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1. HEREUNDER ARE IN LIEU OF ALL OTHER WARRANTIES EXPRESSED OR IMPLIED INCLUDING WITHOUT LIMITATION THE WARRAN TIES OF MERCHANTABILITY AND OF FITNESS FOR A PARTICULAR PURPOSE NOTE When repairs on the unit are made under warranty because of faulty material or workmanship within one year from the date of delivery to the customer the customer will not be billed for parts repaired or replaced Also the customer will not be charged for labor involved in connection with the installation of such parts furnished under warranty Shipping costs for units returned to Ross including loaners shall be paid by the customer Ross Authorization Forms should be completed and accompany the returned unit
2. Automatic Flush Mode for patients with volume sensitivity or fluid restriction ie cardiac renal pulmonary or pediatric patients For such patients the Feed Only Mode using the system without automatic flush feature may be desired NOT FOR PARENTERAL USE Confirm proper placement and function of patients enteral feeding tube nasogastric jejunostomy gastrostomy etc Failure to do so may result in vomiting and or aspira tion Verify the following before initiating feeding 1 A Quantum Pump Set is being used 2 Cassette is properly seated in pump and door is closed 3 Flow rate is set at the prescribed mL hr 4 Before putting pump in RUN mode be sure line clamps are fully open 5 If a pump set with flush bag is used be sure both line clamps are closed during setup and when the door on the pump is open Otherwise the fluids will mix For optimum operation observe the following precautions Low level electrical emissions are commonly observed when fluids are administered using an enteral feed ing pump The emissions observed with the QUANTUM pump may create artifacts on voltage sensing equipment such as ECG EMG and EEG monitoring devices if the monitoring device is not operating correctly or has loose or defective connections to its sensing electrodes These artifacts may be mistaken as actual physiologic signals and may vary at a rate that is associated with the delivery rate set on the pump To deter mine if the abnormal
3. DOSE COMPLETE page 14 DOSE may also be set during the automatic priming phase NOTE If zero dose is entered 0000 this feature is deactivated RUN Only setting that activates feeding Visual display shows rate of flow in mL hr and a dropletshaped image will move across the bottom of the visual display Also a small green light on lower left hand corner of pump will flash when pump is in RUN mode CONTROL DIAL SETTINGS continued DIAL FUNCTION HOLD Stops pumping action and audio alarms HOLD is used when correcting an alarm con dition or whenever temporary cessation of pumping action is desired such as when con necting a new feeding container If pump dial is left on HOLD for more than 5 minutes an alarm will sound and the message TURN TO RUN will be displayed VOL FED Stops pumping action The FEEDING display will show feed volume delivered and the FLUSH display will show flush volume deliv ered Pump accumulates feed volume deliv ered up to 9999 mL and flush volume up to 999 mL unless these volumes are reset to zero by turning to CLEAR VOL or the pump is unplugged while in the OFF CHARGE mode Upon exceeding the maximum feed or flush volume allowed on the display the value turns to zero and a new accumulation begins CLEAR VOL Stops pumping action and clears to zero both the feed and flush volume fed NOTE The pump will beep four times before erasing volumes to alert the us
4. N LOW BATTERY Pump has approx imately 30 minutes of battery opera tion before complete shutdown A completely blank front panel no lights symbols message indicates that the battery is depleted and the unit is not plugged into a live AC circuit NOTE Complete shutdown is preceded by a continuous alarm for 1 minute Plug power cord into AC outlet Turn dial to HOLD then RUN Pump will operate normally while battery is charging ERR System Malfunction Must turn pump OFF to reset If alarm condition persists pump requires service FLUSH Display Blank with FEED FLUSH SET in use Clamp is closed on the Flush Bag or Flush Bag is empty Turn pump OFF Fill Flush Bag Open clamp Restart pump CLEANING There are no routine calibration or adjustment procedures required with the Quantum Pump All servicing or adjustments should be referred to qualified technical personnel refer to Service Manual For trouble free operation check the pump daily and clean immediately after spills occur While cleaning pump should be turned off and unplugged Do not submerge autoclave heat steam ETO or radiation sterilize the pump THE PUMP CAN BE CLEANED AS FOLLOWS HOUSING Clean outside surface with soft cloth and warm soapy water For general cleaning use dishwashing detergent nonchlorine based or isopropyl alcohol For general disinfecting use 70 concentra
