Compression Solutions TriplePlay TPVT-01 User manual

Tr i p l e
Play VT
Vascular Therapy System
(Compressible Limb Sleeve Device)
Manufactured for: Customer Service
Wildcat Medical, Inc. Toll Free :
dba: Compression Solutions 1-800-994-0464
1638 South Main Street Email:
Tulsa, OK 74119 USA [e-mail]
Document # OM-TPV T-01 rev. 9
Copyright 2011 Wildcat Medical, Inc
.
Technical Data Specifications:
MAIN UNIT:
Dimensions: ........................ 6.9 x 4.3 x 1.8 inches (1.75 x 1.1 x 4.6 centimeters)
Weight: ................................................................ Approximately 1.1 lbs. (0.50 kg)
Mode of Operation: ....................................................................................... Cyclic
Source of Power: ............................ 6 Volt, 2.0 Ah NiMH rechargeable battery
CAUTION: Charge batteries using only the power supply provided by
Wildcat Medical.
POWER SUPPLY:
Use only UL/CSA 60601-1 approved power supplies from Wildcat Medical
for use in hospital settings
Output: ................................................................................................. 10 Vdc, 1.1 A
Mode of Operation: ............................................................................. Continuous
SYSTEM OPERATING ENVIRONMENT:
Temperature: ............................................................ +10˚C (50˚F) to +40˚C (104˚F)
Humidity: ................................................................................................... 30 to 75%
DEFAULT SETTINGS:
Leg Pressure (not adjustable) ............................................................... 50 mmHg
Auxiliary Pressure ............................. 35 mmHg (adjustable from 20-50 mmHg)
Cycle Time for each output............................................................ 60-70 seconds
TOLERANCES:
Pressure ............................................................................................................ ±5%
Single output run time ........................................................................... 25 hours*
Double output run time .......................................................................... 17 hours*
Triple output run time .............................................................................. 9 hours*
*Battery run time may vary when using the AUX function and/or wraps with
higher air bladder capacity than that of Wildcat Medical model TP-3333 leg cuffs.
This device is not protected against the ingress of water (ordinary protection,
IPX0).
Equipment is not suitable for use in the presence of flammable anesthetic
mixture with air or with oxygen or nitrous oxide.
The rechargeable batteries supplied in this unit are not field replaceable.
Return unit to Wildcat Medical if batteries require replacement.
NOTE: Recharge batteries every 60 days when unit is not in use in order
to maintain battery integrity. Batteries can be recharged approximately 500
times between replacements.
Battery charge (from depleted state) takes approximately 4 hours and is
terminated automatically by the control circuitry.
Warnings and Precautions
WARNING: Do not open or remove covers. No user serviceable parts
inside. Direct all service needs to Wildcat Medical, Inc.
WARNING: If pulsations or throbbing occur, the cuff may be wrapped too
tightly. Loosen immediately.
WARNING: Stop using device if swelling occurs; consult physician.
WARNING: Device is to be used only by the patient prescribed, and only
for its intended use.
WARNING: Ensure the pump control unit is turned off and unplugged
from the wall outlet prior to and while cleaning or disinfecting.
WARNING: Equipment should not be used in the presence of any
FLAMMABLE ANESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR
NITROUS OXIDE.
CAUTION: Do not immerse in any liquid for any reason.
CAUTION: Do not operate device in a wet environment.
CAUTION: Allow cuffs to warm to room temperature if exposed to
temperatures below 5°C
CAUTION: Do not subject the unit to extreme shocks, such as dropping
the pump unit.
CAUTION: Contains no user serviceable parts. Contact Compression
Solutions Customer Service.
CAUTION: Do not place any items in an autoclave.
Environmental Considerations
• Donotexposedevicetodirectsunlight.
• Donotoperatepumpbelow0˚C(32˚F).
• Donotexposetoheatexceeding65˚C(149˚F).
• Donotoperatethepumpifithasbeenstoredinfreezingconditions.Allow
cuffs to warm to room temperature if exposed to temperatures below 5˚C
(41˚F).
• Do not unroll or attach the cuffs in below freezing temperatures (0˚C /
32˚F) as damage to the air bladders can occur, making them unable to hold
pressure.
• Storeinadrylocationbetween+10˚C(50˚F)and+40˚C(104˚F),30%-75%
relative humidity.
