EnteraLite Operator`s Manual (English)
Contents
1. 2 4 Display Segment esee 2 5 Alphanumeric Characters and Units 2 6 Setting Indicators 2 7 Run Indicator eee 2 8 Power Indicators sees 2 9 Load Tubing in Air Sensor esee 2 10 Load Tubing in Upstream Pressure Sensor 2 11 Load Tubing around Pump Wheel 2 12 Load Tubing in Downstream Pressure Sensor and Load Pinch Clip Occluder 2 13 Time Displayed Between Interval Feedings 2 14 Fuel Gauge Displays Ascending Low to High Pattern While Charging eene 2 15 Battery Power Indicator esee 3 1 Pump Label Warning eese 3 2 Pump Label Feeding Bag Connection 3 3 Pump Label Patient Connection 3 4 Pump Label Shock Hazard 7 1 Disposable Sets eese 8 1 Flow Rate Accuracy LIST OF WARNINGS and CAUTIONS A WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING Use ONLY feeding solutions prescribed by the responsible physician regis tered dietitian registered nurse or other licens2. LESS Press this key to decrease the displayed feed parameter either rate dose or feed interval Press and hold this key to decrease the value rapidly This key operates only when the pump is in pause mode CLEAR Press this key when volume or total volume is displayed to set either to zero Press this key when rate or dose is displayed to set either to its minimum value Minimum Rate 1 ml hr Minimum Dose 10 ml Press this key when FEED INTERVAL is dis played to disable interval feed operation This key operates only when the pump is in pause mode EnteraLite Light Press the key labeled EnteraLite to light the display to view in a dark room The pump will automatically turn the display light off 10 seconds after the last key is pressed The light is on constantly when the battery charger is connected between the pump and a wall outlet and the pump is turned on NOTE On early versions of the pump the display light turns off after 10 seconds even when the battery charger is connected between the pump and a live wall outlet CHAPTER 2 DIRECTIONS FOR USE The Display The pump communicates to the user through the display which includes large alphanumeric charac ters as well as smaller symbols and words All the segments and symbols in the display are shown in Figure 2 4 Important information is displayed through the large alphanumeric characters shown in Figure 2 5 When the pump displays the rate with these c
3. Accuracy Volume Delivered Volume Programmed x 100 Volume Programmed 29 CHAPTER 9 TECHNICAL INFORMATION Occlusion Pressure delivery Others won t deliver the correct dose may allow dangerous free flow conditions and may generate hazardous fluid pressures which may activate occlusion alarms at unpredictable pressures 1 WARNING Use ONLY EnteraLite Disposable Sets to ensure proper fluid The occlusion alarm pressure of the EnteraLite is 8 psi 55 kPa or 12 psi 83 kPa as set by authorized service personnel The pump produces both audible and visual alarms when the downstream fluid pressure reaches the preset limit within a 2 psi 14 kPa tolerance Battery Operation Time The EnteraLite will deliver fluid at 125 ml hr for more than 24 hours when running on a fully charged battery Adequate charge of a depleted battery is accomplished in approximately 5 hours of uninterrupted battery charge time Fluid Delivery Characteristics The EnteraLite delivers a bolus of solution at a nominal flow rate of 600 ml hr while plugged into the charger The flow rate will decrease to approximately 440 ml hr when the battery is low The minimum delivery volume is approximately 0 08 ml each frac tional turn of the pump wheel When the flow rate is set to 300 ml hr or less increments of volume are delivered once every 20 seconds At higher flow rates increments of volume are delivered once each minute Note that at very
4. E 606 S8e0 VEX EnteraLite TICS Amtitlatory E teral Feeding Pump TABLE OF CONTENTS Page LIST OF RIGU RES LIST OF WARNINGS CAUTIONS iii CHAPTER 1 GENERAL INFORMATION 1 CHAPTER 2 DIRECTIONS FOR USE 2 Pump Features 2 The Keypad 4 The Display 2 6 Preparing the Disposable Set 7 Loading the Disposable Set 8 A Single Feeding Example 10 An Interval Feeding Example 11 Charging the Battery 14 Running on Battery Power 15 CHAPTER 3 LABELS ea a a Aae ra aaan eo 17 CHAPTER 4 ALARMS and INDICATIONS eese 18 CHAPTER 5 CLEANING 21 CHAPTER 6 MAINTENANCE and CALIBRATION eene 22 CHAPTER 7 DISPOSABLE SETS and ACCESSORIES 23 CHAPTER 8 IMPORTANT PEDIATRIC CONSIDERATIONS 27 CHAPTER 9 TECHNICAL INFORMATION 29 CHAPTER 10 WARRANTY 32 CHAPTER 11 WHO TO CALL dieci eee tenait data ura 33 LIST OF FIGURES Figure Description 2 1 Pump Features Front 2 2 Pump Features Rear 2 3 Keypad Layout
5. Figure 2 5 Alphanumeric Characters and Units RATE DOSE VOLUME FEED INTERVAL Figure 2 6 Setting Indicators 7 Figure 2 7 Indicator Figure 2 8 Power Indicators CHAPTER 2 DIRECTIONS FOR USE Preparing the Disposable Set WARNING Use ONLY EnteraLite Disposable Sets to ensure proper fluid delivery Others won t deliver the correct dose may allow dangerous free flow conditions and may generate hazardous fluid pressures which may activate occlusion alarms at unpredictable pressures WARNING Use ONLY feeding solutions prescribed by the responsible physi cian registered dietitian registered nurse or other licensed practitioner Follow your health care provider s instructions regarding cleanliness in preparing the feed ing solution and the disposable set Remove the disposable set from the package Remove any plastic band around the tubing WARNING Dispose of the packaging properly The plastic bag and band could be a hazard to children Remove the Stepped Enteral Adapter cover from the pinch clip occluder to prevent solution free flow Leave the cover on the Stepped Enteral Adapter until ready to connect to the patient s enteral feeding tube If you are using the spike set with a vented bottle or a pre filled bag Insert the spike into the spike adapter of the vented bottle or the pre filled bag If you are using the 500 ml or 1200 ml disposable set Hold the bag upright an
