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Ipump Pain Management System Operator’s Manual

10-1

CD07-19-E4-766

Chapter 10. Electromagnetic Compatibility Statement

This statement and the information provided in the following tables are required by IEC 60601-1-2, second
edition. The tables can be used to identify the EMC standards Ipump Pain Management System (hereinafter
referred to as the “pump”) was subjected to, the minimum test level identified in the standard, the level that
the pump meets, and general guidance on the EMC environment. The pump is intended for use in the
electromagnetic environment specified in the following tables. As with most microprocessor-based electronic
products, the pump creates RF (radio frequency) energy as a side effect of its internal functions.

Precautions should be taken to avoid exposing the pump to powerful sources of electromagnetic radiation
such as MRI (magnetic resonance imaging) and ESU (electro-surgical equipment).

Note:

Portable and mobile communications equipment such as cell phones can affect medical electrical equipment such

as the pump.

Oct02_0719E4766.book Page 1 Friday, August 3, 2007 1:46 PM

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Summary of Contents for 2L3107

Page 1: ...O p e r a t o r s M a n u a l Oct02_0719E4766 book Page 1 Friday August 3 2007 1 46 PM ...

Page 2: ...Oct02_0719E4766 book Page 2 Friday August 3 2007 1 46 PM ...

Page 3: ...rator s Manual Appendix A Product Code 2L3107 2L3107K Software Versions 2 03 00 Note Before operating this pump the user should carefully read this manual to fully understand how the pump functions and to ensure its safe and proper operation Oct02_0719E4766 book Page i Friday August 3 2007 1 46 PM ...

Page 4: ...ts reserved For use only by Baxter Healthcare Corporation The software contains proprietary information belonging to Baxter Healthcare Corporation The software must not be reproduced or disclosed to others without prior written approval Any unauthorized use of this information may subject the user to substantial liability Documentation Copyrights Duplication or distribution of this manual and any ...

Page 5: ...ormation Baxter the Baxter wordmark Ipump Viaflex and IntraVia are trademarks of Baxter International Inc TOR and Hi TOR are trademarks of Huntington Professional Products LpH and Septisol are trademarks of STERIS Corporation Super Edisonite is a trademark of Colgate Palmolive Co Other product names appearing in this manual are the property of their respective owners Year 2000 Compliance This prod...

Page 6: ... for use with the Ipump Pain Management System Baxter s warranty to repair or replace the product will be null and void if this product is used contrary to the directions for use contained in the labeling Baxter will assume no responsibility for incidents that may occur if the product is not used in accordance with product labeling THERE ARE NO OTHER WARRANTIES INCLUDING ANY IMPLIED WARRANTY AND A...

Page 7: ...mpatibility EMC requirements are part of the essential requirements of the MDD Device Ipump Pain Management System Catalog Number xxxxx 2L3107K Manufacturer Manufactured by an affiliate of Baxter Healthcare Corporation Deerfield IL 60015 USA Made in Singapore Authorized Baxter S A representative B 7860 Lessines Belgium 0123 REF EC REP Oct02_0719E4766 book Page v Friday August 3 2007 1 46 PM ...

Page 8: ...Ipump Pain Management System Operator s Manual vi CD07 19 E4 766 Oct02_0719E4766 book Page vi Friday August 3 2007 1 46 PM ...

Page 9: ...erview 1 1 Key Features 1 1 Programming Options 1 2 Record Management 1 2 Security 1 3 Organization of This Manual 1 3 Safety Summary 1 5 General Information 1 5 Serial Number Format 1 6 Label Symbol Definitions 1 7 Definitions 1 9 Warnings 1 9 Cautions 1 13 Notes 1 15 Oct02_0719E4766 book Page vii Friday August 3 2007 1 46 PM ...

Page 10: ... Chapter 3 Setting Up the Pump Installing and Changing the Battery 3 2 Install the 9 volt Alkaline Battery 3 2 Change the Battery 3 4 Connecting the AC Adapter 3 5 Connecting the PCA Cord 3 7 Unlocking and Opening the Cover 3 10 Removing or Changing the Cover 3 10 Preparing Loading and Changing the Tubing Set and Fluid Bag 3 13 Loading the Tubing Set 3 14 Filling and Loading the Fluid Bag 3 16 Oct...

Page 11: ...nfigurable Options Chapter 5 Using the Pump Preliminary Information 5 2 Select Settings and Enter Values 5 2 Turn on the Back Light 5 3 Retain Programming Data 5 3 Display the Power Status 5 3 Basic Pump Procedures 5 4 Turn On the Pump 5 5 Turn Off the Pump 5 6 Select the Language 5 7 Accept or Modify Date and Time Settings 5 8 Unlock and Lock the Cover 5 10 Enter the Security Code 5 11 Oct02_0719...

Page 12: ...rogramming the Prescription 5 19 Programming the PCA Dose 5 20 Setting the PCA Delay Period 5 21 Programming the Basal Rate 5 22 Setting the Dose Limit 5 23 Programming the Continuous Rate 5 25 Programming the Bolus Dose 5 26 Programming a Supplemental Clinician Bolus 5 28 Starting Stopping Restarting the Infusion 5 31 Starting the Infusion 5 31 Stopping the Infusion 5 32 Sleep Mode Option 5 32 Oc...

Page 13: ...tory 5 39 View a Patient s History 5 40 History Not Available Message 5 49 Optional History Printout 5 49 Chapter 6 Alerts and Alarms Alerts 6 1 Alarms 6 10 Chapter 7 Preventive Maintenance Authorized Service Centers 7 1 Cleaning the Pump 7 1 Cleaning the Carrying Case 7 1 Preventive Maintenance Checklist 7 4 Transporting and Storing the Pump 7 5 Repair and Troubleshooting 7 6 Oct02_0719E4766 book...

Page 14: ...Flow Rate Accuracy of the System 9 5 Startup Graph Description 9 6 How Trumpet Graphs are Interpreted 9 7 How Trumpet Graphs are Created 9 8 How Trumpet Graphs Can be Used 9 9 Startup and Trumpet Graphs at 0 1 mL hr 9 10 Startup and Trumpet Graphs at 3 0 mL hr 9 11 List of Materials 9 12 Chapter 10 Electromagnetic Compatibility Statement Glossary Index Oct02_0719E4766 book Page xii Friday August 3...

Page 15: ... battery operated for portability or connected to an AC power source for stationary use A specially designed optional locking pole mounting clamp allows the pump to be attached to a standard IV pole With the pole clamp removed the pump can be placed into a comfortable carrying case Key Features The pump s key features include Q Air sensor Q Preventive maintenance alert Q Multilanguage interface Q ...

Page 16: ... analgesic medications on an as needed basis The Basal PCA programming option combines this patient controlled method with a minimum continuous dose Record Management The pump tracks the programming time and history of each infusion All of this data is retained in the memory of the pump s microprocessor when the pump is off The pump is equipped with a real time clock that provides the correct date...

Page 17: ...configured to require only the entry of a security code the cover that holds the IV bag is optional Note Use of security features such as KEY CODE should be governed by individual care site policies and regulations regard ing the use of controlled substances Organization of This Manual This manual is designed for use by trained health care professionals WARNING This manual is intended for clinicia...

Page 18: ...g a patient s prescription history Q Chapter 6 Alerts and Alarms provides an alphanumeric list of the alert and alarm messages that may occur and how to resolve them Q Chapter 7 Preventive Maintenance contains references on conducting functional checks and storage procedures and authorized service center contacts Q Chapter 8 Accessories Disposables and Recommended Sets contains a list of accessori...

Page 19: ... electric shock fire and mechanical hazards only in accordance with UL 2601 1 UL 60601 1 Second edition and CAN CSA C22 2 No 601 1 In accordance with these documents and in accordance with international standard IEC 60601 1 1988 12 Medical Electrical Equipment Part 1 General Requirements for Safety the pump is classified as Q Class II internally powered Q Type CF Q Drip proof IPX1 Q Not suitable f...

Page 20: ...uirements in the Collateral Standard IEC 60601 2 24 First Edition 1998 02 Medical Electrical Equipment Part 2 24 Particular Requirements for the Safety of Infusion Pumps and Controllers When disposing of this device or the sets designed for use with the device follow local regulations and guidelines Serial Number Format 10090343AL Sequential Number Product Identifier Year of Manufacture 11 2001 9 ...

Page 21: ...ction port for the AC to DC converter adapter This product is classified by Underwriters Laboratories Inc with respect to electric shock fire and mechanical hazards only in accordance with UL 2601 1 UL 60601 1 Second edition and CAN CSA C22 2 No 601 1 The symbol of conformity to the Council directive 93 42 EEC EU Authorized Representative Baxter S A B 7860 Lessines Belgium CAUTION Consult Accompan...

Page 22: ...disposal ensure the following Do not dispose of this product as unsorted municipal waste Collect this product separately Use collection and return systems available to you Bar below bin Product distributed after August 13 2005 For more information on return recovery or recycling of this product please contact your local Baxter representative Manufacturer Authorized Representative in the European C...