• LimitTransportTemperaturestobetween-20˚C(-4˚F)and+60˚C(140˚F)
• Normal Operating Conditions Temperature Range +10˚C (50˚F) to +40˚C
(104˚F) Relative Humidity 30% to 75%
Purpose of this Device
The purpose of the TPVT-01 is to aid in the prevention of Deep Vein
Thrombosis (DVT) by helping to stimulate blood flow in the legs. This is
accomplished by an electronically controlled pump unit delivering a set
amount of air to the leg cuffs (model TP-3333) that, in turn, compress the calf
or calves to aid blood flow out of the lower extremities.
The TPVT-01 can also provide compression therapy to additional limb or
joint cuffs (as may be prescribed by a physician) through the use of the AUX
(auxiliary) function and output provided.
The pump unit will inflate the leg cuffs to a specified preset pressure of
50 mmHg, and the auxiliary cuff to a pressure of 20-50 mmHg (set by the user
or health care provider), and deflate once that pressure is reached. Cycles
are repeated until the unit is turned off. Internal rechargeable batteries
allow the system to be completely portable, thus preventing interruptions
in treatment.
Intended Uses
The TriplePlay TPVT-01 is intended to be an easy to use portable system,
prescribed by a physician, to help prevent the onset of DVT in patients by
stimulating blood flow in the extremities (simulating muscle contractions).
This device can be used to:
• AidinthepreventionofDVT;
• Enhancebloodcirculation;
• Diminishpost-operativepainandswelling;
• Reducewoundhealingtime;
• Aidinthetreatmentof:stasisdermatitis,venousstasis ulcers, arterial
and diabetic leg ulcers, chronic venous insufficiency and reduction of
edema in the lower limbs;
• AsaprophylaxisforDVTbypersonsexpectingtobestationaryforlong
periods of time.
Contraindications
The TriplePlay TPVT-01 must not be used to treat the following conditions:
•
Persons with suspected, active or untreated: deep vein thrombosis,
ischemic vascular disease, severe arteriosclerosis, pulmonary edema,
congestive heart failure, thrombophlebitis or an active infection;
• On a leg where cuffs would interfere with the following conditions:
vein ligation, gangrene, dermatitis, open wounds, a recent skin graft,
massive edema or extreme deformity of the leg;
• Onpatientswithneuropathy;
• Onextremitiesthatareinsensitivetopain;
• Whereincreasedvenousorlymphaticreturnisundesirable;
Default Settings
Leg Pressure Preset Level....................................................................... 50 mmHg
Default AUX Pressure Setting ................................................................ 35 mmHg
Auxiliary Output Pressure Range......................................................20-50 mmHg
Cycle Time (approximate) ...............................................................60-70 seconds
Internal Safety Valve Relief Pressure.................................................. 100 mmHg
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Pressure
Display Pressure
Increase
Button
Power
Button
(ON/OFF)
Mode
Select
Button
Low
Battery
Indicator
Selected Function
Indicators
Battery
Charging
Indicator
Red = Charging
Green = Charge
Complete
Pressure
Decrease
Button
Battery
Charger
Input
Leg 1
Air Connector Leg 2 Air
Connector
Auxiliary
Air Connector
Description of System Components ITEMS INCLUDED BUT NOT SHOWN:
• WallPlugTypeCharger(DCConnectormateswithcontrolunitcharger
input)
OTHER ITEMS THAT MAY BE INCLUDED BUT NOT SHOWN:
• Legwraps
• KneeWrap
• ShoulderWrap
Set-Up Instructions
1. Remove items from packaging and plastic bags.
2. Make sure all of the pieces listed on pages 6 and 7 are readily available.
3.
Inspect all components for damage. If any parts appear damaged or are
inoperable, contact Compression Solutions Customer Service (front cover).
4. Before using, connect the supplied power adapter plug into the jack on
the pump and plug into the main wall socket. The LED CHARGE indicator
will turn RED during the charge cycle and GREEN when the charge is
complete. The unit may be used while connected to the charger.
5. Uncoil the tubing being careful to remove any kinks from tubing due to
compression in shipping.
6. Apply garments to leg(s) (see “Attaching Leg cuffs”), route tubing under
clothingorinamannertopreventatrippinghazardandtoavoidkinking.
7. Ensure metal thumb tabs on the pump unit and cuffs’ air connectors are
depressed to allow the air tube connector(s) to engage.
8. Connect air tube(s) to pump air outlets.
Attaching the Leg Cuffs
1. Make sure that the securing tabs are on the inside of the sleeve relative
to your leg.
2. Place the cuff so the middle of the bladder outline is against the back of
your calf with the air tube fitting facing out.
