Avanos ambIT PreSet v1.5 Clinician Manual
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Avanos ambIT PreSet v1.5 Clinician Manual

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ambIT
PreSet v1.5 Pump
®
C L I N I C I A N
M A N U A L
.
MORE THAN PAIN RELIEF...
SUPERIOR PAIN CONTROL
IP22

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Summary of Contents for Avanos ambIT PreSet v1.5

  • Page 1 ambIT PreSet v1.5 Pump ® C L I N I C I A N M A N U A L MORE THAN PAIN RELIEF... SUPERIOR PAIN CONTROL IP22...
  • Page 2 Become familiar with the ambIT ® pump Solution container Cassette Pump display RUN/PAUSE button Tubing BOLUS clamp button Tubing clamp ON/OFF switch ambIT Pump ® To solution container (Side view of cassette) Cassette shaft To patient...

  • Page 3: Table Of Contents

    Table of Contents SECTION 1 - INTRODUCTION ......................1 1.1 D efinitions and Symbols .......................1 1.1.1 D efinitions ........................1 1.1.2 D efinition of Symbols....................2 1.2 Warnings ..........................5 1.2.1 Sterile, Disposable (Single-Use) Administration Set ..........7 1.2.2 Protection From Air Infusion ..................7 1.2.3 Protection From Unintended Bolus ................7 1.2.4 Use of ambIT PreSet 1.5 Pump in MRI Environment .........7...
  • Page 4 SECTION 8 - TROUBLESHOOTING .....................34 SECTION 9 - SPECIFICATIONS .....................35 9.1. General Specifications Applicable to All Pumps ............35 SECTION 10 - DELIVERY RATE ACCURACY ................36 10.1 Data from Volumetric Accuracy Testing .................37 10.2 Factors That May Affect Volumetric Accuracy ...............38 SECTION 11 - GENERAL CARE INSTRUCTIONS ..............42 11.1 Warranty Information ......................42 11.2 Cleaning and Disinfecting Instructions ................43 SECTION 12 - ELECTROMAGNETIC IMMUNITY (EMC) ............44...

  • Page 5: Section 1 - Introduction

    Se c t io n 1 • I n tr od u c t io n SECTION 1 - INTRODUCTION 1.1 D efinitions and Symbols 1.1.1 D efinitions ANALGESIA: Relief from pain. BASAL FLOW RATE: The continuous flow rate. It occurs when the pump is not delivering a bolus. The basal flow rate is adjustable and has units of milliliters per hour (ml/hr). BOLUS: A volume of medication infused over a relatively short period of time. The bolus is infused at the bolus flow rate. A bolus is delivered when a patient requests it by pushing the BOLUS button.

  • Page 6: D Efinition Of Symbols

    Se ct i on 1 • In tr o d uctio n 1.1.2 1.1.2 D efinition of Symbols D efinition of Symbols Consult instructions for use. Consult instructions for use. International symbol International symbol meaning meaning “Attention, consult accompanying “Attention, consult accompanying documents.” documents.” IE IEC symbol for “Type BF Applied Part.”...
  • Page 7 Se c t io n 1 • I n tr od u c t io n K K eep away from heat eep away from heat K K eep dry eep dry Ca Caution: ution: This device is restricted to sale by or on the order of a This device is restricted to sale by or on the order of a physician.
  • Page 8 Se ct i on 1 • In tr o d uctio n Bo Bolus volume in milliliters lus volume in milliliters Volume in milliliters lume in milliliters Basal infusion rate in ml/hr al infusion rate in ml/hr Number of boluses delivered ber of boluses delivered Number of bolus requests Number of bolus requests...

  • Page 9: Warnings

    Se c t io n 1 • I n tr od u c t io n B B attery orientation attery orientation Pr Program lockout code ogram lockout code Progr Program lockout mode am lockout mode Pump Pump program mode program mode Review p Review pump program...
  • Page 10 Se ct i on 1 • In tr o d uctio n The pump will warm from the minimum storage/transportation temperature to room temperature (about 20ºC [68ºF]) in approximately 30 minutes. The pump will cool to room temperature from the maximum storage/transportation temperature in about 35 minutes. Operating conditions: +5ºC to +40ºC (+41ºF to +104ºF); relative humidity range of 15% to 93%, non-condensing; and an atmospheric pressure of 700 hPa to 1060 hPa (10.2 psi to 15.4 psi).

  • Page 11: Sterile, Disposable (Single-Use) Administration Set

    Se c t io n 1 • I n tr od u c t io n Before starting therapy, check that all connections are secure and that there are no leaks in the fluid path. After the infusion is finished, the pump will give the infusion complete alarm and continue infusing at a KVO rate. The rate is dependent on the basal rate programmed. If the basal rate is 0.5ml/hr or greater, the KVO will be 0.5 ml/hr.

