Delfi P.t.s. Installation instructions

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

2.4 INITIALSETUP

During shipping and storage, the unit'sbattery couldbecomeweak. Prior to initialuse, the unitmustbe

plugged into AC power using the AC power supplyand cord assemblyuntil the battery isfullycharged. This

initialcharge shouldtake no more than 8hours.The battery mustbe fullycharged before any initialuse,

including any calibration checking procedures,initialchecks,or testsperformed by biomedicalengineering at

your facility.

WARNING: Use only the Delfi REF 4-2100-013 AC power supply and cord assembly supplied with your

P.T.S. Do not use any other ACpower supply or cord. Use of an improper power supply may cause

irregular operation that could be hazardous to the patient and/or user, and may permanently damage

the P.T.S. unit.

CAUTION: Avoid exposing the ACpower supply to liquids. Do not immerse in fluid. Do not allow

the ACpower supply to lie on the floor where pooling of liquids may occur. Clean by damp cloth

(alcohol or mild detergent wipe) only. The ACpower supply is resistant to occasional splashing or

dripping of fluids, but is not fluid-tight. If immersed in or exposed to excessive amounts of liquids,

the AC power supply may fail and may pose an electrical shock hazard.

WARNING: Use battery packs supplied by Delfi only. Do not use any other batteries. Use of an

improper battery pack may cause irregular operation that could be hazardous to the patient and/or

user, and may permanently damage the P.T.S. unit.

2.5 FUNCTIONALAND CALIBRATION CHECK

Each P.T.S. unitisfullytested before shipping. However, the following functionaland calibration checks

shouldbe performed by the user before the firstclinicaluseofthe P.T.S. to ensure that ithasnot been

damaged inshipping. After charging the battery asdescribed above, the unitshall produce the results

explained inthe following stepsexactlyasindicated. Failure to do soindicatesthat aproblem may existand

the device isnot to be used until necessary repair or calibration hasbeen made.

2.5.1 AC POWER CONNECTION AND INDICATOR:

Connect the AC power plug to aproperlypolarized and grounded power source with voltage and frequency

characteristicscompatiblewith the specificationslisted inSection 2.1. Observethat the green AC power

indicator light turnson.

2.5.2 POWER-UP SEQUENCE AND SELF-TESTS:

Power up the unitby pressing the ‘ON/STANDBY’ button and observethe following (the P.T.S. may be

plugged in to AC power or not for the remaining tests):

a) All display segmentsand symbolsinthe pressure and timedisplay and the message display (asshownin

Figures2.2 and 2.3) illuminate, the red alarmindicator light illuminates,and the alarmtone soundsfor 2

seconds.All displaysand tonesthen shut off for 0.5 seconds,then the cyclerepeats.Note that ifAC

power isnot connected, the green AC power indicator light doesnot comeon at any time, and ifAC

power isconnected it remainson constantly.

b) The pressure display shows "CAL" for approximately2seconds.During thistimethe unitisself-testing

specific pressure sensing calibration parameters.

c) "0" isdisplayed for both pressure and timeinthe pressure and timedisplay after the startup routine is

complete. Ifnumbersother than zero are shown in either display, the unit should be calibrated.

2.5.3 PRESSURE SETPOINTADJUSTMENT:

a) Momentarilypress the ‘PRESSURE +‘button and release(within1second). The pressure display reads

"250* "(the defaultpressure set point) for 2seconds.Note that the trailing asteriskindicatesthat the

pressure displayed isa set point, not the current cuff pressure. The pressure display then returnsto “0”.

b) Press and holdthe ‘PRESSURE +‘button. The pressure display shouldread "250* ", and after 1second

beginincreasing in5mmHg and then by 10 mmHg incrementsto the maximumpressure set point of

“475* “ mmHg.

c) Release the ‘PRESSURE +‘ button. Within 2 seconds, the pressure display returnsto “0”.

d) Momentarilypress the ‘PRESSURE –‘button and release(within1second). The pressure display reads

"475*" (the newpressure set point) for 2 seconds. The pressure display then returnsto “0”.

e) Press and holdthe ‘PRESSURE –‘button. The pressure display shouldread "475*", and after 1second

begindecreasing in5mmHg incrementsand then by 10 mmHg to the minimumpressure set point of“50*“

mmHg.

f)Release the ‘PRESSURE – ‘ button. Within 2 seconds, the pressure display returnsto “0”.