3. Wrap the cuff around your calf so that it is a snug fit and fasten the securing
tabs. A loose fitting cuff can cause a low pressure (LO) error alarm.
4. Adjust as necessary.
Disposal
• This unit is an electromechanical device that includes printed circuit
boards and rechargeable batteries. Do not discard in landfill. Consult local,
state, federal and country requirements for proper disposal instructions.
• CuffsmaybediscardedinUSlandlls.
• Pumpcontrolunitcontainsrechargeablebatteries.Donotdiscardthe
pump unit in regular waste. Bring the unit to your local recycle center or
return to Wildcat Medical.
The use of accessories, power supplies and cables other than
those specified, with the exception of components sold by the
manufacturer of the TriplePlay TPVT-01 as replacement parts,
may result in increased emissions or decreased immunity of the
TriplePlay TPVT-01.
Class II medical electrical equipment.
The cuffs are single-use devices. One patient may use a cuff
multiple times, but a single cuff may not be shared between
patients.
This unit is an electromechanical device that includes printed
circuit boards and rechargeable batteries. Do not discard in
landfill. Consult local, state, federal and country requirements for
proper disposal instructions.
This symbol designates the degree of protection against electrical
shock as being a type BF applied part.
Customer Service
Toll Free: 1-800-994-0464
Email: [email protected]
Wildcat Medical, Inc.
dba: Compression Solutions
1638 South Main Street
Tulsa, OK 74119 USA R90MTPVT01

Troubleshooting
PROBLEM
Air tube outlet connector will not fit in port
Unit will not turn on
Cannot feel pressure on leg(s)
Pressure on Auxiliary cuff is too high
HI alarm (High pressure detected or set
pressure detected too soon)
LO alarm (Set pressure not detected
within allotted time period)
BL alarm (Pump will not operate)
BL alarm (Battery pack has expired.)
If you encounter any problems that cannot be
resolved by the preceding information, contact
Compression Solutions Customer Service
Operating Instructions
1. After following the set-up instructions, ensure that the cuffs are wrapped
snugly and fastened securely as indicated.
2. To turn the system on, press and hold the power button for 1-2 seconds.
If the unit will not power on, connect the wall supply to charge the
battery. Unit may be used while battery is being recharged.
3. The display will show any pressure reading detected by the unit and should
read“00.”Ifanyothernumberisdisplayed,the“zeroreference”requires
reset. To reset, turn the unit off by holding the power button pressed for
1-2 seconds and remove any cuff connected to the Leg 1 air outlet. Press
and HOLD BOTH the pressure DECREASE button and the power button for
at least 2 seconds to turn the unit back on. The unit should reset to a “00”
reading on the display. Reconnect the Leg 1 cuff if applicable.
4. Press the MODE button to select either 1 of 5 different output modes
(leg 1, leg 2, AUX, or a combination of leg 1 + AUX or leg 1 + leg 2 +
AUX). The selected outputs will be indicated by the illumination of the
corresponding function indicators near the bottom of the control panel.
Note: Adjustments can be made at any time that the pump is at “rest” (i.e.,
before cycling begins or during “rest” periods between cuff inflations).
Initial adjustments (immediately after power ON) must be initiated within
5 seconds of power ON. The unit will begin to cycle through the selected
functions 5 seconds after all adjustments have been completed.
5. If using the AUX function, adjust the pressure to the desired setting
using the Pressure Increase or Pressure Decrease buttons. The
pressure of the AUX cuff is set to 35 mmHg when that function is initially
selected. The auxiliary cuff pressure can be adjusted only when the
auxiliary mode is included in the selected functions and only during
“rest” periods (when no cuff is being inflated). To change the pressure
settings by 1 mmHg increments, press the Increase or Decrease buttons
briefly. Holding the buttons down for 2 seconds or more will cause the
pressure setting to change by increments of 5 mmHg. The pressure of
both Leg cuffs is preset to 50 mmHg and cannot be adjusted.
6. The unit will begin to cycle through the selected functions 5 seconds after
power is turned on, or 5 seconds after the initial adjustments are completed.