Page 23: ... the pump s security codes to patients WARNING The pump has been configured with factory defaults Please verify the appropriateness of the pump configuration for your institution prior to initial use See Configurable Options 4 1 for more details WARNING Baxter will assume no responsibility for incidents that may occur if the product is not used in accordance with product labeling WARNING Always re...

Page 24: ...thdraw up to 0 03 mL of fluid and subsequently deliver up to 0 09 mL of fluid at the end of the test period If these volumes are clinically significant for the patient please take appropriate measures See Upstream Occlusion Testing 5 18 for more details WARNING When infusing at low flow rates less than 0 5 mL hr the pump may not detect air in the tubing In addition when infusing at low flow rates ...

Page 25: ...tration sets incorporating injection sites during epidural delivery Q It is strongly recommended that the pumps programmed for epidural drug delivery be clearly differentiated from those programmed for other routes of administration WARNING Hospital protocol for the management of high alert medications must be followed with this device WARNING To help prevent medication errors Baxter recommends th...

Page 26: ...ers filters or intra arterial infusion The pump is designed to stop fluid flow when an alarm occurs but it is neither designed nor intended to detect infiltrations and will not alarm under infiltration conditions WARNING This pump should be used only with the Baxter accessories specified for it There are risks associated with using anything other than the recommended accessories with this pump Acc...

Page 27: ...r If occlusion alarms continue contact your nearest authorized service center CAUTION Do not use sharp objects to press keys CAUTION The time to detect occlusions increases proportionally with a decrease in flow rates At flow rates below 0 5 mL hr an occlusion may not be detected Baxter recommends that extra care be taken to ensure that neither the tubing nor the bag are pinched twisted or occlude...

Page 28: ... may lead to reduced safety levels of the resulting system Consideration relating to accessory choice shall also include the use of the accessory in the patient vicinity and evidence that the safety certification of the accessory has been performed in accordance with the appropriate UL2601 1 UL 60601 1 or IEC 60601 1 and or IEC 60601 1 1 harmonized national standard CAUTION Use this product for it...

Page 29: ... this device to Baxter Q Report the device s purchase receipt in trade return after sale loss destruction or retirement Q If this is an initial purchase from Baxter returning a signed copy of the packing list to Baxter will fulfill this request Contact your local Baxter service facility for additional information Note No natural latex was used in the manufacture of this pump CAUTION When attaching...

Page 30: ...Ipump Pain Management System Operator s Manual 1 16 CD07 19 E4 766 Oct02_0719E4766 book Page 16 Friday August 3 2007 1 46 PM ...

Page 31: ...agement System Description This section will acquaint you with the various components of the pump including the Q Ipump Pain Management System Package Contents Q Pump Components Q Pump Key Pad Q Action Keys Q Pump Symbols Q LCD Symbols Oct02_0719E4766 book Page 1 Friday August 3 2007 1 46 PM ...

Page 32: ...h should include the Q Ipump Pain Management System Q 250E Cover Q Key s Q PCA Cord and Button Q Pump Carrying Case Q Operator s Manual s Q Configuration Manual If you need to connect the pump to an electrical power source you will also need a Baxter AC adapter which is sold separately See Accessories Disposables and Recommended Sets 8 1 Oct02_0719E4766 book Page 2 Friday August 3 2007 1 46 PM ...

Page 33: ...ystem Operator s Manual 2 3 CD07 19 E4 766 PCA Cord and Button Ipump Pain Management System Carrying Case Key 250E Cover Figure 2 1 Ipump Pain Management System Package Oct02_0719E4766 book Page 3 Friday August 3 2007 1 46 PM ...

Page 34: ...mp that consists of a Q Key pad for programming Q Container cover that holds the fluid bag in place and can be locked Q Tubing door that holds the tubing in place and protects it Q Battery compartment to hold the battery Q AC Power port Q Printer port Q PCA port Oct02_0719E4766 book Page 4 Friday August 3 2007 1 46 PM ...

Page 35: ...nactivity the back light and key pad are deactivated to save energy Press any key other than the START key once to reactivate the back light and key pad then press the desired action key s Retaining Clip Enter On Off Start Stop Clear Silence History Liquid Crystal Display LCD Left Scroll and Right Arrow Keys Oct02_0719E4766 book Page 5 Friday August 3 2007 1 46 PM ...

Page 36: ...pump For more detailed information see Turn On the Pump 5 5 and Turn Off the Pump 5 6 The left and right arrow keys move the cursor on the LCD to the left and right The scroll key displays the next available option or scrolls through the digits 0 9 at the cursor s current position on the LCD Press and hold the key to increase the scrolling speed The Enter key sets the value displayed on the LCD Oc...

Page 37: ...ng the START key resumes the infusion if the condition no longer exists The STOP key must be pressed twice in 1 second to stop the operation of the pump After you press the STOP key you can press the ON OFF key to turn the pump off The History key displays the infusion history on the LCD The Clear Silence key either clears the data shown on the LCD or silences an alert or alarm signal generated by...

Page 38: ...Pain Management System Operator s Manual 2 8 CD07 19 E4 766 Alert LED Infusing LED PCA Port AC Adapter Port Printer Adapter Port Figure 2 3 Pump Labels Oct02_0719E4766 book Page 8 Friday August 3 2007 1 46 PM ...

Page 39: ...alarm The green Infusing LED flashes intermittently when the pump is operating normally The printer communication port is an RS232 compatible port connection for a printer adapter The AC adapter port is used to plug in a Baxter AC adapter approved for use with the pump The PCA port is used to connect the PCA cord which is attached to the PCA button Oct02_0719E4766 book Page 9 Friday August 3 2007 ...

Page 40: ... CD07 19 E4 766 LCD Symbols Symbol Description When the 9 volt battery appears on the screen it is the primary power source If an electrical plug is displayed the pump is powered by an AC adapter Oct02_0719E4766 book Page 10 Friday August 3 2007 1 46 PM ...

Page 41: ...attery Q Connecting the AC adapter Q Connecting the PCA cord Q Unlocking and opening the cover Q Removing or changing the cover Q Preparing loading and changing the tubing set and fluid bag Q Attaching or removing the pump from a pole optional The following sections contain step by step procedures for completing these tasks Oct02_0719E4766 book Page 1 Friday August 3 2007 1 46 PM ...

Page 42: ...rt period of time to notify the user that no power source is available To silence the chirp press the Clear Silence key Install the 9 volt Alkaline Battery 1 Open the battery compartment by sliding the battery latch door on the top of the pump in the direction of the arrow see Figure 3 1 and then lifting the latch door 2 Check the and labels inside the battery compartment to determine the correct ...

Page 43: ...ttery Insert the Battery As you insert the battery make sure that the poles are facing downward Then close the battery door securely by sliding the cover back over the battery 2 Lift up the latch door 1 Slide the battery door to the right Oct02_0719E4766 book Page 3 Friday August 3 2007 1 46 PM ...

Page 44: ...e 9 volt Alkaline Battery 3 2 Q If the pump is powered by the AC adapter you can replace the battery at any time without interrupting operation During the battery change the pump will display the PCA message and the BATTERY MISSING alert but will not interrupt service Q If the pump is battery operated and the infusion has not been started press Enter to acknowledge the alert and replace the batter...

Page 45: ...figured for upstream occlusion detection are complete If the pump is configured as CODE ONLY the SELECT ACTION options may be accessed prior to resuming the infusion press Clear Silence at the PUMP READY START OR CLEAR screen after the power on self test runs See Restarting the Infusion 5 33 for more information Note Always follow manufacturer s recommendations and applicable local regulations whe...

Page 46: ...infusion 3 Align the red dot on the connector with the red dot on the AC connector port see Figure 3 2 If these dots are not lined up the connector will not seat firmly in the port 4 Insert the AC adapter cable connector into the pump s AC port 5 To disconnect the AC adapter from the pump pull back on the connector ring to release the locking mechanism then disconnect the connector CAUTION The loc...

Page 47: ...o operate in Continuous mode The PCA button is required if the pump is programmed to operate in the PCA or Basal PCA mode with a non zero PCA dose The PCA button is not required if the pump is programmed to operate with a 0 0 mL PCA dose in the Basal PCA mode WARNING Patients receiving narcotic analgesic drugs with any patient controlled analgesia PCA pump should be instructed in the proper use of...

Page 48: ... 19 E4 766 To connect the PCA button 1 Plug the PCA cord into the PCA connector on the pump and gently press the cable into the retaining clip Figure 3 3 PCA Cord Connection Through the Retaining Clip Oct02_0719E4766 book Page 8 Friday August 3 2007 1 46 PM ...

Page 49: ...perator s Manual 3 9 CD07 19 E4 766 2 Make sure the PCA cord and plug are installed as shown in Figure 3 4 Figure 3 4 Connected PCA Cord and Plug PCA Cord Plug Retaining Clip Oct02_0719E4766 book Page 9 Friday August 3 2007 1 46 PM ...