2.5.4 TIME LIMITSETPOINTADJUSTMENT:

a) Momentarilypress the ‘TIME +‘button and release(within1second). The timedisplay reads"60* "(the

defaulttimelimitset point) for 2seconds.Note that the trailing asteriskindicatesthat the timedisplayed

isaset point, not the current elapsed timethat the cuff hasbeen inflated. The timedisplay then returns

to “0”.

b) Press and holdthe ‘TIME +‘button. The timedisplay shouldread "60* ", and after 1second begin

increasing in5minute and then by 10 minute incrementsto the maximumtimelimitset point of“240* “

minutes.

c) Release the ‘TIME +‘ button. Within 2 seconds, the time display returnsto “0”.

d) Momentarilypress the ‘TIME –‘button and release(within1 second). The time display reads"240* " (the

newtime limit set point) for 2 seconds. The time display then returnsto “0”.

e) Press and holdthe ‘TIME –‘button. The timedisplay shouldread "240* ", and after 1second begin

decreasing in5minute and then by 10 minute incrementsto the minimumtimelimitset point of“5* “

minutes.

f)Release the ‘TIME – ‘ button. Within 2 seconds, the time display returnsto “0”.

NOTE: Anytime atrailing asterisk (*) appears, the data being displayed is the set point. Set pressure

and time will revert to the default pressure and time when the unit is powered off and powered up

again.

2.5.5 CALIBRATION CHECK:

NOTE: Every P.T.S. unit is calibrated at the factory before shipping. The unit also self-tests specific

calibration parameters upon power-up. Should apotential out of calibration condition be detected,

the unit will display error messages (see Table 2.1). However even though the unit performs aself-

test of calibration at every power-up, the following quantitative check is recommended prior to initial

use, and at regular intervals according to the policies in your practice setting.

a) Connect the P.T.S. hoseset to the P.T.S. unit, then connect the hoseto areference pressure gauge

knownto be accurate (e.g. manometer or calibrated gauge). Ifrequired, usethe PositiveLocking

Connector to Luer adapter supplied with your P.T.S. unitto connect the end ofthe P.T.S. hoseto the

reference gauge.

b) Power up the unit by pressing the ‘ON/STANDBY’ button, set the pressure set point to 50 mmHg using the

‘PRESSURE – ‘ button and press the ‘INFLATE’ button.

c) Allowthe pressure to stabilize. The pressure reading on the P.T.S. and the reference gauge shouldbe

within 5 mmHg ofeach other, and within 5 mmHg ofthe pressure set point of50 mmHg.

d) Using the ‘PRESSURE +‘button to increasethe pressure, repeat step 2.5.5(c) abovefor 250 mmHg and

475 mmHg.

e) Press and holdthe ‘DEFLATE’ button for 2secondsto deflate the unit. Disconnect the hosefromthe

P.T.S. unit. The pressure display should decrease to 0 mmHg.

f)If any stablized pressure reading isoff by more than 5mmHg during the calibration check or the pressure

display doesnot return to zero, the unit must be calibrated. See Section 3.3 below.

2.5.6 “PRESSURE LOW” and “CUFF LEAK” ALARMCHECK:

Connect the hoseassemblyand acuff to the P.T.S. and press the ‘INFLATE’ button. The cuff inflatesto the

defaultpressure set point of 250 mmHg. Create aleak by partiallydetaching the hosefrom the unit while the

cuff isinflated. Make the leak large enough that the pressure dropsmore than 15 mmHg belowset point.

The pumpinthe P.T.S. unitwill start asthe unit triesto maintain the set pressure. After the cuff pressure has

been more than 15 mmHg belowthe set point constantly for more than 1 second, confirmthat:

a) The pressure display flasheson/off;

b) “PRESSURE LOW” appearsin the message display (“CUFF LEAK” may also appear);

c) The red alarmindicator light isilluminated;

d) The alarmtone soundsconstantly.

