Instech Blog

The Interface Between Syringe Pump and Human

In the first blog post in this series we identified over 40 potential sources of error when a syringe pump delivers a dose, all of which we considered when designing our new infusion pump for laboratory animal research. In this second post we will focus on the interface between the pump and the operator.

Potential sources of error in delivering a dose from a syringe pump
Operator
Data input error
Entered incorrect flow rate
Entered incorrect dose volume or time
Selected wrong units
Selected wrong syringe from lookup table
Entered wrong syringe ID for custom syringe
Did not start pump on time
Unintentionally stopped pump
Set pump to withdraw instead of infuse
Dislodged syringe
Pump
Not moving pusher block/arm at expected rate
Motor speed variability*
Lead screw pitch tolerance*
Thread gap when engaging lead screw
Clutch not engaged/riding on top of lead screw
Pump components compressing or deflecting*
Pulsatile flow timing error*
Software error
Power failure - power outage
Power failure - cord disconnected
Power failure - battery dies
Faulty occlusion or other alarm
Pusher moving correctly but not moving plunger at expected rate
Gap between pusher and syringe
Syringe not perpendicular to pusher
Syringe siphoning
Syringe
Inner diameter variability
Manufacturing variability*
Variability in design
Expansion/contraction due to temperature*
Expansion due to pressure*
Syringe plunger compression*
Syringe plunger sticks
Infusion set and catheter
Air in line
Bubbles not cleared
Line not primed
Air permeating through tubing
Air coming out of solution
Expansion of infusion set*
Occlusion
Blockage/clot
Kink
Clamp not opened
ID restriction too great for given flow rate
Leak
Puncture
Loose connection
Rupture under pressure
Evaporation
Laminar flow*

 

For an example of how critical the user interface can be, consider the case of the Alaris SE pump, a hospital pump that had an occasional problem with key bounce: you would press a button once and it might register it twice. This is a common problem with certain types of mechanical buttons; however, if you were setting the flow rate and you didn’t notice the error you might infuse 11 mL/hr instead of 1mL/hr. In 2006, federal agents showed up at the manufacturer and seized all the devices in production. Over 140,000 pumps were recalled.

Syringe Pump User Interfaces (Ease of Use)

While the FDA is not concerned with laboratory pumps, errors caused by a user interface that is confusing or overly complex can harm animals and ruin a study. Syringe pumps are relatively unique among electronic devices in that designs that are decades old are still in use, so there are a wide range of interfaces based on the technology that was available at the time the pump was designed.

Pump

Interface Type

How to Deliver 1mL over 30 min with BD 3mL syringe

Med Associates PHM-210

Med Associates PHM-210

  • Knob to set motor RPM (0.1-30)
  • Numeric display of RPM
  • 2 rocker switches
  • Calculate required RPM from Flow rate (mL/min)=0.19538 x RPM x Syringe Cross Sectional Area (cm2)
  • Start pump
  • Stop manually after 30 min

New Era NE-1000

New Era NE-1000

  • 4 digit numeric display
  • 8 red LEDs
  • 9 buttons
  • Enter syringe ID of 8.585mm using up arrows under digits
  • Set volume units to mL
  • Set volume to 1.00 using up arrows
  • Set rate units to mL/hr
  • Set rate to 2.00 using up arrows
  • Press "Start"

Baxter AS-50 / SAI 3D

baxter-tight-vert

 

  • 5x11cm LCD display
  • 9 LEDs
  • 21 buttons
  • Select “mL/hr” mode (one of 18 modes)
  • Select “B-D” as manufacturer
  • Select 3mL as syringe size
  • Enter 2 for rate
  • Enter 1 for volume
  • Press "START"

OrchesTA™ Model 100

OrchesTA Model 100

  • 6.5x6.5cm LCD display
  • 4 alarm/status LEDs
  • 26 buttons
  • Select rate mode, “ML/HR” (one of 14 modes)
  • Select “B-D” as manufacturer
  • Detects 3mL syringe; confirm
  • Enter 2 for rate
  • Enter 1 for volume
  • Press "Deliver"

Harvard Apparatus 11 Elite

Harvard Apparatus 11 Elite

  • 9.5x5.5cm 480x272 color touchscreen
  • 1 green power LED
  • Press "Syringe Select", choose “BD plastic”, 3mL, confirm
  • Press "Infusion Rate Select", enter 2, press units, choose mL, choose hr, confirm
  • Press "Target Volume/Time Select", enter 1, press units, choose mL, confirm
  • Press "Start"

Instech Model 400

 

  • 9.5x5.5cm 800x480 color touchscreen
  • 1 status LED
  • 4 buttons
  • Select “BD Plastipak”
  • Detects 3mL; confirm
  • Enter 2 in flow rate, select mL/h
  • Enter 1 in target volume, confirm
  • Press "Start"
 
Syringe Detection

Syringe pumps are only accurate if the inner diameter of the syringe is correctly used to calculate flow rate. Old Harvard Apparatus and New Era pumps require you to know and enter the syringe diameter in mm yourself. If the diameter you enter is incorrect, your flow rate will be incorrect.

In a real example, for many years Harvard Apparatus reported the inner diameter of the BD 1mL plastic syringe as 4.78mm. Somewhere along the way, perhaps due to a manufacturing revision by BD, it changed to 4.699mm. If you are still using the old figure, on average your flow rate will be 3.4% lower than what you have entered on the pump.

Newer laboratory pumps have syringe libraries with the inner diameters programmed in the pump. They should display the inner diameter as well as the syringe pump so that you can double check that it matches your syringe. However, there is nothing preventing you from selecting a different syringe from the one you are using, which will likely lead to a large error in flow rate. Note the message on the Harvard 11 Elite screen: “Make sure to select the right syringe.”

Manufacturers of clinical pumps cannot tolerate this flow rate error risk, so those pumps have sensors that measure the outer diameter of the syringe to confirm or in some cases auto-detect the installed syringe. These sensors have the added benefit of being able to detect if a syringe has become dislodged, another potential cause of a large dose error. The downside of a clinical pump is that if you want to use a syringe that is not in the library, you are out of luck.

The new Instech model 400 pump is the first laboratory pump with syringe detection. It also allows you to enter a custom syringe if yours is not in the library - the best of both worlds. Furthermore, the shape of the pump is such that syringes do not extend past the frame, offering protection against dislodgment.

sp-tight

Infuse vs Infuse/Withdraw

Many industrial syringe pumps have the ability to withdraw as well as infuse. In most cases this is a simple button which could be pressed accidentally. Certain older Harvard Apparatus model 11 pumps even have a toggle switch on the back of the pump; if it is set to withdraw you cannot tell from the front.

ha-flow-switch

This blog series is about accuracy, and withdrawing instead of infusing creates a ridiculous -200% flow rate error, but the real issue here is animal safety. Blood will fill the catheter and clot; the animal will be lost if the mistake is not caught quickly. For animal welfare, our recommendation is that pumps that have the ability to withdraw should never be used in animal infusion studies.

In summary, do not discount the user interface as a significant factor in a pump's ability to deliver accurate doses in real world situations. Stay tuned for our next post where we will look at a syringe pump’s ability to infuse accurately when pumping at the low end of rates used in animal studies.