5. No 50596 Purchase No 50598 Lease Rent FLEXIFLO QUANTUM Enteral Pump OPERATING MANUAL For Enteral Use Only Not For Parenteral Use Bee ROSS SSS MEDICAL SSE NUTRITIONAL BB g SYSTEM PUN ser oose HAD z voL FED SET BATE gt GLEAR LF YOL CHARGE ROSS PRODUCTS DIVISION KON ABBOTT LABORATORIES INC COLUMBUS OHIO 43215 1724 Rev 1 97 17558 7910 50598 50596 FAN 7116 430 00730 007 LITHO IN USA TABLE OF CONTENTS PAGE Pump Characteristics 3 Pediatric Use 4 Precautions 4 Panel Displays 5 Control Dial Settings 6 amp 7 Automatic Prime 8 Pump Sets 9 amp 10 Instructions For Use 11 amp 12 Checking Pump Accuracy 13 Trouble Shooting 14 amp 15 Cleaning 16 Storage I7 Service 17 Flexiflo Quantum Enteral Delivery System 17 Specifications 18 Limited Warranty 19 USER QUALIFICATIONS The Flexiflo Quantum Enteral Pump is for use at the direction of or under the super vision of licensed physicians and by licensed or certified health care professionals who are trained in the use of the pump and the administration of enteral fluids 1997 Ross PUMP CHARACTERISTICS The FLEXIFLO QUANTUM Enteral Pump is a microprocessor computer controlled pump that provides for accurate controlled enteral feeding in a safe user friendly system The Quantum Pump is a volumetric pump that uses a speciall
6. OL SINGLE INLET CASSETTE a i IMPORTANT REMINDER WHEN USING A PUMP SET WITHOUT FLUSH BAG a FLUSH display will be blank when a single inlet cassette is used PUMP SETS continued PUMP SET WITH FLUSH BAG DUAL INLET CASSETTE EXAMPLE SHOWN FLEXIFLO Top Fill Enteral Nutrition Container With Preattached Quantum Pump Set With Flush Bag From Feeding Container From Flush Bag sj anat N IFI Pumping Chamber ai g IMPORTANT REMINDER WHEN USING FEED FLUSH SETS Every 60 minutes of continuous feeding AND before the pump alarms EMPTY DOSE COMPLETE or LOW BATTERY 25 mL of flush solution will be delivered over 1 4 minutes Flush rate is fixed at 999 mL hr NOTE The FLUSH cycle will be aborted if the control knob is turned to any position other than RUN HOLD or VOL FED Assure that the clamp on the filled flush bag is open during priming Otherwise the pump will decide that a Pump Set Without Flush Bag is in place and the FLUSH display will remain blank When the door on the pump is open be sure both clamps are closed Otherwise the fluids will mix Use of the Quantum Pump replaces the need for routine flushing procedures eg 20 30 mL of warm water every 3 4 hours during continuous feeding Flushing with 20 30 mL of warm water using a 30 mL or greater syringe before and after medications is still recommended If pump feeding is manually stopped or turned off autom
7. atic flushing does not occur If pump remains in the OFF CHARGE mode not on HOLD it is recom mended to flush with 20 30 mL of warm water using a 30 mL or greater syringe to rinse remaining product from the feeding set Additional information or action may be included in your facilitys required procedures DUAL INLET CASSETTE cal INSTRUCTIONS FOR USE Before initial use on battery power and after extended storage periods the pump must be plugged into an AC power source for a minimum of 8 hours pump may be operated during this time The pump should be operated on battery power for a minimum of 6 continuous hours at least once every 6 months for best performance and battery life Use AC power whenever possi ble Plug in during storage to assure a fully charged battery for emergencies DANGER Possible explosion hazard if used in the presence of flammable anesthetics ASSURE THAT ALL CLAMPS ON FEED AND FLUSH SETS ARE CLOSED BEFORE SETUP TO ASSEMBLE 1 Attach pump to stand using pole clamp Plug in cord if power is avail able If using battery power do not let battery run down When the low battery message appears the battery has approximately 30 minutes of energy left 2 Close CAIR Clamp flow regulator on Quantum Pump feeding bag an slide clamp on flush bag if used 6 Fully open clamp on feeding set and slide clamp on flush bag if used lay 3 A
8. c Covered by one or more of the following US Patent Nos 3 685 787 3 893 468 4 013 263 4 047 694 4 238 108 4 181 476 t If desired CAIR clamp may be used to regulate flow rate by gravity but all tubing must be completely disconnected from pump This set delivers approximately 14 drops per mL CHECKING PUMP ACCURACY Fluid head height and viscosity are two variables that can affect flow rate To check flow rate use the following procedure Select a pump set without a flush bag or fully close clamp on flush bag if using a feeding pump set with flush bag Be sure to use a graduated cylinder for volume measurement not an enteral container Using Ensure Complete Balanced Nutrition or Osmolite Isotonic Liquid Nutrition fill the feeding container only and set up pump according to instructions Suspend bag to side or behind and 20 inches above pump see illustration With a test pump connected to AC power start the pump and let it run for 15 minutes Then run product into a graduated cylinder for 30 minutes and compare to rate set on pump Amount Expected in Graduated Cylinder Rate Set 30 minutes 76 mL hr 34 2 mL to 41 8 mL 150 mL hr 67 5 mL to 82 5 mL If flow rate is incorrect try a new pump set and repeat procedure TROUBLE SHOOTING The Quantum Enteral Pump is designed to be highly reliable As with any electro mechanical device however problems may occur The following tips will help corr
