ambIT Pump PIB PCA v1.5 Clinician Manual March 2020

Become familiar with the ambIT® pump Solution container

Cassette

Pump display RUN/PAUSE button Tubing clamp

BOLUS button Tubing clamp

ON/OFF switch ambIT® Pump

Remote BOLUS switch (optional)

To solution container (Side view of cassette)

Cassette shaft

To patient

Table of Contents SECTION 1 - INTRODUCTION...1 1.1 Definitions and Symbols...1 1.1.1 Definitions ...1 1.1.2 Definition of Symbols...2 1.2 Warnings ...6 1.2.1 Sterile, Disposable (Single-Use) Administration Set ...7 1.2.2 Protection From Air Infusion ...8 1.2.3 Protection From Unintended Bolus ...8 1.2.4 Use of ambIT® PIB· PCA v1.5 Pump in MRI Environment ...8 1.3 Indications for Use...8 1.4 Product Description ...9 1.4.1 Product Overview ...9 1.4.2 ambIT® Pump User Interface ...14 1.4.3 ambIT® Cassette ...15 SECTION 2 - SET UP ...16 2.1 Required Materials ...16 2.2 ambIT® Cassette ...17 2.3 Priming the Cassette ...17 2.4 Attach Cassette to Pump ...20 2.5 Remove Cassette from Pump...20 2.6 Changing Fluid Reservoir ...21 2.7 Battery Installation and Replacement...21 2.7.1 Battery Installation ...21 2.7.2 Battery Replacement ...22 2.8 Pump Power On and Off ...23 SECTION 3 - PROGRAMMING INSTRUCTIONS ...24 3.1 General Information ...24 3.2 Program Options ...25 3.2.1 PCA Mode ...26 3.2.2 PIb Mode ...31 3.2.3 P+P Mode...35 3.3 Program Review ...40 SECTION 4 - OPERATING INSTRUCTIONS ...41 4.1 Start Infusion ...41 4.1.1 PCA Mode Start Infusion ...41 4.1.2 PIb Mode Start Infusion ...41 4.1.3 P+P Mode Start Infusion ...42 4.2 Pause Infusion ...42 4.3 Resume Infusion ...42 4.4 Silence Alarm ...42 4.5 Bolus Activation...43 4.6 Summary of Operating Controls ...44

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SECTION 5 - INFUSION HISTORY REPORTS...45 5.1 Pump Infusion History ...45 5.1.1 PCA Mode Infusion History ...45 5.1.2 PIb Mode Infusion History...46 5.1.3 P+P Mode Infusion History ...46 5.2 Clearing Pump Infusion History. ...47 SECTION 6 - PATIENT LOCKOUT ...48 6.1 Accessing Lockout Mode...48 6.2 To Lock the Pump...48 6.3 To Unlock the Pump ...49 SECTION 7 - ALARMS AND SIGNALS ...50 SECTION 8 - TROUBLESHOOTING...52 SECTION 9 - SPECIFICATIONS...53 SECTION 10 - DELIVERY RATE ACCURACY ...55 10.1 Data from Volumetric Accuracy Testing ...56 10.2 Factors That May Affect Volumetric Accuracy ...56 SECTION 11 - GENERAL CARE INSTRUCTIONS ...61 11.1 Warranty Information ...61 11.2 Cleaning and Disinfecting Instructions ...62 SECTION 12 - ELECTROMAGNETIC IMMUNITY (EMC) ...63 SECTION 13 - CUSTOMER ASSISTANCE ...65

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SECTION 1 - INTRODUCTION 1.1

