Stryker HydroSet - User Manual

HydroSet Mixing Instructions
A Step-By-Step Guide
Indications for Use
HydroSet is a self-setting calcium phosphate cement indicated
to fill bony voids or gaps in the skeletal system (i.e. extremities,
craniofacial, spine and pelvis). These defects may be surgically
created or osseous defects created from traumatic injury to the
bony. HydroSet is indicated only for bony voids or gaps that are not
intrinsic to the stability of the bony structure.
HydroSet cured in situ provides an open void/gap filler that can
augment provisional hardware (e.g. K. wires, plates, screws)
to help support bone fragments during the surgical procedure.
The cured cement acts only as a temporary support media and is
not intended to provide structural support during the healing process.
HydroSet is a self-setting calcium phosphate cement intended for
use in the repair of neurosurgical burr holes, contiguous craniotomy
cuts and other cranial defects as well in the augmentation or
restoration of bony contour in the craniofacial skeleton.
Note
For optimal performance store HydroSet between
18-22˚C for at least 1.5 hours prior to surgery.
Please see the pack insert for detailed information.
Step 1
Firmly click the Cement Delivery Syringe into
place in the inner
blister tray so it is at an angled
position with the finger loops resting on the
shelves of the tray.
Step 2
Inject all the liquid from the glass syringe into
the mixing bowl.
Step 3
Vigorously mix the powder and solution in
a circular motion for 45 seconds, ensuring
that all of
the solution has been distributed
throughout the powder.
Step 4
Transfer the HydroSet to the syringe by
pouring it into the side of the funnel. Use
spatula to assist.
Step 5
Remove pre-attached funnel by turning
counter-clockwise.
Step 6
Attach the supplied cannula by turning clockwise.
Please remove the plastic cannula cover.
Step 7
Screw the plunger rod into the plunger at the base
of the syringe, while keeping the cannula elevated.
Step 8
Position the syringe so the cannula is pointing
up and push the plunger rod to remove excess air.
STEP TOTAL
TIME
1
34
56
78
2
Mix
45 sec
Load
Syringe
1 min
45 sec
Inject &
Sculpt
2 min
Harden
4 min
45 sec
2 min
30 sec
*4 min
30 sec
8 min
30 sec
*Sculpting beyond 4 min
30 sec may inhibit the
cement setting properties

Summary

HydroSet Mixing Instructions

Step 1: Prepare Syringe

Firmly click the Cement Delivery Syringe into the inner blister tray at an angled position.

Step 2: Transfer Liquid

Inject all the liquid from the glass syringe into the mixing bowl.

Step 3: Mix Powder and Solution

Vigorously mix the powder and solution in a circular motion for 45 seconds until distributed.

Step 4: Transfer to Syringe

Transfer HydroSet to the syringe by pouring it into the side of the funnel, using a spatula.

Step 5: Remove Funnel

Remove the pre-attached funnel by turning it counter-clockwise.

Step 6: Attach Cannula

Attach the supplied cannula by turning clockwise and remove its plastic cover.

Step 7: Insert Plunger Rod

Screw the plunger rod into the syringe plunger while keeping the cannula elevated.

Step 8: Remove Excess Air

Position the syringe with the cannula pointing up and push the plunger rod to remove excess air.

Indications for Use

HydroSet is indicated for filling bony voids or gaps in the skeletal system, not for structural support.

Storage Note

For optimal performance, store HydroSet between 18-22°C for at least 1.5 hours prior to surgery.

Stryker HydroSet Specifications

General

Application	Bone void filler
Material	Calcium phosphate
Sterility	Sterile
Delivery Method	Injectable
Resorption	Resorbable