Summit Medical ambIT Clinician Manual
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Summit Medical ambIT Clinician Manual

Pib pumps
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ambIT
PIB Pumps
®
C L I N I C I A N
M A N U A L
.
®
MORE THAN PAIN RELIEF...
SUPERIOR PAIN CONTROL
IP22
0088

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Summary of Contents for Summit Medical ambIT

  • Page 1 PIB Pumps ® C L I N I C I A N M A N U A L ® MORE THAN PAIN RELIEF... SUPERIOR PAIN CONTROL IP22 0088...
  • 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 Remote BOLUS switch (optional) To solution container (Side view of cassette) Cassette shaft To patient...

  • Page 3: Table Of Contents

    1.2 Warnings ..........................7 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 ................9 1.2.4 Use of ambIT PIB Pumps in MRI Environment ............9 ® 1.3 Indications for Use.........................9 1.4 Product Description ......................10 1.4.1 Product Overview .....................10...
  • Page 4 SECTION 5 - INFUSION HISTORY REPORTS ................47 5.1 Pump Infusion History .......................47 5.1.1 PCA Mode Infusion History ..................47 5.1.2 PIb Mode Infusion History..................48 5.1.3 P+P Mode Infusion History ..................48 5.2 Clearing Pump Infusion History..................49 SECTION 6 - PATIENT LOCKOUT ....................50 6.1 Accessing Lockout Mode....................50 6.2 To Lock the Pump........................50 6.3 To Unlock the Pump ......................51...

  • Page 5: Section 1 - Introduction

    The bolus has units of milliliters (ml). BOLUS/DOSE FLOW RATE: The fl ow rate at which a bolus or dose is delivered. It is a higher fl ow rate than the basal fl ow rate. In the ambIT PIB pumps, the bolus fl ow rate varies ®...

  • Page 6: Defi Nition Of Symbols

    0088 documents.” IEC symbol for “Type BF Applied Part.” (IEC Classifi cation: 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 60601-1-6:2013, Edition ®...
  • Page 7 Sec t i on 1 • I nt ro d u c ti o n The “NRTL/C” indicator adjacent to the CSA (Canadian Standards Association) mark signifi es 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.
  • Page 8 Sec ti on 1 • In t r oduct ion Keep dry Caution: This device is restricted to sale by or on the order of a physician. Temperature limitation Sterilized using irradiation DEHP-free fl uid path Not made with natural rubber latex To solution container Indicates which tubing connects to (side view of cassette)
  • Page 9 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 Low/dead battery indicator Alarm indicator ambIT pump display ® Pump power on...
  • Page 10 Sec ti on 1 • In t r oduct ion Pump power off Battery orientation PIb mode PCA mode P+P mode Program lockout code Program lockout mode Pump program mode Review pump program Infusion history report Pump infusion history cleared Bolus button on Bolus button off...

  • Page 11: Warnings

    This pump does not have an air in-line alarm. A cassette with an air elimination fi lter 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 ®...

  • Page 12: Sterile, Disposable (Single-Use) Administration Set

    Sec ti on 1 • In t r oduct ion 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 ®...

  • Page 13: Protection From Unintended Bolus

    MRI environment. It has not been tested for heating, migration, or image artifact in the MRI environment. The safety of the ambit PIB pumps in the MRI environment is unknown. Scanning a patient who has this device may result in patient injury.

  • Page 14: Product Description

    This patient-specifi c 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.
  • Page 15 The purpose of the increased rate is generally to fl ood a greater area with analgesic medication or to increase the concentration of the medication. The fl ow rate at which the ambIT PIB pump infuses a bolus or dose is dependent on the energy state of the ®...
  • Page 16 Sec ti on 1 • In t r oduct ion Basal Time (Minutes) Figure 1-1 Basal fl ow rate only (PCA mode) infusion pattern For Figure 1-1, the basal fl ow rate is 10 ml/hr. The maximum available basal fl ow 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.
  • Page 17 Sec t i on 1 • I nt ro d u c ti o n Figure 1-3 Basal fl ow rate and bolus (PCA mode) infusion pattern For Figure 1-3, the settings are a basal fl ow rate of 10 ml/hr, a bolus volume of 10 ml, and a lockout time of 30 minutes NOTE: The basal fl...
  • Page 18 Sec ti on 1 • In t r oduct ion Figure 1-5 Dose and bolus (P+P mode) infusion pattern (PIB PCA, KIDS PIB and Australian PIB PCA pumps only; does not apply to the PIB-IL) ● • • 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.
  • Page 19 Sec t i on 1 • I nt ro d u c ti o n Figure 1-6 Dose and bolus (P+P mode) infusion pattern of multiple dose delays (PIB PCA, KIDS PIB and Australian PIB PCA pumps only; does not apply to the PIB-IL) ●...
  • Page 20 Sec ti on 1 • In t r oduct ion Dose interval Dose interval Bolus delivery is stopped and Dose delivery is started because a new interval is started. Undelivered bolus volume is not made up. Lockout Time Lockout Time Lockout Time Time Interval Limit...
  • Page 21 Sec t i on 1 • I nt ro d u c ti o n NOTE: The total volume is controlled by the IL over the dose interval. This means it is possible for the bolus and dose to be delivered back-to-back (i.e., the bolus at the end of one dose interval and the dose at the start of the next dose interval).