Definitions and Symbols

1.1.1

Definitions

ANALGESIA: Relief from pain. BASAL FLOW RATE: The continuous flow rate. It occurs when the pump is not delivering a bolus in PCA mode. 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.1 The bolus is infused at the bolus flow rate. A bolus is delivered when a patient requests it by pushing the BOLUS button or the optional remote BOLUS switch. A bolus is sometime referred to as a PCA bolus. The bolus has units of milliliters (ml). BOLUS/DOSE FLOW RATE: The flow rate at which a bolus or dose is delivered. It is a higher flow rate than the basal flow rate. In the ambIT® PIB· PCA v1.5 pump, the bolus flow rate varies from 210 ml/hr to 125 ml/hr, depending on the energy left in the battery. Flow rate accuracy is not affected by the bolus 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. CAUTION: A caution usually appears in front of a procedure or statement. Failure to observe a caution could result in serious patient or user injury. Cautions are found 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 a dose is referred to as a PIB or as a PIEB. In this manual, the term “dose” will be used when discussing either PIB or PIEB. The dose has units of milliliters (ml). INTERVAL OR DOSE INTERVAL: The time between the start of one dose and the start of the next dose. The dose interval has units of hours and minutes (hh:mm). LOCKOUT TIME: 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 (hh:mm). NOTE: A note highlights information that acts as a reminder or helps explain a concept or procedure. P+P: An acronym for a combination of programmable intermittent bolus (“PIb”) and patient controlled analgesia (“PCA”) and allows for dose volumes occurring at set intervals, as well as optional boluses. PCA: An acronym for patient controlled analgesia. If a pump is in PCA mode and the patient has been prescribed a bolus volume, then PCA allows for a lay user to periodically give the

1 2

The bolus is delivered at a higher flow rate than the basal rate; therefore, for a given volume, the bolus is delivered faster. The dose is delivered at a higher flow rate than the basal rate; therefore, for a given volume, the dose is delivered fast.

1

Section 1 • Introduction

patient a bolus of medication. If the infusion is into the epidural space the PCA is referred to as patient controlled epidural analgesia (PCEA). PIB (PIb): An acronym for programmable intermittent bolus. If the infusion is into the epidural space, the PIB or PIb is referred to as programmable intermittent epidural bolus (PIEB or PIEb).3 Within this manual, when referring to the pump itself, “PIB· PCA v1.5” is used; when referring to the dose, display or mode, “PIb” is used. VOLUME TO BE INFUSED: The total amount of fluid in the solution container or reservoir to be infused. The volume to be infused has units of milliliters (ml). WARNING: A warning message contains special safety emphasis and must be observed at all times. Warnings are found at Section 1.2, as well as throughout this document emphasized with grey shading. Failure to observe a warning message is potentially life threatening.

1.1.2

Definition of Symbols

Consult instructions for use.

International symbol meaning “Attention, consult accompanying documents.”

IEC symbol for “Type BF Applied Part.” (IEC Classification: Internally powered.)

®

IP22 3

2

The ambIT® pump complies with ES 60601-1:2012, 1st Edition, including Amend. 1; CSA C22.2 NO. 60601-1:2014, 3rd Edition; IEC 60601-1:2005, including Corr. 2:2007 and Amend. 1:2012; IEC 60601-16:2013, Edition 3.1; IEC 60601-1-8:2012, Edition 2.1; IEC 60601-1-11:2015; 60601-2-24:2012, Edition 2; IEC 62304:2006, 1st Edition; IEC 62366:2007, 1st Edition, and Amend. 1:2014; IEC 60601-1-2:2014, 4th Edition, 201402. Protected against insertion of fingers and will not be damaged or become unsafe during a specified test in which it is exposed to vertically or nearly vertically dripping water.

In some publications, the PIb is referred to as an “automated bolus” or “automated mandatory bolus.” This usage is less common than PIb or PIEb.

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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

Caution: This device is restricted to sale by or on the order of a physician.

