AQUA-RELIEF ARS-2000D User manual

~ K L LI C I Hot and coldportabletherapy system
Model ARS-2000D Note:pleaseread all instructions and warningsbeforeoperatingthisunit
OPERATING INSTRUCTIONS The AKS 2000 can seriously injure skin if used improperly. Follow all instructions to ensureproduct safety.
Discuss TREATMENT WITH YOUR LICENSED HEALTH CARE PRACTITIONER
Provide a complete medical history including any reactions to cold. Ask your practitioner about potential adverse reactions and cold-induced injuries. Certain conditions make cold-induced injuries more likely. Use
only according to your prescription. Adhere strictly to doctor'sinstructionsregardinguse,treatmenttimes,treatment frequency, settings, self-assessment and generalbest practices regardingyourspecificcondition.
1. Connecttherapy pad(or booties if provided) tothe coolerhose.Couplings will click when theylock together.
2. Make sure the powersupply is unplugged while adding water;
3. For coldtherapy,open the cooler and fill with iceto above the fill line and then fill with water tothe fill line; for heattherapy, add warm tap water to fill line.
NEVER OPERATE UNIT WITHOUT WATER. User must fill water tothe fill line before turning onthe pump.
4. Plugpowersupply into the wall outlet. (Seepowersupplylabel for voltage.) NOTE: Always unplug unit when refilling with ke and water.
5. Position padonthe target therapyarea with the smoothsidetoward the skin or slip onthe booties.
6. If booties are included with yoursystem,always use with the diabeticsocks provided; the socksprovidebuffering and comfort tothe area. Place feet into the booties and
secure Velcrostrap.Always usean insulation barrier(such as Webril,Kerlix,cast padding, or elasticbandage) between the ARS therapy padand skin. NOTE: Donotletthe AKS
therapy pad treat exposed skin. If a sterile dressing is required by your doctor, but does not wholly cover the skin under the therapy pad, usean additional insulation barrier.
7. Ifyouare using the universal or backpad, usethe enclosedelastic belt to comfortably hold the wrap in place. Donot over-tighten the elastic belt.
8. Set-yourtemperaturemode tothe desired temperature; cold, low heat or high heat. Be sure to consultyourphysician ifyouare treating a condition.
9. The Control Panel settings onthe unit are Cold, when using with iceand water, andHot when using tap water.Whenusingcoldtherapy,periodicallyreplenish iceas needed.
10. The treatment timer isan analogue timer, onceadjusted, the timer will setto that time till expired.DANGER: TheC setting isa continuous operation ofthe unit (with no
auto-shutoff) anditcanbe dangerous. Please Consultyourphysician for recommended treatment time settings.
11. User MUSTemptywater from the unit afterevery treatment session.
CAUTIONS AND WARNINGS
Danger - to reduce the risk of burns, adverse reactions, and malfunction, this product must be used
in accordance with the following instructions.
cold therapy could result in serious injury like full thickness skin necrosis. Supervision may be necessary to ensureprecautions are followed, especially with youngchildren andthe elderly.
1. Ensurepads arenot wrapped too tight.
2. If numbness or burning occurs, discontinue useand
consult yourprescribingphysician.
3. Heat can burn or irritate skin. For this reason, itis best
nottouseit directlyagainst the skin. Note: Minor skin
redness istobe expected.
4.Ifthe ARS pump is beingused onan injury; refrain from
usingheat forat least 48 hours.
5. While in use, keep ona low surface, but awayfrom
disturbance by pets or children.
