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Section 1 • Introduction

Indicates the medical device manufacturer, as defined in EU Directives

90/385/EEC, 93/42/EEC and 98/79/EC.

Indicates the date after which the medical device is not to be used.

Indicates the manufacturer’s batch code so that the batch or lot can be

identified.

Indicates the manufacturer’s serial number so that a specific medical

device can be identified.

Single-use only (cassettes)

Keep away from heat

Keep dry

ution: This device is restricted to sale by or on the order of a

physician.

Temperature limitation

Sterilized using irradiation

DEHP-free fluid path

t made with natural rubber latex

Содержание PIB v1.5

Страница 1: ...MORE THAN PAIN RELIEF SUPERIOR PAIN CONTROL C L I N I C I A N M A N U A L ambIT PIB v1 5 Pumps IP22 IP22...

Страница 2: ...IT pump Solution container Tubing clamp BOLUS button ambIT Pump ON OFF switch Remote BOLUS switch optional Tubing clamp Pump display RUN PAUSE button Cassette To solution container Side view of casset...

Страница 3: ...ng Fluid Reservoir 23 2 7 Battery Installation and Replacement 23 2 7 1 Battery Installation 23 2 7 2 Battery Replacement 24 2 8 Pump Power On and Off 25 SECTION 3 PROGRAMMING INSTRUCTIONS 26 3 1 Gene...

Страница 4: ...SECTION 8 TROUBLESHOOTING 54 SECTION 9 SPECIFICATIONS 55 SECTION 10 DELIVERY RATE ACCURACY 57 10 1 Data from Volumetric Accuracy Testing 58 10 2 Factors That May Affect Volumetric Accuracy 58 SECTION...

Страница 5: ...throughout this document emphasized with grey shading DOSE A volume of medication infused over a relatively short period of time2 and is programmed to occur at regularly scheduled intervals Sometimes...

Страница 6: ...observed at all times WarningsarefoundatSection1 2 aswellasthroughoutthisdocumentemphasizedwithgrey shading Failuretoobserveawarningmessageispotentiallylifethreatening 1 1 2 Definition of Symbols Cons...

Страница 7: ...the manufacturer s batch code so that the batch or lot can be identified Indicates the manufacturer s serial number so that a specific medical device can be identified Single use only cassettes Keep a...

Страница 8: ...e patient Bolus Program lockout Bolus lockout time in hours minutes Bolus volume in milliliters Volume in milliliters Basal infusion rate in ml hr Number of boluses delivered Number of bolus requests...

Страница 9: ...n 5 Low dead battery indicator Alarm indicator ambIT pump display Pump power on Pump power off Battery orientation PIb mode PCA mode P P mode Program lockout code Program lockout mode Pump program mod...

Страница 10: ...humidity of up to 93 non condensing The pump will warm from the minimum storage transportation temperature to room temperature about 20 C 68 F in approximately 30 minutes The pump will cool to room t...

Страница 11: ...disassembled by any user If equipment is tampered with to the point it is ineffective consult the prescribing physician Keep out of reach of animals or children Safety hazards are associated with the...

Страница 12: ...ounts are similar there is no risk of over infusing and the unintended bolus may not need to be removed 1 2 4 Use of ambIT PIB v1 5 Pumps in MRI Environment Safety in MRI not evaluated The ambIT PIB v...

Страница 13: ...PIb and PCA P P The three different modes allow for the following five types of infusion patterns 1 basal flow rate only 2 bolus only 3 basal flow rate and bolus 4 dose only 5 dose and bolus In PCA mo...

Страница 14: ...ttery alarm being activated The purpose of allowing the infusion rate to drop is to maximize battery life The pump will NOT inform the user that the bolus dose infusion rate has dropped No other param...

Страница 15: ...us is requested and delivered a lockout time begins A bolus is delivered only when the BOLUS button or remote BOLUS switch is pressed During the lockout time the pump will beep when a bolus is request...

