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Nimbus

EU Patient Manual --560-IFU-IT1098, Rev. A 3

Pack and Wear Pouch ..................................................................... 20

Section 4: Battery Replacement .................................................. 21

Authorized Battery ........................................................................... 21

Section 5: Troubleshooting .......................................................... 22

Summary of Contents for EU

Page 1: ...Nimbus EU Ambulatory Infusion Pump Patient Manual Read this entire manual prior to operating the Nimbus EU Ambulatory Infusion Pump ...

Page 2: ...Ambulatory Infusion Pump 13 Infusion Mode 13 Pause Mode 13 Options 14 Pump Set Up and Programming 14 Section 3 Operating your Pump 15 Start or Resume the Infusion 15 Demand Bolus if enabled 15 Delay Start Infusion if enabled 15 Cancel a Delay Start 15 Retrieving and selecting the Current Rx 16 Resume Infusion New Infusion Menu 16 Infusion Display screen 17 Acknowledge an Alert 17 Stop or Pause the...

Page 3: ...______________________________________________________ Nimbus TM EU Patient Manual 560 IFU IT1098 Rev A 3 Pack and Wear Pouch 20 Section 4 Battery Replacement 21 Authorized Battery 21 Section 5 Troubleshooting 22 ...

Page 4: ...mber and title of symbol Description of symbol ISO 15223 1 2012 Medical devices Symbols to be used with medical device labels labelling and information to be supplied Part 1 General requirements 5 4 3 Consult instruction for use Indicates the need for the user to consult the instructions for use ISO 15223 1 2012 Medical devices Symbols to be used with medical device labels labelling and informatio...

Page 5: ... General requirements 5 3 2 Keep away from sunlight Indicates a medical device that needs protection from light sources ISO 15223 1 2012 Medical devices Symbols to be used with medical device labels labelling and information to be supplied Part 1 General requirements 5 3 7 Temperature limit Indicates the temperature limits to which the medical device can be safely exposed ISO 15223 1 2012 Medical ...

Page 6: ...ls Safety Colours and Safety Signs Registered Safety Signs Part 5 Registered Safety Signs M002 Refer to instruction manual booklet Indicates that failure to follow operating instructions could place the PATIENT or OPERATOR at risk MDD 93 42 EEC Annex XII CE Marking of Conformity Indicates the device meets essential requirements of MDD 93 42 EEC ...

Page 7: ...e patient s health care provider at all times when not under direct supervision As applicable provide the patient or caregiver with instructions for proper handling and or disposal of the pump the cassette administration set and the pouch If the Nimbus TM EU pump is used to provide medication or fluid therapy to any patient under the age of 18 that patient should during therapy and while having ph...

Page 8: ...ollapsible reservoir or syringe Attach the medication fluid container to the cassette administration set before attaching the cassette to the pump Prime the cassette administration set according to the instructions provided in this manual prior to connecting the cassette administration set to the pump Ensure that the entire fluid path is free of all air before connecting to the patient Carefully f...

Page 9: ...lose the slide clamp before removing the cassette from the pump Do not store the pump with a cassette administration set attached Do not place objects over the pump that may muffle the pump If the pump is not functioning as expected the pump should not be used and should be returned for inspection or repair There are no user serviceable parts inside the pump Refer all services repairs and calibrat...

Page 10: ...______________________ 10 Nimbus TM EU Patient Manual 560 IFU IT1098 Rev A Device Diagrams Front View Rear View Liquid Crystal Display LCD Keypad LED Indicator Cassette Cassette Latch Cassette Latch Lock Black Battery Compartment Product Labels ...

Page 11: ...or 3 seconds to pause the infusion BOLUS Press and release the BOLUS key to request a Demand Bolus delivery Hold the BOLUS key for 3 seconds to cancel a Delay Start infusion Note The pump has additional functions beyond those shown above These functions are intended to be used by medical professionals only Do not attempt to use these functions unless specifically instructed to do so and trained to...

Page 12: ...a full battery level This symbol indicates a medium battery level This symbol indicates a low battery level This symbol indicates an empty battery level 4 Alert This symbol will display if an alert condition is present 5 Prescription mode The pump is in Prescription mode 6 Pause The infusion is paused Note This table includes references to functions that are intended to be used by medical professi...

Page 13: ... is normal Along the bottom of the screen additional information is displayed about your infusion The letters VTBI followed by a number will tell you the remaining Volume To Be Infused VTBI before the therapy ends The letters VINF followed by a number will tell you how much medication has been infused so far during your infusion Next AB followed by a time will indicate when the next Auto Bolus dos...