Page 50: ...g the Cover The highest level of drug security is attained by programming the combination of KEY CODE and using the cover However if the pump is configured for CODE ONLY the cover may be removed completely 1 To remove or change the cover unlock the cover if necessary and open it as described above 2 Place the pump face down 3 Detach the cover and hinge cover if removing the 250E bag cover from the...

Page 51: ...nagement System Operator s Manual 3 11 CD07 19 E4 766 Figure 3 5 Unlocking and Opening the Pump Cover Unlock the cover Open the cover with the pump face down Oct02_0719E4766 book Page 11 Friday August 3 2007 1 46 PM ...

Page 52: ... 19 E4 766 Figure 3 6 Removing the Bag Cover Remove the three screws that secure the hinges Make sure that you line up the hinges when you reattach the fluid bag cover Hinge cover 250E bag covers only Oct02_0719E4766 book Page 12 Friday August 3 2007 1 46 PM ...

Page 53: ...lex or IntraVia containers or similar fluid bags up to 500 mL The following directions are provided to assist you in using the different types of bags in the pump These directions cover Q Loading the Tubing Set Q Filling and Loading the Fluid Bag Q Changing the Tubing Set and or Fluid Bag WARNING This pump should be used only with the Baxter accessories specified for it There are risks associated ...

Page 54: ...Ensure the sensor tab see INSET is properly positioned WARNING Only use sets manufactured by Baxter as specified in Accessories Disposables and Recommended Sets 8 1 WARNING Avoid getting any liquids on the tubing set inside the tubing door or in the tubing channel Air sensor functioning could be compromised or permanent damage may result CAUTION Ensure that the set is oriented as shown in Figure 3...

Page 55: ...sing the bag cover ensure that neither the tubing nor the bag are pinched twisted or occluded Run your fingers around the edges of the bag cover to ensure that no part of the bag or tubing is pinched in the cover Do not force the bag cover closed if it appears to be obstructed Clear any obstruction and then close the bag cover WARNING Failure to latch the tubing door properly and completely may re...

Page 56: ...Do not confuse the nonvented cap which is supplied in its own package with the cap attached to the outlet tubing The cap attached to the outlet tubing is not airtight and will not prevent fluid leakage Q Fill a sterile syringe with the solution to be placed in the bag Q Remove and discard the cap from the outlet tubing of the bag Q Connect the syringe to the female luer lock fitting on the bag s o...

Page 57: ...ented cap to the bag after the bag is filled For Baxter Viaflex IntraVia or similar spike fluid bags Q Add any additional drug diluent to the bag using a syringe and needle appropriate for the injection port of the bag Mix or shake the bag to dilute the drug and solution appropriately Q Remove all air from the bag by aspirating with the syringe and then remove the syringe Q Insert the tubing set s...

Page 58: ...roperly closed and latched 7 For Spiked Bag Set Loading Take the spiked bag and fold it about 1 3 of the way from the spike port Place the bag in the cover with the set pulling across the hinge of the pump and the spike pointing towards the lock or upper corner above the lock see Figure 3 9 For Luer Lock Bag and Set Loading Place the Luer Lock bag in the cover with the Luer Lock connector closest ...

Page 59: ...er ensure that neither the tubing nor the bag are pinched twisted or occluded Run your fingers around the edges of the bag cover to ensure that no part of the bag or tubing is pinched in the cover Do not force the bag cover closed if it appears to be obstructed Clear any obstruction and then close the bag cover Figure 3 9 Placing the Bag in the Cover Oct02_0719E4766 book Page 19 Friday August 3 20...

Page 60: ...f required see Prime the Tubing Set 5 16 4 When the pump displays the PUMP READY prompt press START to restart the infusion WARNING If the tubing is pinched by the closed tubing door resistance to flow may increase and fluid delivery to the patient may be compromised If this occurs open the bag cover reseat the tubing and check the tubing door for proper closure close the bag cover then restart th...

Page 61: ...e clamp align with the two smaller holes on the bracket 3 To keep the clamp attached to the pump insert the two enclosed screws through the clamp and into the holes in the bracket WARNING To avoid personal injury ensure that the IV pole is stable and secure Ensure that the pole can support the pump along with any other devices without tipping or falling The pole diameter should be between 1 3 and ...

Page 62: ...ing up Note The pump must be in the clamp before locking the clamp Fail ure to do so makes it possible for the pump to be removed with out using a key 5 Lock the clamp by inserting the Pole Clamp key not the Lock Box key pushing it in and rotating it clockwise to the locked position Although the clamp may be tightened when it is locked it cannot be loosened enough to remove it Figure 3 11 Locking ...

Page 63: ...ting it counter clockwise to the unlocked position 2 If the clamp has not been screwed onto the pump slide the pump up and out of the clamp to remove the pump from the clamp If the clamp has been screwed onto the pump loosen the clamp by turning the knob counter clockwise to remove both the clamp and the pump from the pole Figure 3 12 Unlocking the Clamp Oct02_0719E4766 book Page 23 Friday August ...

Page 64: ...Ipump Pain Management System Operator s Manual 3 24 CD07 19 E4 766 Oct02_0719E4766 book Page 24 Friday August 3 2007 1 46 PM ...

Page 65: ...d as Q Preferences for a particular language date format clock type decimal mark security method security code and identification label see Configurable Options Preferences 4 2 Q Limits for the infusion mode units dose limit type max maximum PCA dose max continuous rate and max bolus dose see Configurable Options Limits 4 4 Q Controls for restarting the pump after the bolus and setting the alert s...

Page 66: ...e 4 1 Configurable Options Preferences Preferences Available Settings Factory Settings Language ENGLISH SPANISH FRENCH JAPANESE GERMAN DANISH SWEDISH ITALIAN NONE NONE Date Format MM DD YY DD MM YY YY MM DD MM DD YY Oct02_0719E4766 book Page 2 Friday August 3 2007 1 46 PM ...

Page 67: ...used in countries that use decimal points instead of commas POINT decimal point COMMA POINT decimal point Security Method This setting determines the security requirements for operating the pump KEY CODE CODE ONLY KEY ONLY KEY CODE Security Code 001 999 123 Table 4 1 Configurable Options Preferences continued Preferences Available Settings Factory Settings Oct02_0719E4766 book Page 3 Friday August...

Page 68: ... and characters and accents for specific languages such as Japanese characters German Ä Ö Ü the Danish Ä Å Ö and the Spanish Ñ None Table 4 2 Configurable Options Limits Limits Available Settings Factory Settings Infusion Modes PCA Basal PCA Continuous All modes enabled Table 4 1 Configurable Options Preferences continued Preferences Available Settings Factory Settings Oct02_0719E4766 book Page 4 ...

Page 69: ...OUR PCA DOSES HR 1 HOUR Maximum PCA Dose 0 2 to 9 9 mL 9 9 mL Maximum Basal Rate 0 2 to 19 9 mL hr 9 9 mL hr Maximum Continuous Rate 0 2 to 90 0 mL hr 19 9 mL hr Maximum Bolus Dose 0 2 to 49 9 mL 9 9 mL Table 4 2 Configurable Options Limits continued Limits Available Settings Factory Settings Oct02_0719E4766 book Page 5 Friday August 3 2007 1 46 PM ...

Page 70: ...us This setting determines whether the pump will begin infusion automatically after completing initial bolus delivery or whether the operator must press START to begin infusion AUTO RESTART MANUAL RESTART AUTO RESTART Alert Silencing Time 2 15 30 or 60 MIN 2 MIN Low Volume Alert Time 30 60 90 or 120 MIN 120 MIN Oct02_0719E4766 book Page 6 Friday August 3 2007 1 46 PM ...

Page 71: ...entive Maintenance Alert 0 no alert to 12 MONTHS 0 no alert Upstream Occlusion Detection ON OFF ON NOTE When the pump is configured for upstream occlusion detection it continuously detects for upstream occlusions throughout an infusion This is in addition to the upstream occlusion testing performed at the start of an infusion see Upstream Occlusion Testing 5 18 Table 4 3 Configurable Options Contr...

Page 72: ...easure the accumulated amount of air detected over an amount of fluid delivered The amounts of delivered fluid depend on the programmed air bubble size The air alarm is triggered for a single air bubble greater than the set threshold or an accumulation of air greater than the threshold WARNING The air sensor detects and measures the accumulated amount of air over an amount of fluid delivered Howev...

Page 73: ... time or restarting a pump The chapter is organized as follows Q Preliminary Information Q Basic Pump Procedures Q Upstream Occlusion Testing Q Programming the Prescription Q Starting Stopping Restarting the Infusion Q Changing the Prescription During Infusion Q Reviewing the Therapy History WARNING Do not use any pump that has readily apparent defects or damage including missing or misaligned com...

