User Manual
37 Pages
Preview
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Caesarea Medical Electronics
NeoFeed® Enteral Feeding Pump User Manual
Table of Contents Introduction and Features Indications for Use Contraindications Operating Instructions: Pump Overview Operating Instructions: Pump Controls Operating Instructions: Set-Up Power On Pre-Loading Syringe Installation Syringe Detection and Confirmation Operating Instructions: Programming a Delivery Set Delivery Volume Set Delivery Duration and Rate Confirm Delivery Rate Limits Confirm Delivery Parameters Special Operations: During a Delivery To Check Delivery Status To Check Delivery Progress To Adjust the Rate To Stop or Interrupt Delivery To Check Battery Status (if running on battery back-up) Special Operations: While Pump is Stopped To Power Down To Perform Partial Power Down To Lock the Keypad General Operation: Special Display Messages When the Pump Displays the ‘End Delivery’ Message General Operation: Info Menu Screens General Operation: Error Alarm Screens General Operation: Event Log Troubleshooting Alarms and Alerts Guide to Symptoms and Causes Basic Pump Care Cleaning Storage Batteries and Power Product Specifications Warnings and Precautions Warnings Precautions Maintenance and Service Terms Marked on Pump Technical Support Ordering Information NeoFeed Enteral Feeding Pump/To Place an Order Warranty
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Caesarea Medical Electronics
NeoFeed® Enteral Feeding Pump User Manual
Introduction CME NeoFeed Enteral Feeding Pumps and Syringes comprise the first dedicated system for delivering enteral feeding. These products represent a breakthrough in safety by preventing enteral tubing misconnections to parenteral lines. As a result, they safeguard fragile patients. The CME NeoFeed product line includes a dedicated enteral feeding pump and enteral feeding syringes. NeoFeed syringes feature a unique dispenser tip that cannot be connected to a luer connection or needleless valve. They are also clearly marked for enteral use only and feature an “enteral orange” stripe as an additional visual indicator. Professional and regulatory organizations concur on the importance of preventing enteral misconnections. In its April 3, 2006 Sentinel Event Alert, the Joint Commission on Accreditation of Healthcare Organizations (TJC) stated that standard luer syringes should “never” be used for oral medications or enteral feedings. Devices that incorporate a forcing function – physically preventing misconnection – offer the optimal patient safety and compliance solution. CME NeoFeed products combine this forcing function with distinctive labeling to ensure safe connectors for enteral delivery.
NeoFeed Enteral Feeding Pump Features The NeoFeed Enteral Feeding Pump is simple to operate. It is small and lightweight, making it ideal for use in a variety of settings. The back-up battery power feature provides added flexibility to the user. The NeoFeed Pump delivers contents of 3 to 60 mL syringes over a specific duration and rate in milliliters per hour, adjustable to 0.1 mL. The pump has multiple safety features including: • Three-point syringe detection that recognizes the CME NeoFeed Enteral Syringes exclusively • Sensors that signal alarm if the syringe is removed or partially displaced during delivery • Display screens that continuously provide delivery volume, rate, and duration information • Event Log that records details of each delivery • Alarms and alerts that call attention to situations requiring action • Bold enteral pink labeling for a visual cue that the pump is for enteral use only • Controls that are easy to read and use • Pump design that requires little maintenance and is easy to clean NOTE: This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. NOTE: The user that changes or makes modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. 2
Caesarea Medical Electronics
NeoFeed® Enteral Feeding Pump User Manual
Indications for Use The NeoFeed Enteral Feeding Pump is designed for delivery of enteral fluids at precisely controlled delivery rates. It is designed for enteral feeding only. NOTE: The NeoFeed Enteral Feeding Pump is a medical device designed for the safe, accurate delivery of appropriate enteral treatments and should only be operated by, or under the supervision of, a medical professional. Incorrect or inappropriate use could lead to serious injury or death.
Contraindications •
• • •
Infusion of blood and blood products. Infusion of insulin. Infusion of critical medications whose stoppage or interruption could cause serious injury or death. Use in ambulatory regimens by patients who do not possess the mental, physical or emotional capability to self-administer their therapy; or who are not under the care of a responsible individual.