Page 14: ...d to do so by a member of your clinical care team Your pump can be programmed to infuse medication using any combination of the following methods Basal Rate A continuous low volume infusion of medication Bolus A bolus dose of medicine that is delivered quickly A bolus can be programmed to function 2 different ways Demand Bolus When enabled a patient can press the BOLUS key to request an extra bonu...

Page 15: ...wn the Bolus volume indicating the medicine is being delivered Delay Start Infusion if enabled A delay start feature can be activated to extend the duration of therapy up to 24 hours longer without adding extra medicine to the IV bag The delay start function places the pump on hold to run in standby mode When the timer counts down to zero the infusion will automatically run without requiring any u...

Page 16: ...if a therapy was interrupted and the choice is to continue The pump picks up where it left off and continues the therapy 2 New Infusion Can be selected to infuse a new Rx All the therapy parameters are set to infuse from the beginning of the therapy Note The pump will detect from the infusion history whether or not a previous infusion was interrupted and left incomplete If completed or never run N...

Page 17: ...id bag icon will display at the top right corner of the screen A green LED light will display for 10 minutes indicating the infusion is actively running Note The LED will turn off after 10 minutes of operation and will remain off until any new key is pressed or an alert condition is detected This is normal Acknowledge an Alert In the event a condition that could interrupt an infusion is detected t...

Page 18: ...review Press the ENTER key to confirm the Rx and begin the infusion Or to turn the pump off press and hold ON OFF key for 3 seconds Infusion Complete When the infusion is completed the VTBI reaches 0 mL and the pump stops infusing The LCD screen displays the screen shown on the right indicating that the end of infusion state has been reached Three beeps of audio alert will sound and the LED flashe...

Page 19: ...Rev A 19 Power the Pump back on and Resume the Infusion Hold ON OFF key for 3 seconds to power on the pump Highlight Current Rx then press OK key to adance Press OK key to select Resume Infusion Press RUN STOP key initiating a review of the prescription and then press OK key to confirm and resume the infusion ...

Page 20: ...en close the Velcro straps tightly to hold the pump securely in the window Place the drug fluid bag in the bag chamber with the bag spike pointing left Fold the bag spike over the top of the medicine bag and route the upstream end of the tubing between drug fluid bag and pump carefully so that the tubing does not have kinks or occlusions Route the downstream end of the tubing carrying fluid to the...

Page 21: ...ays the message Battery Depleted or Power Off and Replace Battery Authorized Battery Only use batteries authorized by the manufacturer The quality of the battery is a significant factor in determining battery life and runtime Use of batteries from any other brands may yield unexpected performance and will invalidate the warranty To replace the battery Please contact your clinical care team for bat...

Page 22: ...as become dislodged Note The infusion will be stopped automatically The screen displays Cassette Loading Error the LED flashes a red light the audio alert sounds Press the RUN STOP key to acknowledge the condition and silence the alert Clamp the tubing unload and reload the cassette unclamp the tubing Press the RUN STOP key to return to the programming menu Press the RUN STOP key again to resume t...

Page 23: ...re than 10 minutes The screen displays Pump Unattended the LED shows a solid yellow light the audio alert sounds Press and release the RUN STOP key to acknowledge the condition and silence the alert The pump will return to the programming screen Press the RUN STOP key then follow the prompts to start or resume the infusion Or press and hold the ON OFF key for 3 seconds to power off the pump Note T...

Page 24: ...laying every 20 seconds the empty battery level indicator symbol flashes the LED shows a solid yellow light the audio alert sounds Press the RUN STOP key to suspend the infusion Press the ON OFF key for 3 seconds to power off the pump Replace the battery following the instructions provided in Section 4 Battery Replacement in this user manual Power Off and Replace Battery This battery has been used...

Page 25: ...e the parameter Enter the Clinician Code to unlock the prescription Change the value Press ENTER to confirm the new parameter Press the RUN STOP key to activate the change in the therapy Invalid Infusion Parameter The parameter value entered exceeds the remaining pump life The screen displays Invalid Infusion Parameter the LED flashes a red light the audio alert sounds Press and release the RUN ST...

Page 26: ...560 IFU IT1098 Rev A How to Load the Cassette 1 Engage the cassette fingers with the pump hinge 2 Press the cassette latch lock down and firmly push the cassette towards the pump 3 Release the cassette latch lock 4 Confirm that the 3 hooks on the cassette latch are fully engaged with the cassette ...

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Page 29: ...ect Going Home with a Nimbus EU Pump When the pump is running there will always be information available on the screen to reassure you it is functioning properly A fluid bag icon will display on the screen for as long as the medicine is infusing InfuTronix LLC 177 Pine Street Natick MA 01760 Email info infutronix com www infutronix com ...

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