Delfi P.T.S. Instrucciones de instalación

OPERATOR and MAINTENANCE MANUAL

DELFI P.T.S. PORTABLE TOURNIQUETSYSTEM

PORTABLETOURNIQUET

SYSTEM

PRESSURE

DEFLATE

INFLATE

TIME

P.T.S.

REF9-2100-001

U.S. PATENTS 6,213,939; 5,931,853; 5,649,954; 4,469,099; PAT. PEND. and FOREIGN PATENTS

Delfi

medical

innovations inc.

Delfi Medical Innovations Inc.

Vancouver BC, Canada

800-933-3022 (US & Canada)

+ 604-742-0600 (Global)

Fax. + 604-742-3800

www.delfimedical.com

LIMITED ONE YEAR WARRANTY(U.S.A. only)

SCOPE OFWARRANTY

DelfiMedicalInnovationsInc. (‘Delfi’) warrantsthe P.T.S. PortableTourniquet System(‘product’) for one

year fromdate ofpurchase. During the warranty period, Delfiwill repairor replace, at itsoption, any product

which isdefectiveinmaterialsor workmanshipor which failsto meet the published specification for that

model.ThisLimited Warranty ismade onlyto the originalpurchaser ofthe product and isnon-transferable.

The remediesdescribed inthe Limited Warranty are the exclusiveremediesfor breach ofwarranty. THIS

WARRANTY SHALL NOT APPLY TO ANY PRODUCT WHICH HAS BEEN ALTERED, MODIFIED,

DISASSEMBLED OR SERVICED BY ANYONE OTHER THAN DELFI STAFF IN ANY WAY, OR WHICH

HAS BEEN SUBJECTED TO MISUSE OR ABUSE.

DISCLAIMER OFIMPLIED WARRANTIES

The foregoing Express Limited Warranty isgiven inlieu ofany and all other express or implied warranties.

DELFI MAKES NO OTHER WARRANTIES INCLUDING THE IMPLIED WARRANTIES OF

MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

LIMITATION OFREMEDIES

In no caseshall DelfiMedicalInnovationsInc. be liablefor any specialincidentalor consequentialdamages

whether based on breach of warranty or other legaltheory. Somestatesdo not allowlimitationson warranties

or on remediesfor breach in certain transactions. In such states, the limitsin thisparagraph and the preceding

paragraph do not apply.

WARRANTY CLAIMS

In the event ofa warranty claim within the warranty period please take the following steps:

1. NotifyCustomer Service Department, DelfiMedicalInnovationsInc. at 800-933-3022. Pleaseprovide

detailsabout the nature ofthe problemand include the product serialnumber. Upon receipt ofthis

information, Delfiwill provide a date for service or a return shipping authorization.

2. Upon receipt ofthe shipping authorization, forward the equipment, freight prepaid, to the location specified

in the shipping authorization.

Your compliance with these stepswill help assure that you receive prompt warranty service for your product.

WARRANTY(OUTSIDE U.S.A.)

Please contact Delfifor warranty information.

Unit SerialNumber _________________

AC Power Supply SerialNumber _________________

TABLE OFCONTENTS

SECTION 1.0: DELFI PORTABLE TOURNIQUETSYSTEM (P.T.S.) GENERAL INFORMATION.........2

1.1 INTENDED USE...........................................................................................................2

1.2 CONTRAINDICATIONS................................................................................................2

1.3 PRECAUTIONS IN USE................................................................................................2

1.4 ADVERSE EFFECTS....................................................................................................3

SECTION 2.0: P.T.S. INSTALLATION AND OPERATING INSTRUCTIONS..........................................4

2.1 SPECIFICATIONS........................................................................................................4

2.1.1 POWER REQUIREMENTS..........................................................................4

2.1.2 PERFORMANCE.........................................................................................4

2.1.3 SIZE............................................................................................................4

2.1.4 ENVIRONMENTAL......................................................................................4

2.2 INITIAL INSPECTION...................................................................................................4

2.3 CONTROLS, INDICATORS, DISPLAYS, AND CONNECTORS....................................5

2.4 INITIAL SETUP.............................................................................................................9