  • Page 22: Ambit ® Pump User Interface

    Sec ti on 1 • In t r oduct ion 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 Cassette located just below the pump display. The BOLUS button is located just below the RUN/PAUSE button.
  • Page 23 Sec t i on 1 • I nt ro d u c ti o n WARNING: Free fl ow 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.

  • Page 24: Section 2 - Set Up

    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.

  • Page 25: 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 fi lter, it is not recommended to use a separate ®...
  • Page 26 Sec ti on 2 • S e t Up CAUTION: Verify that all connections are secure, all clamps are opened, and that there are no leaks in the fl uid path before starting therapy. If the fi lled solution container is not going to be used immediately, clamp the tubing and cap the connector with the protective cap provided to prevent contamination.
  • Page 27 S ect i on 2 • S e t U p WARNING: Failure to properly snap the cassette bottom disc into the cassette body may result in incorrect fl ow rates or free-fl ow conditions. Placing the cassette on the pump will snap the cassette disc bottom in place, if it is not done prior.

  • Page 28: Attach Cassette To Pump

    Sec ti on 2 • S e t Up NOTE: The fi lter bonded to the ambIT cassette tubing is an air-elimination fi lter ® (“AEF”). The AEF has two membranes. The larger membrane is a hydrophilic membrane and the smaller membrane is a hydrophobic membrane. The hydrophobic membrane will not allow water to fl...

  • Page 29: Changing Fluid Reservoir

    CAUTION: Summit Medical Products, Inc. has not validated all types of batteries (non- alkaline, rechargeable, specifi c brands, previously-used, etc.); therefore, we cannot ensure that any specifi c battery will power the pump for a specifi c period of time.

  • Page 30: Battery Replacement

    Sec ti on 2 • S e t Up Step #2 Remove the cover and insert the batteries according to the illustrations at left. Step #3 Place the battery cover onto the pump as illustrated to the left (OFF symbol (O) on the cover slightly to the left of the ( I ) mark on the pump).

  • Page 31: Pump Power On And Off

    S ect i on 2 • S e t U p Press and release the RUN/PAUSE button to review the current program settings. Press and release the RUN/PAUSE button a second time to resume the current infusion program. Pump Power On and Off CAUTION: Always place the pump in pause mode prior to turning the pump off.

  • Page 32: Section 3 - Programming Instructions

    Holding the RUN/PAUSE button or BOLUS button does not increment or decrement any numbers. The buttons must be pushed and released to increment or decrement any numbers. There are three different modes that may be programmed into the ambIT PIB pumps: ®...

  • Page 33: Program Options

    Se ct i o n 3 • P ro gra mmi ng I nst ru c t io n s Program Options To enter program mode: Step #1 Place the pump in pause mode. If the pump is not on, turn it on (see Section 2.7). Step #2 Press and hold both the RUN/PAUSE button and the BOLUS button for two seconds until one beep is heard.
  • Page 34 The bolus has units of milliliters (ml). • Bolus/dose fl ow rate is the fl ow rate at which a bolus or dose is delivered. It is a higher fl ow rate than the basal fl ow rate. In the ambIT ®...
  • Page 35 Se ct i o n 3 • P ro gra mmi ng I nst ru c t io n s 3.2.1.2 PCA Mode Programming Steps AUDIBLE ACTION VISUAL INDICATOR INDICATOR Enter program mode: From pause mode, press and hold One beep “PRO”...
  • Page 36 Sec ti on 3 • P r o gram m ing Inst ruc ti ons AUDIBLE ACTION VISUAL INDICATOR INDICATOR Repeat the steps 4(A) and 4(B) to set Letter “b” is displayed and the digit to the right of the decimal the number to the right of point.
  • Page 37 Se ct i o n 3 • P ro gra mmi ng I nst ru c t io n s AUDIBLE ACTION VISUAL INDICATOR INDICATOR (B) Press and holder either the “boff” or “bon” will stop RUN/PAUSE button or the BOLUS blinking for 2-3 seconds button to select either “boff”...

