The ambIT® PCA Pump is intended for use by a physician or by a trained individual under direct supervision of a physician. The ambIT® PCA Pump is used to infuse medicines and/or fluids into patients primarily for pain management. Modes of action are generally intravenous, epidural and/or regional.
Note: Any use of the Pump other than those indicated herein is regarded as an off-label use.
Note: Sorenson Medical Products, Inc. does not recommend or endorse any one specific medication to be used with the ambIT® Family of Pumps. The medical provider is the sole individual who decides upon the prescribed medication, pump programmed parameters, method and location of infusion.
Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
This product should only be used by a physician or by a trained individual under direct supervision of a physician.
Read instructions before use. The Pump must be used strictly in accordance with these instructions.
Safe use of this Pump is the primary responsibility of the user. The user is responsible for monitoring this Pump. Contact Clinical/Technical Support if Pump appears to be operating incorrectly.
All patients should be given a Patient Manual and instructed to read it carefully.
The Pump must be used only by the person for whom it is prescribed.
Patients should never perform any function or push any button unless instructed by their health care professional.
Do not allow the Pump to get wet. If the Pump is immersed in any liquid, it must be replaced with a new Pump.
Transport and storage conditions: -7ºC to 70ºC (20ºF to 158ºF), 10% to 90% relative humidity and 500 hPa to 1060 hPa atmospheric pressure.
Operating conditions: 10ºC to 43ºC (50ºF to 110ºF), 10% to 90% relative humidity and 500 hPa to 1060 hPa atmospheric pressure.
Never attempt to open the Pump case. Only the battery cover may be removed when changing batteries. If the Pump is dropped, it must be replaced with a new Pump.
This Pump is not to be used for infusion of blood or blood products.
This Pump is not to be used for infusion of life sustaining medications.
Failure to follow manufacturer’s instructions while replacing batteries may result in loss of program settings and report data. Dispose of batteries properly after use.
This Pump does not have an air in-line alarm. A Cassette with an air elimination filter is available.
Safety hazards such as under infusion may be associated with external radio frequency interference (RFI) or electromagnetic radiation. Typical equipment which may generate such radiation include x-ray machines, MRI equipment, and any other non-shielded electrical equipment.
Failure to use the approved Sorenson Medical Products, Inc. Remote Bolus Button could result in an inadvertent bolus dose.
When the desired Volume to be Infused has been delivered, and the "Infusion Complete" alert has sounded, the Pump will deliver a KVO rate (0.5 ml/hr) until the Pump is reset (history cleared) or turned off. If the Basal Infusion Rate is less than 0.5 ml/hr, the Pump will continue at the set basal rate.
The Pump should be programmed by a physician or under the direction of a physician. Patients should be instructed not to program the Pump or attempt to change the program.
Pump failure may be caused by the application of cleaning solutions other than those recommended by the manufacturer.
Do not immerse the Pump or sterile Cassette in any cleaning solutions.
When you program the Pump, any lockout time in effect will be cleared. A bolus dose could be requested and delivered immediately upon starting the Pump, and could result in serious injury or death.
Safety hazards are associated with the interconnection of other infusion systems. Refer to: Terry, Judy (Ed.), Intravenous Therapy, W. B. Sanders Co. 1995, pp 192–193.
The Cassette should not be used for infusion volumes greater than two (2) liters.
In order to minimize the possibility of infection, Cassettes should be changed in accordance with your institution's policies.
When the desired volume to be infused has been delivered, the empty solution container must be changed. Failure to do so may result in cessation of fluid delivery.
Before starting therapy, check that all connections are secure and there are no leaks in the fluid path.
Bolus and infusion history reports should never take the place of good clinical judgement. Always perform a clinical evaluation whenever interpreting these reports.
Infusing viscous solutions (e.g. D25W) into high pressures (e.g. approaching 300mm Hg) may decrease volumetric accuracy.