6. Current Dose Status Accumulated Pump on or off INTERVAL FEED Interval Feed Indication Time To Next Feed Indication PROGRAM MEMORY RETAINED When Pump is on or off LIFE EXPECTANCY The pump will survive a minimum of 5 000 loadings At a typical use of 1 3 loads per day this is equiva lent to 5 10 years PRIME approximately 600 ml hr ALARMS Chek Programming error Load Set Set not loaded properly Low Batt Battery Low No Flow In Upstream occlusion No Flow Out Downstream occlusion Select 8 psi 55 kPa or 12 psi 83 kPa Tolerance 2psi 14 kPa psi pounds per square inch kPa kilopascals No Food Bag or set is empty Pump Won t Run Motor slow or jammed Push Run To Feed Pump unused for 2 minutes ERRA ERRZ Self test error DISPOSABLE SET FEATURES Automatic Anti free flow Drip Chamber Eliminated ACCESSORIES Multi purpose EnteraLite packs Multi position Pole Clamp rotatable 360 EnteraLite AC Adapter Charger WARRANTY 2 years OPERATING ENVIRONMENT specified per IEC 60601 1 Temperature 50 F to 104 F 10 C to 40 C Humidity 30 to 7596 STORAGE ENVIRONMENT Temperature 4 F to 149 F 20 C to 65 C Humidity 10 to 95 noncondensing Atmospheric pressure 700 hPa to 1060 hPa IEC 60601 1 CLASSIFICATIONS Class and Internally Powered BF Applied Part CHAPTER 2 DIRECTIONS FOR USE Pump Features Door Upstream Pressure Sensor Air Sensor Re
7. approx imately 13 Press and hold the PRIME key to rapidly fill the disposable set with fluid Release the key to stop The PRIME key operates only while the pump is in pause mode Use this key to fill the tubing set when air has been introduced into the tubing indicated by the NO FOOD alarm VOL TOTAL Press this key once to display the current volume delivered for this feed cycle Press this key again to display the total cumulative volume delivered in all feed cycles since the total volume was last cleared in this mode the display flashes TOTL then the total cumulative volume FEED INT Press this key to display the feed interval FEED INTERVAL flashes and the display indicates the number of hours in which the pump will repeat the programmed dose at the selected rate CHAPTER 2 DIRECTIONS FOR USE RATE DOSE MORE ZEVEX Enteratite mee C If the rate is displayed press this key to vou mi display the dose if the dose is dis RATE DOSE VOLUME played press this key to display the rate FEED INTERVAL amp If neither is displayed press once to dis play the rate and again to display the dose Press this key to increase the displayed ED ae S feed parameter either rate dose or feed interval Press and hold this key to increase the value rapidly This key 5 operates only when the pump is in Figure 2 3 Keypad Layout pause mode
8. Never press fingers or other objects into the cavities over the pressure sen sors Load only the silicone tubing of the disposable set into these sensors When feeding human milk fat separation may occur The feeding solution should be periodically checked during the feed regimen If the pump is dropped or falls onto a hard surface from a height of 3 feet or more it is recommended that it be returned for service CHAPTER 1 GENERAL INFORMATION WARNING U S law restricts this device to sale by or on the order of a physician registered dietitian registered nurse or other licensed practi tioner The EnteraLite is a rotary peristaltic enteral feeding pump order number Z 11583 1 designed to deliver programmed doses of enteral nutrition solutions at selectable rates This small lightweight pump operates in any orientation making it ideal for ambulatory use SIZE Pump Dimensions 4 97 H x 4 47 W x 2 00 D 13cm x 11cm W x 5 D Pump Weight 1 30 Ib 590g BATTERY Type NiMH Nickel Metal Hydride Life 24 hours 125 ml hr Charge Time approximately 5 hours see note in Chapter 2 Running on Battery Power Charge Level Indicator Compact Charger 105 to 129 VAC 60 Hz 0 22A DISPLAY Backlit LCD OPERATING ORIENTATION Any FLOW RATE Range 1 600 ml hr Increment 1 over full range Accuracy t 596 including high viscosity solutions DOSE Maximum 3000 ml Increment 10 ml VOLUME DISPLAY
9. low flow rates the pump won t deliver fluid every 20 seconds because of the minimum volume increment 1 ml hr at the minimum delivery volume of 0 08 ml means that the pump wheel must rotate only thirteen times during the hour or once every 4 to 5 minutes Amount of Air Before the Bag Is Considered Empty Generally the amount of air which must pass the air sensor before the bag is consid ered empty is 1 ml but this figure varies with battery condition it is approximately 0 5 ml when the battery is low The range of 0 5 to 1 ml relates to a bubble which is approximately 2 5 to 5 inches 6 to 13 cm in continuous length within the silicone tub ing segment of an EnteraLite Disposable Set 30 CHAPTER 9 TECHNICAL INFORMATION Power Requirements The EnteraLite AC Adapter Charger 11938 001 requires 105 to 129 VAC 60 Hz and a minimum current capacity of 0 22 Amp Output is 12 VDC and 1 5 Amp Where the integrity of the external protective conducter in the installation or its arrange ment is in doubt equipment shall be operated from its internal electrical power source The Universal AC Adapter Charger 19162 002 19162 003 19162 010 requires 100 to 240 VAC 50 60 Hz and a minimum current capacity of 0 75 Amp for 100 VAC or 0 35 Amp for 240 VAC Operational Conditions The EnteraLite is designed in accordance with IEC 60601 1 to operate in a tempera ture range of 50 F to 104 F 10 C to 40 C and in a relativ
10. mes FEED INTERVAL sage NEXT DOSE hr where the format indicates the time Figure 2 13 Time Displayed Between hours minutes until the next dose An Interval Feedings example is shown in Figure 2 13 3 59 hr equals three hours and fifty nine minutes NOTE On early versions of the pump the next dose timer is displayed using the format hr As an example 3 9 hours equals 3 hours and 54 minutes Every 0 1 hr equals 6 minutes 13 CHAPTER 2 DIRECTIONS FOR USE Charging the Battery To charge the battery insert the plug from the EnteraLite AC Adapter Charger into the match ing jack on the pump marked CHARGER Plug the charger into a wall outlet rated at 105 to 129 VAC 60 Hz 0 22A When using the international charger plug the power cord into a wall outlet rated at 100 to 250 VAC 50 60 Hz 0 39A The pump can continue to operate while charg ing the battery or charge when the pump is turned off The EnteraLite AC Adapter Charger may be left continuously connected to the wall outlet The battery charging circuit stops automatically when the battery is fully charged When the charger is plugged in and charging the plug symbol will appear in the display as shown in Figure 2 14a The fuel gauge then indicates that the battery is charging by display ing the segments in an ascending low to high pattern starting with the leftmost segment This pattern continuously repeats while
