Clinician Manual
60 Pages
![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 ...8 1.2.2 Protection From Air Infusion ...8 1.2.3 Protection From Unintended Bolus ...8 1.2.4 Use of ambIT® Pump in MRI Environment ...8 1.3 Indications for Use...9 1.3.1 Continuous Pumps ...9 1.3.2 PreSet Pumps ...9 1.3.3 PCA Pumps ...9 1.3.4 PreSet*PCA Pump ...9 1.4 Overview...9 1.4.1 Continuous Pumps ...10 1.4.2 PreSet Pumps ...10 1.4.3 PCA Pumps ...10 1.5 Infusion Patterns ...11 SECTION 2 - SET UP ...13 2.1 Required Materials ...13 2.2 ambIT® Cassette ...14 2.3 Priming the Cassette ...14 2.4 Attach Cassette to the Pump ...17 2.5 Remove Cassette from the Pump ...18 2.6 Changing the Fluid Reservoir ...18 2.7 Battery Installation and Replacement...18 2.7.1 Battery Installation ...19 2.7.2 Battery Replacement ...19 2.8 Pump Power On and Off ...20 SECTION 3 - PROGRAMMING INSTRUCTIONS ...21 3.1 General Information ...21 3.2 ambIT® Pump User Interface ...22 3.3 Program Options ...23 3.4 Continuous Pump Programming Steps ...23 3.5 PreSet Pump Programming Options ...24 3.6 PCA Pump Programming Steps ...29 3.7 Program Review ...31 SECTION 4 - OPERATING INSTRUCTIONS ...32 4.1 Start Infusion ...32 4.2 Pause Infusion ...33 4.3 Resume Infusion ...33 4.4 Silence Alarm ...33 4.5 Bolus Activation...34 4.5a FUNCTION Button Activation ...34 4.6 Summary of Operating Controls for Continuous Pumps ...35 4.7 Summary of Operating Controls for PreSet and PCA Pumps ...35 i](https://images.bioclinicalservices.com.au/NAUDruFvCC2cmwdphiVrFuF6/320w/ambIT%20Pumps%20-%2063076.034%20-%20ambIT%20Pump%20Clinician%20Manual%20Jan%202019%20-%202019-01.png)
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ambIT Pump ®
C L I N I C I A N
M A N U A L
.
®
MORE THAN PAIN RELIEF... SUPERIOR PAIN CONTROL
0088
IP22
0088
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
t BOLUS Switch Remote (optional for select models)
To solution container (Side view of cassette)
Cassette shaft
To patient
Continuous pumps have FUNCTION button in place of BOLUS button
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 ...8 1.2.2 Protection From Air Infusion ...8 1.2.3 Protection From Unintended Bolus ...8 1.2.4 Use of ambIT® Pump in MRI Environment ...8 1.3 Indications for Use...9 1.3.1 Continuous Pumps ...9 1.3.2 PreSet Pumps ...9 1.3.3 PCA Pumps ...9 1.3.4 PreSet*PCA Pump ...9 1.4 Overview...9 1.4.1 Continuous Pumps ...10 1.4.2 PreSet Pumps ...10 1.4.3 PCA Pumps ...10 1.5 Infusion Patterns ...11 SECTION 2 - SET UP ...13 2.1 Required Materials ...13 2.2 ambIT® Cassette ...14 2.3 Priming the Cassette ...14 2.4 Attach Cassette to the Pump ...17 2.5 Remove Cassette from the Pump ...18 2.6 Changing the Fluid Reservoir ...18 2.7 Battery Installation and Replacement...18 2.7.1 Battery Installation ...19 2.7.2 Battery Replacement ...19 2.8 Pump Power On and Off ...20 SECTION 3 - PROGRAMMING INSTRUCTIONS ...21 3.1 General Information ...21 3.2 ambIT® Pump User Interface ...22 3.3 Program Options ...23 3.4 Continuous Pump Programming Steps ...23 3.5 PreSet Pump Programming Options ...24 3.6 PCA Pump Programming Steps ...29 3.7 Program Review ...31 SECTION 4 - OPERATING INSTRUCTIONS ...32 4.1 Start Infusion ...32 4.2 Pause Infusion ...33 4.3 Resume Infusion ...33 4.4 Silence Alarm ...33 4.5 Bolus Activation...34 4.5a FUNCTION Button Activation ...34 4.6 Summary of Operating Controls for Continuous Pumps ...35 4.7 Summary of Operating Controls for PreSet and PCA Pumps ...35
i
SECTION 5 - INFUSION HISTORY REPORTS...36 5.1 Pump Infusion History ...36 5.2 Clearing Pump Infusion History. ...37 SECTION 6 - PATIENT LOCKOUT ...38 6.1 Accessing Lockout Mode...38 6.2 To Lock the Pump...38 6.3 To Unlock the Pump ...39 SECTION 7 - ALARMS AND SIGNALS ...40 SECTION 8 - TROUBLESHOOTING...42 SECTION 9 - SPECIFICATIONS...43 9.1. General Specifications Applicable to All Pumps ...43 9.2. Continuous Pump Specifications ...43 9.3. PreSet and PCA Pump Specifications ...44 SECTION 10 - DELIVERY RATE ACCURACY ...45 10.1 Data from Volumetric Accuracy Testing ...46 10.2 Factors That May Affect Volumetric Accuracy ...47 SECTION 11 - GENERAL CARE INSTRUCTIONS ...51 11.1 Warranty Information ...51 11.2 Cleaning and Disinfecting Instructions ...52 SECTION 12 - ELECTROMAGNETIC IMMUNITY (EMC) ...53 SECTION 13 - CUSTOMER ASSISTANCE ...55