2.5 FUNCTIONAL AND CALIBRATION CHECK................................................................9

2.5.1 AC POWER CONNECTION AND INDICATOR:...........................................9

2.5.2 POWER-UP SEQUENCE AND SELF-TESTS:.............................................9

2.5.3 PRESSURE SET POINT ADJUSTMENT:....................................................9

2.5.4 TIME LIMIT SET POINT ADJUSTMENT:...................................................10

2.5.5 CALIBRATION CHECK:.............................................................................10

2.5.6 “PRESSURE LOW” and “CUFF LEAK” ALARM CHECK:...........................11

2.6 PRESSURE AND TIME DEFAULTS...........................................................................11

2.7 OPERATION...............................................................................................................11

2.8 ALARM CONDITIONS................................................................................................13

2.8.1 ALARM SILENCE FUNCTIONS.................................................................17

2.8.2 INTERNAL HARDWARE FAILURES.........................................................17

2.8.3 PRESSURE HIGH or LOWALARMS.........................................................17

2.8.4 LEAK ALARMS..........................................................................................17

SECTION 3.0: P.T.S. MAINTENANCE INSTRUCTIONS.......................................................................18

3.1 GENERAL MAINTENANCE INFORMATION..............................................................18

3.2 PERIODIC MAINTENANCE........................................................................................18

3.2.1 CLEANING................................................................................................18

3.2.2 INSPECTION.............................................................................................18

3.2.3 FUNCTIONAL AND CALIBRATION CHECKS............................................18

3.3 CALIBRATION............................................................................................................18

3.4 LEAK TESTING..........................................................................................................19

3.5 BATTERY TESTING and REPLACEMENT.................................................................20

3.5.1 BATTERY TESTING..................................................................................20

3.5.2 BATTERY PACK REPLACEMENT............................................................20

3.6 TROUBLESHOOTING GUIDE....................................................................................21

3.7 INTERNAL HARDWARE SERVICING........................................................................23

3.8 WARNINGS, CAUTIONS, LABELS, and SYMBOL DEFINITIONS..............................23

FIGURES and TABLES:

Figure 2.1 P.T.S. Controls, Indicators, Displays, and Connectors------------------------------------------- 7

Figure 2.2 P.T.S. Pressure and Time Display Detail ------------------------------------------------------------ 8

Figure 2.3 P.T.S. Message Display Detail ------------------------------------------------------------------------- 8

Figure 3.1 Labels--------------------------------------------------------------------------------------------------------- 23

Table 2.1 AlarmConditions------------------------------------------------------------------------------------------- 13

Table 3.1 Troubleshooting -------------------------------------------------------------------------------------------- 21

SECTION 1.0:DELFI PORTABLE TOURNIQUETSYSTEM(P.T.S.)

GENERALINFORMATION

NOTE: Use this tourniquet system according to the policies in your practice setting. The following

information on intended use, precautions, contraindications, and adverse effects are offered as a

guide to assist in this process.

1.1 INTENDED USE

The DelfiPortableTourniquet System(P.T.S.) isintended to be used by qualified medicalprofessionalsto

temporarilyocclude blood flowinapatient'sextremity during surgicalprocedureson that extremity.

Tourniquetsare generallyused for operationslasting less than 90 minutes.Tourniquetshavebeen found

usefulin producing a bloodless operation field in surgicalproceduresinvolving the extremitiesincluding:

- Reduction ofcertain fractures- Kirschner wire removal

- Tumor and cyst excisions- Knee joint replacements

- Arthroscopy ofcertain joints- Replacement offinger joints

- Bone grafts- Amputations

- Subcutaneousfasciotomy - Nerve injuries

- Tendon repair - Totalwrist joint replacement

WARNING: Do not use tourniquet cuffs to control the distal flow of CO2or any other gases used as a

distention media. Tourniquet cuffs have not been evaluated for safety or effectiveness in controlling

gas flow beyond the surgical site during arthroscopic insufflation procedures. Possible effects of

using atourniquet cuff in this manner include serious subcutaneous emphysema proximal to the

cuff.