CONTRAINDICATIONS
» History of coldinjury,frostbite, or adverse reactions
to cold application
» History of heatinjury or adverse reactions to heat
» Monitor patients skin condition during therapy(every
20 minutes); special care monitoringmust be
provided for children, patients on prolonged therapy,
unconscious or incapacitatedpatients,diabetics, and
those with poorcirculation
» Application areas with compromisedlocalcirculation
» Potentialwoundhealingproblems,includingthose
from multiple surgical procedures; donot apply heat
to areas that are susceptible to developing bedsores
» Circulatory syndromes such as Raynaud's disease,
Buerger's disease, peripheral vascular disease,
vasospastic disorders, sickle cell anemia, and
hypercoagulable clotting disorders
» Local tissue infection
» Hand/wrist or feet/ankle surgery w/ polyneuropathy
RISK FACTORS FOR COLD-INDUCED INJURY
» Pathologicalsensitivity to cold
» Youngchildren andthe elderly
» Behaviors that negatively effect circulation, such as
poor nutritional habits,usingtobacco,caffeineabuse,
and alcohol abuse
» Medications that negativelyimpactmentalcapacity
» Diabetes
» Application areadesensitization dueto local
anesthesia or regionalnerveblocks
» Medications that have a negativeeffect on peripheral
vascular circulation:betaadrenergicblockers and
localized epinephrine
» Excessive moisture atthe applicationsite
» Hand/wrist or feet/ankle surgery
» Communication barriers
If theriskof cold-inducedinjury is greaterthan the
benefit of coldtherapy, donot prescribe the ARS 2000,
When prescribing to patientswith risk factors:
» Use highertemperatures ora thickerinsulationbarrier
on the skin
.» Shorter treatmenttimes, less frequentapplication, or
eliminatingnighttimeapplication
» Frequent skin checks and follow up examinations
ELECTRICAL PRECAUTIONS
Keep connectionsdry. Thq ARS 2000holds and pumps
water, the electricalconnections atthe power outlet and
from the powercord tothe ARS 2000 unit arenot
waterproof and must be keptdry. Always keep the unit in
a placewhere the connections will not fall into water
(e.g., a tub,sink, etc.). Ifthe electricalconnections fall
into water, donot touch anywet part ofthe product.
Unplug only atdry electrical connections.
Do not operate — or unplug immediately — if
transformer, plug, or cord is damaged. To resolve
damaged parts, unplug and contactPMT.
.. CONNECT TOA PROPERLY GROUNDED OUTLET ONLY.
» DONOT HANDLE THE TRANSFORMER OR ELECTRICAL
CORD WITH WET HANDS.
.. UNPLUG TO STOP THE PRODUCT WHEN NOTIN USE.
Unplugimmediatelyafteruse. Never leave unattended
when plugged in.
» USE INDOORS ONLY
. FLAMMABILITY
Do notusein places with flammable vapors or gasses,
high oxygen concentrations or other oxidizers. Risk of
explosion if used inthe presence of flammable
anesthetic. Keep the cord and transformerawayfrom
heated surfaces
WATER DAMAGE AND LEAKS » WATER SPILLAGE CAN HAPPEN DURING USE. THEREFORE, PLEASE SET THE ARS-2000 ONA
SURFACETHAT CAN TOLERATE SPILLS OR WATER ABSORPTION. DoNOTUSEON WOOD THAT CAN WARP, FINE CARPET, MATERIAL
THAT WILL BLEED COLOR, ETC. HOWEVER, IF VOUR PRODUCT LEAKS ORHASANY OTHER MECHANICAL DEFECT, DISCONTINUE USEAND
CONTACT YOUR PROVIDER IMMEDIATELY.
CARE AND MAINTENANCE | WARRANTY
The ARS Therapy pump canrun on tap water.Distilled water will help keep the unit running cleaner than tap water- but it is not
necessary to its operation. To clean your device, fill unit to fill line and then add a quarter cup of bleach or rubbing alcohol
circulate through your unit for 10 minutes then drain and rerun with tap water- and then drain again. This should be
preformed once every 6-12 months.
When using the large therapy boot (after turning the unit on), add water to the fill line, asthe large boot consumes more water.
It is optimal to empty the water out of the hose and therapypad. However, all water does not need to be removed from the
therapy pad (it is going to be difficult to do so). If you do not empty the water out of your hose, upon your next use you will
hove cold water mixing with your warm tap water.Either let it cycle with the heater on - or replenish the reservoir with hotter
tap water.
WARRANTY: A one year manufacturer's
warranty is given to all Water therapy
systems. This warranty is for replacement of
like items only. The warranty does not cover
items out of production. If the Item isno
longer in stock, then we will upgrade to a
like model. The warranty policy only applies
to the device and does not include the pad
or accessories supplied with the unit. The
pad is coveredunder a 30-day warranty.
Units used as commercial rentals can void
the warranty.
Prescription labeling: Federal law restricts this device to sale orusebyoronthe order ofa practitioner so licensed bythe state.

