Contraindications; Intended Patient Population; Intended Operators/Users; Required Skills/Operator Training - Riester metpak Mode D'emploi

The infusion rate is determined by the height of the pressure and the flow rate
of the IV cannula.

1.4.2 Contraindications

Any other use or use that goes beyond the above mentioned use is not in ac-
cordance with the intended use. The manufacturer is not liable for any damage
that may result from such use. The risk is borne solely by the user.

1.4.3 Intended patient population

Pressure infusion devices are intended for patients ranging from pediatric to
geriatric patients.
1.4.4 Intended operator/user
The pressure infusion devices are for outpatient and inpatient care and are
used by doctors in hospitals, medical institutions, clinics, and doctor's offices.

1.4.5 Required skills/operator training

The user must be a licensed physician, nurse, or similar licensed clinician.
All functions, ports and connections are clearly explained in the user manual.
The user must adhere precisely to the specifications of the user manual.

1.4.6 Environmental conditions

The device is intended for use in a controlled environment.
The device must not be exposed to any adverse/harsh environmental condi-
tions.
1.5 Warnings / Caution
Regulate the amount of infusion via the clamp on your infusion set. Follow the
manufacturer's instructions exactly.
Never exceed the maximum pressure of 300 mm Hg indicated on the manometer.
Do not connect the metpak to other pressure-generating devices.
The cuff cover must not be ironed!
Never expose the cuff to intense sunlight!
Avoid touching the cuff cover, the bulb, the pad or the tubes with pointed
objects!
When using 70% isopropyl alcohol, ensure that the room is well ventilated!
Do not use in the vicinity of fire-triggering devices or fire.
Never place the metpak pressure infusion device in liquids!
Pressure infusion devices
The metpak device is not approved for machine reprocessing and sterilization.
This will lead to irreparable damage!
All serious incidents occurring in connection with the product must be repor-
ted to the manufacturer and the competent authority of the Member State in
which thethe user and/or the patient is a resident.
12