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Sect i on 1 • I nt r o d u c tio n
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. 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). Not available on Continuous pumps. BOLUS FLOW RATE: The flow rate at which a bolus is delivered. It is a higher flow rate than the basal flow rate. In the ambIT® pump, the bolus flow rate is either 100 ml/hr or 125 ml/hr (pump model dependant). The bolus 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. LOCKOUT TIME: The time between the end of one bolus and the start of the next bolus. 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. 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 patient a bolus of medication. If the infusion is into the epidural space the PCA is referred to as patient controlled epidural analgesia (PCEA). 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
The bolus is delivered at a higher flow rate than the basal rate; therefore, for a given volume, the bolus is delivered faster.
1
Section 1 • Introduction
1.1.2
Definition of Symbols
Consult instructions for use.
0088
International symbol meaning “Attention, consult accompanying documents.”
IEC symbol for “Type BF Applied Part.” ((IEC IEC IEC Classification: Internally powered.)
®
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.
CE symbol certifying that the product complies with the essential requirements of the Medical Device Directive.
The “NRTL/C” indicator adjacent to the CSA (Canadian Standards Association) mark signifies that the product has been evaluated to the applicable ANSI/UL and CSA standards for use in the U.S. and Canada. NRTL (Nationally Recognized Testing Laboratory) is a designation granted by the U.S. Occupational Safety and Health Administration (OSHA) to laboratories that have been recognized to perform certification to U.S. standards.
IP22
Protected against insertion of fingers and will not be damaged or become unsafe during a spec specifi ified test in which it is exposed to vertically or nearly vertically dripping water.
Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC.
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Sect i on 1 • I nt r o d u c tio n
Indicates the Authorized Representative in the European Community.
Indicates the date after which the medical device is not to be used.
Indicates the manufacturer’s batch code or lot number 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 Sin gle-use only (cassettes)
Keep away from heat
Keep dry
Caution: This device is restricted to sale by or on the order of a Caution: physician.
Temperature Te mperature limitation
Sterilized Ste rilized using irradiation
3
Section 1 • Introduction
DEHP-free fluid path
Nott made with natural rubber latex No
To solution container
Indicates which tubing connects to Indicates the solution container
(side view of cassette)
Cassette shaft
Indicates which tubing connects to Indicates the patient To patient
Bolus
Program Pro gram lockout
Bolus lockout time in hours:minutes
Bolus Bo lus volume in milliliters
Volume Vo lume in milliliters
Basal Bas al infusion rate in ml/hr
Number Num ber of boluses delivered
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Sect i on 1 • I nt r o d u c tio n
Number of bolus requests Elapsed time Volumee to be infused Volum
RUN/PAUSE button
BOLUS BO LUS button
FUNCTION button
Low/dead Low /dead battery indicator
Alarm indicator
ambIT® pump display
Pump Pum p power on
Pump po power wer off
Battery orientation
Program Pr ogram lockout code
5
Section 1 • Introduction
Program Progr am lockout mode
Pump program mode
Review p pump ump program
Infusion history report
Pump Pum p 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. 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. 6
Sect i on 1 • I nt r o d u c tio n
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. 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. 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.