ARS-2000 IMPORTANT SAFETY INSTRUCTIONS READ AND FOLLOW ALL INSTRUCTIONS DONOT DESTROY
MUSTREADBeforeUsing ARS System ? DONOT SIT.STAND ORLAYON PADS
Pleaseconsultphysicianbeforeusingthisdevice
A WARNING
The ARS-2000 canbe cold enough to seriously injure the skin.
Follow these Operating Instructions, the must-read safety instructions
and all accompanying documentation.
WATER DAMAGE and LEAKS ? WATER SPILLAGE CAN HAPPENDURINGUSE.
THEREFORE, PLEASE SETTHE ARS-2000 ONA SURFACE THAT CAN TOLERATE SPILLS OR WATER
ABSORPTION. DONOTUSEON WOODTHAT CAN WARP, FINE CARPET,MATERIALTHATWILL
BLEEDCOLOR,ETC.HOWEVER, IF YOURPRODUCTLEAKS ORHASANY OTHERMECHANICAL
DEFECT,DISCONTINUE USEAND CONTACT YOUR PROVIDERIMMEDIATELY.
TO REDUCE THE RISK OF BURNS, ELECTRICAL SHOCK AND FIRE, THIS PRODUCT MUST BE USED IN ACCORDANCE WITH THE FOLLOWING INSTRUCTIONS.
Cautions and warnings: to reduce the risk of burns,adversereactions, and malfunction,thisproductmust be used in accordancewithinstructions.
Contraindications
SAFETY FORTHEARSFORUSE DURINGPREGNANCY HASNOT BEENESTABLISHED.
CAUTIONSHOULD BE USED FOR PATIENTSWITHSUSPECTED OR DIAGNOSEDHEARTPROBLEMS.
CAUTIONSHOULD BE USED FOR PATIENTSWITHSUSPECTED OR DIAGNOSEDEPILEPSY.
Precautions
SENSITIVESKINPATIENTS OR PATIENTSWITHCOMPROMISEDCIRCULATORYDISORDERSMUSTCONSULTTHEIRPHYSICIAN INALL SITUATIONS.
THERE is ABSOLUTEDANGER IN USING ARSIN CONJUNCTIONWITHEXTERNALANALGESICS. PLACING METHYLSALICYLATE,CAMPHOR, OR MENTHOL-CONTAININGEXTERNAL
ANALGESICS ONTHE PAINFULAREAINCREASESSUPERFICIALBLOODFLOW. IFA HEATINGPRODUCT IS SUBSEQUENTLYPLACED ONTHE MEDICATEDAREA, THE HEATDELIVERED TO
THE SITECANNOT BE REDISTRIBUTED VIA BLOOD FLOW. THIS INCREASES THE RISK OF BURNS.
Warnings
IFYOUARE PREGNANT,PLEASECONSULTYOURPHYSICIANBEFOREUSING BURNS CAN OCCURREGARDLESS OF CONTROLSETTING. CHECK SKIN
PLEASECONSULTYOURPHYSICIANBEFOREUSINGUNDER PAD FREQUENTLY
IFYOU HAVESENSITIVESKIN, OR SKININSENSITIVITY,PLEASECONSULTNEVERUNPLUG BY PULLING ONTHE CONNECTINGCORDS
YOUR PHYSICIAN TURN OFF WHEN NOTINUSE
ARS SHOULD BE KEPT OUTOFTHE REACH OF INFANTS AND CHILDREN AFTER APPLYING PADRUN UNIT FOR15 MINUTES AND CHECK FORANY
DONOTUSE WHILESLEEPINGDISCOMFORT. IFYOU FEELTHAT THE TEMPERATURE ISTOOHOT? PLEASE
THIS PRODUCT ISNOTTOBE USED BYAN INVALID,UNCONSCIOUS PERSONDISCONTINUE USEAND CONTACTYOURSUPPLIER
OR PERSONWITH LOW BLOODCIRCULATIONUNLESSATTENDED DoNOT TOUCH ANYOFTHE COMPONENTSINSIDEYOURRESERVOIRWHILE
DONOT LEAVEUNATTENDEDWHILETURNED ONTHE SYSTEM IS PLUGGED IN
DISCONTINUE USEIFYOU EXPERIENCE IF RASH OR DISCOMFORTPERSISTS PATIENT SHOULD USE EXTREME CAUTION WHEN USING UNIT FOR LONG
CHECK SKINUNDERNEATHTHERAPYWRAPPERIODICALLYTHROUGHOUT A PERIODS OF TIME AND SHOULDMONITORSKINUNDERNEATH PAD EVERY 20
TREATMENT SESSIONMINUTES. ITIS RECOMMENDED TO TAKERESTTIMEFROMTREATMENTS ?