Page 74: ...ed of the scrolling you can Q Press and hold key for more than 1 second to scroll at a rate of 2 characters second Q Release key and press it again to scroll at the slower rate 3 Press the Enter key to accept the selected value 4 Press the Clear Silence key to reset numerical values to zero Table 5 1 Cursor Movement Cursor Position Action far left value press the key to move wrap the to the far ri...

Page 75: ... START key will initiate a PCA dose but will not turn on the back light Retain Programming Data The pump automatically saves the prescription settings and tracking information in memory This information will not be lost if the pump is turned off If a pump is restarted the previous prescription can be accessed as described in Reviewing the Therapy History 5 37 Display the Power Status The power sta...

Page 76: ...ures apply to PCA Basal PCA and Continuous infusions The following procedures include specific instructions and examples that describe how to Q Turn On the Pump Q Turn Off the Pump Q Select the Language Q Accept or Modify Date and Time Settings Q Unlock and Lock the Cover Q Enter the Security Code Q Use the Initial Prescription Q Select the Mode and Units Q Set the Concentration Q Set the Fluid Vo...

Page 77: ...iefly If the pump fails to display the entire display screen flash both LEDs sound a brief alarm tone or fails the self test contact your nearest authorized service center see Authorized Service Centers 7 1 WARNING Do not use any pump that has readily apparent defects or damage including missing or misaligned components missing display pixels or missing audio Action Message Displayed 1 Press the O...

Page 78: ...t or print a hard copy before proceeding with this procedure See Reviewing the Therapy History 5 37 When turned back on the pump reverts back to the initial prescription programmed for that patient See Restarting the Infusion 5 33 Action Message Displayed 1 If an infusion is in progress press STOP twice within 1 second This will stop the infusion but will not turn off the pump KEY CODE or KEY ONLY...

Page 79: ...anagement System Global Configuration Manual Action Message Displayed 1 Wait for the correct language to appear on the screen Press Enter to accept the language OR Wait for the list to repeat or press the key to scroll to the correct language if you missed the required entry Example PRESS ENTER FOR ENGLISH 2 After the language has been selected the appropriate software will load The software versi...

Page 80: ...lock military time Action Message Displayed 1 Wait for the software to load When the date and time appear Press Enter to accept the values and go to the next required procedure OR Press Clear to modify the values then go to Step 2 Example US 06 30 99 08 55PM ENTER OR CLEAR Example EU 30 06 99 20 55 ENTER OR CLEAR 2 Press the or key to position the under the number that you want to change Example U...

Page 81: ...until the correct value appears OR or key to reposition the cursor OR Clear Silence key to restore the previous values Example US 10 07 99 08 35PM SET MONTH 06 30 99 08 35PM SET MONTH 06 30 99 08 35PM SET DAY 5 Repeat the preceding steps until you have set the month day year hour and minute When the values are correct press Enter UNLOCK THE COVER Action Message Displayed Oct02_0719E4766 book Page ...

Page 82: ...ER Action Message Displayed 1 Place the key inside the lock twist it one quarter turn counter clockwise and open the back cover of the pump UNLOCK THE COVER 2 When the cover is unlocked the pump displays the LOCK THE COVER prompt while sounding a repeating alert tone LOCK THE COVER 3 Lock the cover by turning the key clockwise one quarter turn Oct02_0719E4766 book Page 10 Friday August 3 2007 1 46...

Page 83: ...figuration Manual for directions on how to customize this code Action Message Displayed 1 Press the key to enter the first number of the security code for the pump 000 ENTER CODE 2 Press the key to position the under the second number 100 ENTER CODE 3 Press the key to display the second number If you make a mistake use the or keys to enter the correct value 120 ENTER CODE 4 Repeat the preceding st...

Page 84: ... unit and or bolus and then press Enter to accept the new value If NO is selected the pump will display SELECT MODE allowing you to program a new prescription Refer to page 5 13 NOTE Rx is a symbol that represents a prescription for drugs or medical devices USE INITIAL Rx NO WARNING To help prevent medication errors Baxter recommends that both the clinician programming the pump and another clinici...

Page 85: ...nter to select the current mode displayed or use the key to display the desired mode PCA BASAL PCA or CONTINUOUS then press Enter Example SELECT MODE PCA 2 Select the units currently displayed or use the key to display the required units mL mg or μg then press Enter Example SELECT UNITS mL 3 If you make a mistake press the key until the correct selection appears 4 When the correct selection is dis...

Page 86: ...oes If mL units are selected you do not have to enter a concentration Action Message Displayed 1 Use the or keys and key to set the correct concentration 00 0 mg mL SET CONC 2 If you make a mistake press the key until the correct value appears OR or key to reposition the OR Clear Silence key to reset the previous value to 0 000 μg mL SET CONC 3 Press Enter when the desired value is displayed Examp...

Page 87: ...set the fluid volume in the bag Action Message Displayed 1 Press the or key to position the 0000 mL SET FLUID VOLUME 2 Press the Clear Silence key to reset the values to zero or the previous setting If desired press the key as necessary to set the volume 3 Press the Enter key to set the value Oct02_0719E4766 book Page 15 Friday August 3 2007 1 46 PM ...

Page 88: ...e pump is priming the tubing set the air in tubing alarm is disabled Note To skip priming press Enter However if air is detected in the tubing set during the upstream occlusion test at the start of the infusion the operator will be required to prime the tubing set at that time See Upstream Occlusion Testing 5 18 WARNING The tubing set MUST NOT be connected to the patient while priming Action Messa...

Page 89: ...OCEED prompt START TO PRIME ENTER TO PROCEED 5 Repeat priming as many times as necessary until the tubing set is fully primed NOTE After 10 priming steps that is when 5 mL is delivered the clinician must enter the security code or use the key to demonstrate authority to use the pump 6 Press Enter to continue prescription entry Action Message Displayed Oct02_0719E4766 book Page 17 Friday August 3 2...

Page 90: ...there is a kink or block age during the Upstream Occlusion Test See Maximum Infusion Pressure Generated on page 9 2 If no upstream occlusion is detected the pump passes the test and the infusion or bolus if one is programmed will begin automatically If an upstream occlusion is detected during the test the UPSTREAM OCCLUSION alarm is triggered See Table 6 2 Alarm Messages and Responses on page 6 18...

Page 91: ...Dose Q Setting the PCA Delay Period Q Programming the Basal Rate Q Setting the Dose Limit Q Programming the Continuous Rate Q Programming the Bolus Dose Q Programming a Supplemental Clinician Bolus All of the units presented in this section are provided only as examples The actual units displayed are determined by the selected programming units mL mg or μg If the initial prescription settings are ...

Page 92: ...drug to be delivered when requested by the patient Note The pump produces an audible tone whenever the PCA button is pressed Action Message Displayed 1 Use the and keys and to program the PCA dose 0 0 mL SET PCA DOSE 2 If necessary press the Clear Silence key to reset the displayed value to zero 3 Press Enter when the desired value is displayed Oct02_0719E4766 book Page 20 Friday August 3 2007 1 4...

Page 93: ... period another PCA dose may not be started even if a PCA dose is interrupted Important The delay time must elapse before a patient attempt will result in an injection whether or not a bolus dose was given This delay allows any bolus to take effect before allowing an injection Action Message Displayed 1 Use the and keys and to set the PCA delay period 000 MINUTES SET DELAY 2 If necessary press the...

Page 94: ...amming a PCA or Continuous prescription Action Message Displayed 1 Use the and keys and to program the basal rate 000 00 mg hr SET BASAL RATE 2 If necessary press the Clear Silence key to reset the displayed value to zero 3 Press Enter when the desired value is displayed Oct02_0719E4766 book Page 22 Friday August 3 2007 1 46 PM ...

Page 95: ...e that was stopped before the delivery was completed will be counted towards the dose per hour limit in the new time period Action Message Displayed 1 Use the and keys and to set the dose limit NOTE The maximum 1 and 4 hour limit that can be programmed is the total amount of medication called for in the programmed prescription The minimum 1 and 4 hour limit for a Basal PCA prescription is a factor...

Page 96: ... Manual 5 24 CD07 19 E4 766 3 Press Enter when the desired value is displayed Example 010 0 mg SET 1 HR LIMIT 010 00 mg SET 4 HR LIMIT 01 SET MAX PCA DOSES HR Action Message Displayed Oct02_0719E4766 book Page 24 Friday August 3 2007 1 46 PM ...

Page 97: ...ming a PCA or Basal PCA prescription Action Message Displayed 1 Use the and keys and to program the continuous rate 000 00 mg hr SET CONTINUOUS RATE 2 If necessary press the Clear Silence key to reset the displayed value to zero 3 Press Enter when the desired value is displayed Oct02_0719E4766 book Page 25 Friday August 3 2007 1 46 PM ...