7
Section 1 • Introduction
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. • 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. • If infusion of air could cause harm to the patient, the ambIT® pump should be used with air elimination filters because air detection 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 (1) 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® Pump in MRI Environment Safety in MRI not evaluated. The ambIT® pumps have 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® pumps in the MRI environment is unknown. Scanning a patient who has this device may result in patient injury
8
Sect i on 1 • I nt r o d u c tio n
1.3
Indications for Use
1.3.1
Continuous Pumps
The ambIT® Continuous pumps are intended for continuous volumetric delivery of intravenous medicines and/or fluids into patients at a consistent volume for prescriptive treatment by a physician. 1.3.2
PreSet Pumps
The ambIT® pumps with PreSet settings are intended for use by surgeons and anesthesiologists for the peri-operative and post-operative infusion of local anesthetics and narcotics for pain management and regional anesthesia. Routes of administration include intravenous, subcutaneous, intramuscular, perineural and epidural. The ambIT® pumps with PreSet settings are also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or in close proximity to nerves when compared with narcotic only pain management. 1.3.3
PCA Pumps
The ambIT® PCA pump is used to infuse medicines and/or fluids into patients primarily for pain management. Modes of action are generally intravenous, epidural and/or regional. 1.3.4
PreSet*PCA Pump
The ambIT® PreSet PCA pump is used to infuse medicines and/or fluids into patients primarily for pain management. The routes of administration are generally intravenous, epidural, nerve blocks, subcutaneous, local infiltration and/or intramuscular. The ambIT® PreSet*PCA pump is not intended to supersede, augment or replace any other medical device or drug indications for use or intended uses. The ambIT® PreSet*PCA pump is intended to be used in the home and in healthcare facilities.
1.4
Overview
The ambIT® family of pumps are designed for the ambulatory infusion of fluids and medications in home and healthcare facilities. The pumps have simple controls that are easily operated by both caregivers and patients. References to the remote BOLUS switch apply only to pumps with the remote BOLUS port. See the diagram on inside front cover to determine if pump has a remote BOLUS switch option. The operator position with respect to the device is considered arms length (no more than 0.5 meters direct view). If any of the acronyms or words are not understood, see the Definitions given in Section 1.1. There are three categories of ambIT® pumps within this manual: Continuous, PreSet and PCA. Continuous pumps allow for continuous infusion. The PreSet category of pumps contain up to five programming options on the back of the pump and in the programming steps. All other pumps are PCA pumps. Below are descriptions of these three pump types. See Section 10 for individual pump specifications.
9
Section 1 • Introduction
NOTE:
Any use of the ambIT® pump other than those indicated in this manual is regarded as an off-label use. The ambIT® pumps are 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.
NOTE:
Summit Medical Products, Inc. does not recommend or endorse any one specific medication to be used with the ambIT® family of pumps. The healthcare provider is the sole individual who decides upon the prescribed medication, programmed pump 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 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 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.
1.4.1
Continuous Pumps
The ambIT® Continuous family of pumps allow only continuous flow rates (i.e., basal only flow rates). These pumps contain no bolus feature. 1.4.2
PreSet Pumps
The ambIT® PreSet family of pumps allow for the following three types of infusion patterns: (1) basal flow rate only, (2) bolus only, and (3) basal flow rate and bolus. These pumps simplify pump programming by providing the clinician with the option to choose from up to four (4) preprogrammed infusion protocols (PRO1 - PRO4), or to program infusion parameters individually (PRO5). NOTE:
1.4.3
Some ambIT® pumps with PreSet settings have 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. After the infusion beyond 2,000 ml has been completed, the next time the pump is powered on the ALARM icon ( ) and “EEE” will appear in the display, indicating that the pump has reached its end of life and must be replaced. PCA Pumps
The ambIT® PCA pumps do not include PreSet settings. The clinician may select different delivery profiles, which include: (1) basal flow rate only, (2) bolus only, and (3) basal flow rate and bolus.
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Sect i on 1 • I nt r o d u c tio n
1.5
Infusion Patterns
Flowrate (ml/hr)
The different parameters of an infusion interact with each other to create an infusion pattern. Examples of the infusion patterns are provided graphically in Figures 1-1 through 1-3 that follow. The flow rates, volumes and lockout times discussed in the graphs are examples only.
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 infusion pattern - applicable to all pumps For Figure 1-1, the basal flow rate is 10 ml/hr. The maximum available basal flow rate is 20 ml for PreSets and PCA pumps. The maximum available basal flow rate is 125 ml/hr for a Continuous pump.