Страница 16: ...nutes NOTE The basal flow rate is discontinued while a bolus is being delivered and resumes once the bolus has been completed Figure 1 4 Dose only PIb mode infusion pattern The settings for Figure 1 4...

Страница 17: ...t time has expired If a bolus is requested and delivered the lockout time may delay the dose until the lockout time has expired A lockout time occurs immediately after either a bolus or dose12 The thi...

Страница 18: ...0 minutes to 100 minutes This means that the third dose should have occurred at 190 minutes but due to the second delay of a little over 5 minutes second dose delay the third dose occurs at a little o...

Страница 19: ...7 then the bolus is stopped immediately NOTE The undelivered portion of the bolus will not be delivered later Time Time Volume per interval ml Flowrate ml hr Dose interval Dose interval Bolus Dose Pa...

Страница 20: ...shown in Figure 1 7 The total volume infused from the time the bolus is started at the end of the first dose interval to the time at the end of the first bolus in the second dose interval may exceed t...

Страница 21: ...The RUN PAUSE button is used to start resume or pause the infusion The RUN PAUSE button toggles between run mode and pause mode The RUN PAUSE button will also silence any alarm that occurs while the...

Страница 22: ...in the proper use of the pump NOTE It is the responsibility of the healthcare provider to modify any guidelines provided to the lay user patient along with the pump as appropriate for the individual...

Страница 23: ...flow of fluid see lower figure to the left When primed the cassette simply snaps onto the pump WARNING Free flow will occur until the cassette bottom disc is snapped in place No alarm will sound if t...

Страница 24: ...attaching the cassette to the pump To prime the cassette follow these steps Step 1 Remove the protective cover from the bottom of the cassette see illustration at left Step 2 Connect the solution con...

Страница 25: ...y to remove more than 20 ml of air from the solution container and tubing boluses can be repeatedly initiated by clearing the history see Section 5 2 between each bolus Once all the air has been remov...

Страница 26: ...membranes The larger membrane is a hydrophilic membrane and the smaller membrane is a hydrophobic membrane The hydrophobic membrane will not allow water to flow through it However in conjunction with...

Страница 27: ...used etc therefore we cannot ensure that any specific battery will power the pump for a specific period of time The battery condition and pump settings will determine how the battery will perform with...

Страница 28: ...se loss of timing and a delay in therapy The pump will not sound an alarm if it is turned off without being placed in pause mode Step 1 If the pump is in run mode place the pump in pause mode by pushi...

Страница 29: ...the pump in pause mode prior to turning the pump off Failure to do so may cause the therapy to be delayed and or history to be lost The pump will not sound an alarm if the pump is not placed in pause...

Страница 30: ...nts failure to do so will lead to under infusion and potential patient pain NOTE Holding the RUN PAUSE button or BOLUS button does not increment or decrement any numbers The buttons must be pushed and...

Страница 31: ...nfusion without clearing the infusion history by placing the pump in pause mode and then entering program mode See Section 3 2 1 through 3 2 3 for programming steps The pump can be reprogrammed after...

Страница 32: ...ges The bolus dose flow rate is not adjustable The lockout time is the time between the end of one bolus or dose and the start of the next bolus or dose The lockout time has units of hours and minutes...

Страница 33: ...ep PCA flashes in the display Mode is established 3 Set basal flow rate A Press and release the RUN PAUSE button to increase the number or press and release the BOLUS button to decrease the number Num...

Страница 34: ...ss and hold the BOLUS button until one beep is heard Each time the BOLUS button is pressed the display moves backward one screen to enable review or correction NOTE The limits for bolus volume are 0 0...

Страница 35: ...ppears in the display press and hold the RUN PAUSE button until one beep is heard to accept the setting One beep NOTE Volume to be infused is displayed in ml C Repeat the steps 6 A and 6 B to set the...

