Heraeus PALABOWL Instructions For Use Manual

Bone Cement Mixing System

Instructions for use

EN

PALABOWL

®

1. Device name

1) Device name: PALABOWL® Bone Cement Mixing System

2) Type: CL006-01

3) REF: 5050166

2. Indications

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): 106mm × 72 mm; Vacuum hose
size (length): 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: Two 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.

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 two 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 if
packaging 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:

08611

(5) (3) (4)

(6)

(1)

(2)

2

(1) Mixing bowl
(2) Mixing paddle

(3) Spatula

(4) Curette
(5) Vacuum hose
(6) Rotating handle

1.

Place the bowl on a
flatsurface and open
thelid.

2.

1

Connect the shorter end
of the vacuum hose to the
vacuum pump and the
opposite end (longer end)
to the lid.
If conditions permit,
adjust negative pressure
to the optimal range

2

between 65 kPa to
73kPa.

3.

5.

2

7.

2

1

Pour the single compo­nents into the bowl
according to the instruc­tions provided by the

cement manufacturer.

Start the vacuum and
begin mixing for about
45seconds or according
to the instructions for use
of the bone cement.

1

Turn the lid counterclock­wise and remove the lid.

4.

1

2

6.

2

8.

Close the lid and twist
clockwise to lock.

Once mixing is complete,
stop the vacuum and
remove the vacuum hose.

1

To scrape the bone
cement on the mixing
paddle into mixing bowl
by using spatula or

curette.

9.

Remove the thoroughly
mixed bone cement with
the spatula.

3