1.2 CONTRAINDICATIONS

Refer to the medicalliterature for possiblecontraindicationsto tourniquet use. A partiallist isprovided below,

however in every case the finaldecision to use a tourniquet restswith the attending physician.

- Open fracturesofthe leg - Post-traumatic lengthy hand reconstruction

- Severe crushing injuries- Diabetesmellitus

- Severe hypertension

- Elbowsurgery (where there isconcomitant excess swelling)

- Skin graftsin which all bleeding pointsmust be readily distinguished

- Compromised vascular circulation, e.g., peripheralartery disease

- Sickle cell disease or trait (relative contraindication, see PRECAUTIONS IN USE).

- Secondary or delayed proceduresafter immobilization.

1.3 PRECAUTIONS IN USE

•The tourniquet systemmustbe kept well calibrated and inoperablecondition. Accessoriesshouldbe

checked regularly for leaksand other defects.

•The tourniquet cuff mustnever be punctured; therefore towelclipsused near the systemmustbe

handled with specialcare.

•Cuffswith inner rubber bladdersmustbe completelyenclosed by the outer envelope to preclude

ballooning and possiblerupture ofthe bladder. Cleaning and assemblyinstructionsofthe cuff

manufacturer should be followed carefully.

•Do not usean elasticbandage for exsanguination incaseswhere thiswill causebacteria, exotoxins,

or malignant cellsto spread to the generalcirculation, or where itcoulddislodge thromboemboli that

may have formed in the vessels.

•The tourniquet cuff mustbe applied inthe proper location on the limb. Tourniquet pressure and the

timethe tourniquet isinflated on the limbshouldboth be minimized. There isadditionalpotentialrisk

to superficialnervesinunprotected areas;never applyatourniquet over an area where major nerves

may be directlycompressed againstbone (eg. peronealnervenear the proximalhead ofthe fibula).

Never applyatourniquet over the jointsofthe limb. Do not readjustan already inflated cuff by

rotating itbecausethisproducesshearing forceswhich may damage the underlying tissue. Prolonged

ischemia may lead to temporary or permanent damage to tissues, blood vessels, and nerves.

•Prolonged tourniquet timecan alsoproduce changesinthe coagulability ofthe blood with increased

clotting time. Alwaysminimize tourniquet time.

•Tourniquet paralysismay resultfromexcessivepressure. Insufficient pressure may resultinpassive

congestion ofthe limbwith possibleirreversiblefunctionalloss.Alwaysusethe minimumeffective

tourniquet pressure, asdescribed in the medicalliterature.

•Inflation should be done rapidly to occlude arteriesand veinsasnear simultaneously aspossible.

•Carefuland complete exsanguination reportedlyprolongspain-free tourniquet timeand improvesthe

quality ofIntravenousRegionalAnesthesia(Bier Block anesthesia). In the presence ofinfection and

painfulfractures,after the patient hasbeen inacast, and inamputationsdue to malignant tumors,

exsanguination before tourniquet application may be done without the useofan elasticbandage by

elevating the limb for 3 to 5 minutes.

•In caseoffailure, the tourniquet cuff mustbe fullydeflated and the limbexsanguinated againbefore

reinflation. Reinflation over blood-filled vasculature may lead to intravascular thrombosis.

•Tourniquet usersmustbe familiar with the inflation-deflation sequence when using twotourniquet

cuffsand twoP.T.S. unitstogether for IVRA (Bier Block anesthesia), sothat the wrong tourniquet will

not be released accidentally.

•Testfor hemoglobintype and levelbefore using atourniquet on patientswith sickle-cell anemia.

When the tourniquet isused for thesepatients,the limbshouldbe carefullyexsanguinated and the

PO2and pH should be closely monitored.

•Select the proper cuff size to allowfor the overlap recommended by the cuff manufacturer. Too

much or too littleoverlap may causecuff rolling and telescoping, unexpected releaseof the cuff from

the limb, inability to maintainabloodless fieldat normalpressures,and/or undesired pressure

distribution on the limb.