  • Page 12: Indications For Use

    This patient- specific information should be relied upon to decide if the pump should be used to infuse any medication into any part of the patient’s body. The distributors and Avanos Medical, Inc. can only provide general guidelines regarding the set up and programming of the pump. They may also provide journal articles referring to applications. They are neither qualified nor permitted to provide specific recommendations for treating any specific patient. In general, to avoid complications, use the lowest flow rate, volume and drug concentration required to produce the desired result.

  • Page 13: Infusion Patterns

    Se c t io n 1 • I n tr od u c t io n NOTE: The ambIT PreSet 1.5 pump has a limited life of 2,000 ml total infusion. Once ® 2,000 ml has been reached, the pump will continue to infuse uninterrupted as programmed, until the current infusion program is complete.
  • Page 14 Se ct i on 1 • In tr o d uctio n The settings for Figure 1-2 are a bolus volume of 10 ml and a lockout time of 30 minutes. After a bolus is requested and delivered, a lockout time begins. A bolus is delivered only when the BOLUS button is pressed.

  • Page 15: Section 2 - Set Up

    Contact Avanos Medical, Inc. to obtain a complete list of cassettes. Accessories such as MediBag™ solution containers and carrying pouches may be added as required by the therapy. Contact Avanos Medical, Inc. to obtain a complete listing of all optional accessories.

  • Page 16: Ambit ® Cassette

    The ambIT PreSet v1.5 requires the use of an ambIT cassette. Use of cassettes ® ® not manufactured by Avanos Medical, Inc. may cause the pump to malfunction and may cause an over-infusion or an under-infusion. NOTE: If an ambIT cassette already has a filter, it is not recommended to use a separate ®...
  • Page 17 S e c ti o n 2 • S et U p CAUTION: Verify that all connections are secure, all clamps are opened, and that there are no leaks in the fluid path before starting therapy. If the filled solution container is not going to be used immediately, clamp the tubing and cap the connector with the protective cap provided to prevent contamination. Always verify that the cassette bottom disc is snapped closed before attaching the cassette to the pump.
  • Page 18 Se ct i on 2 • S et U p To remove the air using the BOLUS button, complete Steps 6a and 6b, as follows: Program the pump to deliver a 20 ml bolus (see Section 3.4). Start the infusion (see Section 4.1) and press the BOLUS button (see Section 4.5) Once all the air has been removed from the cassette tubing and fluid reservoir, stop the pump by placing it in pause (see Cassette shaft...

  • Page 19: Attach Cassette To The Pump

    PAUSE button (see Section 4.2). Failure to do so will cause the pump to alarm when the pump attempts to infuse medication. 2.7 B attery Installation and Replacement The pump is powered by two (2) AA 1.5V batteries. NOTE: Avanos Medical, Inc. has not validated all types of batteries (non-alkaline, rechargeable, specific brands, previously-used, etc.); therefore, we cannot ensure that any specific battery will power the pump for a specific period of time. The...

  • Page 20: Battery Installation

    NOTE: Avanos Medical, Inc. recommends that the batteries be changed at the end of each session or when the low battery alarm occurs. The pump memory is designed to retain program settings and infusion history for up to six months without power.

  • Page 21: Pump Power On And Off

    S e c ti o n 2 • S et U p Step #1 Rotate the battery cap counter-clockwise until the line ( I ) on the pump is slightly to the right of the OFF (O) position (i.e., until the battery cap stops or meets resistance).

  • Page 22: Section 3 - Programming Instructions

    Se ct i on 3 • P r o g r amm ing Inst r u c t ions SECTION 3 - PROGRAMMING INSTRUCTIONS 3.1 G eneral Information The ambIT PreSet v1.5 must be programmed and have the history cleared before ®...

  • Page 23: Ambit ® Pump User Interface

    Se c t ion 3 • Pr o g ra m m in g In s t ru c ti o n s 3.2 a mbIT Pump User Interface ® The pump program is determined by selecting the desired parameters during program mode. Cassette The pump has two buttons: the RUN/PAUSE button and the BOLUS button button.
  • Page 24 Se ct i on 3 • P r o g r amm ing Inst r u c t ions If you have selected a preset infusion protocol (PRO1 - 4), the volume to be infused must be programmed. Refer to the table on the back of the pump for the volume settings available for the program.