Страница 36: ...parameter For example if the left most value of the bolus lockout time hours is blinking and the BOLUS button is pushed and held held until a beep is heard the hours value is accepted and the display...

Страница 37: ...ttery Flow rate accuracy is not affected by the bolus dose flow rate See Section 1 4 1 for an explanation of how the bolus flow rate changes The bolus dose flow rate is not adjustable Interval or dose...

Страница 38: ...play Mode is established 3 Set dose volume A Press and release the RUN PAUSE button to increase the number or press and release the BOLUS button to decrease the number The letter d the number left of...

Страница 39: ...interval time is established D If during programming you need to move backwards in the display to a previous setting press and hold the BOLUS button until one beep is heard Each time the BOLUS button...

Страница 40: ...beep is heard causes the currently blinking value to be accepted i e stored in memory and the value to the left on the display to start to blink so that it can be changed If the leftmost value is blin...

Страница 41: ...ustable The dose is a volume of medication infused over a relatively short period of time20 and is programmed to occur at scheduled intervals Sometimes a dose is referred to as a programmed intermitte...

Страница 42: ...de 2 Select P P Press and release the RUN PAUSE button to scroll up or press and release the BOLUS button to scroll down through the program modes until P P appears in the display Press and hold the R...

Страница 43: ...t dose interval time A Press and release the RUN PAUSE button to increase the interval time or press and release the BOLUS button to decrease the dose interval time INT is displayed for two seconds to...

Страница 44: ...ton until one beep is heard Each time the BOLUS button is pressed the display moves backward one screen to enable review or correction NOTE The limits for the bolus volume are 0 0 to 50 0 ml 7 Set loc...

Страница 45: ...ed in ml C Repeat steps 7 A and 7 B to set the digits in the tens and ones sections ml is displayed Bag icon and respective digit flashes Volume to be infused is established D If during programming yo...

Страница 46: ...a beep is heard the mode is accepted and the pump displays the first parameter for that mode and the left most value is blinking NOTE If the mode is blinking then the BOLUS button functions the same a...

Страница 47: ...tarted after programming or after powering on the pump will review the program settings RX when either the RUN PAUSE button or the BOLUS button is pressed After this review the pump will return to pau...

Страница 48: ...e green run light will stop blinking and the pause mode icon I I will flash in the pump display If left in pause mode the pump will beep two times every four minutes CAUTION Always place the pump in p...

Страница 49: ...the infusion the pump will beep once If the bolus is permitted the lockout time has elapsed then the pump will begin bolus administration During bolus infusion the green run light will double blink I...

Страница 50: ...needs to be pressed once Pause infusion Press and release the RUN PAUSE button Two beeps every four minutes Pause icon II flashes in the display green run light inside the BOLUS button stops blinking...

Страница 51: ...sed time since the last time the pump was cleared e g if the pump is in PCA mode no dose information will be seen To view specific history parameters for any mode the pump must be in that mode NOTE Th...

Страница 52: ...0H 5 1 3 P P Mode Infusion History INFUSION HISTORY VISUAL INDICATOR Current delivery mode P P Total volume infused including boluses in ml ml icon Total number of doses delivered No icon Total number...

Страница 53: ...pting to clear the pump infusion history LOC will appear in the pump display if the pump program is in lockout mode see Section 6 Patient Lockout NOTE The BOLUS button on the pump must be used to clea...

Страница 54: ...until one beep is heard and PRO appears in the pump display Step 3 Release both buttons and immediately press and release both the RUN PAUSE button and the BOLUS button again Four dash symbols will a...

Страница 55: ...the right Step 1 The first digit space is flashing Step 2 Press and release the RUN PAUSE button to increase the number or press and release the BOLUS button to decrease the number Step 3 When the des...

Страница 56: ...t inside the BOLUS button is off Two beeps every four minutes Low Low battery Battery icon flashes in the display Five short beeps every four minutes The battery icon will remain flashing in the displ...

