Indications; Contraindications; Warnings; Precautions - Codman MedStream Gebrauchsanweisung

ENGLISH
IMPORTANT INFORMATION
Please Read Before Use
MedStream™ Bolus Kit (REF 91-4284)
Become thoroughly familiar with the information contained in this user
manual prior to administering a bolus into a MedStream Programmable
Infusion System. Failure to adhere to these instructions can result in patient
complications, such as a drug overdose.
For additional information, refer to the user manual packaged with the
infusion pump.

Indications

The MedStream Bolus Kit is used access the bolus port of a MedStream pump.
The pumps are indicated for the intrathecal infusion of the drugs listed below.
• For use with preservative-free morphine sulfate sterile solution in the
treatment of chronic pain
• For use with preservative-free baclofen sterile solution (5.0–7.0 pH) for relief
of spasticity
Use preservative-free sterile solution of 0.9% sodium chloride (4.5–7.0 pH) to
achieve the physician-prescribed drug concentration.
WARNING: Use only the drugs and diluent listed above with the
MedStream pump.
WARNING: Refer to the appropriate drug labeling for a complete list of drug
indications, contraindications, warnings, precautions, adverse reactions,
dosage and administration information, screening procedures, and
overdose procedures.

Contraindications

There are no known contraindications for the use of the Bolus Kit.
Observe all contraindications relating to the use of the prescribed drug.
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WARNINGS

Improper use of implanted infusion pumps could result in drug under- or overdose.
Users must comply with product instructions for injecting into the bolus port of the
pump. Only qualified medical personnel must perform these procedures.
Do not mix drugs. The effects of mixing drugs in the pump are not known.
Use only the drugs and diluent listed in Indications with the MedStream pump.
The physician must consider the drug concentration, dose and flow rate
relationships of the pump before selecting the pump volume and flow rate.
Failure to consider these factors can lead to a drug under- or overdose.
Never inject into the pump catheter or the intraspinal catheter; a drug under- or
overdose or damage to the catheter can result.
Injection in the bolus port or into the pump pocket can result in drug overdose.
To prevent injection errors:
• identify the location of the central port and the bolus port;
• use the bolus needle provided in the MedStream Bolus Kit for accessing the
bolus port.
When the bolus channel has been rinsed, intrathecal delivery of the drug solution
from the drug reservoir will be delayed until the solution traverses the total
catheter length. Carefully calculate the amount of the delay, based on the total
catheter length and the flow rate, before administering additional medication by
another delivery method.

Precautions

Inspect the sterile package carefully. Do not use if:
• the package or seal appears damaged,
• contents appear damaged, or
• the expiry date has passed.
The Bolus Kit is for single use only. Do not reuse.
Use sterile technique in all phases of handling this product.
The catheter(s) of an implanted pump system are filled with infusion solution.
During a bolus injection, the patient receives an additional bolus of the drug,
which is approximately equal to the contents of the catheter(s). To prevent drug
overdose during injection through the bolus port, aspirate fluid to ensure drug
removal. Use the MedStream Control Unit to access the catheter volume of the
implanted pump (refer to the MedStream System Programming Guide).
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