•The skinunder the tourniquet cuff mustbe protected frommechanicalinjury by smooth, wrinkle-free

application ofthe cuff.Ifthe tourniquet cuff isapplied over any materialthat may shed loosefibers

(such asWebril)the fibersmay becomeembedded inthe contact closuresand reduce their

effectiveness. Followthe cuff manufacturer’srecommendationsfor limb protection materialunder the

cuff.In general,alimbprotection sleevedesigned specificallyfor the cuff providesthe best

protection.

•Ifskinpreparationsare used preoperatively, they shouldnot be allowed to flownor collect under the

cuff where they may cause chemicalburns.

•Whenever the tourniquet cuff pressure isreleased, the wound should be protected fromblood surging

back by applying pressure dressingsand, ifnecessary, elevating the limb. Transient painupon

tourniquet pressure releasecan be lessened by elevation ofthe limb. Iffull color doesnot return

within 3 to 4 minutesafter release, the limb should be placed in a position slightly belowbody level.

•The deflated cuff and any underlying limb protection material should be completely removed

as soon as tourniquet pressure is released. After the cuff has been fully deflated and removed

from the patient, the unit can be set to STANDBY. Even the slightest impedance of venous

return may lead to congestion and pooling of blood in the operative field.

•Whenever IVRA (Bier Block anesthesia) isused, itisrecommended that the tourniquet remain

inflated for at least 20 minutesfromthe time ofinjection.

1.4 ADVERSE EFFECTS

Adull aching pain(tourniquet pain) may develop throughout the limbfollowing use. Stiffness,weakness,

reactive hyperemia, & skin discolouration may also occur to some degree in all patientsafter tourniquet use.

Pathophysiologicchangesdue to pressure, hypoxia, hypercarbia, and acidosisofthe tissuesoccur and

become significant after about 1 1/2 hoursoftourniquet use.

Symptomsoftourniquet paralysisare motor paralysisand loss ofsense oftouch, pressure, and proprioceptive

responses.

Intraoperative bleeding may be caused by:

•The slight impeding effect exerted by an unpressurized cuff (and itslimbprotection materialor

padding, ifused), which preventsvenousreturn at the beginning ofthe operation,

•Blood remaining in the limb because ofinsufficient exsanguination,

•Inadequate tourniquet pressure, or slowinflation and deflation, all ifwhich allowarterialblood to enter

while preventing venousreturn,

•Blood entering through the nutrient vesselsofthe long bones, such asthe femur or humerus.

SECTION 2.0:P.T.S. INSTALLATION AND OPERATING INSTRUCTIONS

2.1 SPECIFICATIONS

2.1.1 POWER REQUIREMENTS

Mains Line Voltage (AC Powered Mode):

90-264 VAC. 47/63 Hz.

Line current:

<0.5 A RMS at 90 VAC input.

Input Power:

20 wattsmaximum.

AC Power Adaptor:

Use only supplied AC adapter / power cord assembly DelfiREF 4-2100-013.

AC Power plug: (North America)

Hospitalgrade, 3 prong straight blade, 15 amp.

Battery Type:

Sealed 4.8V nickel-metal-hydride (NiMh) pack, 1800 milliamp hours

Use only DelfiREF 4-2100-017 battery pack.

Battery Recharge Time:

8.0 hours(typical).

2.1.2 PERFORMANCE

Cuff Pressure Range:

50-475 mmHg, 5 mmHg increments.

Pressure Accuracy:

+/- 5 mmHg.

Pressure Regulation:

+/- 10 mmHg ofset point (10 second average under non transient conditions).

Time Alarm Set Point Range:

0-240 minutes.

Timer Accuracy:

0.1% ofelapsed time.

Inflation Rate:

34 inch cylindricalcuff applied to a 30 inch thigh inflatesto 350 mmHg in less than 20 seconds.

Deflation Rate:

34 inch cuff applied to a 30 inch thigh deflatesto less than 10 mmHg in less than 25 seconds.