ARS SHOULD NOTBE APPLIEDOVERCANCEROUSLESIONS,WOUNDS,ESPECIALLYTREATMENTSEXCEEDING 60 MINUTES
INFECTEDAREAS OR OPENSORES
PHYSICIAN INSTRUCTIONS for PRESCRIPTION of thisITEM:
PLEASE READ THE FOLLOWING AND PROVIDETHISFORM TO YOURLICENSEDHEALTHCAREPROFESSIONAL
Provide Prescription and Instructions
The ARS-2000 is classified bytheFDAasa Class II medicaldevicethatmust be prescribed bya physician or licensedhealthcarepractitioner. A properprescription foruse
must include:
Operating temperaturerangeFrequency and instruction on skininspections
Frequency and duration ofuse (andbreaks if applicable)TreatmentPeriod
Treatment protocolsvarybaseduponspecificpatientconditions and healthhistory,physician experiencewith continuous-flow coldtherapyapplication, and medicaljudgment.
Tellpatients howto inspectskin ofthe treatment sitewithoutcompromising the sterility, andhow often todoso. Instructpatients to stopusing the ARS-2000 and contact you
immediately if theyexperience any adversereactionssuch as:
increased pain, burning, increasedswelling,itching,blisters,increasedredness,discoloration, welts, or otherchanges in skinappearance
Review all product informationwithyourpatient.Review the Information for Patients and MedicalProfessionals in thisdocument, the OperatingInstructions onthe unit, andall
ancillary instructions.
PATIENT DISCHARGE PROTOCOL : Follow this protocol prior to discharging the patient from facility care to home use
1. Screening . Screen the patient forany contraindicationsand/orassociated risk factors. Ifthe patient hasany contraindications, donot prescribe the ARS-2000 tothe
patient. Ifthe patient hasany associatedriskfactors,consultwith the licensedhealthcarepractitioner to determine the appropriatenessofapplication ofthe ARS-2000.
2. Prescription . Instruct the patientregarding the licensedhealthcarepractitioner'sprescribedprotocol(temperature,frequency and duration of use,and, if applicable,
breaks), frequency and instruction on skin inspections, and treatment period.
3. Potential For Injury . Inform the patientthatimproper usecan result in seriousskininjury,includingnecrosis.Emphasize the importance of following the prescribed
protocol,proper pad application, and skininspection.
4. Instructions . Instruct the patient onhowto properly usethe ARS-2000.Review the OperatingInstructions witheach patient.
5. Proper Therapy Pad Application . Instruct the patientthat an insulationbarriermust be between the Therapy Padand skinduringuse. No part ofthe Therapy Pad
should touch the skin forany period of time.
6. Skin Inspection . Instruct the patient to inspect the skinreceivingcoldtreatment perthe practitioner'sinstructions,typicallyevery 20 minutes. If dressing,wrapping,
bracing, or casting over the Therapyprevents the ability ofthe patient to regularlyperformskinchecksunder the pad, donot dispense the ARS2000 tothe patient.
7. Discontinue . Instruct the patient to stopusing the ARS-2000 and contact theirlicensedhealthcarepractitionerimmediately if theyexperience any adversereactions
such as: increasedpain,burning,increasedswelling,itching,blisters,increasedredness,discoloration,welts, or otherchanges in skinappearance.
Apply InsulationBarrier & Therapy Pad
Always usean insulationbarrier(such as Webril,Kerlix,castpadding, or elastic bandage)between theARS therapy padand skin. DonotletanyARS theepy pad treat
exposed skin. Ifa sterile dressing is required by yourdoctor, but does not whollycover the skinunder the therapypad, usean additionalinsulationbarrier.
Skin Inspection
Inspect the skin ofthe treatmentareas as prescribed(every 20 minutes). Donotusethe ARS-2000 if dressing,wrapping,bracing, or castingoverpreventsskinchecks.Stop
using and contactyourpractitionerimmediately ifyou experience any adversereactions, such as:
increasedpain,burning,increasedswelling, itching, blisters,increasedredness,discoloration,welts,otherchanges in skinappearance, orany otherreaction
identified by yourpractitioner