Page 98: ...rogrammed bolus dose has not been started the pump will display the programmed dosage instead of zeroes Action Message Displayed 1 Use the and keys and to program the bolus dose NOTE If no bolus is desired enter zero 0000 0 mg SET BOLUS 2 If necessary press the Clear Silence key to reset the displayed value to zero 3 Press Enter when the desired value is displayed 0100 0 mg SET BOLUS 4 Connect the...

Page 99: ...infusing until it has successfully passed the upstream occlusion test If an UPSTREAM OCCLUSION or SET NOT PRIMED alarm occurs the test must be repeated until it passes successfully See Table 6 2 Alarm Messages and Responses on pages 6 18 and 6 15 for more information TESTING UP OCCLUSION Example BOLUS INFUSING 1000 0 mg 6 Wait until the bolus delivery is completed or press STOP twice in 1 second t...

Page 100: ...fusion or bolus KEY CODE or KEY ONLY PUMP READY PRESS START CODE ONLY PUMP READY START OR CLEAR 2 If the pump is configured as KEY CODE or KEY ONLY unlock and lock the fluid bag cover If the pump is configured as CODE ONLY press Clear Silence If the pump is configured as KEY CODE or CODE ONLY enter the correct security code at the ENTER CODE OR START prompt and press Enter PUMP READY PRESS START P...

Page 101: ...played 00 0 mL SET BOLUS 5 Press Enter to review or change the prescription See Review the Prescription 5 37 or Changing the Prescription During Infusion 5 35 OR Press START to begin infusing the supplemental clinician bolus START BEGINS Rx ENTER REVIEWS Rx 6 If you pressed START the pump resumes the infusion and displays BOLUS INFUSING The bolus delivery will continue until the bolus dose is deli...

Page 102: ...plays a BOLUS DONE message Example BOLUS DONE 002 0 mg 8 Press START to resume the infusion NOTE If the pump configuration specifies automatic start after bolus infusion will resume automatically in approximately 10 seconds PCA BASAL PCA Action Message Displayed Oct02_0719E4766 book Page 30 Friday August 3 2007 1 46 PM ...

Page 103: ...es green NOTE The pump will not begin infusing until it has successfully passed the upstream occlusion test If an UPSTREAM OCCLUSION or SET NOT PRIMED alarm occurs the test must be repeated until it passes successfully See Table 6 2 Alarm Messages and Responses on pages 6 18 and 6 15 for more information NOTE If the pump is configured for an automatic start after bolus the infusion will begin imme...

Page 104: ...f the pump and then slide the battery back into the compartment 3 Close the battery compartment door 4 Press Clear Silence to silence the alert sound 5 To resume the current infusion open the battery compartment door and remove the battery 6 Insert the battery with the and poles properly facing into the pump and then slide the battery back into the compartment 7 Close the battery compartment door ...

Page 105: ...ons If the pump is configured as CODE ONLY press START to restart the infusion or press Clear Silence to access the SELECT ACTION options If the pump is configured as KEY CODE or CODE ONLY at the ENTER CODE OR START prompt press START to restart the infusion or enter the correct security code and press Enter to access the SELECT ACTION options PUMP READY PRESS START PUMP READY START OR CLEAR 000 E...

Page 106: ...e fluid bag OR SET BOLUS to program a supplemental clinician bolus dose See Programming a Supplemental Clinician Bolus 5 28 OR CHANGE Rx to modify the prescription See Changing the Prescription During Infusion 5 35 OR START INFUSION to restart the infusion SELECT ACTION FLUID VOLUME SELECT ACTION SET BOLUS SELECT ACTION CHANGE Rx SELECT ACTION START INFUSION Action Message Displayed Oct02_0719E476...

Page 107: ... can review and record the history data on the patient s chart or print a hard copy before proceeding with this procedure See Reviewing the Therapy History 5 37 To program a supplemental clinician bolus see Programming a Supplemental Clinician Bolus 5 28 Action Message Displayed 1 Press STOP twice to interrupt the infusion or bolus KEY CODE or KEY ONLY PUMP READY PRESS START CODE ONLY PUMP READY S...

Page 108: ...ty code at the ENTER CODE OR START prompt and press Enter PUMP READY PRESS START PUMP READY START OR CLEAR 000 ENTER CODE OR START 3 At the SELECT ACTION prompt use the key to display the CHANGE Rx prompt then press Enter SELECT ACTION CHANGE Rx 4 Use the and keys and to program the new prescription See Programming the Prescription 5 19 5 Press START to begin the infusion START BEGINS Rx ENTER REV...

Page 109: ...ge Q Optional History Printout All of the totals displayed reflect current information at the time that they are displayed The date and time formats are determined by the configuration of the pump and the units displayed are the programmed units in mL mg or μg Review the Prescription To review a prescription you can view the patient s prescription details as described in View a Patient s History 5...

Page 110: ...eview the prescription The messages displayed will vary depending upon whether a prescription has been started If a prescription has not been started the pump will prompt you to begin the steps for setting up the pump for use See Select the Mode and Units 5 13 If a prescription has been started you can stop the pump and review or change the prescription that was previously programmed See Changing ...

Page 111: ...ERAPY STARTED PRESCRIPTION DETAILS advance to HOURLY HISTORY scroll through the prescription detail screen by screen return to SHIFT HISTORY HOURLY HISTORY advance to EVENT HISTORY scroll through the hourly history screen by screen return to PRESCRIPTION DETAILS EVENT HISTORY advance to END OF HISTORY scroll through the event history screen by screen return to HOURLY HISTORY END OF HISTORY Not app...

Page 112: ...ars on the screen Go to Step 4 3 If a patient s history is not available see History Not Available Message 5 49 Note Pressing Enter at the REVIEW HISTORY or PRESS ENTER message clears the history PUMP READY PRESS START PUMP READY START OR CLEAR REVIEW HISTORY OR PRESS ENTER ENTER CODE ENTER CODE OR START USE INITIAL Rx YES NOTE Several date time format options are available for the pump see Config...

Page 113: ...ry review screens 4 2 Press the key to go back to the previous history screen or the start of the previous group of screens 4 3 Press to proceed to the SHIFT HISTORY group messages 4 4 Press the History key again to exit the history review at any time Example THERAPY STARTED 03 10 99 08 11AM 5 As you scroll the following messages are displayed 5 1 TOTAL GIVEN including any PCA BASAL PCA CONTINUOUS...

Page 114: ...an occur when a dose is interrupted by an occlusion or when the dose is interrupted because the 1 hour limit or 4 hour limit has been reached Example 0008 TOTAL INJ 0010 TOTAL ATT 5 3 For bolus infusions the total of the initial and supplemental clinician bolus infusions Example 0012 0 mL BOLUS INFUSED 5 4 The FLUID VOLUME REMAINING Example 0039 3 mL FLUID VOLUME REMAINING Action Message Displayed...

Page 115: ...ormation you can delete the data and initiate a new shift At the SHIFT HISTORY message 6 1 Press the key to scroll through the history review screens 6 2 Press the key to go back to the previous history screen or group of screens 6 3 Press the History key again to exit the history review at any time 6 4 Press to proceed to the PRESCRIPTION DETAILS group messages SHIFT HISTORY Action Message Displa...

Page 116: ...4 TOTAL ATT 7 3 The Shift Total for any PCA Basal PCA Continuous or bolus infusions Example 0031 5 mL SHIFT TOTAL 8 After you view the SHIFT TOTAL screen you may as an option choose to 8 1 Press Clear Silence to clear the totals and begin a new shift 8 2 Wait for the INITIAL SETTINGS of the prescription to appear on the screen SHIFT TOTALS CLEARED NOTE Pressing Clear Silence will reset the total i...

Page 117: ...r press to proceed to the HOURLY HISTORY group messages PRESCRIPTION DETAILS 9 1 Concentration Example 05 0 mg mL CONCENTRATION 9 2 Dose Example 6 0 mg PCA DOSE 9 3 Delay Example 003 MINUTES DELAY 9 4 Rate settings Example 004 00 mg hr BASAL RATE Action Message Displayed Oct02_0719E4766 book Page 45 Friday August 3 2007 1 46 PM ...

Page 118: ...mple 11 30 12 00AM 10 2 The number of PCA doses administered and the number requested during the hourly period Example 0004 INJECTIONS 0004 ATTEMPTS 10 3 The cumulative total infused at the end of the hourly period including any bolus PCA and Basal PCA infusions Example 0031 5 mL GIVEN AS OF 12 00AM 11 The EVENT HISTORY group displays a chronological list of events that occurred during the therapy...

Page 119: ... 03 17 99 12 15PM 12 2 Date and time infusion was started Example START INFUSION 03 17 99 01 20PM 12 3 Date and time infusion was stopped Example STOP INFUSION 03 18 99 02 20PM 12 4 Date and time bolus was started Example START BOLUS 03 17 99 12 20AM 12 5 Total bolus infused Example 008 0 mg BOLUS DONE Action Message Displayed Oct02_0719E4766 book Page 47 Friday August 3 2007 1 46 PM ...