9. cal device however minor problems may occur In the event of a pump malfunction need for technical assistance or parts please contact Ross OPERATING INSTRUCTION VIDEOTAPE An instructional videotape in VHS format assists nursing personnel and other medical professionals in learning procedures for operating the FLEXIFLO Quantum Enteral Delivery System This videotape is available for your use through a Ross Representative FLEXIFLO QUANTUM Enteral Delivery System PUMPS 50596 Enteral Pump Purchase 50598 Enteral Pump Lease Rent PUMP SETS 50600 Pump Set w Piercing Pin 50602 Pump Set w 40mm Screw Cap 50604 Pump Set w Piercing Pin With Flush Bag CONTAINERS WITH PREATTACHED PUMP SETS 50608 1000 mL Top Fill Bag w Pump Set 50610 1000 mL Toptainer w Pump Set 50606 1000 mL Top Fill Bag w Pump Set With Flush Bag 50614 1000 mL Toptainer w Pump Set With Flush Bag All Quantum pump sets and containers with preattached pump sets can be used in the gravity mode of feeding 17 SPECIFICATIONS Power Voltage 100 to 130 VAC 47 63 Hz 1 Phase Power 4 watts average Fuse AMP SB type Line Cord Hospital grade nondetachable 10 feet Leakage Less than 100 microamps Mechanical Height 8 25 inches Width 7 5 inches Depth 6 0 inches 8 0 inches with pole clamp Weight 7 2 Ibs Operational Specifications Flow Rates Range 1 300 mL hr Increments 1 mL hr Accuracy 10 refer to CHECKING PUMP ACCURACY
10. ect minor in service problems that may arise Intermittent audio alarms are accompanied by messages on the front panel indicating the cause of the alarm for all alarm conditions except LOW AUDIO visual only which indicates low alarm volume has been selected VISUAL DISPLAY OR PROBLEM CORRECTIVE ACTION OCCLUSION Flow has stopped Turn dial to HOLD Clear obstruction check for kinked tubing or closed clamps Turn dial to RUN to start pump EMPTY Feed or flush bag empty Turn dial to HOLD Refill container s Turn dial to RUN to start pump DOSE COMPLETE VOL FED is equal to the SET DOSE Pump stops Turn dial to SET DOSE Press keypad arrows to increase dose OR to zero dose setting OR turn dial to CLEAR VOL To silence alarm turn dial to HOLD then RUN SET RATE Dial turned to RUN with out entering rate Select flow rate 1 to 300 mL hr To silence alarm turn dial to HOLD then RUN TURN TO RUN Pump dial in setting other than RUN or OFF more than 5 minutes Turn the dial to HOLD or RUN to reset DOOR CASSETTE Door open cassette not properly loaded or excess foam or air in cassette Confirm cassette in place and close door Manually reprime to remove foam or air from cassette Replace set If alarm condition persists pump requires service TROUBLE SHOOTI NG continued VISUAL DISPLAY OR PROBLEM CORRECTIVE ACTIO
11. er that the dial has been turned to CLEAR VOL The user must turn dial away from CLEAR VOL to any other setting before the fourth beep to avoid an unintentional erasure of volume total s CLEAR VOL does not work while pump is priming AUTOMATIC PRIME PUMP SETS The Quantum Pump offers a wide choice of feeding sets with either a Pump Set FEEDING FEEDING Without Flush Bag single inlet cassette or Pump Set With Flush Bag dual inlet cassette LOW AUDIO LOW BATTERY EMPTY DOOR CASSETTE MINUTES PRIMING DOSE EOMELETEN Kun PUMP SET WITHOUT FLUSH BAG SINGLE INLET CASSETTE amg EXAMPLE SHOWN ML FLEXIFLO Top Fill Enteral Nutrition Bag With Preattached Quantum Pump Set RUN SET DOSE I HOLD z SET RATE VOL FED SET RATE VOL FED Ca A OFF _ CLEAR OFF CLEAR CHARGE voL CHARGE VOL From Feeding Container es EN System Self Check Display Priming Display Automatic Priming is initiated when Pump dial is turned from OFF CHARGE position to SET RATE SET DOSE or RUN position The system self check on the pump is followed by automatic priming of the set Fluid fills the tubing during this priming sequence This fluid is not counted in VOL FED NOTE Automatic priming expels air from the set which may result in a small amount of fluid being expelled beyond the adapter on the feeding set Automatic Priming does not occur in the following dial settings HOLD VOL FED CLEAR V