11. ATE DOSE VOLUME The rate will be displayed by the large charac FEED INTERVAL gt ters after the pump s self test Figure 2 4 Display Segments Press the MORE or LESS key to change the rate to 120 ml hr Hold down either key to change rapidly Press the RATE DOSE key to display the dose Press the MORE or LESS key until a dose of 500 is displayed The pump should stop when the dose has been deliv ered so press the FEED INT key and then press the CLEAR key This disables inter val feed operation The pump will display NONE with the large characters Prepare the disposable set and enteral feeding solution as described in CHAPTER 2 PREPARING THE DISPOSABLE SET and load the set into the pump as described in CHAPTER 2 LOADING THE DISPOSABLE SET Close the pump s door Hang the feed ing bag or container so that the bottom of the bag is at or above the level of the pump door If any of the EnteraLite packs are to be used load the pump and feeding bag into the prop er compartments securing the pump bag and tubing with the pack s straps Prime the set by pressing and holding the PRIME key until the set is filled with enteral feed ing solution approximately 13 ml Connect the stepped enteral adapter at the patient end of the set to the patient s enteral feeding tube Press the RUN PAUSE key and the pump will begin delivering fluid If you want to stop the pump at any time press the RUN PAUSE key When the dose has be
12. a generic volume accuracy calculation Accuracy Volume Delivered Volume Programmed x 100 Volume Programmed utilizing ZEVEX disposable sets fluid head height at 6 0 inches 0 3 inches 15 cm 0 75 cm with respect to the top of the pump downstream back pressure range from 1 9 psi to 5 8 psi 13 kPa to 40 kPa over the range of environmental operating conditions Specified per IEC 60601 1 Operating Temperature Range 50 F to 104 F 10 C to 40 C Operating Humidity Range 30 to 75 noncondensing Accuracy for the range of 1 to 250 ml hr is illustrated in Figure 8 1 occlusion alarm pressure of the EnteraLite is 8 psi 55 kPa or 12 psi 83 kPa as set by authorized service personnel If these specifications are consistent with the required feed regimen the EnteraLite can be used to deliver enteral formulas to pediatric patients ALWAYS VERIFY THE RATE DOSE AND FEED INTERVAL BEFORE PROCEEDING TO FEED 27 CHAPTER 8 IMPORTANT PEDIATRIC CONSIDERATIONS The EnteraLite contains safety features which reduce the incidence of free flow and over infusion When the set is improperly loaded the pump will display a LOAD SET alarm and the pump will not start Additionally the pinch clip mechanism on the set will automatically occlude the tubing when the set is removed from the pump thus preventing the possibility of free flow tery power if the overcurrent or temperature protection circ
13. approximately 1 hour of charge left based on a flow rate of 125 ml hr At higher flow rates this time will be reduced while at lower flow rates this time will increase When the battery symbol blinks the display will flash LOW BATT every 7 seconds alter nating with the active display and the pump will beep every 3 minutes to remind the user of the low battery charge condition Plug in the charger to continue to run and recharge the batteries When the battery is fully depleted the pump will turn off automatically NOTE As battery charge level decreases the pump may not be able to deliver enteral fluid at rates greater than 300 ml hr even though some battery capacity remains The pump will alarm and indicate PUMP WONT RUN or RATE TOO FAST FOR BATT If this happens either recharge the battery or select a lower rate to complete the feed cycle NOTE Some pumps contain an updated battery that can store a larger charge when charged for more than 5 hours When charged for 5 hours the first two bars will last for approximately 4 hours while the remaining two bars will last approximately 10 hours each NOTE Battery life approximation is based on a battery with full charge range charged for approximately 5 hours and a flow rate of 125 ml hr Higher flow rates will reduce battery life while lower flow rates and interval feeding will increase the battery life Also longer charging will increase battery life NOTE The battery may take long
14. available for use in various countries WARNING Do not use an extension cord with the AC Adapter Charger WARNING The AC Adapter Charger is intended for indoor dry area use only Do not allow adapter to be exposed to liquids Please contact your health care provider to obtain additional disposable sets and acces sories see CHAPTER 11 WHO TO CALL 26 CHAPTER 8 IMPORTANT PEDIATRIC CONSIDERATIONS A A WARNING Low flow rates combined with high dose settings may exceed the life of the disposable set The disposable set must be replaced every 24 hours to maintain delivery accuracy and prevent the growth of bacteria DO NOT PROGRAM RATE AND DOSE COMBINATIONS WHICH EXCEED A 24 HOUR FEED REGIMEN CAUTION When feeding human milk fat separation may occur The feed ing solution should be periodically checked during the feed regimen The EnteraLite can be used on pediatric patients provided that the specifications of the pump meet the delivery requirements of these patients Those specifications of primary importance are flow rate range of the EnteraLite is 1 ml hr to 600 ml hr in 1 ml hr increments EnteraLite pump delivers the dose at the specified rate both programmed by the user within 5 volumetric flow rate accuracy under the following conditions NOTE For test methodology refer to ANSI AAMI 1026 1992 American National Standard for Infusion Devices The reported accuracy is based upon
15. ceptacle for Upstream Tubing Fitting Receptacle for Pinch Clip Occluder Pump Wheel with Rotation Label 2 SE CN Pump Alarms Label ou Downstream Pressure Sensor Light Key Display Keypad Figure 2 1 Pump Features Front CHAPTER 2 DIRECTIONS FOR USE Pump Features Flow Direction Labels CER han Pump Instructions Label Charger Power Connector Receptacle for Pole Clamp Pole reference Pole Clamp Z 11981 AC Adapter Charger 23159 001 Figure 2 2 Pump Features Rear CHAPTER 2 DIRECTIONS FOR USE ZEVEX Enteratite ON OFF fA Press this key for 2 seconds to either I AN M turn the EnteraLite or off When the XTOTAL RATE DOSE VOLUME ENH charger is plugged in the pump is not FEED INTERVAL amp completely off instead it displays the battery charge status RUN PAUSE Press this key to either start the pump or place it in pause mode When you press the key to run the pump resumes oper ation with the current rate dose feed interval and volume delivered the rate Figure 2 3 Keypad Layout dose or feed interval can be changed while in pause mode in which case the volume is cleared and the pump begins a new feed cycle PRIME Press this key to fill or prime the disposable set once it is loaded into the pump