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NeoFeed® Enteral Feeding Pump User Manual
Operating Instructions: Pump Overview
Protective Cover Barrel Clap Arm
Yes/Start Stop/No Plunger Holder/Actoatur
On/Off
Display Screen Flange Holder
Information
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Caesarea Medical Electronics
NeoFeed® Enteral Feeding Pump User Manual
Close-Up: Flange holder
Close-Up: Plunger holder/actuator
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Caesarea Medical Electronics
NeoFeed® Enteral Feeding Pump User Manual
Operating Instructions: Pump Controls Control/Indicator
Function Indicator Light • GREEN: ◦ Lights during system self test ◦ Intermittent green light indicates delivery in process •
RED: ◦ Lights when the pump is in stand-by mode during programming process ◦ Continuous red light indicates alarm
•
On/Off Button ◦ Turns pump on and off
•
Yes/Start Button ◦ Confirms choices during programming ◦ Starts delivery
•
No/Stop Button ◦ Takes user back a step during programming ◦ Stops delivery
•
+ Plus Button ◦ Scrolls between operations
•
- Minus Button Scrolls between operations
◦
•
Info Button ◦ Presents delivery status and technical data ◦ Locks and unlocks keypad
•
> Button ◦
•
Adjusts position of actuator (plunger holder) for syringe loading
< Button ◦
Adjusts position of actuator (plunger holder) for syringe loading
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Caesarea Medical Electronics
NeoFeed® Enteral Feeding Pump User Manual
Operating Instructions: Set-Up Power On 1. Check that the power cord is connected to the back of pump. The cord can be plugged into any wall outlet. NOTE: The pump will function on back-up battery power, but connection to wall power is recommended whenever possible.
2. Press the On/Off button. The screen will display the NeoFeed home screen.
NeoFeed Feeding System Version CME010609 ID: Enteral Pump
The pump then advances to the Pre-Loading Screen
Pre-Loading 1. The pump automatically begins a pre-loading sequence. 2. The display screen indicates Pre-Loading and the actuator will begin to move.
Pre-Loading Press NO to Interrupt
NOTE: Pre-Loading is not required. To bypass this step, press NO to proceed.
However, during pre-loading, the actuator returns to the start position of the last delivery setting. If the same syringe and delivery volume will be used again, the actuator will return to the correct position and will not require manual adjustment.
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Caesarea Medical Electronics
NeoFeed® Enteral Feeding Pump User Manual
Operating Instructions: Set-Up Syringe Installation
Load Syringe
Following the pre-loading OR interrupted pre-loading step, the pump displays Load Syringe to prompt the user to begin syringe installation.
1. Adjust actuator (plunger holder) position: a. With the barrel clamp arm in the down/unengaged position, hold the syringe so that the syringe finger flanges are parallel to the flange holder.
Finger flanges
Barrel clamp arm
Flange holder
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Caesarea Medical Electronics
NeoFeed® Enteral Feeding Pump User Manual
b. Holding the syringe in this position, press the > or < buttons to adjust the position of the actuator so that it is parallel to the end of the plunger. Repeated > or < presses may be necessary.
End of Plunger
Actuator (plunger holder)
c. When pressing the > or < buttons, press in pulses only. Do not apply continuous or sustained pressure as this may cause the mechanism to jam.
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Caesarea Medical Electronics
NeoFeed® Enteral Feeding Pump User Manual
2. Load the syringe a. Lift and turn the barrel clamp arm. b. Place the lower flange in the flange holder. c. Place the end of the plunger into the actuator. d. Lower the clamp arm so that it rests on the syringe barrel. Plunger end in actuator Barrel clamp arm
Lower flange seated in flange holder
3. Check the following: a. Lower flange is seated properly in the flange holder. b. End of the plunger is aligned to the center of the actuator. c. Barrel clamp arm is in the engaged position.
a b c
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Caesarea Medical Electronics
NeoFeed® Enteral Feeding Pump User Manual
Operating Instructions: Set-Up
Once the syringe is correctly seated, the pump will display the syringe size. Syringe is properly loaded. Screen displays syringe size for confirmation.
Syringe Detection and Confirmation 1. Check the display to confirm that the pump has identified the correct syringe size. 2. If the correct data is not displayed, scroll up or down (+ or -) to select it.
35 mL Baxa
20 mL Baxa
Press YES to confirm or +/- for select
Press YES to confirm or +/- for select
Press the Yes/Start button to confirm that the correct syringe size is displayed.