  • Page 25: Programming The Pump

    Se c t ion 3 • Pr o g ra m m in g In s t ru c ti o n s 3.4 Programming the Pump If at any point during programming the user needs to move backward in the NOTE: display, refer to instructions found at 3.5.

  • Page 26: Programming A Custom Infusion Protocol (Pro5)

    Se ct i on 3 • P r o g r amm ing Inst r u c t ions 3.4.2 Programming a Custom Infusion Protocol (PRO5) AUDIBLE ACTION VISUAL INDICATOR INDICATOR Enter program mode: “PRO” is displayed for two (2) seconds to indicate that the From pause mode, press and hold both the One (1) beep pump is in program mode.
  • Page 27 Se c t ion 3 • Pr o g ra m m in g In s t ru c ti o n s AUDIBLE ACTION VISUAL INDICATOR INDICATOR Number right of decimal point, (C) Repeat steps 4(A) and 4(B) to set the digit “ml” iocon and bolus icon flash.

  • Page 28: Moving Backward In Display While Programming

    Se ct i on 3 • P r o g r amm ing Inst r u c t ions AUDIBLE ACTION VISUAL INDICATOR INDICATOR (D) If during programming, you need to move Each time the BOLUS button backwards in the display to a previous setting, is pressed, the display moves press and hold the BOLUS button until one backward one screen to enable...
  • Page 29 Se c t ion 3 • Pr o g ra m m in g In s t ru c ti o n s 3.6 Program Review CAUTION: After programming the pump, always verify the program by performing a program review. After turning on, programming, locking or unlocking the pump, the RUN/ NOTE: PAUSE button may also be pressed and immediately released to review the program.

  • Page 30: Section 4 - Operating Instructions

    Se ct i on 4 • Op er at in g In stru ct ion s SECTION 4 - OPERATING INSTRUCTIONS Pump display may not be clearly visible in bright light. Shading the display will NOTE: allow viewing of the display by the user. 4.1 S tart Infusion Before starting infusion, the pump must be...

  • Page 31: Resume Infusion

    NOTE: Most “CASS” alarms can be resolved by pressing and releasing the RUN/PAUSE button to silence the alarm. To restart the infusion, press and release the RUN/ PAUSE button. If the alarm persists, contact Avanos Medical, Inc. 4.5 B olus Activation The BOLUS button is located on the pump directly below the RUN/ PAUSE button.

  • Page 32: Summary Of Operating Controls

    Se ct i on 4 • Op er at in g In stru ct ion s S ummary of Operating Controls AUDIBLE ACTION STEPS TO TAKE VISUAL INDICATOR INDICATOR Start infusion Program the pump, then press and One (1) beep Green run light (inside the BOLUS release the RUN/PAUSE button.

  • Page 33: Section 5 - Infusion History Reports

    S e c ti on 5 • Inf u s io n H i s to ry R e p o rt s SECTION 5 - INFUSION HISTORY REPORTS 5.1 P ump Infusion History To obtain the pump infusion history: Place the pump in pause mode. Press and hold the BOLUS button for two (2) seconds until one (1) beep is heard and “HX”...

  • Page 34: Section 6 - Patient Lockout

    Se ct i on 6 • P at ien t L ocko ut SECTION 6 - PATIENT LOCKOUT The pump has been designed with patient lockout features: WARNING: Locking the pump prevents unauthorized tampering with the infusion parameters, and prevents the infusion history from being cleared. The steps required for entering the pump’s program mode should not be revealed to the patient.

  • Page 35: To Unlock The Pump

    NOTE: If a code is forgotten, contact Avanos Medical, Inc. to obtain technical support. (See Section 13.) The pump program must be unlocked for programming, reprogramming and NOTE: clearing the infusion history.

  • Page 36: Section 7 - Alarms And Signals

    Se ct i on 7 • Ala r m s and Sign als SECTION 7 - ALARMS AND SIGNALS AUDIBLE PRIORITY STATUS ICON VISUAL INDICATOR COMMENTS INDICATOR Green run light (inside Pump is the BOLUS button) Periodic movement of the infusing blinks, “ml”...
  • Page 37 (Hold for 5 second alarm “OCL” are in the display on military pumps.) If unable itself if to resolve (silence) the alarm, source of contact Avanos Medical, Inc. occlusion is removed Immediately close the Alarm icon and “CASS” Constant High Malfunction tubing clamp.

  • Page 38: Section 8 - Troubleshooting

    Se ct i on 8 • Tr o ub lesh oo ting SECTION 8 - TROUBLESHOOTING PROBLEM RESOLUTION REFERENCE • Verify that all tubing clamps are open • If a spike cassette is used, verify that the spike is Cassette will not prime completely inserted into the solution container Section 2 •...

