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Related Manuals for Summit Medical ambIT
Summary of Contents for Summit Medical ambIT
- Page 1 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 Remote BOLUS Switch To solution container (optional for select models) (Side view of cassette) Cassette shaft...
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Page 3: Table Of Contents
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... - Page 4 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...
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Page 5: Section 1 - Introduction
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... -
Page 6: D Efinition Of Symbols
IE IEC symbol for “Type BF Applied Part.” ( C symbol for “Type BF Applied Part.” (IEC Classification: Internally IEC Classification: Internally powered.) powered.) T T he he ambIT® pump complies with ES 60601-1:2012, 1st Edition, ambIT® pump complies with ES 60601-1:2012, 1st Edition, including Amend. 1; CSA C22.2 NO. 60601-1:2014, 3rd Edition; IEC 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- 60601-1:2005, including Corr. 2:2007 and Amend. 1:2012; IEC 60601-1-... - Page 7 Se c t io n 1 • I n tr od u c t io n Indicates the medical device manufacturer, as defined in EU Directives Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC. 90/385/EEC, 93/42/EEC and 98/79/EC. Indicates the Authorized Representative in the European Community. Indicates the Authorized Representative in the European Community. Any natural or legal person established within the Union that places a device from a third country on the Union market.
- Page 8 Se ct i on 1 • In tr o d uctio n Sterilized using irradiation rilized using irradiation DEHP-free fluid path DEHP-free fluid path Not made with natural rubber latex t made with natural rubber latex To solution container Indicates which tubing connects to icates which tubing connects to (side view of cassette) the solution container...
- Page 9 UN/PAUSE button BOLUS button LUS button FUNCTION button FUNCTION button Low/dead battery indicator /dead battery indicator Alarm indicator Alarm indicator ambIT ambIT pump display pump display ® Pump power on p power on Pump po Pump power off wer off...
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Page 10: Warnings
Se ct i on 1 • In tr o d uctio n Pump Pump program mode program mode Review p Review pump program ump program Infusion history report Infusion history report Pump infusion history cleared 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. - Page 11 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 ®...
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Page 12: Sterile, Disposable (Single-Use) Administration Set
• 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 ®... -
Page 13: Indications For Use
The ambIT ® PreSet*PCA pump is intended to be used in the home and in healthcare facilities. The ambIT ® PreSet*PCA pump is intended to be used by patients 12 years old and above. -
Page 14: Continuous Pumps
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. -
Page 15: Infusion Patterns
Se c t io n 1 • I n tr od u c t io n 1.5 I nfusion Patterns 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. - Page 16 Se ct i on 1 • In tr o d uctio n 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. WARNING: 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.
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Page 17: 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 18: Ambit ® Cassette
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. If an ambIT cassette already has a filter, it is not recommended to use a separate NOTE: ®... - Page 19 S e c ti o n 2 • S et 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.
- Page 20 Se ct i on 2 • S et U p 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...
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Page 21: Attach Cassette To The Pump
Rotate shaft by through the wetted hydrophilic membrane). hand Due to the nature of the hydrophilic membrane, it is NOTE: important to prime the ambIT cassette without getting ® water in the filter. This will allow air to flow through very easily. Once the filter is wet, it may be more difficult to prime, because the air has a much smaller area to flow out of (air will only flow out of the smaller hydrophobic membrane). -