WARNING: If the volume displayed after loading the syringe is significantly different than the volume visually confirmed on the syringe scale, remove the syringe, turn off the pump, remove the pump from use and return to an authorized service centre for inspection, testing and re-calibration.
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Caesarea Medical Electronics
NeoFeed® Enteral Feeding Pump User Manual
Operating Instructions: Programming a Delivery Set Delivery Volume If the previous feed used a different syringe size, the pump defaults to the ‘Set Delivery Volume’ screen. If the previous feed used the same syringe size, the pump defaults to the Resume screen below.
Press YES to Resume, No for New Delivery
1. After the syringe size has been confirmed, the
pump calculates and displays the deliverable volume in the syringe. 2. If necessary, adjust the volume to be delivered
35 mL Baxa
Volume 30.0mL Change +-, Press YES
by pressing the plus or minus (+ or -) buttons. 3. Press YES to confirm desired volume.
a. Press YES to resume the identical delivery as was programmed for the last feed. • The pump then defaults to the Summary screen, and no changes can be made to the delivery parameters. b. Press NO to continue programming a new Delivery. • Always press NO if any change to the delivery parameters (volume, duration, or rate) is required.
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Caesarea Medical Electronics
NeoFeed® Enteral Feeding Pump User Manual
Operating Instructions: Programming a Delivery Set Delivery Duration and Rate 35 mL Baxa Volume 30.0mL Duration 02:00
Rate
15.0mL/h
Change +-, Press YES
1. After the delivery volume is confirmed, the display prompts the user to set
the delivery duration. 2. The pump will automatically calculate and display the rate (in mL per
hour) required delivering the set delivery volume over the selected duration. 3. Press Yes to confirm the 2 hour default OR 4. Use the plus or minus (+ or -) keys to increase or decrease the rate. 5. Press Yes to confirm desired rate and duration.
NOTE: Since rate and duration are directly related, based on the set delivery volume, adjusting the rate (increasing or decreasing) automatically results in a change in the duration. a. If the feeding delivery is to be provided at a specific rate: • press the + or - buttons to directly adjust the rate to the desired mL/hour. b. If the feeding delivery is to be provided over a specific duration: • adjust the rate by pressing the + or – buttons until the desired duration is displayed.
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Caesarea Medical Electronics
NeoFeed® Enteral Feeding Pump User Manual
Operating Instructions: Programming a delivery Confirm Delivery Rate Limits 1. After the delivery rate and duration are selected, the pump prompts the user to
confirm or adjust Delivery Rate Limits. • This step provides an extra safety parameter and is designed to allow rate/duration adjustments during an enteral delivery, without requiring the user to stop the delivery and reprogram the pump. • The limits prevent any mid-delivery adjustment (intentional or accidental) outside the specific maximum and minimum rate range selected by the user. 2. The pump defaults to the following: • The maximum delivery limit = double the set rate. • The minimum delivery limit = half the set rate. 3. The defaults depicted below are based on a programmed delivery rate of 15 mL/hour.
Maximum Delivery Limit
30.0mL/h Change +/-, Press YES
Minimum Delivery Limit
7.5mL/h Change +/-,Press YES
4. These limits can be adjusted if necessary by pressing the + or – buttons. 5. The user also has the option to accept the default limits and proceed with
programming.
NOTE: The pump is designed to deliver at rates ≤ 120 mL/hr. If the maximum limit calculation (double the programmed rate) is larger than the 120 mL/hr maximum pump delivery rate, the maximum limit will default to and display 120 mL/hr. WARNING: Do not enable this function for patients in a home setting.
WARNING: Set a Maximum Rate limit from the Change Set Up menu to ensure that healthcare provider titration settings are limited to prevent accidental over infusion.
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Caesarea Medical Electronics
NeoFeed® Enteral Feeding Pump User Manual
Operating Instructions: Programming a Delivery Confirm Delivery Parameters 1. After the Delivery Limits are confirmed, the pump displays
a program Summary screen, including: a. installed syringe size b. programmed volume c. delivery duration d. ordered rate e. selected delivery limits
35 ml Baxa Volume 30.0ml Duration 02:00
Rate
15.0ml/h
Delivery limits 7.5 – 30.0 mL/h ml/h XX.XX – XX.XX Confirm, Press YES
2. If all parameters are correct, press YES to confirm and proceed.
Start Delivery
Start Delivery?