When a cuff is being inflated, the active outlet is indicated by a slow
flashing of the corresponding “function indicator.” If adjustments are
made during a “rest” period, the unit will resume cycling at the end of that
rest period. The “rest” time is determined by the number of cuffs selected
with the output mode. In a single cuff mode (leg 1, leg 2 or AUX only modes),
the rest period is 60 seconds from the time that the pressure is reached and
thepumpisturnedoffuntilthetimethatthecuffisre-pressurized.Inadual
cuff mode (leg 1 + leg 2 or leg 1 + AUX), the rest period is 25 seconds from
the time the pressure is reached and the pump is turned off until the time
thenextcuffispressurized.In thetriple cuff mode (leg 1 + leg 2 + AUX),
the rest period is 15 seconds from the time the pressure is reached and the
pumpisturned offuntil the timethe next cuffis pressurized.Thistiming
ensures that each cuff is being deflated for approximately 60 seconds, thus
allowing ample rest time between compressions on the affected limb or
extremity. It should be noted that the inflated wraps exhaust during the rest
period and the display will show “
— — ” during the rest periods.
7. To turn off the pump unit, depress and hold the power button for 1-2 seconds.
8. For uninterrupted extended operation, connect AC adapter while in use.
9. To remove cuff, pull securing straps and unwrap from leg.
10. To disconnect the air tube from pump unit, depress thumb tab on the
connector while pulling the tube away.
Low Battery Indicator
In order to ensure that proper pressure is always reached during operation,
regardless of the charge state of the battery, there are THREE stages of the
LOW BATTERY INDICATOR as follows:
STAGE 1 – The yellow LOW BATTERY INDICATOR illuminates when the
pump is NOT RUNNING, turns OFF when the pump starts and illuminates
again when the pump is in the REST period. This is the FIRST indication that
a recharge is needed at the earliest opportunity;
STAGE 2 – The yellow LOW BATTERY INDICATOR will REMAIN ILLUMINATED
during both the pumping time and the rest period. At this stage the battery
charger MUST be connected immediately to avoid any interruption in the
treatment session;
STAGE 3 – If the battery voltage drops to a critical level at any time, the
yellow LED will illuminate AND the display will show “BL”. In addition, the
audible alarm will sound and cycling of the pump will be inhibited. The unit
will then automatically shut off after two minutes.
Using the AC Adapter / Battery
Charger
Insert the supplied power supply plug into the adapter jack on the pump unit and
connect the power supply adapter to the main voltage wall socket. The battery
charge LED will illuminate RED while charging battery and turn GREEN when
charge is complete. It will not be illuminated if the charger is not connected. For
extended operation periods, or to charge the battery during treatment sessions,
the AC adapter can be connected while the device is in use.
NOTE: In hospital settings, use only a UL/CSA 60601-1 approved power
supply provided by Wildcat Medical, Inc. (output of +10 Volts DC @ 1.1
Amperes). Use of alternate power supplies could damage the system.
Cleaning and Disinfecting
NOTE: Inspect the TriplePlay unit and follow the cleaning and disinfecting
procedures prior to each use.
WARNING: Device must be turned off and disconnected from the power
mains (wall outlet) prior to and while cleaning or disinfecting.
CAUTION: Do not place any items in an autoclave.
CAUTION: Do not immerse pump unit in any liquid for any reason.
• Cleantheoutersurfaceofthepumpunitusingasoftcloth,moistened
with soapy water or 70% isopropyl alcohol.
• Donotusebleachonanyitem.
• Donotuseabrasiveorvolatilecleaners–displayorcontrolpanelcould
become scratched and hard to read.
• Donotplacecuffindryer,asthebladdercouldmelt.
• Hand wash exterior of cuff using a soft cloth moistened with soapy
water or 70% isopropyl alcohol and let air dry.
• Ensureproductiscompletelydrypriortouse.
User Maintenance
NOTICE: Contains no serviceable parts. Contact Compression Solutions
Customer Service.
• Inspect the unit and all components for any damage that may have
occurred during shipping or general handling prior to each use (for
example, frayed or cut cord, split air tubes, cracked plastic housing,
damaged LED display, torn cuff, etc.). Refer to pages 6 and 7 for a
description of all components.
• Donotattempttoconnectthewallsupplyifanydamageisnoticed.
• Avoidsubjectingtheunittoshocks,suchasdroppingthepumpunit.
• NotifyWildcatMedicalforimmediatereplacementofanydamageditems.
• Do not handle the leg cuffs with any sharp objects. If a bladder is
punctured, do not attempt to repair the cuff. Replacement cuffs (model
TP-3333) are available through customer service.
• Rollcuffforstoragetransportation;avoidfoldingorcreasingthebladder.
• Batteryisnotreplaceable–returnunittoWildcatMedicalifserviceis
needed.
• Duringextendeduse,anairleakmaydevelopfromover-exingofthe
elbow joint (the connecting piece between the hose and the cuff).