16. d pour the feeding solution into it NOTE Allow blenderized solutions to sit for 10 to 15 minutes before pouring them into the bag Firmly seal the bag closure If you are using the mini backpack waistpack or sports pack remove excess air from the bag To remove excess air from the bag Invert the bag so that the outlet is at the top Squeeze the buttons on the Pinch Clip Occluder to allow flow Squeeze the bag until all of the air has passed out of the bag and feeding solu tion extends beyond the Pinch Clip Occluder If you wish continue to squeeze the bag to prime the tubing set Release the Pinch Clip Occluder CHAPTER 2 DIRECTIONS FOR USE Loading the Disposable Set CAUTION Never press fingers or other objects into the cavities over the pressure sensors Load only the silicone tubing of the disposable set into these sensors A CAUTION Dispose of EnteraLite Sets Properly as required by local law Food Source Silicone Tube Segment Air Sensor Round Fitting yo Flow 5 Figure 2 9 Load Tubing in Air Sensor Upstream Pressure Sensor g Flow Figure 2 10 Load Tubing in Upstream Pressure Sensor To load the disposable set start with the tube fitting closest to the feed bag Position the round fitting on the outside of the pump and then press the silicone t
17. e humidity range of 30 to 75 EnteraLite Disposable Set Displacement The EnteraLite Disposable Set displaces approximately 13 ml of fluid when primed Approximately 3 ml of air is drawn into the tubing before the enteral pump detects that the bag is empty Therefore approximately 10 ml of fluid remains in the disposable set when the pump stops feeding These values vary by approximately 0 5 ml depend ing on whether the batteries are low or fully charged 31 CHAPTER 10 WARRANTY Solely for the benefit of the original buyer ZEVEX INCORPORATED ZEVEX warrants all new EnteraLite products of its manufacture to be free from defects in material and work manship and will replace or repair F O B at its factory in Salt Lake City Utah USA or other location designated by ZEVEX any EnteraLite products returned to it within twenty four 24 months of original purchase by the buyer Such repair or replacement shall be free of charge ZEVEX warrants to the original buyer all repaired or replaced products to be free from defects in material and workmanship and will replace or repair such products F O B at its factory in Salt Lake City Utah USA or other location designated by ZEVEX Such repair or replacement shall carry a warranty of ninety 90 days from the date of repair or replace ment or the balance of the new product warranty as described above whichever is greater This Warranty applies to all EnteraLite p
18. e or replaceable components inside the EnteraLite pump or EnteraLite AC Adapter Charger 20 CHAPTER 5 CLEANING gt gt gt WARNING To avoid electrical shock never clean the pump or the EnteraLite AC Adapter Charger with the charger plugged in or the pump on WARNING Never immerse the pump or the EnteraLite AC Adapter Charger in liquids Electrical shock or pump damage can result WARNING Make sure the EnteraLite AC Adapter Charger is completely dry before plugging into an electrical outlet CAUTION Gently clean the pressure sensors Excessive pressure due to aggressive cleaning can damage them Don t use abrasive materials to clean the EnteraLite Clean the pump only with warm soapy water a 5 bleach solution in water or a mul tipurpose disinfectant cleaner When using the cleaner or bleach solution apply for approximately 10 minutes and then wipe the pump clean with water Carefully clean debris from each of the 3 rollers on the roller assembly on a regular basis This will help ensure accurate volumetric delivery Use a soft cloth or sponge to clean the pump surfaces including the keypad Use a cotton swab to gently clean the pathways under the door and the air and pres sure sensors The compartments of the EnteraLite packs can be cleaned with a damp sponge The EnteraLite packs are machine washable Use warm water and the gentle cycle whenever possible The Ente
19. ective Cover Spike Set P N EL0010 Figure 7 1 Disposable Sets 24 CHAPTER 7 DISPOSABLE SETS ACCESSORIES Additional accessories are available for use with the EnteraLite EnteraLite Pole Clamp Order Number 2 11981 Tighten the black wheel to mount the clamp on a pole Thread the bolt into the receptacle on the back of the pump and tighten the gray wheel to mount the pump on the clamp If the gray wheel is slightly loosened the pump can be rotated to snap into different positions Retighten the gray wheel when the pump is in the desired position EnteraLite Waistpack Order Number 11939 001 This pack provides two ways to carry the EnteraLite Waistpack with 500 ml bag An elastic strap secures the neck of the 500 ml bag with a clip in the compartment on the right side The pump fits in the left side The tubing is loaded into the pump and any excess length of tubing can be secured with a Velcro strap inside the right hand compartment The patient end of the tubing then feeds through a gap in the zipper and through a button hole in the right hand waist strap of the pack Waistpack expanded to become a backpack with 1200 ml bag An elastic strap secures the neck of the 1200 ml bag with a clip in the backpack portion of the pack An elastic strap can be used to secure the body of the bag with a clip The pump is placed in the Waistpack portion The tubing is fed through a button hole from the backpack into t
20. ed practitioner Use ONLY EnteraLite Disposable Sets to ensure proper fluid delivery Others won t deliver the correct dose may allow dangerous free flow condi tions and may generate hazardous fluid pressures which may activate occlusion alarms at unpredictable pressures Replace the disposable set every 24 hours to maintain delivery accuracy and prevent the growth of harmful bacteria Low flow rates combined with high dose settings may exceed the life of the disposable set The disposable set must be replaced every 24 hours to maintain delivery accuracy and prevent the growth of bacteria DO NOT PROGRAM RATE AND DOSE COMBINATIONS WHICH EXCEED A 24 HOUR FEED REGIMEN The battery capacity is an approximation If you re unsure that enough capacity remains for your intended use recharge it To avoid electrical shock never clean the pump or the EnteraLite AC Adapter Charger with the charger plugged in or the pump on Never immerse the pump or the EnteraLite AC Adapter Charger in liquids Electrical shock or pump damage can result The EnteraLite must be periodically calibrated to ensure proper fluid delivery Do not use the EnteraLite Enteral Feeding Pump for the delivery of non enteral solutions Serious injury may result For enteral feeding only Not for IV use The Total Volume may be incorrect due to an interruption of battery power if the overcurrent or temperature protection circuits are triggered In such a case one o