1. When the pump prompts Start Delivery, confirm the following: a. The pump’s power cord is plugged into the wall. b. The pump is on a stable surface or securely seated in the clamp and attached to the pole. c. All connections on the enteral syringe/feeding tube set-up are secure. d. The feeding tube extension set (if required) is attached to feeding tube. e. Any clamps are released and there are no kinks in the tubing. 2. When these checks are complete, press YES to begin feeding delivery.
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Caesarea Medical Electronics
NeoFeed® Enteral Feeding Pump User Manual
Special Operations: During a Delivery To Check Delivery Status Time Remaining 01:59
1. Check the display screen to confirm that the pump is running at the correct delivery rate. 2. Check that the Pump Delivering message appears on the display screen.
To Check Delivery Progress 1. Press the Info ( i ) button to display a real-time update of: a. Volume To Be Delivered (VTBD) b. Volume Delivered (VD)
Rate 15.0mL/h <<<<Pump Delivering 35 mL Baxa
Delivery Summary VTBD 13.5
VD 26.1
2. Pump switches back to Pump Delivering screen after 5 seconds.
To Adjust the Rate If the delivery rate or duration must be altered during the delivery: 1. 2. 3. 4.
Press the + or – buttons to increase or decrease rate accordingly. Press YES to accept the new parameters. The pump displays the new rate and delivery time. If YES is not pressed after rate is adjusted, the pump defaults back to the delivery rate as initially entered.
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Caesarea Medical Electronics
NeoFeed® Enteral Feeding Pump User Manual
Special Operations: During a Delivery To Stop or Interrupt Delivery 1. Press STOP/NO 2. Pump displays:
Pump Stopped Press YES to Resume
3. At this point, the only options are: a. Press YES to Resume Delivery b. Press the On/Off button to power down
To Check Battery Status (if running on battery back-up) 1. Press the Info ( i ) button twice to display the current battery charge level.
Battery Level ▓▓▓████████████□ 30%
Empty
Full
2. Pump switches back to Pump Delivering screen after 5 seconds
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Caesarea Medical Electronics
NeoFeed® Enteral Feeding Pump User Manual
Special Operations: While Pump is Stopped To Power Down 1. Pump can only be powered down if it is in stop mode. 2. Press the On/Off button. 3. Pump displays:
██████████████ OFF WAIT FOR BEEP
4. Keep On/Off button depressed until the pump beeps and the screen is
blank.
To Perform Partial Power Down 1. Follow Power Down Steps 1 and 2. 2. Release the On/Off button prior to the beep. 3. The pump will first display:
35 mL Baxa Press YES to continue
4. Press YES to confirm the correct syringe size. 5. Pump then displays:
Press YES to Resume, No for New Delivery
a. If YES is pressed: The pump displays the Summary screen, allowing the user to resume the delivery from the same point at which it was stopped, with the previously selected parameters. b. If NO is pressed: The pump defaults to the Set Delivery Volume screen, and requires a new program with new delivery parameters (volume, rate, and time) to be selected and confirmed.
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Caesarea Medical Electronics
NeoFeed® Enteral Feeding Pump User Manual
Special Operations: While Pump is Stopped To Lock the Keypad 1. Press and hold the Info ( i ) button for two seconds to enable the lock
option.
Keypad
Keypad Lock
Low Battery
Locked OFF
ON
2. All buttons except STOP, YES and Info ( i ) are locked (cannot be used)
when lock option is enabled. 3. Press and hold the Info ( i ) button for two seconds to disable the lock.
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Caesarea Medical Electronics
NeoFeed® Enteral Feeding Pump User Manual
General Operation: Special Display Messages 1. If the user has not pressed a key for two minutes during the set up or programming process:
Pump Paused Too Long Press YES to Resume
2. 15 minutes before delivery is complete:
Near End 3. When delivery is complete:
End Delivery Press YES to Confirm
When the Pump Displays the ‘End Delivery’ Message a. Remove the syringe and power down. b. If another syringe is required (i.e., for ‘continuous’ feed orders or large-volume feeds), remove the syringe, perform the ‘Partial Power Down’ and proceed with standard set up and programming process. NOTE: As an added convenience, the pump is designed to ‘remember’ and default to the previous delivery’s parameter settings.
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