Page 22: Remove Cassette From The Pump
2.7 B attery Installation and Replacement The pump is powered by two (2) AA 1.5V batteries. Summit Medical Products, Inc. has not validated all types of batteries (non- NOTE: 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 battery condition and pump settings will determine how the battery will perform with regard to the pump. -
Page 23: Battery Installation
S e c ti o n 2 • S et U p 2.7.1 B attery Installation To install batteries: If the pump is in run mode, place the pump in pause mode by pushing the RUN/PAUSE button (see Section 4.2). Step #1 Rotate the battery cap counter-clockwise until the line ( I ) on the pump is slightly to the right of the OFF Remove battery battery... -
Page 24: Pump Power On And Off
Se ct i on 2 • S et U p Step #4 Rotate the battery cap clockwise to the OFF (O) position. Power on the pump according to the instructions in Section 2.8. After the batteries are replaced and the pump is powered on, the pump will return to pause mode. -
Page 25: Section 3 - Programming Instructions
Se c t ion 3 • Pr o g ra m m in g In s t ru c ti o n s SECTION 3 - PROGRAMMING INSTRUCTIONS 3.1 G eneral Information The ambIT pump must be programmed and have the history cleared before administering any ® medication or fluid. The pump has two buttons: the RUN/PAUSE button and the BOLUS or FUNCTION button. A specific combination of pressing these buttons programs the pump. -
Page 26: Ambit ® Pump User Interface
Se ct i on 3 • P r o g r amm ing Inst r u c t ions 3.2 a mbIT Pump User Interface ® The pump program is determined Cassette by selecting the desired parameters during program mode. The pump has two buttons: the RUN/PAUSE button Pump display and a BOLUS button or FUNCTION... -
Page 27: Program Options
Se c t ion 3 • Pr o g ra m m in g In s t ru c ti o n s 3.3 P rogram Options To enter program mode: Place the pump in pause mode. If the pump is not on, turn it on (see Section 2.8). Step #1 Press and hold both buttons for two seconds until one beep is heard. -
Page 28: Preset Pump Programming Options
After programming the pump, always verify the program settings by performing a program review (see Section 3.7). 3.5 PreSet Pump Programming Options The ambIT pump with preset settings has up to five (5) programs from which the clinician may ® choose. There may be up to four (4) presets (PRO1 - 4). Only the programs with presets will be available to be selected (e.g., if no parameters were selected for PRO2, it will not appear when... - Page 29 Se c t ion 3 • Pr o g ra m m in g In s t ru c ti o n s Summit Medical Products, Inc. makes multiple ambIT pumps with preset NOTE: ® settings. Each model is distinguished by a specific pump color and model number (example: Pump number 220326 is always dark gray). The preset settings for each model can be found on the label on the back of the pump.
- Page 30 Se ct i on 3 • P r o g r amm ing Inst r u c t ions 3.5.1 Programming a Preset Infusion Protocol (PRO1 - 4) AUDIBLE ACTION VISUAL INDICATOR INDICATOR “PRO” is displayed Enter program mode: for two (2) seconds to indicate that the pump From pause mode, press and hold both the RUN/ One (1) beep is in program mode.
- Page 31 Se c t ion 3 • Pr o g ra m m in g In s t ru c ti o n s 3.5.2 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 32 Se ct i on 3 • P r o g r amm ing Inst r u c t ions AUDIBLE ACTION VISUAL INDICATOR INDICATOR Set Bolus lockout time: “hr:min” icon is displayed (A) Press and release the RUN/PAUSE and the bolus, lock and clock button to increase the time or press and icons flash.
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Page 33: Pca Pump Programming Steps
Se c t ion 3 • Pr o g ra m m in g In s t ru c ti o n s 3.6 PCA Pump Programming Steps AUDIBLE ACTION VISUAL INDICATOR INDICATOR Enter program mode: “PRO” is displayed for two (2) seconds to indicate that the pump is in program From pause mode, press and hold One (1) beep... - Page 34 Se ct i on 3 • P r o g r amm ing Inst r u c t ions AUDIBLE ACTION VISUAL INDICATOR INDICATOR (C) If portions of the digits displayed are flashing, the option is available to set each digit. One (1) beep Bolus lockout time is established.