Page 120: ...f alarm Example AIR IN TUBING 03 17 99 09 30AM 12 8 Change to prescription value NOTE This information is only displayed in the printout of the Patient History See Optional History Printout 5 49 12 9 Date and time when the infusion ended Example THERAPY ENDED AT 03 17 99 09 30AM 12 10 End of the patient s history review END OF HISTORY Action Message Displayed Oct02_0719E4766 book Page 48 Friday Au...

Page 121: ... modified Optional History Printout The therapy history data can be printed using an optional printer and printer adapter Some information such as changes made to prescription values can only be viewed in a printout Contact your local Baxter Service Center for details Note DO NOT connect the printer adapter and printer to the pump while the pump is infusing Note Make sure the printer adapter conta...

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Page 123: ...tention because it stops the infusion Alerts and alarms are indicated by Q Flashing red Alert LED indicator Q Audible tone consisting of a single or repeating tone of one long beep followed by three short beeps Q Screen message that describes the cause of the alert or alarm Note If the pump is battery operated the alert or alarm message will not be displayed until you press a key Alerts Alert mess...

Page 124: ...t parameters have been entered Evaluate the current prescription Infusion and or availability of PCA as programmed will resume when the 1 hour period expires 3 If the patient requires an additional drug dosage after the infusion has been interrupted by the 1 hour limit then Q administer a bolus dose see Programming the Bolus Dose 5 26 or Q reprogram an increased 1 hour limit If the 1 hour limit is...

Page 125: ...nd or availability of PCA as programmed will resume when the 4 hour period expires 3 If the patient requires an additional drug dosage after the infusion has been interrupted by the 4 hour limit then Q administer a bolus dose see Programming the Bolus Dose 5 26 or Q reprogram an increased 4 hour limit If the 4 hour limit is reprogrammed the pump starts a new 4 hour accounting period Changes to oth...

Page 126: ...mp will continue to operate on battery power if the AC adapter fails If the battery power is low the AC ADAPTER FAILURE condition could become an ALARM and stop the infusion Action 1 Make sure the AC adapter is plugged into the pump and the power outlet properly 2 Try a different power outlet 3 If the alert condition persists replace the AC adapter Table 6 1 Alert Messages and Responses continued ...

Page 127: ... LOW Situation The pump has just completed the power on self test and the battery power is low Three short tones are sounded NOTE If the battery voltage reaches a low level during an infusion the BATTERY VOLTAGE IS LOW condition could become an ALARM Action 1 Press Clear Silence during the alert to silence the audio for 2 minutes regardless of the Alert Silencing Time configuration setting 2 Repla...

Page 128: ...r is less than the amount required for configured time parameters Action Prepare to replace the fluid bag if necessary LOW BATTERY Situation The battery power is low A repeating alert tone is sounded Remaining battery life is approximately 6 hours or less when running the pump at 1 mL hr Action 1 Press Clear Silence during the alert to silence the audio for 60 minutes regardless of the Alert Silen...

Page 129: ... After its initial occurrence the PREVENTIVE MAINTENANCE DUE message will appear each time the pump is turned on until the preventive maintenance is reset PUMP LEFT IN CONFIG MODE Situation The configuration mode time period has elapsed Action Press Enter to cancel the alert and restart the configuration mode time period PUMP LEFT IN PROGRAMMING MODE Situation The programming mode time period has ...

Page 130: ...nearest authorized service center RELEASE PCA BUTTON Situation The PCA button has been pressed continuously for 3 minutes Action 1 Release the PCA button 2 Advise the patient to press the PCA button briefly when requesting a PCA dose 3 If this alert occurs and the PCA button is not being pressed intentionally there may be a mechanical or electronic fault in the PCA button Do not use the pump Take ...

Page 131: ... on AC and the battery power remaining is too low to power the pump This message is displayed in Run mode on the second line of the screen Action Replace the battery as described in Installing and Changing the Battery 3 2 Table 6 1 Alert Messages and Responses continued Alert Message Situation Action Oct02_0719E4766 book Page 9 Friday August 3 2007 1 46 PM ...

Page 132: ...pump may not detect all instances of micro or champagne air bubbles Situation The pump has detected air in the tubing set The infusion is stopped Action 1 Press Enter The pump will display the START TO PRIME ENTER TO PROCEED prompt WARNING The tubing set MUST NOT be connected to the patient while priming 2 Disconnect check and possibly aspirate the tubing set See Preparing Loading and Changing the...

Page 133: ...operly loaded or damaged Action 1 Ensure that the set is not damaged and is properly loaded For information on loading the tubing set refer to Preparing Loading and Changing the Tubing Set and Fluid Bag 3 13 NOTE If the tubing door is opened and closed the upstream occlusion test will run when START is pressed See Upstream Occlusion Testing 5 18 2 If the alarm condition persists a sensor failure m...

Page 134: ...ATION TIMEOUT Situation The configuration mode transfer was incomplete or was interrupted Action Press Clear Silence to cancel the alarm and return to the START TO PROCEED CLEAR TO CANCEL display COVER IS UNLOCKED Situation The cover is unlocked while the pump is active and the pump is configured for KEY CODE or KEY ONLY Action Lock the cover and press the START key to resume the infusion Table 6 ...

Page 135: ...mps or kinks are found engage the distal slide clamp before opening the tubing door to check for tubing obstructions 3 Check the injection site 4 When the pump detects that the occlusion has been cleared it will resume operation automatically or press START to resume the infusion after the occlusion has been cleared NOTE If the tubing door is opened and closed the upstream occlusion test will run ...

Page 136: ...n has been pressed continuously for 6 minutes Action 1 Release the PCA button 2 Advise the patient to press the PCA button briefly when requesting a PCA dose NOTE If this alarm occurs and the PCA button is not being pressed intentionally the PCA button may have a mechanical or electronic fault Do not use the pump Take the pump out of service and contact your nearest authorized service center Table...

Page 137: ...ed to the patient while priming 2 Press START If the pump is configured as KEY CODE or CODE ONLY enter the security code at the 000 ENTER CODE prompt and press Enter If the pump is configured as KEY ONLY unlock and lock the fluid bag cover at the UNLOCK THE COVER and LOCK THE COVER prompts Priming begins see Prime the Tubing Set 5 16 3 After the tubing set is primed press Enter for the PUMP READY ...

Page 138: ...n does not match the pump configuration Action 1 Turn off the pump and then turn it on again 2 Reconfigure the pump as described in the Ipump Pain Management System Device Configuration Manual Table 6 2 Alarm Messages and Responses continued Alarm Message Situation Action Oct02_0719E4766 book Page 16 Friday August 3 2007 1 46 PM ...

Page 139: ...agement System Service Manual Action 1 Record the system error code 2 Turn off the pump and then restart the pump 3 If no system error code is displayed continue to use the pump 4 If the same code or a new code is displayed after the restart do not use the pump Take the pump out of service and contact your nearest authorized service center Table 6 2 Alarm Messages and Responses continued Alarm Mes...

Page 140: ... for closed clamps and kinks 2 If no closed clamps or kinks are found engage the distal slide clamp before opening the tubing door to check for tubing obstructions 3 After clearing the occlusion press START to resume the infusion NOTE If the tubing door has been opened and closed or if this alarm condition occurred during the upstream occlusion test the upstream occlusion test will run before the ...

Page 141: ...hnical Services Center at 1 800 THE PUMP Outside North America visit www baxter com baxter_worldwide html or call your Baxter customer service representative to locate the nearest service center Cleaning the Pump Clean the pump and PCA button with a soft cloth sparingly dampened with any of the cleaners listed in Table 7 1 on page 7 2 Note Some of the listed cleaners may not be available at your l...

Page 142: ...s dilution instructions for concentrated cleaners Table 7 1 Recommended Cleaners Recommended Cleaner Manufacturer Cleaner Disinfectant Soapy water n a XXX A solution of 10 bleach and water n a XXX XXX LpH STERIS Corporation XXX XXX Septisol STERIS Corporation XXX XXX Super Edisonite Colgate Palmolive Co XXX TOR or Hi TOR Plus Huntington Professional Products XXX XXX Oct02_0719E4766 book Page 2 Fri...

Page 143: ...ce Center see Authorized Service Centers 7 1 WARNING Liquids must not be allowed to enter the inside of the pump through the battery compartment or through the power printer or PCA ports Liquid ingress into the pump may cause the pump to fail or operate in an unintended manner during the current or future patient use CAUTION The Ipump Pain Management System is not waterproof and should not be imme...

Page 144: ...roperly when the door is closed Labels Clean as recommended in the cleaning instructions Check for scratches cuts or obliterated words AC adapter Verify that the optional AC adapter is undamaged over the entire length of the cord and the molded plugs Cover Clean as recommended in Cleaning the Pump 7 1 Ensure that the cover is intact fits properly when closed and locked and has no obvious cracks or...