  • Page 39: Section 9 - Specifications

    Se ct i on 9 • S p ecif icat ions Se c t io n 9 • S p e c if ic a t io n s SECTION 9 - SPECIFICATIONS 9.1. General Specifications Applicable to All Pumps SPECIFICATION DETAILS Stroke volume 50 microliters (0.050 ml) Volumetric accuracy +/- 6% Pump mechanism...

  • Page 40: Section 10 - Delivery Rate Accuracy

    Se ct i on 1 0 • D elive ry Ra te Acc ur a c y SECTION 10 - DELIVERY RATE ACCURACY The ambIT PreSet v1.5 is a pseudo-continuous, positive displacement pump. This means ® that the pump infuses a specific amount of fluid (0.050 ml) each revolution. The cassette is the pumping mechanism and the pump is the driver. The pump counts the number of revolutions and time between revolutions.

  • Page 41: Data From Volumetric Accuracy Testing

    S e c ti on 1 0 • D e li v e ry R a te A cc u r ac y It is important to note that for the ambIT PreSet v1.5 virtually all the pressure generated by the ®...

  • Page 42: Factors That May Affect Volumetric Accuracy

    Se ct i on 1 0 • D elive ry Ra te Acc ur a c y 10.2 F actors That May Affect Volumetric Accuracy Changes Effect Comments Viscosity of fluid Volume This may result in an under-infusion due to the speed at which the fluid increases as infused flows from the fluid reservoir into the pump. The more viscous the fluid, the compared to water decreases greater the under-infusion and lower the flow rate. Volume This may result in an under-infusion due to the speed at which the fluid Syringe is used as a infused flows from the syringe into the pump. The more friction required to move the fluid reservoir...
  • Page 43 S e c ti on 1 0 • D e li v e ry R a te A cc u r ac y 20 ml/hr flow rate 25.0 20.0 15.0 10.0 -5.0 EP Max EP Min -10.0 -15.0 Observation window (min) 20 ml/hr + 100 mmHg back pressure 45.0 40.0 35.0 30.0...
  • Page 44 Se ct i on 1 0 • D elive ry Ra te Acc ur a c y 20 ml/hr - 100 mmHg back pressure 45.0 40.0 35.0 30.0 25.0 20.0 15.0 10.0 EP Max EP Min -5.0 Observation window (min) Supply container below pump 20 ml/hr -2.0 -4.0 -6.0 -8.0 -10.0 EP Max EP Min -12.0...
  • Page 45 S e c ti on 1 0 • D e li v e ry R a te A cc u r ac y 25 0.1 ml bolus/dose volumes 5.0% 4.5% 4.0% 3.5% 3.0% 2.5% 2.0% 1.5% 1.0% 0.5% 0.0% 10 11 12 13 14 15 16 17 18 1 9 20 21 22 23 24 25 Bolus number 25 20 ml bolus/dose volumes 3.5%...

  • Page 46: Section 11 - General Care Instructions

    To obtain warranty service, the pump and cassette must be returned to Avanos Medical, Inc. with postage prepaid. The replacement of a pump and cassette will not extend the original term...

  • Page 47: Cleaning And Disinfecting Instructions

    S ec t io n 11 • Ge n e ra l C a re In s t ru c ti o n s 11.2 C leaning and Disinfecting Instructions Dampen a clean rag or paper towel with any household cleaners such as: •...

  • Page 48: Section 12 - Electromagnetic Immunity (Emc)

    Se ct i on 1 2 • E lec tr om agn etic Im m unit y ( EM C) SECTION 12 - ELECTROMAGNETIC IMMUNITY (EMC) Mobile RF communications equipment can affect the operation of the ambIT pump. ® TThe ambIT PreSet v1.5 uses RF energy only for its internal function.
  • Page 49 Se c t ion 1 2 • El e c tr oma g n e ti c I m mu n i ty (E M C ) Table 12-1. Electromagnetic immunity levels tested and passed by ambIT PreSet v1.5 . ® Phenomenon Basic EMC Standard Or Test Immunity Test Levels Method ±2, 4, 6, 8 kV contact Electrostatic discharge IEC 61000-4-2...

  • Page 50: Section 13 - Customer Assistance

    Toll free: 1-800-444-2728 E-mail: PIQ@ambitpump.com Website: www.ambitpump.com Copyright © 2020 All rights reserved. This document contains proprietary information and may not be reproduced, published or distributed in any form, in whole or in part, without written authorization from Avanos Medical, Inc.
  • Page 52 ambIT Infusion Pump is a trademark of: ® Finding better ways to care For people™ 63296.00 (08/20)

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