12. ets are used in the Optional FLUSH MODE will deliver at least 600 mL of additional fluid flush solution per day on continuous feeding the FLUSH sets must NOT be used for feeding infants under 12 months of age In addition use of the FLUSH feature in all pediatric patients 12 months of age or older must be carefully evaluated A physician who has training in pediatrics must take into account the effect of this additional volume on intestinal tolerance and overall fluid balance of the individual patient and should accordingly determine the maximum amount of flush solution to be hung CAUTION The Quantum Pump can be used on pediatric patients provided the patients can tolerate a feeding range within the pump operational specifications Those specifications are The flow rate range of the Quantum Pump is 1 300 mL hr in 1 mL increments The flow rate accuracy of the pump is 10 see page 13 of the Quantum operating manual for checking pump accuracy The mean occlusion pressure limit of the Quantum Pump is 15 PSI If these specifications are not appropriate for a given patient the Quantum Pump should not be used All enteral pumps have the potential to bolus feed or overdeliver which is an important consideration in feeding volume sensitive patients In these patients a volume of product no more than four times the hourly feeding rate should be hung PRECAUTIONS Caution should be exercised in the use of this pump in the
13. ity in the monitoring device is caused by the QUANTUM pump set the pump so it is temporarily not delivering fluid Disappearance of the artifact indicates it was probably caused by the pump Proper setup and maintenance of the monitoring device should eliminate the artifact 4 BACK PANEL PANEL DISPLAYS Here is a simple explanation of the panel displays Understanding them is necessary for successful operation of the pump FRONT PANEL FEEDING Display FLUSH Display Pump Dial Light will FLASH when pump is in RUN mode Blue Lever HI LO AUDIO Alarm Ground Test Point HOSPITAL GRADE POWER CORD BOTTOM VIEW BATTERY ACCESS DOOR CONTROL DIAL SETTINGS DIAL FUNCTION OFF CHARGE Stops all pump functions Battery charges in all dial settings when pump is plugged in The pump will retain current RATE DOSE and VOL FED values indefinitely unless the pump is unplugged from an AC power source while in the OFF CHARGE setting FREDNE SET RATE Allows flow rate to be set 1 to 300 mL hr in I mL increments by pressing the keypad arrows when the pump is in the SET RATE mode Rate may be set during or after the automatic priming phase FEEDING SET DOSE Allows dose to be limited 1 to 1999 mL for Models A B amp C and 1 to 9999 mL for Model D and higher in 1 mL increments by pressing the keypad arrows Completion of this dose triggers DOSE COMPLETE alarm Refer to
14. ivated 13 Turn dial to RUN to start feeding 14 To see feeding volume delivered and flush volume delivered if this feature is used turn dial to VOL FED 15 To clear the feeding and flush volume delivered turn dial to CLEAR VOL This occurs after four beeps NOTE If alarm sounds turn pump dial to HOLD Correct alarm condi tion indicated by visual display then 1 turn pump dial to RUN to restart feeding For explanation of alarms see pages 14 15 When desired disconnect pump set tubing from patients enteral feeding tube Close clamp on feeding bag and flush bag if used Lift blue lever on face of pump remove cas sette and discard set and container When feeding is complete turn pump dial to OFF NOTE Pump stops and sounds an alarm automatically when the con tainer is empty If the DOSE function is in use the pump will stop sound the alarm and display the DOSE COMPLETE message when the selected dose is reached PRECAUTION The pump set and container should be replaced as needed or at least every 24 hours to avoid product contamination prob lems For single patient use only TO GRAVITY FEED OR MANUALLY PRIME Completely close CAIR clamp and slide clamp if flush set is used Remove cassette from pump Pull out orange plunger knob and regulate flow with CAIR clamp CAIR clamp manufactured under license from Adelberg Laboratories In
15. page 13 Pressure Pumps against 15 psi mean back pressure before occlusion alarm Battery Operation Type 2 1 Ah rechargeable sealed lead acid Voltage 8V the pump will fully recharge in a maximum of 8 hours if turned off or a maximum of 12 hours if running Expected Life When fully charged 8 hours at 125 mL hr Standards Designed and manufactured to meet requirements of UL 544 1976 LIMITED WARRANTY PLAN Ross warrants the Flexiflo Quantum Enteral Pump against defects in material and workmanship for a one 1 year period from date of delivery This warranty is valid only to the original purchaser and does not extend to any product or part thereof which has been subjected to accident alteration damage misuse repair by other than Ross authorized representatives or has not been operated and maintained in the manner prescribed in the Operating Manual or which at the time of pump failure was being used with pump sets or containers other than Ross pump sets and con tainers Examples of damage or misuse include but are not limited to pumps that have been dropped have had fluid spilled into or onto the casing or have been submerged In no event shall Ross be liable for any incidental indirect or consequential damages in conjunction with the purchase or use of the pump Ross reserves the right to repair or replace at its option any pump that fails to meet the foregoing warranty THE WARRANTIES