Temperature limitation

Sterilized using irradiation

DEHP-free fluid path

Not made with natural rubber latex

3

Section 1 • Introduction

Indicates which tubing connects to the solution container

To solution container (side view of cassette)

Indicates which tubing connects to the patient

Cassette shaft

To 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

Volume to be infused

RUN/PAUSE button

BOLUS button

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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 mode

Review pump program

5

Section 1 • Introduction

Infusion history report

Pump infusion history cleared

1.2

Warnings

Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. Read instructions before use. The pump must be used strictly in accordance with these instructions. Safe use of this pump is the primary responsibility of the user. The user is responsible for monitoring this pump. Contact clinical/technical support if pump appears to be operating incorrectly. All patients should be given a Patient Manual and instructed to read it carefully. The pump must be used only by or on behalf of the person for whom it is prescribed. Patients should never perform any function or push any button unless instructed by their healthcare provider. Do not allow the pump to get wet. If the pump is immersed in any liquid, it must be replaced with a new pump. Transport and storage conditions: -25ºC (-13ºF) without relative humidity control; and +70ºC (+158ºF) at relative humidity of up to 93%, non-condensing. 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). Never attempt to open the pump case. Only the battery cover may be removed when changing batteries. If the pump is dropped, it must be replaced with a new pump. This pump is not to be used for infusion of blood or blood products. This pump is not to be used for infusion of life-sustaining medications. Failure to follow manufacturer’s instructions while replacing batteries may result in loss of program settings and report data. Dispose of batteries properly after use. Contact the local authorities to determine the proper method of disposal of potentially biohazardous parts and accessories.

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This pump does not have an air in-line alarm. A cassette with an air elimination filter is available and recommended for intravenous use or where infusion of air would cause a safety hazard. Safety hazards with the ambIT® pump, including under-infusion, may be associated with external radio frequency (RF) interference or electromagnetic radiation. Typical equipment that may generate such radiation includes x-ray machines, magnetic resonance imaging (MRI) equipment, and any other non-shielded electrical equipment. Use of any remote BOLUS switch other than the approved remote BOLUS switch could result in an inadvertent bolus. Do not use any other administration set other than the approved ambIT® cassettes. The pump will not function properly with any other administration sets. Do not use additional untested/unapproved components as their use may lead to underinfusion and the potential of increased pain to the patient. No modification of this equipment is allowed. The cassette tubing or BOLUS switch cord may cause strangulation if used improperly. The pump should not be 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 interconnection of other infusion systems. Refer to: Terry, Judy (Ed.), Intravenous Therapy, W. B. Sanders Co. 1995, pp 192–193. A single cassette should not be used for infusion volumes greater than two liters. In order to minimize the possibility of infection, cassettes should be changed in accordance with your institution’s policies. When the desired volume to be infused has been delivered, the empty solution container must be changed. Failure to do so will result in cessation of fluid delivery. Before starting therapy, check that all connections are secure and that there are no leaks in the fluid path. Bolus and infusion history reports should never take the place of good clinical judgment. Always perform a clinical evaluation whenever interpreting these reports. Infusing viscous solutions (e.g., D25W) into high pressures (e.g., approaching 300mm Hg) may decrease volumetric accuracy. 1.2.1

Sterile, Disposable (Single-Use) Administration Set • Carefully examine each cassette before use. Make sure there are no damaged or missing parts. • Do not use a cassette if the outer package is torn, punctured, wet or damaged. 7

Section 1 • Introduction

• Do not touch the sterile open end of tubing. Use the aseptic technique utilized by your facility. • Do not re-sterilize cassette. 1.2.2

Protection From Air Infusion • The solution must be provided in a non-vented, collapsible container. • Remove all air from solution container and tubing before use. • For IV applications, the ambIT® PIB· PCA v1.5 pump should be used with air elimination filters because air protection is not provided.

1.2.3

Protection From Unintended Bolus • The unintended bolus volume that could be released into a patient prior to clearing a downstream occlusion may be released by breaking the seal on the connection between the pump and the catheter. • Breaking the connection between the catheter and the pump may introduce contamination into the fluid path. Do not try to clear the unintended bolus volume if any concerns exist about introducing contamination. • The maximum unintended bolus volume released into the patient when occluded on the downstream side is between 0.050 and 0.10 ml. One stroke of an infusion is 0.050 ml. Since these amounts 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· PCA v1.5 Pump in MRI Environment Safety in MRI not evaluated. The ambIT® PIB· PCA v1.5 pump has not been evaluated for safety and compatibility in the MRI environment. It has not been tested for heating, migration, or image artifact in the MRI environment. The safety of the ambIT® PIB· PCA v1.5 pump in the MRI environment is unknown. Scanning a patient who has this device may result in patient injury.