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Page 35: 3.7 Program Review
Se c t ion 3 • Pr o g ra m m in g In s t ru c ti o n s 3.7 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 36: Section 4 - Operating Instructions
Se ct i on 4 • Op er at in g In stru ct ion s SECTION 4 - OPERATING INSTRUCTIONS NOTE: Pump display may not be clearly visible in bright light. Shading the display will allow viewing of the display by the user. 4.1 S tart Infusion NOTE:... -
Page 37: Pause Infusion
Most “MA” alarms can be resolved by pressing and releasing the RUN/PAUSE NOTE: button to silence the alarm. To restart the infusion, press and release the RUN/ PAUSE button. If the alarm persists, contact Summit Medical Products, Inc. -
Page 38: Bolus Activation
Se ct i on 4 • Op er at in g In stru ct ion s 4.5 B olus Activation NOTE: Continuous pumps have a FUNCTION button instead of a BOLUS button. See Section 4.5a for Continuous pumps. The BOLUS button is located on the pump directly below the RUN/PAUSE button. -
Page 39: Summary Of Operating Controls For Continuous Pumps
S ec t io n 4 • Op e ra t in g In s t ru c ti o ns 4.6 S ummary of Operating Controls for Continuous Pumps AUDIBLE ACTION STEPS TO TAKE VISUAL INDICATOR INDICATOR Start infusion Program the pump, then press and One (1) beep Green run light (inside the release the RUN/PAUSE button. -
Page 40: Section 5 - Infusion History Reports
Se ct i on 5 • In fu sio n H istor y Re po r t 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 or FUNCTION button for two (2) seconds until one (1) beep is heard and “HX”... -
Page 41: Clearing Pump Infusion History
S e c ti on 5 • Inf u s io n H i s to ry R e p o rt s 5.2 C learing Pump Infusion History. CAUTION: Do not clear the infusion history unless the pump is being used for a new infusion or patient, as doing so will allow a bolus immediately once the infusion is started. -
Page 42: 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 43: To Unlock The Pump
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 44: 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 the BOLUS or Pump is FUNCTION button) Periodic movement of the infusing None blinks, “ml”... - Page 45 If alarm “OCL” are in the display occlusion is unable to resolve (silence) the removed alarm, contact Summit Medical Products, Inc. Immediately close the Alarm icon and “MA” Constant High Malfunction tubing clamp. See Section 8 -...
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Page 46: 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 47: Section 9 - Specifications
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 Microprocessor controlled rotary-peristaltic Maximum infusion/occlusion pressures 25 +/- 12 Psi Maximum activation time of occlusion alarm (minimum... -
Page 48: Preset And Pca Pump Specifications
Se ct i on 9 • S p ecif icat ions 9.3. PreSet and PCA Pump Specifications SPECIFICATION DETAILS Bolus delivery rate* 100 ml/hr or 125 ml/hr Basal flow rates 0 to 20 ml/hr in 0.1 ml increments Bolus volumes 0 to 20 ml in 0.1 ml increments Lockout times (hh:mm)* 00:05 to 12:00 or 00:01 to 24:00 Volumes to be infused (ml) -
Page 49: Section 10 - Delivery Rate Accuracy
S e c ti on 1 0 • D e li v e ry R a te A cc u r ac y SECTION 10 - DELIVERY RATE ACCURACY The ambIT pump is a pseudo-continuous, positive displacement pump. This means that the ®... -
Page 50: Data From Volumetric Accuracy Testing
Based on the volumetric accuracy testing carried out, as described above, the ambIT pump met ®... -
Page 51: Factors That May Affect Volumetric Accuracy
The trumpet curves are used to describe the flow rate in basal mode. The trumpet curve defines, for a programmed flow rate, the maximum and minimum percentage variation from the expected flow rate for given time intervals measured from the start-up. Over short time intervals, fluctuations in flow rate have a greater effect on accuracy as represented by the “bell” portion of the trumpet curve. As the time interval increases, short term fluctuations 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 profile of the ambIT ® pump and to ensure that the delivery profile is acceptable for the drug being infused, the drug’s concentration, and the drug’s rate of delivery. - Page 52 Se ct i on 1 0 • D elive ry Ra te Acc ur a c y Startup graph (average flow) 20 ml/hr for 24.83333333333 hours 45.0 40.0 35.0 30.0 25.0 20.0 15.0 10.0 -5.0 1000 1200 1400 1600 Observation window (min) 20 ml/hr flow rate 25.0 20.0 15.0 10.0 -5.0 EP Max EP Min...
- Page 53 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 - 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...
- Page 54 Se ct i on 1 0 • D elive ry Ra te Acc ur a c y 25 0.1 ml bolus 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 volumes 3.5%...
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Page 55: 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 56: Cleaning And Disinfecting Instructions
Se ct i on 11 • Gen er al Ca re Ins t r uc t io ns 11.2 C leaning and Disinfecting Instructions 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 57: 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, ®... - Page 58 Se ct i on 1 2 • E lec tr om agn etic Im m unit y ( EM C) 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 Electrostatic discharge IEC 61000-4-2 ±2, 4, 8, 15 kV air...
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Page 59: Section 13 - Customer Assistance
Se c t ion 1 3 • C u s t om e r A s s is t a nc e SECTION 13 - CUSTOMER ASSISTANCE For customer assistance, please contact your ambIT distributor, or Summit Medical Products, ®... - Page 60 Infusion Pump is a trademark of: ® Finding better ways to care For people™ 63076.07 (04/20)
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