Inspect this joint for leaks and contact Compression Solutions Customer
Service at 800-994-0464 if necessary.
• Contact Wildcat Medical to receive replacement instructions for any
damaged items. This may include returning the damaged part to Wildcat
Medical for service.
Storage
• Storeinadrylocationbetween+10˚C(50˚F)and+40˚C(104˚F),30%-75%
relative humidity.
• Donotexposetoheatexceeding65˚C(149˚F).
• Donotstoreitemsindirectsunlight.
• Rollcuffanddonotfold,asfoldingwilldecreasethelifeofyourproduct.
• Connectunittochargerforrechargenolessthan2hoursevery60days
to preserve integrity of internal batteries.
Troubleshooting
SOLUTION
Make sure the metal thumb latch is pressed until it clicks, such that the two ends of the
connectors will fit together.
Battery charge is too low. Connect unit to a wall supply for a fresh charge and turn on.
• Cuffisnotwrappedtightlyenough
• Airtubesarenotconnected
• Bladder is damaged and will not hold air. Replacement leg cuffs, model TP-3333, are
available in pairs by contacting customer service.
• Tubeisdamaged
• Ensurethatthecuffisconnectedtotheproperoutletcorrespondingtotheselectedmode
• Verifysettingsarecorrectlysetasprescribed
• Decreasepressuresetting.Contactphysician.
Remove any kinks from line. Be sure the tubes are not tangled or constricted. Start pump again
by turning unit OFF and back to ON.
Ensure tubing is properly connected, cuffs are attached to be snug and there are no air leaks.
Start pump again by turning unit OFF and back to ON.
Battery charge is low. Connect charger.
Contact Compression Solutions at 800-994-0464
Customer Service
Toll Free: 1-800-994-0464 Email: [email protected]
Wildcat Medical, Inc.
dba: Compression Solutions
1638 South Main Street
Tulsa, OK 74119 USA
Alarms
“KINKED HOSE” or “HIGH PRESSURE” – If a pressure limit
isreached inlessthan 2seconds afterpumpis energized,cycling stops,
audible alarm sounds, and display reads “HI”. In addition, the LED indicator
coincidingwithwhichevercuffwasenergizedwhentheconditionoccurred
flashes rapidly.
“LEAK” or “LOW PRESSURE” – When a LEG cuff is activated, if the
pressure limit is NOT reached within 20 secondsafter pumpis energized
(or within 2 minutes when the AUXILIARY cuff is activated), cycling stops,
audible alarm sounds, and display reads “LO”. In addition, the LED indicator
coincidingwithwhichevercuffwasenergizedwhentheconditionoccurred
flashes rapidly. Note: it is important that the cuffs are fitted to be snug to
avoid false low pressure alarms.
“BATTERY CRITICAL” – If battery voltage drops to a critical level,
cycling stops, audible alarm sounds, and display reads “BL”. In addition, the
LOW BATTERY LED indicator illuminates.
To reset an alarm condition, the unit must be turned OFF. If not manually
turned OFF within 2 minutes of an alarm condition occurring, unit
automatically turns itself OFF.
If you encounter any problems that cannot be resolved by the preceding
information, contact Compression Solutions Customer Service
Customer Service
Toll Free: 1-800-994-0464
Email: [email protected]
Wildcat Medical, Inc.
dba: Compression Solutions
1638 South Main Street
Tulsa, OK 74119 USA
12
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9
14
10
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11
WARNING: If pulsations or throbbing occur, the cuff is wrapped too
tightly. Remove the cuff and re-wrap for comfort. If pain or swelling
occurs, discontinue use and notify your medical professional immediately.
Using the Auxiliary Function
Various additional compression wraps may be prescribed by your physician
to aid in therapy. The Auxiliary function and additional (third) output provided
on the TriplePlay-VT unit is designed to allow this flexibility.
Before using an auxiliary wrap, ensure that the connector on the wrap is
of the type required to fit the mating connector on the TriplePlay-VT unit
(contact Compression Solutions Customer Service for assistance or to order
any adapters which may be needed for this connection). Place the wrap on
the extremity and secure it firmly into place as instructed by your healthcare
professional. Connect the end of the air tube to the auxiliary connector on
the pump unit. Once the wrap is secure and the tube is connected, turn
the unit on; ensure that the AUX function is selected and make any needed
pressure adjustments as instructed in the Operating Instructions on page 9.
Air Tube
Press Power
Air Tube
(Back
of Calf)
Fasten
Power Adapter
Leg Two
Leg One