21. en delivered DOSE DONE will appear and the pump will beep or mute depending upon the pump s configuration contact your healthcare provider if a change is desired 10 CHAPTER 2 DIRECTIONS FOR USE An Interval Feeding Example Suppose you want to deliver 300 ml of enteral feeding solution at a rate of 80 ml hr and repeat this feeding every 6 hours Turn the pump on by pressing the ON OFF AU ae FN key Verify that all display segments and sym M M M run bols are active as shown in Figure 2 4 and FE NE PE Pul Nw that the audible alarm sounds Once the IN IN IN pump finishes its self test the rate will be dis played by the large characters ml hr RATE DOSE VOLUME cil FEED INTERVAL WES Press the MORE key or the LESS key to Figure 2 4 Display Segments increase or decrease the rate to 80 ml hr Press the RATE DOSE key to display the dose Press the MORE or LESS key until a dose of 300 ml is displayed Now press the FEED INT key Press the MORE or LESS key until the feed interval is set to 6 hr WARNING Replace the disposable set every 24 hours to maintain delivery accuracy and prevent growth of harmful bacteria the life of the disposable set The disposable set must be replaced every 24 hours to maintain delivery accuracy and prevent the growth of bacteria DO NOT PROGRAM RATE AND DOSE COMBINATIONS WHICH EXCEED A 24 HOUR FEED REGIMEN WARNING Low flow rates combined with high dose set
22. er to charge if the temperature is below 50 F 10 or above 85 30 15 CHAPTER 2 DIRECTIONS FOR USE WARNING The Total Volume may be incorrect due to an interruption of battery power if the overcurrent or temperature protection circuits are triggered In such a case one of the following conditions occurs During Single Feeding The pump enters pause mode but does not display DOSE DONE or turns off but not due to a low battery During Interval Feeding The pump enters pause mode or turns off but not due to a low battery If one of these conditions occurs check the disposable set feed bag to estimate how much volume was actually delivered If these conditions occur frequently contact your healthcare provider or refer the pump for service 16 CHAPTER 3 LABELS Brief instructions for the operation of the pump as well as a brief explanation of each alarm message which the pump may communicate are printed on labels attached to the pump These are not intended to be used in place of the Operators Manual They are simply a quick reference guide Please read the Operators Manual before operating the EnteraLite The bag symbol shown in Figure 3 2 is printed on the side label under the port where the loaded set leads directly to the feeding bag The patient symbol shown in Figure 3 3 is printed on the side label under the port where the loaded set leads directly to the stepped entera
23. ered dietitian registered nurse or other licensed practi tioner Indications The EnteraLite is to be used only with EnteraLite Disposable Sets for the delivery of enteral feeding solutions The pump s sensitivity to occlusion and its low flow rate capability allow the pump to be used on adult and pediatric patients This pump must not be used for the delivery of non enteral solutions Volumetric Flow Rate Accuracy WARNING Use ONLY EnteraLite Disposable Sets to ensure proper fluid delivery Others won t deliver the correct dose may allow dangerous free flow conditions and may generate hazardous fluid pressures which may activate occlusion alarms at unpredictable pressures The EnteraLite pump delivers the dose at the specified rate both programmed by the user within 5 volumetric flow rate accuracy under the following conditions utilizing ZEVEX disposable sets fluid head height at 6 0 inches 0 3 inches 15 cm 0 75 cm with respect to the top of the pump downstream back pressure range from 1 9 psi to 5 8 psi 13 kPa to 40 kPa over the range of environmental operating conditions Specified per IEC 60601 1 Operating Temperature Range 50 F to 104 F 10 C to 40 C Operating Humidity Range 30 to 75 noncondensing NOTE For test methodology refer to ANSI AAMI 1026 1992 American National Standard for Infusion Devices The reported accuracy is based upon a generic volume accuracy calculation
24. essed by pressing the VOL TOTAL key once shows the volume being delivered for the current feed cycle In 6 hours the next feed cycle will begin If you would like to display the total cumulative volume press the VOL TOTAL key once more Now the display indicates the total vol ume delivered since last cleared alternating with TOTL You cannot set the feed interval shorter than the current rate and dose settings will allow To set a shorter feed interval first change the rate and dose settings then set the feed interval If you want to start with the total volume from zero then the volume must be cleared This can be done any time that the pump is in the pause mode Press the VOL TOTAL key twice so the total volume is displayed Press the CLEAR key The total volume is reset to zero There is a limit to the total volume that the pump can count It will display up to 9998 ml If the maximum value of 9998 ml is exceeded OVER FLOW will be displayed by the large characters instead of the total volume Clear it to start over 12 CHAPTER 2 DIRECTIONS FOR USE An Interval Feeding Example Once the feed interval dose and rate have been set and the RUN PAUSE key is pressed the pump will keep running until the bag or solution container is empty Between interval feed cycles the words a hr run and FEED INTERVAL will blink but the arcs around run will not appear Also the large characters will display the
25. f the following conditions occurs During Single Feeding The pump enters pause mode but does not display DOSE DONE or turns off but not due to a low battery During Interval Feeding The pump enters pause mode or turns off but not due to a low battery LIST OF WARNINGS and CAUTIONS WARNING WARNING WARNING WARNING WARNING WARNING WARNING CAUTION CAUTION CAUTION CAUTION CAUTION When simultaneously charging and operating the pump position the pump to avoid contact with the patient s skin Place the pump on a table top in an EnteraLite pack or secure the pump to an appropriate fixture using a pole clamp Make sure the EnteraLite AC Adapter Charger is completely dry before plugging into an electrical outlet Do not use an extension cord with the AC Adapter Charger The AC Adapter Charger is intended for indoor dry area use only Do not allow adapter to be exposed to liquids Possible explosion hazard if used in the presence of flammable anesthetics U S law restricts this device to sale by or on the order of a physician regis tered dietitian registered nurse or other licensed practitioner Dispose of the packaging properly The plastic bag and band could be a haz ard to children Dispose of EnteraLite Disposable Sets properly as required by local law Gently clean the pressure sensors Excessive pressure due to aggressive cleaning can damage them
