5
B - General Warnings
To reduce potential risks to patients and healthcare providers.
The T34 is a medical device designed for the safe, accurate delivery of appropriate infusion
regimes and should only be operated by, or under the supervision of, a medical/healthcare
professional.
For pumps used in a home setting, once the prescription has been programmed into the
pump, lock the system to ensure that the program cannot be changed by the patient.
The equipment is not suitable for use in the presence of flammable anesthetic gas
/oxygen/nitrous oxide mixture. Do not use the system in environments where these agents
are present.
Do not use the T34 pump in the presence of high-intensity magnetic fields (e.g., MRI
scanners). Exposure to strong magnetic fields may impair the operation of the pump
and/or the accuracy of the infusion.
Never take a syringe that is not empty off the pump if it is still connected to the patient.
Before removing the syringe, the infusion line must be disconnected or clamped to
prevent free flow. Depending on the medication and route of administration, free flow
into the patient may cause serious injury or death.
Before connecting to the patient, purge all air from the syringe and the administration set.
Depending on the route of administration and the volume of air, air emboli infused into
the patient may cause serious injury or death.
Patients using the T34 Syringe Pump on their own, or individuals responsible for helping
a patient using the pump, must be instructed in its proper use.
Adjustments, maintenance, or repair made by un-certified service personnel may impair
the operation of the T34 System and/or the accuracy of the infusion. Make sure any
adjustments, maintenance, or repair of the device is carried out by authorized skilled
technicians trained by the T34 distributor.
Dropping the Syringe Pump could cause damage to components. If the pump is dropped,
return the pump for inspection by qualified service personnel.
Use good aseptic technique when filling the syringe and priming the infusion set. Patient
infection may result from the use of non-sterile components. Maintain sterility of all
disposable components and do not re-use single use IV sets.
Immersing the T34 Syringe pump in liquid could cause damage to components. Do not
immerse the pump into any type of liquid.
Caution: Federal [USA] Law restricts this device to sale by, or on the order of, a
physician.