3400 Control unit - -
REPLACEMENTPARTSLIST

P10424 Inflation system 75" Mattress
P10425 Inflation System 80 & 84" Mattress
P10502 PG Protocol Rubber Feet and screws
P10503 PG Protocol Hooks Set (2)
P10504 PG Protocol Air Filters
P10433 PG Protocol Airline Set (3 lines)
P17284 PG Protocol Power Cord
P10510 PG Protocol Front Overlay
P10511 PG Protocol Rear Label