1.3

Indications for Use

The ambIT® PIB· PCA v1.5 pump is used to infuse medicines and/or fluids into patients primarily for pain management. The routes of administration are generally intravenous, epidural, and/or regional. The ambIT® PIB· PCA v1.5 pump is not intended to supersede, augment, or replace any other medical device or drug indications for use or intended uses. The ambIT® PIB· PCA v1.5 pump is intended to be used in the home and in healthcare facilities. NOTE:

8

Any use of the pump other than those indicated above is regarded as an off-label use. The ambIT® PIB· PCA v1.5 pump is not equipped with an air detection circuit, therefore if infusion of air could cause harm to the patient, it is recommended to use a filtered cassette or air elimination filter.

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NOTE:

Summit Medical Products, Inc. does not recommend or endorse any one specific medication to be used with the ambIT® PIB· PCA v1.5 pump. The healthcare provider is the sole individual who decides upon the prescribed medication, pump programmed parameters, method and location of infusion.

NOTE:

The suitability of this product for use with any specific patient is to be determined solely by the healthcare provider. The healthcare provider should understand the interaction between the infusion characteristics of the pump, the physiological response of a patient to the drug (overall and at the infusion site), the pharmacokinetics of the drug, any potential adverse effects, etc. This patientspecific 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 Summit Medical Products, 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.

1.4

Product Description

1.4.1

Product Overview

If any of the acronyms or words are not understood, see the Definitions given in Section 1.1. The ambIT® PIB· PCA v1.5 pump is a unique pump. There are three different modes of operation. The first mode is PCA. The second mode is PIb4. The third mode is 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 mode, the pump can be programmed in basal flow rate mode, bolus only, or basal flow rate and bolus. In PCA mode the parameters available are (1) basal flow rate5, (2) bolus volume6, (3) lockout time7, and (4) volume to be infused8. The PIb mode is added to simplify programming a dose-only therapy. Therefore, in PIb mode the pump can only be programmed to deliver doses. The programmed parameters available in PIb mode are (1) dose volume, (2) dose interval and (3) volume to be infused.

4 5 6 7 8

PIb stands for programmable intermittent boluses, but in order to avoid confusion, we refer to all automatically delivered boluses as doses and PCA boluses as boluses. The units for the basal flow rate are milliliter per hour (ml/hr). When the basal flow rate is set to zero (0.0) the PCA program is set to bolus only. The unit for the bolus volume is milliliter (ml). When the bolus volume is set to zero (0.0) the PCA program is set to basal flow rate only. The units for the lockout time are hours and minutes (hh:mm). The lockout time is bypassed automatically if the bolus volume is set to zero (0.0). The volume to be infused unit is milliliter (ml). It is the reservoir volume. It is required to be programmed in all modes.

9

Section 1 • Introduction

In P+P mode, the pump can be programmed to deliver a dose only, a bolus only, or a dose and a bolus. The programmed parameters available are (1) dose volume9, (2) dose interval10, (3) bolus volume11, (4) lockout time, and (5) volume to be infused. The goal of the bolus or dose is to infuse the medication at an increased rate - mimicking an injection as much as possible. The purpose of the increased rate is generally to flood a greater area with analgesic medication or to increase the concentration of the medication. The flow rate at which the ambIT® PIB· PCA v1.5 pump infuses a bolus or dose is dependent on the energy state of the batteries. The bolus/dose infusion rate will be 210 ml/hr until the low battery alarm is activated if a new, unused set of AA alkaline batteries are used at the start of the infusion. After the low battery alarm is activated, the bolus/dose infusion rate may be reduced from the 210 ml/hr to about 180 ml/hr. On a new, unused set of alkaline batteries, the low battery alarm will not be reached until at least 500 ml have been infused. If one or both batteries have been previously used, non-alkaline batteries are used, or the pump is repeatedly cycled off and on, the bolus/ dose infusion rate may drop to a minimum of 125 ml/hr prior to the low battery 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 parameters are affected as the batteries are depleted.

