Heraeus PALABOWL Gebrauchsanweisung Seite 4

EN
PALABOWL
1. Medical Device
1) Device name: PALABOWL
2) Model No.: CL006-01
3) REF: 5050166
2. Indications (Intended Use)
1) The Bone Cement Mixing System is for mixing of the bone
cement powder and liquid monomer.
2) This device can mix up to three units (total 120 g powder)
of bone cement of any viscosity.
3. Working principles
The Bone Cement Mixing System's rotating axis paddle allows
for a thorough cement mix of all angles without unmixed
powder collecting at the edges of the bowl. While mixing,
vacuum removes air via a filter from the bowl to reduce
porosity of the cement and cement fume.
4. Specification
1) Mixing bowl size (ID × H): About 106 mm × 72 mm;
Vacuum hose size (length): About 2.4 m.
2) Net weight: Not more than 0.3 kg.
3) Air tightness: There is no leak under negative pressure
75 kPa ± 1k Pa.
4) Vacuum hose: The vacuum hose shall not shrink under
negative pressure 75 kPa ± 1 kPa.
5) Mixing paddle: The Mixing paddle can rotate freely under
negative pressure 75 kPa± 1 kPa.
6) Sterilization: Sterilized using ethylene oxide before
delivery.
7) Valid period (Shelf life): Three years.
8) The maximum allowable negative pressure value during
operating: 73 kPa (550 mmHg).
9) To reach the negative pressure value 73 kPa (550 mmHg)
needed time: about 25 s.
(6)
(1)
(2)
®
Bone Cement Mixing System
®
(5)
5. Components
1) This device consists of Vacuum Mixing bowl, Mixing
paddle, Spatula, Curette, Vacuum hose and Rotating
handle.
2) Associated devices: The Bone Cement and Vacuum
extractor are not included in this device.
6. Warning and Precautions
1) This device shall only be operated by qualified
professionals.
2) The bone cement powder and liquid monomer are not
included in this device but prepared by the hospital.
The bone cement must be prepared according to the
instructions for use provided by the bone cement
manufacturer.
3) The Vacuum extractor is not included in this device, but
prepared by the hospital. The negative pressure within the
range of 5 kPa to 75 kPa shall be adjustable.
4) This device is sterilized using ethylene oxide before
delivery. Sterilization validity is three years.
5) This device is for single patient use only. Do not reuse
and do not re-sterilize.
6) Follow current local/national regulations to properly
dispose the device after use.
7) During transportation of this device, prevent severe shock,
vibration, rain/snow, direct sunlight, moist and pressure.
8) This device should be stored in a non-corrosive, cool, dry,
and ventilated environment.
7. Operating instructions
1) Inspect the package prior to each use. Do not use the
device if package is damaged.
2) Read the instructions for use, attached documents
and labels.
3) Open the package, take out the product and operate the
device according to following figures:
(3) (4)
4
(1) Mixing bowl
(2) Mixing paddle
(3) Spatula
(4) Curette
(5) Vacuum hose
(6) Rotating handle