Страница 57: ...Immediately close the tubing clamp See Section 8 Troubleshooting High Malfunction Alarm icon and MA1 are in the display Constant tone Press the RUN PAUSE button to silence the alarm Gently press on t...

Страница 58: ...Check access device patency Check for kinks in the tubing Section 4 Continuous tone Malfunction Possible dead battery alarm battery icon visible replace the batteries Press on the cassette top to ens...

Страница 59: ...ed rotary peristaltic Maximum infusion occlusion pressures 25 12 Psi Maximum activation time of occlusion alarm minimum rate at minimum occlusion pressures 4 hours Maximum activation time of occlusion...

Страница 60: ...istory reports Volume infused Doses delivered Boluses delivered Boluses requested Elapsed time Delivery profiles PIb PCA PCA PIb Estimated life span of pump Approximately 2 years with an infusion rate...

Страница 61: ...edication bag Summit MediBag A second fluid reservoir Summit MediBag was used to represent the patient and collect the output from the pump Catheters24 and needles25 were used to simulate the back pre...

Страница 62: ...f the ambIT PIB v1 5 pumps may also change Factors that may affect volumetric accuracy are shown below in Section 10 2 10 2 Factors That May Affect Volumetric Accuracy Changes Effect Comments Viscosit...

Страница 63: ...r accuracy The accuracy is shown as the percent error for the actual vs prescribed bolus dose volume This error is measured sequentially over a number of bolus dose events at a minimum bolus dose volu...

Страница 64: ...0 12 14 16 18 Observation window min 25 0 20 0 15 0 10 0 5 0 0 0 5 0 10 0 15 0 error 20 ml hr flow rate 45 0 40 0 35 0 30 0 25 0 20 0 15 0 10 0 5 0 0 0 5 0 Flow rate ml hr 0 5 10 15 20 25 30 35 20 ml...

Страница 65: ...0 8 0 10 0 12 0 14 0 error 45 0 40 0 35 0 30 0 25 0 20 0 15 0 10 0 5 0 0 0 5 0 Flow rate ml hr 0 5 10 15 20 25 30 35 Observation window min 20 ml hr 100 mmHg back pressure EP Max EP Min 6000 0 5000 0...

Страница 66: ...5 0 0 error Bolus number 25 0 1 ml bolus dose volumes 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 1 9 20 21 22 23 24 25 3 5 3 0 2 5 2 0 1 5 1 0 0 5 0 0 0 5 1 0 error 1 2 3 4 5 6 7 8 9 10 11 12 13 14...

Страница 67: ...i to 15 4 psi The pump and components should be stored in a dry cool place until used No sterilization of the pump is required Disinfect the pump before and after every patient use procedure and or tr...

Страница 68: ...one 1 part household bleach to nine 9 parts water Rubbing alcohol 70 Isopropyl alcohol 3 Hydrogen peroxide or Equivalent solution i e quaternary ammonium NOTE Follow directions on the household cleane...

Страница 69: ...se of the ambIT pump is to infuse medication from a fluid reservoir into a patient at a controlled rate flow rate The ambIT pump has been tested to ensure that it is not affected by normal electromagn...

Страница 70: ...ic discharge IEC 61000 4 2 2 4 6 8 kV contact 2 4 8 15 kV air Radiated RF EM fields IEC 61000 4 3 10 V m 80 MHz 2 7 GHz Rated power frequency magnetic fields IEC 61000 4 8 30 A m 50 Hz and 60 Hz Table...

Страница 71: ...4 2728 E mail PIQ avanos com Website www ambitpump com EUROPEAN REPRESENTATIVE MT Promedt Consulting GmbH Altenhofstrasse 80 66386 St Ingbert Germany IMPORTER Avanos Medical Belgium bvba Leonardo da V...

Страница 72: ...Section 13 Customer Assistance 68 ambIT Infusion Pump is a trademark of Finding better ways to care for people 63290 00 6 20...

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