CAUTION:

If the medication being infused requires the bolus/dose infusion rate to be 210 ml/hr, only new alkaline batteries should be used and the batteries should be changed immediately when the low battery alarm occurs.

CAUTION:

Repeatedly cycling the pump off and on may cause the bolus/dose infusion rate to drop below 210 ml/hr. In extreme cases, the bolus/dose infusion rate could drop as low as 125 ml/hr.

A new, unused set of alkaline batteries will infuse at 210 ml/hr. For a minimum of 500 ml, the bolus and dose flow rate will be 210 ml/hr. Once the batteries have been depleted, the flow rate may decrease. The lowest flow rate the pump will reach is 125 ml/hr. The different parameters for each mode interact with each other to create an infusion pattern. Examples of the infusion patterns for the different modes are provided graphically in Figures 1-1 through 1-6 that follow. The flow rates, volumes, lockout times, and intervals listed are examples only.

9

The dose volume unit is milliliter (ml). If it is set to zero (0.0), the interval time is bypassed automatically and the dose volume can be set to bolus-only mode. 10 The dose interval or interval units are hours and minutes (hh:mm). 11 If the bolus volume is set to zero (0.0), then the lockout time is automatically bypassed and the pump will only deliver doses (like PIb mode).

10

Flowrate (ml/hr)

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Basal

10

0

0

15

30

45

60

75

90

105

120

135

150

165

180

195

210

235

240

Time (Minutes)

Figure 1-1 Basal flow rate only (PCA mode) infusion pattern For Figure 1-1, the basal flow rate is 10 ml/hr. The maximum available basal flow rate is 20 ml.

Figure 1-2 Bolus only (PCA mode) infusion pattern 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 or remote BOLUS switch is pressed. During the lockout time, the pump will beep when a bolus is requested, but no bolus will be delivered. CAUTION:

Right after programming the pump or clearing history, a bolus will be delivered if requested. The pump assumes that clearing history or programming/ reprogramming a new therapy is starting.

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Section 1 • Introduction

Figure 1-3 Basal flow rate and bolus (PCA mode) infusion pattern For Figure 1-3, the settings are a basal flow rate of 10 ml/hr, a bolus volume of 10 ml, and a lockout time of 30 minutes 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 are a dose volume of 25 ml and a dose interval of 90 minutes. NOTE:

12

An optional dose can be delivered at the start of an infusion by pushing the BOLUS button within 60 seconds of the start of an infusion.

Sect i on 1 • I nt r o d u c tio n

Figure 1-5 Dose and bolus (P+P mode) infusion pattern Boluses are available after a lockout time. In the example used in Figure 1-5 and Figure 1-6, the dose volume is 20 ml, the dose interval is 90 minutes, the bolus volume is 10 ml, and the lockout time is 30 minutes. Automated doses are scheduled at a set interval. An optional dose is available at the start of a new infusion if the BOLUS button is pushed within 60 seconds. Unlike in PCA mode, if the BOLUS button is not pushed, the bolus is NOT available until the lockout 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 third dose in Figure 1-5 has been delayed by a little over five minutes, so instead of occurring at the 180-minute mark, the third dose occurs at about the 185-minute mark. The dose stays delayed for the rest of the therapy.

Figure 1-6 Dose and bolus (P+P mode) infusion pattern of multiple dose delays

Each time a dose is delayed, it is added to the previous delays. In Figure 1-6, the second dose is delayed by about 10 minutes (first dose delay), from 90 minutes to 100 minutes. This means 12 The purpose of the lockout time is two-fold: (1) to allow the medication to work before the patient can receive additional medication and (2) to space out doses and boluses to prevent the patient receiving a harmful amount of medication.