16. tion isopropyl alcohol For disinfecting after exposure to AIDS or hepatitis use 10 concentration of 5 25 sodium hypochlorite household bleach This solution may discolor the pole clamp DO NOT SPRAY THIS SOLUTION INTO PUMP CAVITY After exposure to tuber culosis use 70 concentration isopropyl alcohol These recommendations are not substitutes for official procedures that may differ among institutions PUMP CAVITY To facilitate cleaning the cassette receptacle door may be disconnected from the face of the pump However this should be removed only by a qualified service technician in the following manner Tilt pump back Lift blue lever so cassette door is in open position Push out on door release tab to release cassette door Allow door to open fully Lift up on door to remove com pletely from brown hinge Reinstall cassette door by following above procedures in reverse order Do not spray water or cleaning solution into pump Cavity Clean with a cotton swab soft brush or soft cloth and warm soapy water Dry thoroughly Th Be sure no soap film or residue is left Z in the pump cavity Release Tab Open Position N gt STORAGE The pump should be stored away from excessive heat cold or humidity Be sure pump dial is in the OFF position SERVICE The Quantum Enteral Pump is designed to be highly reliable As with any electro mechani
17. ttach the Quantum Pump Set TO PRIME securely onto a filled enteral nutrition Pump automatically primes container if it is not preattached Sus pend container to side or behind and 20 inches above pump Squeeze sight chamber to full wt 4 Fill flush bag with enteral flush solu tion DO NOT USE CARBONATED SOLUTIONS Suspend bag to side or behind and 20 inches above pump 5 Lift blue lever on face of pump to open door Make sure orange plunger 7 Remove adapter cover knob is oriented to the left as you firmly seat cassette into pump cavity Close door on pump by pushing the blue lever down See illustration top of next column 8 Turn pump dial to SET RATE Pump will initiate system self check procedure followed by automatic priming of the set See illustration top of next page INSTRUCTIONS FOR USE continue NOTE Automatic priming expels air from the set which results in a small amount of fluid being expelled beyond the adapter 9 Confirm proper placement and function of enteral feeding tube 10 Attach adapter to enteral feeding tube 11 Select flow rate from 1 to 300 mL hr by pressing individual arrows Never use sharp objects such as pens pen cils fingernails or paper clips to depress the keypad arrows 12 If desired turn dial to SET DOSE and select dose by pressing individual arrows NOTE If zero dose is entered 0000 this feature is deact
18. y designed feeding set which includes a cassette that delivers measured amounts of enteral product As an optional feature the Quantum Pump will flush the feeding set and indwelling feeding tube each hour with a 25 mL flush PRECAUTION This pump is designed to deliver only a liquid enteral feeding product standard liquid product infant formula or reconstituted powder product that has been thoroughly mixed into solution The Quantum Pump offers these features Automatic priming no manual priming is necessary l 2 Automatic flush feature 3 Dose setting 4 Protection against overdelivery Motor speed is continuously monitored Senses malfunctions that could result in gravity flow 5 Volume fed accumulation displays for enteral product and flush solution 6 Flow rate selection from 1 to 300 mL hr in 1 mL hr increments 7 Accuracy to 10 refer to CHECKING PUMP ACCURACY page 13 8 8 hour battery operation at 125 mL hr when fully charged 9 Alarms OCCLUSION a EMPTY DOSE COMPLETE TURN TO RUN LOW BATTERY s DOOR CASSETTE SET RATE 10 System selfcheck 11 Adjustable alarm volume 12 User friendly operating controls 13 Simple setup one hand cassette loading 14 Memory Automatic retention of the following values until turned off and disconnected from AC power FEED and FLUSH volume accumulations VOL FED SET RATE SET DOSE values PEDIATRIC USE Because the Flexiflo Quantum Pump when FLUSH s

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