Page 145: ...ty 10 to 95 non condensing If conditions fall outside these limits Baxter recommends that the device be repackaged in the original shipping materials Note When storing the pump remove the 9 volt battery from the pump Always store the pump with the tubing door closed Functional Testing Perform as required but recommended every 6 months Check Action Entire device Schedule functional test by qualifie...

Page 146: ...n the event that your pump needs to be returned for service obtain a Return Authorization by contacting your local service center see Authorized Service Centers 7 1 Shipping costs for all pumps returned to Baxter shall be paid for by the customer The pump must be packed in its original container or in another Baxter approved container that will provide adequate protection during shipment To ensure...

Page 147: ...Component Description Product Number Bags Empty 100 mL luer lock bag 2L3256 2L3256K Empty 250 mL luer lock bag 2L3257 2L3257K Empty Non PVC IntraVia Spike Containers with PVC Ports 50 mL 150 mL 250 mL 500 mL 2B8019 2B8011 2B8012 2B8013 Viaflex Bags in the following container sizes 50 mL 100 mL 150 mL 250 mL 500 mL For specific product numbers contact your local Baxter representative to determine t...

Page 148: ...2L3511 US only 2 7 m 107 Epidural Spike Set 2L3512 2 8 m 110 Air Eliminating Spike Set 2L3513 2 7 m 106 Air Eliminating Luer Lock Set 2L3520 3 1 m 122 Epidural Spike Set for 500 mL Bag Cover 2L3522 3 1 m 123 Air Eliminating Spike Set for 500 mL Bag Cover 2L3523 2 9 m 113 Air Eliminating Spike Set with Integral Y Site 2L3525 2 8 m 110 Air Eliminating Luer Lock Set with Integral Y Site 2L3526 3 2 m ...

Page 149: ...Non locking Pole Mount Clamp optional 2L3212 Pump Carrying Case cloth 2L3219 Configuration Transfer Cable 2L3112 Locking Bag Covers 100 mL Cover 2L3218 250 mL Cover 2L3220 250E mL Cover 2L3217 500 mL Cover 2L3221 AC Adapters AC Adapter 100 120V US 2L3210 AC Adapter 220 240V UK Europe 2L3205K Table 8 1 Accessories Disposables and Recommended Sets continued Component Description Product Number Oct02...

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Page 151: ...y 140 hours Typical operating time when operating at a rate of 10 mL hr is approximately 76 hours Leakage Current Less than 0 3 mΑ earth leakage tested per UL 2601 1 AC Adapter Cord 100 120V US Approximately 1 8 m 5 9 feet long AC Adapter Cord 220 240V UK Europe Approximately 2 0 m 6 5 feet long Range of Programmable Flow Rates 0 1 to 90 0 mL hr in 0 1 mL hr increments Maximum Infusion Under Singl...

Page 152: ...arm configured for HIGH sensitivity senses approximately 0 1 mL of air Air in line alarm configured for LOW sensitivity senses approximately 0 5 mL of air Maximum Infusion Pressure Generated The maximum infusion pressure generated prior to alarm activation is 2109 mmHg 41 psi Downstream Occlusion Alarm Pressure The downstream occlusion alarm pressure threshold is 1138 517 mmHg 22 10 psi Operationa...

Page 153: ...Latched tubing door Indicators Alphanumeric description via LCD display Red Alert light Green Infusing light Audible tones Minimum audible alarm sound level 50 dBa Battery 9 volt alkaline Drive Mechanism DC Motor microprocessor controlled precision linear peristaltic pumping mechanism Printer Port 1200 Baud 8 data bits no parity and 1 stop bit Housing Shock and vibration resistant Acrylonitrile Bu...

Page 154: ...mperatures below 15 C 59 F or if cold solutions are used air sensor functionality may be compromised For maximum safety move the pump to an environment above 15 C 59 F and allow cold solutions to warm to appropriate operating temperatures before use Environmental Storage and Transport Limits unpackaged Temperature 20 C to 60 C 4 F to 140 F Humidity 10 to 95 relative humidity non condensing unpacka...

Page 155: ... Manual for information on procedures Flow Rate Accuracy of the System The Ipump Pain Management System using the appropriate Baxter administration sets as identified in Chapter 8 maintains flow rate accuracy with delivery errors not exceeding 8 at 22 C to 23 C 71 6 F to 73 4 F nominal and 10 at the temperature extremes of 10 C 50 F and 40 C 104 F Note that flow fluctuations can be caused by unusu...

Page 156: ...any manufacturer s pump may be erratic during the initial startup period Therefore we have included the startup or stabilization data It should be noted that as the time interval over which accuracy is measured is lengthened all pumps show considerable improvement in flow accuracy WARNING During upstream occlusion testing the pump may withdraw up to 0 03 mL of fluid and subsequently deliver up to ...

Page 157: ...ing intervals or observation windows As the sizes of the sampling intervals increase in minutes the deviations in flow from the programmed delivery rate are reduced as the deviations are spread out over the longer periods of time This results in the narrowing of the trumpet curve giving a more realistic representation of the device s average flow rate accuracy over longer intervals of time For exa...

Page 158: ...lected at the set flow rates over 25 hours Q Every 15 minutes the cumulative weight of the fluid is recorded Q The data from the collection period are divided into observation or time windows and the flow rate accuracy is determined for each window Q The maximum and minimum deviations from the set flow rate for various window sizes 15 60 150 330 570 and 930 minutes are plotted on a graph Q These p...

Page 159: ...alf life very small deviations in flow over the course of an infusion would be desirable to ensure that the deviations in plasma level also remained small The device s ability to deliver very closely to the programmed rate would ensure that the medication s efficacy was being maintained In this example the medical professional would be wise to select a device whose trumpet curve indicated a small ...

Page 160: ...Ipump Pain Management System Operator s Manual 9 10 CD07 19 E4 766 Startup and Trumpet Graphs at 0 1 mL hr Oct02_0719E4766 book Page 10 Friday August 3 2007 1 46 PM ...

Page 161: ...Ipump Pain Management System Operator s Manual 9 11 CD07 19 E4 766 Startup and Trumpet Graphs at 3 0 mL hr Oct02_0719E4766 book Page 11 Friday August 3 2007 1 46 PM ...

Page 162: ...f this pump Q Acrylonitrile Butadiene Styrene ABS Q Polycarbonate PC Q Acetal Polytetrafluoroethylene PTFE Q Polyester Q Nylon Q Synthetic rubber Q Brass nickel plated Q Zinc die cast Q Aluminum Q Stainless steel Q Iron chrome plated Q Polyvinyl Chloride PVC Q Polyphenyl Sulphone Oct02_0719E4766 book Page 12 Friday August 3 2007 1 46 PM ...

Page 163: ...s and general guidance on the EMC environment The pump is intended for use in the electromagnetic environment specified in the following tables As with most microprocessor based electronic products the pump creates RF radio frequency energy as a side effect of its internal functions Precautions should be taken to avoid exposing the pump to powerful sources of electromagnetic radiation such as MRI ...

Page 164: ... ESD Note Table 10 2 Guidance and Manufacturer s Declaration Electromagnetic Immunity contains additional information that is required by IEC 60601 1 2 2001 Ed 2 0 in order to use the connector testing exemption WARNING The use of accessories and cables other than those specified in the operator s manual may result in increased emissions or decreased immunity of the pump CAUTION The pump should no...

Page 165: ... CISPR 11 Group 1 The pump uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The pump is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for d...

Page 166: ...t Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV contact Floors should be wood concrete or ceramic tile If the floors are covered with synthetic material the relative humidity should be at least 30 8 kV air 8 kV air 1 Functions normally except at PRINTER COMM connector pins 15 kV air 2 Pump may stop infusing and alarm at leve...

Page 167: ...es 2 kV for power supply lines Not Applicable 3 Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Table 10 2 Guidance and Manufacturer s Declaration Electromagnetic Immunity continued ...

Page 168: ...ins power quality should be that of a typical commercial or hospital environment If the user of the pump requires continued operation during power mains interruptions it is recommended that the pump be powered from an uninterruptible power supply or a battery User should always have battery installed per operator s manual 4 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power fr...

Page 169: ... can occur in normal practice the damage that can be done to electronic components by electrostatic discharge an explanation of methods to prevent build up of electrostatic charge an explanation on why to discharge one s body to earth or a large metal object an explanation on bonding oneself by means of a wrist strap to earth prior to servicing Note 2 The pump was tested to the EMC requirements of...

Page 170: ...ent Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the pump including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF IEC 61000 4 6 3 Vrms 150 kHz TO...

Page 171: ...transmitter manufacturer and d is the recommended separation distance in meters m b Field strengths from fixed RF transmitters as determined by an electromagnetic site surveyc should be less than the compliance level in each frequency range d Interference may occur in the vicinity of equipment marked with the following symbol Pump may stop infusing and alarm at levels above 3V m Table 10 3 Guidanc...

Page 172: ... The pump was tested to the EMC requirements of IEC 60601 2 24 1998 IEC 60601 2 24 the particular standard for infusion pumps requires higher test levels a The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz Table 10 3 Guidance and Manufacturer s Declaration Electromagneti...