Figure 1-2 Bolus only infusion pattern - not applicable to Continuous pumps 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:
After programming the pump or clearing the history, a bolus will be delivered, if requested, within one minute. The pump assumes that clearing history or programming/reprogramming indicates that a new therapy is starting.
11
Section 1 • Introduction
Figure 1-3 Basal flow rate and bolus infusion pattern - not applicable to Continuous pumps 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.
12
NOTE:
The basal flow rate is discontinued while a bolus is being delivered and resumes once the bolus has been completed.
NOTE:
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 0.5 ml/hr or greater, the KVO will be 0.5 ml/hr. If the basal rate is less than 0.5 ml/hr, then the KVO is the basal rate. The KVO rate is not programmable.
Sect i on 2 • S e t U p
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.
After priming, close the fluid path by snapping the cassette bottom disc into the cassette body. This will prevent free flow.
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.
WARNING:
Protection from air infusion - The infusion solution must be provided in a nonvented, collapsible container. Remove all air from solution container and tubing before use.
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 extension (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.
13
Section 2 • Set Up
WARNING:
If an infusion of air could cause harm to the patient, an air elimination filter should be used. The ambIT® cassette may be ordered with or without an integrated air elimination filter.
WARNING:
The ambIT® pump requires the use of an ambIT® cassette. Use of cassettes not manufactured by Summit Medical Products, 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 air elimination filter. Using a second filter may cause the pressure to exceed the activation pressure for the pressure switch, causing an occlusion alarm (“OCL” in display and a constant beep).
2.2
ambIT® Cassette The cassette contains a rotary mechanism that pumps the infusion solution at an accurate and controlled rate.
Figure 1
During cassette priming, fluid will flow freely through the tubing (Figure 1). Top view of cassette
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 (Figure 2). When primed, the cassette simply snaps onto the pump.
Figure 2
Cassette bottom disc (clear)
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 or the cassette bottom disc is snapped into place. 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, 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.
2.3
Priming the Cassette
WARNING:
14
Do not use a cassette if the outer package is torn, punctured, wet or damaged. Do not touch the sterile open ends of the tubing. Use the aseptic technique utilized by your facility.
Sect i on 2 • S e t U p
WARNING:
The cassette must be primed before use by removing all air from the solution container and tubing.
WARNING:
Do not connect the cassette to the patient until the cassette has been primed, the cassette has been connected to the pump, and the pump has been programmed to the desired therapy and checked per hospital protocol.
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.
To prime the cassette, follow these steps: Protective cover
STEP #1
Remove the protective cover from the bottom of the cassette (see illustration at left).
STEP #2
Connect the solution container to the short tubing of the cassette using the aseptic technique utilized by your facility.
STEP #3
Release all clamps on the tubing.
STEP #4
Invert the solution container to allow air to be evacuated before priming the cassette with fluid (see illustration at left).
STEP #5
Gently squeeze the solution container to force fluid and air upward through the tubing and cassette. Continue until the solution has completely filled the tubing and all air bubbles have been removed.
STEP #6
After priming, close the fluid path by snapping the cassette bottom disc into the cassette body. This will prevent free flow.
15
Section 2 • Set Up
WARNING:
Failure to properly snap the cassette bottom disc into the cassette body may result in incorrect flow rates or free-flow conditions. Placing the cassette on the pump will snap the cassette disc bottom in place, if it is not done prior.
NOTE:
If the cassette bottom disc is snapped closed before the priming process is complete, place the cassette onto the pump (not attached to the patient) and use the instructions below to complete the priming of the cassette.
To remove the air for the Continuous pumps, complete Steps 6a and 6b, as follows: STEP #6a
Set the pump to infuse at 125 ml/hr (see Section 3.4.).
STEP #6b
Start the infusion (see Section 4.1). Once all the air has been removed from the cassette tubing and fluid reservoir, stop the pump by pausing the infusion (see Section 4.2). Once all the air has been removed from the cassette tubing and fluid reservoir, pause the infusion, clear the history and program the pump to the desired settings.
To remove the air using the BOLUS button for the PreSet and PCA pumps, complete Steps 6a and 6b, as follows: STEP #6a
Program the pump to deliver a 20 ml bolus (see Section 3.5 for PreSet pumps or 3.6 for PCA pumps).
STEP #6b
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 Section 4.2). If necessary to remove more than 20 ml of air from the solution container and tubing, boluses can be repeated quickly by clearing the history between each bolus (see Section 5.2). Once all the air has been removed from the cassette tubing and fluid reservoir, clear the history and program the pump to the desired settings.
16