26. har acters it indicates ml hr to the right of the value for the dose it indicates ml and for the feed interval it indicates hr The pump also communicates mes sages with the large alphanumeric characters For example the characters will display DOSE then DONE when the pump has finished delivering a single feed dose When the large alphanumeric characters display numbers the smaller words below the characters shown in Figure 2 6 describe what the numbers mean For example if FEED INTERVAL is dis played then the number of hours between the beginning of each dose will be displayed by the large characters The run symbol shown in Figure 2 7 indicates that the pump is running The arcs around the run sym bol rotate when the pump is in the process of deliv ering fluid The arcs are off but the run symbol blinks when the pump is between feeding intervals only if a feed interval has been selected The wall plug symbol shown in Figure 2 8 indi cates that the charger is plugged in the battery symbol indicates that the pump is running on only the battery and the fuel gauge symbol indicates how much battery charge remains More informa tion is available in the sections of this chapter titled Charging the Battery and Running on Battery Power C S hr RATE DOSE VOLUME ci FEED INTERVAL a Figure 2 4 Display Segments NNI VN WAN ANY ml hr
27. he Waistpack and loaded into the pump Any excess length of tubing can be secured with a Velcro strap inside the right hand compartment of the Waistpack The patient end of the tubing then feeds through a gap in the zipper and through a button hole in the waist strap of the pack A hook is also available in the expanded backpack to secure pre filled containers of formula EnteraLite Mini backpack Order Number 12501 001 black 12501 002 teal 12501 003 red 12501 004 purple 12501 005 pink This pack holds the EnteraLite with a 500 ml bag The pump is secured within a clear pouch by a Velcro strap An elastic strap secures the neck of the 500 ml bag with a clip above the pump The tubing is loaded into the pump and any excess length of tubing can be secured with a Velcro strap behind the bag The patient end of the tubing then feeds through a button hole at the bottom of the pack either side 25 CHAPTER 7 DISPOSABLE SETS ACCESSORIES EnteraLite Sportpack Order Number EL3000 This pack holds the EnteraLite with a 500 bag The tubing is loaded the pump then the pump is placed in the pack with the display facing the clear win dow and with the charger port facing the hole at the bottom of the bag The 500 ml bag is placed inside the pack with the neck of the bag secured by an elastic strap with a clip above the pump Any excess length of tubing can be secured with a Velcro strap inside the bag The
28. l adapter The stepped enteral adapter attaches to the patient s enteral feeding tube There are no user serviceable or replace able components inside the EnteraLite or the EnteraLite Adapter Charger Do not open the pump or the EnteraLite AC Adapter Charger because there is risk of electrical shock Read operator s manual before using Figure 3 1 Pump Label Warning Figure 3 2 Pump Label Feeding Bag Connection Figure 3 3 Pump Label Patient Connection IN Shock hazard inside Figure 3 4 Pump Label Shock Hazard 17 CHAPTER 4 ALARMS and INDICATIONS The audible alarm will sound to call attention to situations which must be corrected The fol lowing messages may be displayed by the large display characters CHEK The three smaller indicators RATE DOSE and FEED INTERVAL are displayed with this message One of the three was programmed so that the pump cannot execute the combination of commands The pump divides the dose by the rate and if the result is greater than the feed interval this message is displayed For example if rate is 100 ml hr and dose is 200 ml then the pump will take 2 hours to deliver the dose However if the feed interval is 1 hour the pump cannot complete the first interval feed before the next is due to start Press the RUN PAUSE key and reprogram the settings The pump will not run until the rate dose and feed interval are compatible DOSE DONE This message indicate
29. nd 69619282 9 08 OTHER U S AND FOREIGN PATENTS PENDING MADE IN USA PART NO DI 0278 1 G EnteraLite is the first enteral feeding pump to be awarded the Seal of Acceptance for Superior Pediatric Product Quality from the Alliance of Children s Hospitals
30. ound the pump wheel and clean according to CHAPTER 5 CLEANING 19 CHAPTER 4 ALARMS and INDICATIONS PUSH RUN TO FEED This battery saving feature indicates that the pump has been inactive in the pause mode for 2 minutes Program and use the pump or turn it off TO STOP LET GO The pump displays this message when priming the set To stop priming release the PRIME key WONT PRIM IN RUN The PRIME key was pressed while the pump was running If you wish to prime the pump press the RUN PAUSE key then press and hold the PRIME key Battery Doesn t Hold Its Charge The battery will lose its charge if stored for a long period of time or if stored at high tem peratures such as in an automobile during the summer Recharge the battery you ve charged the battery and the battery life is still less than expected contact your healthcare provider or refer the pump for service The battery is not user replaceable see CHAPTER 11 WHO TO CALL Charger Installed but No Plug Symbol Visible If the plug symbol remains off after the AC EnteraLite Adapter Charger is plugged into the pump the charger isn t charging the battery Verify that the wall outlet works by plugging in another appliance such as a lamp If the charger is connected properly and the outlet works then the pump or charger may be damaged Contact your health care provider or refer the pump for service see CHAPTER 11 WHO TO CALL NOTE There are no user serviceabl