2.1.3 SIZE

Height: 240 mm (9.45 inches)

Width: 116 mm (4.57 inches)

Depth: 50 mm (1.97 inches)

Weight: 500 g (17.5 oz)

2.1.4 ENVIRONMENTAL

Operating temperature: 10 to 40 °C (15 to 105 °F)

Storage temperature: -20 to 40 °C ( -4 to 105 °F)

Humidity: Max80 % non-condensing

2.2 INITIALINSPECTION

Unpack the P.T.S. upon receipt and inspect the unitfor any obviousdamage that may haveoccurred during

shipment. Werecommend that thisinspection be performed by aqualified biomedicalengineer or other

person thoroughlyfamiliar with electronicmedicaldevices.If the unitisdamaged, notifythe carrier and Delfi

immediately. Ifthe initialinspection resultsare satisfactory, afunctionaland calibration check shouldbe

performed after an 8-hour charge. The attention labelcovering the pressure/timedisplay windowbutton may

be removed and discarded after the initial8 hour charge.

2.3 CONTROLS, INDICATORS, DISPLAYS, AND CONNECTORS

Refer to Figure 2.1 for the locationsofthe unit'scontrols,indicators,displaysand connectorsdescribed

below:

1. ‘ON/STANDBY’ Button

Turnsthe uniton or setsthe unitto standby. In standby mode (powered off), the power to all instrument

functions(i.e. inflation, deflation, etc.) isoff,but power continuesto supplythe battery charging circuitry

whenever AC power ispresent. Thisbutton will not set the unitto standby when there ispressure inthe cuff.

Ensure the cuff isfullydeflated, and the cuff and limbprotection materialhavebeen removed fromthe

patient prior to setting the unit to standby.

2. ‘PRESSURE + ’ Button

Displaysand increasesthe pressure set point inmmHg. Momentarilydepressing the ‘PRESSURE +’button

will display the pressure set point with atrailing asteriskfor 2seconds.For example, if the set point was250

mmHg and the user pressed and released the ‘PRESSURE +’button, the display wouldshow“250* ”for 2

seconds,then revert to the current cuff pressure (displayed without the trailing asterisk). Ifthe ‘PRESSURE +

’button isheldfor more than 1second, the unitwill beginincreasing the pressure set point firstby 5mmHg

then by 10 mmHg increments.If the cuff isinflating or inflated, cuff pressure will change to the newpressure

set point.

3. ‘PRESSURE – ‘ Button

Displaysand decreasesthe pressure set point, asdescribed above for the ‘PRESSURE +’ button.

4. ‘TIME + ’ Button

Displaysand increasesthe timelimitset point inminutes.Momentarilydepressing the ‘TIME +’button will

display the timelimitset point with atrailing asteriskfor 2seconds.For example, ifthe timelimitset point

was60 minutesand the user pressed and released the ‘TIME +’button, the display wouldshow“60* “for 2

seconds,then revert to the current tourniquet elapsed time. Ifthe ‘TIME +’button isheldinfor more than 1

second, the unit advancesthe time limit set point first by 5 minute then by 10 minute increments.

5. ‘TIME – ‘ Button

Displaysand decreasesthe time limit set point, asdescribed above for the ‘TIME +’ button.

6. ‘INFLATE’ Button

Inflatesthe cuff to the pressure set point and startsthe elapsed timemonitor. Momentarilydepressing the

‘INFLATE’ button immediately beginsrapid inflation ofthe cuff.

7. ‘DEFLATE’ Button

Deflatesthe cuff and stopsthe elapsed timemonitor. To prevent accidentaldeflation ofthe cuff,the

‘DEFLATE’ button hasadelay and mustbe pressed and heldfor approximately2secondsbefore the unitwill

deflate the cuff.A short tone issounded after the 2 second delay to indicate that deflation hasstarted and the

user may then releasethe ‘DEFLATE’ button. Ifthe user momentary pressesthen releasesthe ‘DEFLATE’

button, nothing happens.Ifthe user releasesthe ‘DEFLATE’ button any timeafter deflation hasbegun, the

cuff continuesto deflate to zero pressure.