  • Page 38: Pib Mode

    (ml). • The bolus/dose rate is the fl ow rate at which a bolus or dose is delivered. It is a higher fl ow rate than the basal fl ow rate. In the ambIT ® PIB pumps, the bolus fl ow rate varies from 210 ml/hr to 125 ml/hr, depending on the energy left in the battery.
  • Page 39 Se ct i o n 3 • P ro gra mmi ng I nst ru c t io n s 3.2.2.2 PIb Mode Programming Steps AUDIBLE ACTION VISUAL INDICATOR INDICATOR Enter program mode: One beep “PRO” is displayed for 2 seconds to indicate that the From pause mode, press and hold pump is in program mode.
  • Page 40 Sec ti on 3 • P r o gram m ing Inst ruc ti ons AUDIBLE ACTION VISUAL INDICATOR INDICATOR (B) When the desired dose interval NOTE: Dose interval time time appears in the display, press is displayed in hours and and hold either the RUN/PAUSE minutes (hh:mm).

  • Page 41: P+P Mode

    The bolus has units of milliliters (ml). • The bolus/dose fl ow rate is the fl ow rate at which a bolus or dose is delivered. It is a higher fl ow rate than the basal fl ow rate. In the ambIT ®...
  • Page 42 Sec ti on 3 • P r o gram m ing Inst ruc ti ons NOTE: When programming in P+P mode, if the tens and/or ones digits are already set to the desired setting, press both the BOLUS button and the RUN/ PAUSE button to accept the setting and move on to next step.
  • Page 43 Se ct i o n 3 • P ro gra mmi ng I nst ru c t io n s AUDIBLE ACTION VISUAL INDICATOR INDICATOR (B) When the desired number appears One beep NOTE: Dose volume is in the display, press and hold either displayed in ml.
  • Page 44 Sec ti on 3 • P r o gram m ing Inst ruc ti ons AUDIBLE ACTION VISUAL INDICATOR INDICATOR Repeat steps 5(A) and 5(B) to set the Letter “b” is displayed, and digit to the right of the decimal point number right of decimal (00.0 to 00.9).
  • Page 45 Se ct i o n 3 • P ro gra mmi ng I nst ru c t io n s AUDIBLE ACTION VISUAL INDICATOR INDICATOR (B) Press and holder either the RUN/ “boff” or “bon” will stop PAUSE button or the BOLUS button blinking for 2-3 seconds to select either “boff”...

  • Page 46: 3.3 Program Review

    Sec ti on 3 • P r o gram m ing Inst ruc ti ons 3.3 Program Review CAUTION: After programming the pump, always verify the program by performing a program review. NOTE: After turning on, programming, locking or unlocking the pump, the RUN/ PAUSE button may also be pressed and immediately released to review the program.

  • Page 47: Section 4 - Operating Instructions

    S ect i on 4 • Oper at i n g I n st r u c ti o n s SECTION 4 - OPERATING INSTRUCTIONS NOTE: All operating instructions are the same for the three modes of the ambIT ® pumps except “Start Infusion” (Section 4.1). Please read respective sections within Section 4.1 to understand how each mode starts infusion.

  • Page 48: P+P Mode Start Infusion

    Sec ti on 4 • O pera ti ng I ns truct ions If the BOLUS button is pushed within 60 seconds of placing the pump in run mode after changing the settings or clearing the history, the dose is delivered immediately instead of waiting for the dose interval to elapse.

  • Page 49: Silence Alarm

    S ect i on 4 • Oper at i n g I n st r u c ti o n s Silence Alarm To silence an alarm, press and release the RUN/PAUSE button. When the alarm has been silenced, the pump will remain in pause mode. Once the cause of the alarm has been corrected, resume the infusion (see Section 4.3).

  • Page 50: Summary Of Operating Controls

    Sec ti on 4 • O pera ti ng I ns truct ions Summary of Operating Controls AUDIBLE ACTION STEPS TO TAKE VISUAL INDICATOR INDICATOR Review and verify While the pump is in One beep “RX” - display cycles through program setttings pause mode, press and each programmed parameter...

  • Page 51: Section 5 - Infusion History Reports

    Se ct i o n 5 • I n f usi on H i st or y R e p o rts SECTION 5 - INFUSION HISTORY REPORTS Pump Infusion History To obtain the pump infusion history: Step #1 Place the pump in pause mode. Step #2 Press and hold the BOLUS button for two seconds until one beep is heard and “HX”...

  • Page 52: Pib Mode Infusion History

    Sec ti on 5 • In f usion Hi st ory Reports 5.1.2 PIb Mode Infusion History INFUSION HISTORY VISUAL INDICATOR Current delivery mode Total volume infused in ml “ml” icon Total number of doses delivered No. icon Elapsed time (time pump has been in run mode since “hr:min”...

  • Page 53: Clearing Pump Infusion History

    Se ct i o n 5 • I n f usi on H i st or y R e p o rts Clearing Pump Infusion History. CAUTION: Do not clear the infusion history unless the pump is being used for a new patient, as doing so will allow a bolus or dose immediately, resulting in over- infusion.