13

Section 1 • Introduction

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 over 195 minutes. If no other delays occur, then all the remaining doses will be delayed by the sum of the first and second dose delays, or a little over 15 minutes.

1.4.2

ambIT® Pump User Interface

The pump has two buttons: the RUN/PAUSE button and the BOLUS button. The RUN/ PAUSE button is located just below the pump display. The BOLUS button is located just below the RUN/PAUSE button. See figure to the left. Cassette

Pump display RUN/PAUSE button

BOLUS button

®

ON/OFF switch

An ON/OFF switch is part of the battery cap. See figure to the left.

F F

The pump program is determined by selecting the desired parameters during the program mode. Pressing and holding the pump’s RUN/PAUSE button and BOLUS button simultaneously for two seconds allows the user to access the program mode. This specific combination of pressing buttons is designed to prevent inadvertent or unauthorized program adjustments.

The RUN/PAUSE button is used to start, resume or pause the infusion. The RUN/PAUSE button toggles Remote BOLUS switch between run mode and pause mode. The RUN/PAUSE (optional) button will also silence any alarm that occurs while the pump is running. A blinking green run light (inside the BOLUS button) and “ml” (volume infused) in the pump display indicates that the pump is infusing. The table in Section 7 of this manual completely describes each alarm and signal. If the infusion is paused, a flashing pause icon ( II ) appears in the pump display and two beeps sound every four minutes, indicating that the pump infusion has been temporarily stopped. When the BOLUS button is pressed during run mode, the pump will deliver the programmed bolus. During bolus delivery, the green run light (inside the BOLUS button) will double blink.

14

Sect i on 1 • I nt r o d u c tio n

1.4.3

ambIT® Cassette Top view of cassette

The cassette contains a rotary mechanism that pumps the infusion solution at an accurate and controlled rate. During cassette priming, fluid will flow freely through the tubing (see upper figure to the left).

Cassette bottom disc

After priming, snap the cassette bottom disc into the body of the cassette to close the fluid path. This prevents the free 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 the cassette bottom disc is not snapped in place. Do not attach the cassette to the patient until the cassette is placed on the pump. Placing the cassette on the pump will automatically snap the disc in place and prevent free flow.

NOTE:

Once the cassette bottom is snapped into place (see Section 2), the rollers engage and compress the tubing, preventing fluid from flowing unless the pump is rotating and moving the fluid. If a downstream occlusion occurs, the pump will alarm and notify the user.

15

Section 2 • Set Up

SECTION 2 - SET UP (See diagram on inside front cover) The following steps must be accomplished sequentially to properly set up the pump: 1.

Gather required materials (see Section 2.1);

2.

Install new, unused, AA alkaline batteries (see Section 2.7);

3.

Program the pump (see Section 3);

4.

Prime the cassette (see Section 2.3);

5.

Verify that the cassette bottom disc is snapped closed before attaching the cassette to the pump (see Section 2.2);

6.

Attach the cassette to the pump (see Section 2.4);

7.

Attach the long tubing of the cassette to the patient catheter using the aseptic technique utilized by your facility;

8.

Start infusion (see Section 4.1); and,

9.

Ensure the patient is instructed in the use of the pump and receives a patient manual.

NOTE:

It is the responsibility of the healthcare provider to ensure that the lay user/ patient is educated 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 patient’s clinical status and medication provided.

2.1

Required Materials

The ambIT® cassette is a sterile, disposable (single-use) administration set. The upstream (short) tubing of the cassette connects to a non-vented, collapsible solution container. Once the cassette has been primed, the downstream (long) tubing of the cassette connects to the patient’s access device. Contact Summit Medical Products, 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 Summit Medical Products, Inc. to obtain a complete listing of all optional accessories. WARNING:

16

It is recommended that an air elimination filter be used for IV applications to protect them from air embolisms. The ambIT® cassette can be ordered with or without an integrated air elimination filter.