Press the ‘PRESSURE +‘, ‘PRESSURE –‘, ‘TIME +‘, or ‘TIME –‘button to silence the alarm tone. Confirm

that the alarm tone restartsafter 30 seconds. Stop the leak and confirmthat the displayed pressure returnsto

the set point and stopsflashing, the “PRESSURE LOW”(and “CUFF LEAK” ifpresent) messagesdisappear,

the red alarmindicator light turnsoff, and the alarmtone stops.

2.6 PRESSURE AND TIME DEFAULTS

Changing the defaultpressure set point and timelimitset point valuesmay onlybe done after power-up and

before inflation ofthe cuff. To modify the default set points:

a) Adjustthe pressure set point to the desired defaultvalue by pressing and holding the ‘PRESSURE +‘or

‘PRESSURE – ‘ buttonsasrequired.

b) Adjust the time limit set point to the desired default value by pressing and holding the ‘TIME +‘ or ‘TIME –

‘ buttonsasrequired.

c) Momentarilypress and releasethe ‘PRESSURE +‘and ‘PRESSURE –‘buttonssimultaneously. The

alarmtone soundsbriefly, then the pressure and timeset pointsappear (with trailing asterisksymbols)in

the pressure and time displaysto indicate that the newdefault valueshave been stored.

d) After about 2 seconds, the unit resumesnormaloperation.

e) The newdefault set point valueswill nowbe present every time the machine isturned on.

2.7 OPERATION

NOTE: The P.T.S. unit should be powered up at least once each day of use to ensure the self-test

routine is performed regularly. The P.T.S. should be powered off and left plugged in to ACpower

when not in use.

a) Press the ‘ON/STANDBY’ button to turn the uniton. The unitwill execute aself-check diagnostictestas

described inSection 2.5.2 ofthismanual.Observethat all the display segmentsand the red alarm

indicator light illuminate during the self-check asshowninFigs2.2 and 2.3. Successfulcompletion ofthe

self-check indicatesthat the unit isready for use.

WARNING: If aconnected cuff is pressurized to 50 mmHg or more during power-up, the P.T.S. will

assume that asurgical procedure is in progress, adopt the pressure sensed in the cuff as the new set

point, and will automatically regulate the cuff at this pressure. Toalert the operator of this condition,

the unit will sound the alarm tone, illuminate the red alarm indicator light, flash the pressure display,

and show "PRESSURE” in the message display. The operator should immediately check the

pressure set point and readjust to the proper set point if necessary. The alarm will be cleared as

soon as the set point is examined or adjusted (‘PRESSURE +‘or ‘PRESSURE –‘button pressed

momentarily or pressed and held).

b) Connect the hose assembly and a single port cuff to the unit at the hose connector.

c) Select the appropriate tourniquet pressure and tourniquet timelimitset pointsfor the specificprocedure,

asspecified by the surgeon. The defaultset pointsfor pressure and timelimitare retrieved fromthe

memory during power up and are active until the user adjuststhem(see Sections2.5.3 and 2.5.4). These

default valuescan be modified by the user (see Section 2.6).

WARNING: In all cases it is essential to check the pressure and time limit set points and confirm that

they are the desired values before inflating the cuff.

For each patient, tourniquet pressure required to occlude blood flowto operativesite shouldbe set to the

minimumeffectivepressure. The minimumeffectivepressure dependson many factors,including the

location ofthe cuff (upper or lower limb), the type of cuff and quality of fitto the limb, whether the limbis

normal,hypertrophied, or obese, the patient'spreoperativesystolicpressure, and the maximum

anticipated riseinsystolicpressure during the procedure. Refer to the medicalliterature for current

techniquesfor determining the minimumeffective tourniquet pressure for each case.

d) Prepare the patient inaccordance with your established proceduresand cuff manufacturer'sinstructions.