  • Page 54: Section 6 - Patient Lockout

    Sec ti on 6 • P a t i ent Lock out SECTION 6 - PATIENT LOCKOUT The pump has been designed with patient lockout features: WARNING: The steps required for entering the pump’s program mode should not be revealed to the patient. This prevents unauthorized tampering with the infusion parameters, and prevents the infusion history from being cleared.

  • Page 55: To Unlock The Pump

    The clinician can now reprogram the pump, clear the history, or verify and resume the current program settings. NOTE: If a code is forgotten, contact Summit Medical Products, Inc. to obtain technical support. (See Section 13.) NOTE: The pump program must be unlocked for programming, reprogramming and clearing the infusion history.

  • Page 56: Section 7 - Alarms And Signals

    Sec ti on 7 • A l arm s and Signa ls SECTION 7 - ALARMS AND SIGNALS VISUAL AUDIBLE PRIORITY STATUS ICON COMMENTS INDICATOR INDICATOR Green run light (inside the BOLUS Pump is Periodic movement button) blinks, infusing None of the cassette gears is “ml”...
  • Page 57 Alarm icon and tubing clamp and turn “EE1,” “EE2,” off the pump. Contact “EE3,” “EE4,” Ten short High Malfunction Summit Medical “EE5,” “EE6” or beeps Products, Inc. by calling “EE7” are in the the toll-free number on display the pump.

  • Page 58: Section 8 - Troubleshooting

    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 • Verify that the cassette bottom disc has not been snapped into the cassette body.

  • Page 59: Section 9 - Specifications

    Sec ti on 9 • S pe cif ica ti ons S ect i on 9 • Spe ci f i c a tio n s SECTION 9 - SPECIFICATIONS Specifi cation Details Stroke volume bolus 50 microliters **Bolus/dose delivery rate 210 ml/hr Volumetric accuracy +/- 6%...
  • Page 60 Sec ti on 9 • S pe cif ica ti ons Specifi cation Details RUN/PAUSE button BOLUS button Operating controls Remote BOLUS switch (optional) ON/OFF twist cap Volume infused Doses delivered History reports Boluses delivered Boluses requested Elapsed time PIb+PCA Delivery profi...

  • Page 61: Section 10 - Delivery Rate Accuracy

    S ect i on 10 • D el i ver y R at e A c c u ra c y SECTION 10 - DELIVERY RATE ACCURACY The ambIT PIB pumps are pseudo-continuous, positive displacement pumps. This means ® that the pump infuses a specifi c amount of fl uid (0.050 ml) each revolution. The cassette is the pumping mechanism and the pump is the driver.

  • Page 62: Data From Volumetric Accuracy Testing

    Thus, the basal fl ow rate and bolus/dose amounts should always be set at the lowest amount required to achieve the desired effect. Based on the volumetric accuracy testing carried out, as described above, the ambIT ®...
  • Page 63 As the time interval increases, short term fl uctuations have little effect on accuracy as represented by the narrower portion of the trumpet curve. The user is directed to these graphs in order to be aware of the delivery profi le of the ambIT ®...
  • Page 64 Sec ti on 1 0 • De liv ery Ra te A cc ura cy 20 ml/hr fl ow 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...
  • Page 65 S ect i on 10 • D el i ver y R at e A c c u ra 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...
  • Page 66 Sec ti on 1 0 • De liv ery Ra te A cc ura cy 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 67: Section 11 - General Care Instructions

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

  • Page 68: Cleaning And Disinfecting Instructions

    Sec ti on 11 • G e ne ral Car e I ns truct ions 11.2 Cleaning and Disinfecting Instructions Step #1 Dampen a clean rag or paper towel with any household cleaners such as: • A fresh solution of one (1) part household bleach to nine (9) parts water; •...

  • Page 69: Section 12 - Electromagnetic Immunity (Emc)

    BOLUS switch connector should only be used with ® the Summit Medical remote BOLUS switch. Use of any remote BOLUS switch other than the approved ambIT PCA remote BOLUS switch manufactured by Summit Medical Products, Inc.
  • Page 70 Sec ti on 1 2 • E l e ct rom agnet ic Im mu ni ty (E MC ) Table 12-1. Electromagnetic immunity levels tested and passed by ambIT pump. ® Phenomenon Basic EMC Standard Or Test Immunity Test Levels Method ±2, 4, 6, 8 kV contact...

  • Page 71: Section 13 - Customer Assistance

    S ect i on 13 • C ust o mer A ss is t a n c e SECTION 13 - CUSTOMER ASSISTANCE For customer assistance, please contact your ambIT distributor, or Summit Medical Products, ® Inc. at: Summit Medical Products, Inc.
  • Page 72 Infusion Pump is a trademark of: ® finding better ways to care for people™ 63082.07 (05/19)

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