Page 173: ...nd mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the pump is used exceeds the applicable RF compliance level above the pump should be observed to ve...

Page 174: ...terference by main taining a minimum distance between portable and mobile RF communications equipment transmitters and the pump as recommended below according to the maximum output power of the communications equipment Rated Maximum Output Power of Transmitter W Separation Distance According to Frequency of Transmitter m 150 kHz to 80 MHz outside ISM bands d 1 2 P 150 kHz to 80 MHz in ISM bands d ...

Page 175: ...fic and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz Note 3 An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to decrease the likelihood that mobi...

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Page 177: ... LED repeating alert tone and specific message unless otherwise indicated that provides important status information or signals a condition requiring a response by the operator attempt The patient action either the depression of the PCA button or START key intended to initiate a PCA dose basal rate The programmed continuous infusion rate when the pump is operating in Basal PCA mode bolus The quant...

Page 178: ...prescription configuration and historical data delay The programmed time interval that must elapse between the start of therapy and the initial PCA dose or between the start of delivery of one PCA dose and the start of the next PCA dose Doses per Hour Limit The programmed maximum number of PCA doses that may be delivered in a one hour period event log A record of significant operator actions that ...

Page 179: ...NJ ATT shift total The total number of injections and attempts since the start of therapy or since the operator last cleared the total for the current shift LCD Liquid Crystal Display LED Light Emitting Diode mg Milligram mL Milliliter One Hour Limit The programmed maximum volume of drug that may be delivered in a one hour period operator user A professional healthcare person clinician or biomedic...

Page 180: ...urse of treatment using a programmed prescription and initiated by a START key press during which a patient may receive one or more bolus doses one or more PCA doses and or a continuous infusion therapy history A collection of data maintained in nonvolatile memory that relates to the most recent or current therapy consisting of the prescription data current alarm status and infusion totals hourly ...

Page 181: ...R 6 10 BATTERY IS DEPLETED 6 11 CHECK TUBING PLACEMENT 6 11 CODE INCORRECT 6 12 COMMUNICATION TIMEOUT 6 12 COVER IS UNLOCKED 6 12 DOWNSTREAM OCCLUSION 6 13 EMPTY 6 14 RELEASE PCA BUTTON 6 14 SET NOT PRIMED PRESS ENTER 6 15 SOFTWARE VERSION ERROR RECONFIG 6 16 SYSTEM ERROR XX SERVICE PUMP 6 17 UPSTREAM OCCLUSION 6 18 Alert LED 2 8 2 9 Alerts 6 1 1 HOUR LIMIT REACHED 6 2 4 HOUR LIMIT REACHED 6 3 AC ...

Page 182: ...enters 7 1 B back light turning on 5 3 bag carrying See carrying case bag See fluid volume Basal and PCA dosage setting 5 20 5 23 mode selection 5 13 programming a prescription 5 19 programming options 1 2 unit selection 5 13 basal rate configurable option 4 5 history 5 45 programming 5 22 5 25 basic procedures turn off the pump 5 6 turn on the pump 5 5 battery and back light 5 3 changing 3 4 comp...

Page 183: ...LUS INFUSED 5 42 BOLUS INFUSING 5 27 5 29 C carrying case 2 2 8 3 cautions defined 1 9 list of 1 13 CE Mark v CHANGE Rx 5 36 changing battery 3 4 fluid bag 3 19 prescription during infusion 5 35 tubing set 3 19 CHECK TUBING PLACEMENT 6 11 cleaning the pump 7 1 Clear Silence key 2 5 2 7 CODE INCORRECT 6 6 6 12 CODE ONLY 1 3 concentration history 5 45 setting 5 14 configurable options 4 1 Continuous...

Page 184: ...0 dose limit 1 HOUR LIMIT REACHED 6 2 4 HOUR LIMIT REACHED 6 3 configurable option 4 1 4 5 setting 5 23 DOWNSTREAM OCCLUSION 6 13 E EMPTY 6 14 ENTER CODE 5 11 5 40 ENTER CODE OR START 5 28 5 33 5 36 5 40 Enter key 2 5 2 6 entering the security code 5 11 entering values 5 2 EVENT HISTORY 5 46 F filling the fluid bag 3 16 fluid bag available for use with Ipump 8 1 filling 3 16 preparing loading and ...

Page 185: ...2 7 HISTORY NOT AVAILABLE 5 49 history printout 5 49 HOURLY HISTORY 5 46 I identification label configurable option 4 1 4 4 Infusing LED 2 8 infusion mode selection 5 13 mode configurable option 4 1 4 4 programming options 1 2 restarting 5 33 SELECT ACTION options 5 33 Initial prescription 5 12 INITIAL Rx 5 12 INJECTIONS ATTEMPTS 5 46 installing and changing the battery See battery IntraVia bags 3...

Page 186: ...THE COVER 5 10 locking the cover 5 10 LOW BATTERY 3 4 6 6 LOW VOLUME ALERT TIME 4 6 M materials 9 12 MINUTES DELAY 5 45 mode selection 5 13 mode selection See infusion mode selection N notes defined 1 9 list of 1 15 O occlusion detection configurable option 4 1 4 7 DOWNSTREAM OCCLUSION 6 13 TESTING UP OCCLUSION 5 18 UPSTREAM OCCLUSION 6 18 upstream occlusion test 5 18 ON OFF key 2 5 2 6 operationa...

Page 187: ...able option 4 1 4 7 connecting 3 7 3 8 releasing 6 8 6 14 PCA BUTTON NOT CONNECTED 3 7 6 7 PCA dose configurable option 4 1 4 5 PCA port 2 9 PERFORMING POWER ON SELF TESTS 5 5 plug display symbol 2 10 5 3 power status 5 3 pole attaching the pump 3 21 removing the pump from 3 23 port AC adapter 2 9 PCA 2 9 printer 2 9 power status 5 3 prescription changing during infusion 5 35 history 5 46 programm...

Page 188: ... upstream occlusion test 5 18 PRIMING 5 16 PRIMING TOTAL 5 17 printer adapter 8 3 printer port 2 4 2 9 printing history 5 49 product overview 1 1 programming a prescription 5 19 basal rate 5 22 5 25 bolus dose 5 26 dose limit 5 23 PCA delay period 5 21 prime the pump 5 16 set the dosage 5 20 programming data retaining 5 3 programming mode pump left in 6 7 programming options 1 2 programming timeou...

Page 189: ...starting an infusion 5 33 after alarms See Alarms after battery change 3 4 3 5 after occlusion 6 13 6 18 SELECT ACTION options 3 5 5 34 retaining clip 2 5 3 8 REVIEW HISTORY 5 37 REVIEW HISTORY OR PRESS ENTER 5 40 review prescription 5 37 right arrow key 2 5 2 6 5 2 S screen display symbols 2 10 power status 2 10 5 3 scroll key 2 5 2 6 5 2 security 1 3 code 5 11 configurable option 4 1 4 3 lock th...

Page 190: ... 20 SET THE FLUID VOLUME 5 15 SET YEAR 5 9 sets 8 1 setting date and time 5 8 setting fluid volume 5 15 setting language 5 7 setting the concentration 5 14 SHIFT HISTORY 5 43 SHIFT STARTED 5 44 SHIFT TOTAL 5 44 software loading 5 7 SOFTWARE VERSION 5 7 SOFTWARE VERSION ERROR RECONFIG 6 16 spike bags 8 1 START BEGINS Rx ENTER REVIEWS Rx 5 26 5 29 5 36 START key 2 5 2 7 START TO PRIME ENTER TO PROCE...

Page 191: ...TT 5 42 5 44 transporting the pump See preventive maintenance troubleshooting 7 6 trumpet graphs how created 9 8 interpreting 9 7 startup 9 6 using 9 9 tubing set changing 3 20 loading 3 14 preparing 3 13 turning the pump off 5 6 turning the pump on 5 5 U unit selection 5 13 units configurable option 4 1 4 5 select 5 13 setting the concentration 5 14 UNLOCK THE COVER 5 10 unlocking the cover 5 10 ...

Page 192: ...s Manual Index 12 CD07 19 E4 766 V Viaflex bags 3 13 available for use with Ipump 8 1 loading 3 17 W warnings defined 1 9 list of 1 9 WEEE defined Glossary 4 general information 1 8 Oct02_0719E4766 book Page 12 Friday August 10 2007 1 51 PM ...

Page 193: ...Oct02_0719E4766 book Page 185 Friday August 3 2007 1 46 PM ...

Page 194: ...anual was printed on paper stock created with 20 de inked post consumer waste fiber and a total of 100 recycled fiber EC REP Baxter S A B 7860 Lessines Copyright 1999 2003 2006 Baxter Healthcare Corporation All Rights Reserved Oct02_0719E4766 book Page 186 Friday August 3 2007 1 46 PM ...

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