The precautionsofSection 1and the following are offered asaguide to assistinthisprocess.In most

casesatourniquet cuff should be applied to the widest part ofthe limb to allowasmuch tissue aspossible

to liebetween the cuff and any nervesor vascular structuressusceptibleto damage. The optimum

positionsare the upper armand the proximalthird ofthe thigh. In certaincasesoffore-foot surgery, the

tourniquet cuff can be applied around the calfor to the area proximalto the malleoli.For emergency

surgery ofthe hand, asufficientlysmall tourniquet may be selected by the surgeon for fitting around the

forearm.Applyaleak-free tourniquet cuff smoothlywithout wrinklesThe hoseconnectionsshouldbe

placed sothat the hosewill not be kinked when the limbispositioned for surgery. The viability of the skin

and deeper tissuesshouldbe established prior to exsanguination ofthe limband tourniquet inflation.

Exsanguinate the limbby elevating itfor aminimumof2minutesand wrapping it, distalto proximal,

using an Esmarch, Martin, or elasticbandage. The bandage shouldcomeup approximatelyto 1in. (2.5

cm)fromthe edge of the tourniquet cuff.The elasticbandage isremoved following inflation of the cuff.If

regionalanesthesiaisbeing used, the anestheticagent or nerveblock isthen administered. The surgeon

will determine:

•When the tourniquet isto be inflated;

•What pressure isapplied;

•Howlong the tourniquet isapplied;

•Whether to allowfor intermittent aeration oftissue by deflating the cuff,and the duration of

these aeration periods;

•When to deflate and remove the tourniquet.

Appropriate tourniquet timeand the need for intermittent deflation ofthe cuff depend greatlyon the

patient'sanatomy, age, and absence ofvascular disease. In many operating rooms,itiscustomary to

prominentlynote the timeofinflation, and to warn the surgeon after acertaintimehaselapsed. Thiswill

allowthe surgeon to assess the need for further tourniquet time.

e) Press the ‘INFLATE’ button when the cuff mustbe inflated. The unitwill pressurize the cuff to the

pressure set point and start the tourniquet timeclock. Ifthe unitcannot pressurize the cuff to within15

mmHg ofthe set point inless than 45 seconds,aleak alarmwill be sounded (see Table2.1 for

information about possiblealarmconditions). The timedisplay shows the tourniquet time, and the

pressure display shows the current pressure in the cuff.

f)When the cuff mustbe deflated, press and holdthe ‘DEFLATE’ button. After holding the button for 2

seconds,the alarmtone will sound briefly, the pressure display will showthe falling pressure ofthe cuff,

and the tourniquet timeclock will stop and holdthe display ofthe tourniquet time. Remove the

tourniquet cuff and any underlying limb protection material immediately following final cuff

deflation.The timeoftourniquet cuff removalshouldbe noted, and the circulation ofthe limbshouldbe

checked.

NOTE: The elapsed tourniquet time can be zeroed after the cuff is deflated by pressing and holding

the ‘TIME+‘and ‘TIME- ‘buttons simultaneously. The alarm tone will sound briefly to indicate the

time has been zeroed.

g) After the cuff hasbeen removed, disconnect the cuff fromthe P.T.S. During normaluse, the P.T.S.

shouldnot be set to standby ifpressure ispresent inthe cuff.Once the cuff hasbeen properlydeflated,

removed fromthe patient and disconnected fromthe P.T.S., the unit can be set to standby.

2.8 ALARMCONDITIONS

There are anumber ofconditionsfor which the P.T.S. will produce visualand audiblealarms.Thoseconditions,indicationsand appropriate actionsare

showninTable2.1. The appropriate actionsindicated are based on the mostprobablecausesand shouldonlybe used asaguide. Other causesof

alarmconditionsmay indicate a need for other actions.

Table 2.1: Alarm Conditions

Condition Description Message

display

(steady)

Alarm

tone Pressure

display Time

display

Action to silence

alarm tone for 30

seconds

Action required to correct

alarm condition

High

Pressure

above set

point

The unit hasdetected

high pressure in the

cuff. High pressure is

defined aspressure

that is+15mmHg

above the pressure set

point continuously for

more than 1 second.

PRESSURE

HIGH

Constant Current

cuff

pressure,

flashing

NormalMomentarily Press

‘PRESSURE +’,

‘PRESSURE – ‘,

‘TIME +‘, or

‘TIME – ‘.