31. patient end of the tubing then feeds through a gap in the zipper or through a special hole at the bottom of the bag The EnteraLite AC Adapter Charger may also be plugged into the pump through this hole in the pack The sportpack is designed to be worn on a belt It is barely noticeable when worn under a jacket EnteraLite Wheelchair pack Order Number Z 12634 An elastic strap secures the neck of the 500ml or 1200ml bag with a clip at the top right side of the bag A hook is also available to secure pre filled containers of formula The pump is secured within a clear pouch at the bottom left side of the bag by a Velcro strap The tubing is loaded in the pump and any excess length of tubing can be secured by a Velcro strap The patient end of the tubing then feeds through a gap in the zipper The EnteraLite AC Adapter Charger may be stored in a pouch on the left side of the bag There is also room in the bag to store an extra container of formula or other personal items EnteraLite AC Adapter Charger Order Number 23159 001 Use only the EnteraLite AC Adapter Charger with this pump Plug the EnteraLite AC Adapter Charger into wall outlet and plug the connector of the EnteraLite AC Adapter Charger into the pump to operate on AC power and or recharge the battery Note 1 The button on the connector must be pressed in to remove the charger from the pump Note 2 Several optional EnteraLite AC Adapter Chargers and power cords are
32. raLite AC Adapter Charger normally does not require cleaning When desired a dry or slightly damp cloth may be used to clean the outside surface of the EnteraLite AC Adapter Charger while it is disconnected from the wall outlet Do not allow liquid to enter the AC Adapter Charger through the vents 21 CHAPTER 6 MAINTENANCE CALIBRATION WARNING The EnteraLite must be periodically calibrated to ensure er fluid delivery of 3 feet or more it is recommended that it be returned for service CAUTION If the pump is dropped or falls onto a hard surface from a height ZEVEX recommends that the EnteraLite be calibrated by authorized personnel at least every 12 months Please contact your health care provider to arrange for this service see CHAPTER 11 WHO TO CALL 22 CHAPTER 7 DISPOSABLE SETS ACCESSORIES WARNING Replace the disposable set every 24 hours to maintain delivery accuracy and prevent the growth of harmful bacteria delivery Others won t deliver the correct dose may allow dangerous free flow conditions and may generate hazardous fluid pressures which may activate occlusions alarms at unpredictable pressures WARNING Use only EnteraLite Disposable Sets to ensure proper fluid CAUTION Dispose of EnteraLite Disposable Sets properly as required by A local law The disposable set consists of several parts as illustrated in Figure 7 1 bag i
33. roducts manufactured by ZEVEX and is the ONLY WARRANTY GIVEN FOR THE SALE OF PRODUCTS OR SERVICES NO WARRANTIES IMPLIED IN LAW INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR PARTICULAR PURPOSE SHALL APPLY ZEVEX WILL BE LIABLE IN ANY EVENT ONLY FOR THE PURCHASE PRICE OF THE DEFECTIVE PRODUCT BUT NOT FOR ANY CONSEQUENTIAL DAMAGES This Warranty may not be modified amended or otherwise changed except by a written document properly executed by a corporate officer of 2 ZEVEX Inc voids the warranty if the EnteraLite pump is opened or tampered with in any way without prior authorization from ZEVEX Inc 32 CHAPTER 11 WHO CALL This manual is intended to answer the most common questions which may arise during ordi nary use of the EnteraLite Enteral Feeding Pump If further assistance is needed contact your health care provider ADDITIONAL INFORMATION YOUR HEALTHCARE PROVIDER YOUR PHYSICIAN 33 NOTES 34 EnteraLite Ambulatory Enteral Feeding Pump OPERATOR S MANUAL Also available in other languages e ZEMEX THERAPEUTICS 4314 ZEVEX PARK LANE SALT LAKE CITY UT 84123 USA www zevex com TEL 801 264 1001 TOLL FREE IN USA 1 800 970 2337 FAX 801 264 1051 2003 ZEVEX INCORPORATED U S PATENT NO S 5514102 5531680 5704584 5720721 5733061 5810323 6142979 AND D389228 INTERNATIONAL PATENT NO S 0959920 0900106 a
34. s filled with the enteral solution The spike is used to pierce pre filled con tainers pump fitting holds the silicone tubing place in the pump silicone tubing passes through the air sensor and around the pump wheel pass ing over pressure sensors on either side of the pump wheel pinch clip occluder blocks solution flow when the set is out of the pump or when the pump door is open stepped enteral adapter connects to most common patient feeding tubes but is not compatible Enteral Adapter Protective Cover contains a feature which is used to hold the Pinch Clip Occluder open while the set remains packaged to avoid kinking of the sili cone tubing The only disposable sets approved for use with this pump are EnteraLite 500 ml Bag Set Order Number EL0500 EnteraLite 1200 ml Bag Set Order Number EL 1200 EnteraLite Spike Set Order Number EL0010 23 CHAPTER 7 DISPOSABLE SETS ACCESSORIES Silicone Tubing Pump Fitting Stepped Enteral Adapter Fill Cap Pinch Clip Occluder Bag 500 Bag Set P N EL0500 Stepped Enteral Adapter Pinch Clip Occluder Silicone Tubing Pump Fitting A 11 5 rla 5 8 pla 66 0 Fill ae Enteral Adapter Protective Cover 1200 mI Bag Set P N EL1200 Stepped Enteral Adapter Pinch Clip Occluder Silicone Tubing Spike Pump Fitting 11 5 r 5 8 ke 66 0 gt Enteral Adapter Prot
35. s that a single feed dose has been delivered ERRA ERRZ The pump displays ERR followed by a letter to indicate that a self test has failed Turn the pump off and then back on If the problem persists contact your healthcare provider or refer the pump for service see CHAPTER 11 WHO TO CALL LOAD SET The pump attempted to run with the set improperly installed or missing Check the following Make sure an EnteraLite Disposable Set is installed properly and the door is closed Check for spillage especially around the pressure sensors If cleaning is necessary refer to CHAPTER 5 CLEANING LOW BATT The battery is low and the pump will soon stop running Plug in the EnteraLite AC Adapter Charger to recharge the battery The pump can continue to operate while the battery is charging NEXT DOSE The next dose will be delivered in hr where the format indicates the time in hours and minutes until the next dose NO FLOW IN The pump has detected an occlusion upstream in the set between the pump and the bag Check the tubing set for blockage and correct the blockage Also check for spillage where the set is routed under the door If there is spillage refer to CHAPTER 5 CLEANING 18 CHAPTER 4 ALARMS INDICATIONS NO FLOW OUT The pump has detected an occlusion downstream in the set between the pump and the patient Check the tubing set for blockage and correct the blockage Also check for spillage