8. Pressure and Time Display

During normaloperation with no buttonsbeing pressed, the top line ofthe pressure and timedisplay shows

the current sensed cuff pressure inmmHg, and the lower line shows the number of minutesthe cuff hasbeen

inflated (tourniquet time). Anytimeatrailing asterisk(*) appearsafter the pressure or timevalue, the value

being displayed isthe set point. Under certainconditionsthe pressure and timedisplaysmay showerror

codesor alarmmessages.The tourniquet timecan be reset to zero by pressing the ‘TIME+’and ‘TIME- ‘

buttonssimultaneouslyonlywhen the cuff isdeflated. Ifthe cuff isdeflated and then reinflated without

zeroing the tourniquet timedisplay, the tourniquet timerestartsfromthe lastvalue, thereby displaying the

cumulative tourniquet time. Switching the P.T.S. to standby also resetsthe tourniquet time to zero.

9. Message Display

When alarm conditionsare present, the corresponding wordsare displayed and will remain displayed until the

alarmcondition iscorrected, aslong assufficient power isavailable. When operating on battery power the

battery indicator symbolisshown (see below).

10. AC Power Indicator Light

The green AC power indicator light isilluminated at all timeswhen AC power isplugged into the P.T.S., both

inon and standby modes.Note that the AC power indicator light remainsoff at all timeswhen there isno AC

power connected to the P.T.S., even during the startup routine.

11. AlarmIndicator Light

The red alarmindicator light isilluminated when any alarmcondition exists.The alarmindicator will remain

illuminated until the alarmcondition iscorrected, aslong sufficient power isavailable.

12. Battery Indicator Symbol

The battery indicator symbolinthe center of the message display (see above) isvisible when the P.T.S. ison

and operating on battery power (AC power not connected). When all six segmentsinside the battery symbol

are darkened, the battery hasafull charge. Reducing numbersofdarkened segmentsand lowbattery alarm

conditions(see Table2.1) progressivelyindicate decreasing battery capacity and need for recharging. The

battery indicator symboldisappearswhen AC power isconnected to the P.T.S.

13. Hose Connector

The hose assembly (see below) leading to the tourniquet cuff plugsin to the P.T.S. unit at the hose connector.

The hose connector isa positive locking type that makesan audible ‘click’ when properly connected.

14. Hose Assembly

One hoseassemblyissupplied with each P.T.S. unit. The malepositivelocking connector plugsinto the

hoseconnector on the P.T.S. unit(see above). The female end attachesto the tourniquet cuff. The P.T.S. is

designed, tested, and recommended for usewith Delfiand other singleport cuffshaving PositiveLocking

Connectorsonly. Usethe supplied hoseassemblyonly. An adapter isprovided with the P.T.S. unitfor

connection to calibration equipment.

15. AC Power Receptacle

The AC power receptacleislocated beside the hoseconnector. The P.T.S. isdesigned for usewith the

supplied AC power supply (see below) only; do not use any other type ofconnection to AC power.

16. AC Power Supply

An AC power supplyadapter issupplied with every P.T.S. unit. It isa sealed unit designed specifically for the

P.T.S. Contact Delfiifyour power supplyneedsservice or replacement. Plug the locking connector on the

AC power supplycord into the AC power receptacleon the P.T.S. unit(see above), and plug the AC power

cord into apower outlet (see below)whenever using the unitwhere AC power iseasilyaccessible. The AC

connector can onlybe inserted one way into the the AC power receptacle on the P.T.S. unit, and lockswith an

audible‘click’ when properlyconnected. To disconnect, press the black button on the connector and pull it

out.

17. AC Power Cord

An AC power cord with ahospitalgrade plug issupplied with every P.T.S. unit. Plug the socket end ofthe

cord into the AC power supply and the plug end into an AC power outlet.

Figure 2.1: P.T.S. Controls, Indicators, Displays, and Connectors

PORTABLE TOURNIQUET

SYSTEM

PRESSURE

DEFLATE

INFLATE

TIME

P.T.S.

Figure 2.2: P.T.S. Pressure and Time Display Detail

Figure 2.3: P.T.S. Message Display Detail

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