Press and hold ‘PRESSURE +’

to adjust set pressure to within

15mmHg ofsensed pressure

Press and hold ‘DEFLATE’ for 2

secondsto deflate the cuff.

Alarmwill stop automatically

whenever the unit can regulate

the cuff to within 15 mmHg ofthe

pressure set point.

Low

Pressure

belowset

point

The unit hasdetected

lowpressure in the cuff.

Lowpressure isdefined

aspressure that is

15mmHg belowthe

pressure set point

continuously for more

than 1 second.

PRESSURE

LOW

Constant Current

cuff

pressure,

flashing

NormalMomentarily Press

‘PRESSURE +’,

‘PRESSURE – ‘,

‘TIME +‘, or

‘TIME – ‘.

Press and hold ‘PRESSURE – ‘

to adjust set pressure to within

15mmHg ofsensed pressure

Press and hold ‘DEFLATE’ for 2

secondsto deflate the cuff.

Alarmwill stop automatically

whenever the unit can regulate

the cuff to within 15 mmHg ofthe

pressure set point.

Condition Description Message

display

(steady)

Alarm

tone Pressure

display Time

display

Action to silence

alarm tone for 30

seconds

Action required to correct

alarm condition

Tourniquet

time

exceeded

The unit’selapsed

timer, which advances

when the cuff is

inflated, hasreached

the time limit set point

and caused the time

alarmto activate.

TIME LIMIT

Constant NormalCurrent

tourniquet

time,

flashing

Momentarily Press

‘PRESSURE +’,

‘PRESSURE – ‘,

‘TIME +‘, or

‘TIME – ‘.

Press and hold ‘TIME +’ to

increase time limit set point,

Press and hold ‘DEFLATE’ for 2

secondsto deflate the cuff.

Battery

Low

(stage 1)

The battery voltage has

dropped to a level

indicating that the unit

should be plugged into

AC power for continued

use, and to charge the

battery.

BATT LOW

2 segments

darkened in

battery

indicator

symbol.

Cycle 1s

on / 10s

off

NormalNormalMomentarily Press

‘PRESSURE +’,

‘PRESSURE – ‘,

‘TIME +‘, or

‘TIME – ‘.

Plug in AC power

Press ‘ON/STANDBY’ to shut unit

down.

Battery

Low

(stage 2)

The battery voltage has

dropped to a level

indicating that the unit

may trigger a “BATT

ERROR” alarm(see

below) and shut down

at any time.

BATT LOW

1 segment

darkened in

battery

indicator

symbol.

Constant NormalNormalMomentarily Press

‘PRESSURE +’,

‘PRESSURE – ‘,

‘TIME +‘, or

‘TIME – ‘.

Plug in AC power immediately

Press ‘ON/STANDBY’ to shut unit

down.

Battery

Failure The battery voltage has

dropped belowthe

threshold ofsafe

operation and hasshut

down in a safe state*

The battery hasbeen

removed/disconnected.

BATT

ERROR

Battery

indicator

symbol

empty.

Constant “Err” Blank None Press ‘ON/STANDBY’ to shut unit

down. When cuff deflation is

required, disconnect hose to cuff.

Ensure that the battery is

connected properly. Plug in AC

power to attempt to recharge the

battery. Service or replace the

battery pack (see Section 3.5

below).

Condition Description Message

display

(steady)

Alarm

tone Pressure

display Time

display

Action to silence

alarm tone for 30

seconds

Action required to correct

alarm condition

Attempt to

power off

unit with

cuff press-

urized

The unit hasdetected

that the operator has

attempted to set the

unit to standby with

pressure remaining in

the cuff.

CUFF NOT

DEFLATED Constant

while

button

held, and

for 2

seconds

after

button

released.

Current

cuff

pressure,

flashing

NormalMomentarily Press

‘PRESSURE +’,

‘PRESSURE – ‘,

‘TIME +‘, or

‘TIME – ‘.

Press and hold ‘DEFLATE’ for 2

secondsto deflate the cuff, then

press ‘ON/STANDBY’ to shut unit

down.

Cuff

pressuri-

zed during

power up

The unit hasdetected

an approximate

pressure of50mmHg or

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