36. the pump is charging Refer to Figures 2 14a through 2 14e To check the status of the battery disconnect the charger from the pump and then turn the pump on See Chapter 2 Running on Battery Power for information on battery life and charge times WARNING When simultaneously charging and operating the pump position the pump to avoid direct contact with the patient s skin Place the pump on a table top in an EnteraLite pack or secure the pump to an appropriate fixture using a pole clamp 14 E F 2 EM F V 2 C V d 2 Figure 2 14 Fuel Gauge Displays Ascending Low to High Pattern While Charging CHAPTER 2 DIRECTIONS FOR USE Running on Battery Power WARNING The battery capacity is an approximation If you re unsure that enough capacity remains for your intended use recharge it When the pump is running on battery power the battery symbol will appear in the display as shown in Figure 2 15 The segments or bars between E and F rep resent the fuel gauge of the battery Each block is approximately 1 4 of a 24 hour charge If two blocks appear then the battery is half full and the battery operation time remaining is roughly 12 hours As the battery Figure 2 15 Battery Power Indicator charge decreases the blocks will blink before they disappear When the last block is gone the battery symbol will blink to indicate that there is
37. tings may exceed 11 CHAPTER 2 DIRECTIONS FOR USE An Interval Feeding Example Prepare the disposable set and enteral feeding solution as described in CHAPTER 2 PREPARING THE DISPOSABLE SET f a feeding bag is to be used pour the total amount of enteral food to be delivered into the feeding bag Next load the EnteraLite Disposable Set into the pump as described in CHAPTER 2 LOADING THE DISPOSABLE SET and close the door Hang the feeding bag or con tainer so that the bottom of the bag is at or above the level of the pump door If any of the EnteraLite packs are to be used load the pump and feeding bag into the proper compartments securing the pump bag and tubing with the pack s straps Prime the set by pressing and holding the PRIME key until the set is filled with enter al feeding solution approximately 13 ml Connect the stepped enteral adapter at the patient end of the set to the patient s enter al feeding tube Press the RUN PAUSE key to begin feeding The pump will deliver 300 ml every 6 hours at a rate of 80 ml hr until the bag is empty If you want to stop the pump at any time press the RUN PAUSE key You may resume the feed interval by pressing the RUN PAUSE key as long as the rate the dose and the feed interval remain unchanged clearing the volume will cause the pump to restart the feed cycle Additional notes regarding interval feeding Once the pump is running the volume display which can be acc
38. ubing into the air sen sor as shown in Figure 2 9 Next route the silicone tubing segment through the upstream pressure sensor area and toward the pump wheel as shown in Figure 2 10 Do not stretch the tubing at this point CHAPTER 2 DIRECTIONS FOR USE Loading the Disposable Set Pump Wheel Flow Figure 2 11 Load Tubing around Pump Wheel u Pinch Clip Occluder Downstream Pressure Sensor To Patient Figure 2 12 Load Tubing in Downstream Pressure Sensor and Load Pinch Clip Occluder Wrap the silicone tubing around the pump wheel against the pump rollers as shown in Figure 2 11 Minimize the stretching of the silicone tubing when loading the set into the pump As shown in Figure 2 12 guide the silicone tubing in the down stream pressure sensor area Only stretch the silicone tubing enough to place the pinch clip occluder of the disposable set into the rectangular slot with either button facing up Close the door CHAPTER 2 DIRECTIONS FOR USE A Single Feeding Example Suppose you want to deliver 500 ml of enteral feeding solution at a rate of 120 ml hr and then stop the pump Turn the pump on by pressing the ON OFF key ify that all the di i N M veal ale geri AN NLIS UN lt the audible alarm sounds hr R
39. uits are trig WARNING The Total Volume may be incorrect due to an interruption of bat gered In such a case one of the following conditions occurs During Single Feeding The pump enters pause mode but does not display DOSE DONE or turns off but not due to a low battery During Interval Feeding The pump enters pause mode or turns off but not due to a low battery If one of these conditions occurs check the disposable set feed bag to estimate how much volume was actually delivered If these conditions occur frequently contact your healthcare provider or refer the pump for service EnteraLite Volumetric Flow Testing Percent Error vs Flow Rate for Nominal 6 inch Head Height 0 psi Back Pressure Room Temperature 23 Tested AAMI 1026 1992 section 5 1 1 2m 1 Generic Accuracy Reported Volume Delivered vs Volume Expected 10 0 7 5 5 0 5 E Measured Error 2 5 NutriLan i 7 Measured Error Enron cb oe enne eee Water 7 5 10 0 1 5 10 50 125 250 Flow Rate ml hr Figure 8 1 Flow Rate Accuracy 28 CHAPTER 9 TECHNICAL INFORMATION A A WARNING Do not use the EnteraLite Enteral Feeding Pump for the deliv ery of non enteral solutions Serious injury may result For enteral feeding only Not for IV use WARNING Use ONLY feeding solutions prescribed by the responsible physician regist
40. where the set is routed under the door If there is spillage refer to CHAP TER 5 CLEANING NO FOOD The air sensor detects an empty tubing set Check for the following problems If the feeding bag is empty refill the bag and continue feeding If necessary prime the set Make sure the air sensor is clean Make sure an EnteraLite Disposable Set is installed properly seated in the air sensor with the door closed Replace worn tubing with a new tubing set NOTE The air sensor can be sensitive to foamy and or blenderized solutions Allow blenderized solutions to sit for 10 to 15 minutes prior to pouring into the bag and prim ing the disposable set Small air bubbles from the foam may get trapped in the air sen Sor region and must be cleared in order to avoid a NO FOOD alarm WARNING Replace the disposable set every 24 hours to maintain delivery accuracy and prevent the growth of harmful bacteria PUMP WONT RUN or RATE TOO FAST FOR BATT The pump is inhibited from operating at the selected rate Check for the following problems Make sure an EnteraLite Disposable Set is installed properly and the door is closed Check that the battery is fully charged or that the EnteraLite AC Adapter Charger is plugged in Try reducing the rate below 300 ml hr The pump may not be able to deliver highly viscous thick fluids at high rates with the present charge level of the battery Check for contamination ar
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