| 1. |
What`s the
HemaClear® made
of?
The HemaClear® is made of silicone ring wrapped in
a stockinet sleeve and 2 pull handles.
 |
| 2. |
How does
the HemaClear® work?
The surgeon places the HemaClear® silicon ring on
the patient`s fingers or toes and then pulls the handles
proximally. The ring rolls up the limb and the stockinet
sleeve unfolds. During the rolling up the limb, the ring
exerts pressure and squeezes the blood away from the limb,
performing the exsanguinating (blood removal) function
quickly and effectively.
When the ring reaches the occlusion site, the pulling motion
is stopped. The ring exerts pressure on the limb at this
position, blocking arterial blood flow into the limb and
performing the occlusion function.
During the motion over the limb, the stockinet sleeve unfolds
onto the limb, covering it entirely up to the occlusion
level providing a sterile cover of the surgical field.
The entire motion on the limb from fingers or toes to the
occlusion
location, takes less than 12 seconds. *
* de Kiewiet G P. Moving to a new type of sterile and single
use tourniquet for orthopaedic surgery. Orthopaedic Product
News 2006 March/April; 44-48
|
| 3. |
Does the
material that the HemaClear® is
made of add to its sterility?
No. The components of the HemaClear® (silicon ring,
stockinet and pull straps) arrive at OHK factory in Israel
non sterile. After the device is assembled it is sent as
a complete unit for sterilization.
|
| 4. |
How is the
HemaClear® sterilized?
The HemaClear® is sterilized by Ethylene Oxide (ETO).
|
| 5. |
What is
the shelf life of the HemaClear®?
3 years.
|
| 6. |
What happens
if the expiration date of the HemaClear® passes?
Do not use the HemaClear® if the expiration date
passed. After 3 years the sterility of the device might
be damaged.
|
| 7. |
What are
the clinical and financial benefits of the HemaClear®?
The HemaClear ® is superior to the current exsanguination
and occlusion solutions and offers both clinical and financial
advantages:
| 1. |
All in one solution - The
HemaClear® performs exsanguination, occlusion
and sterile field covering in one simple and quick
application. |
| 2. |
Clear visibility - up to 95%
exsanguination compared to 65% with the current techniques,
reducing the amount of stagnant intra vascular blood
left behind
to clot. |
| 3. |
Saves up to 15 Minutes of
Prep and Surgery time and cuts down up to 80 pre
and intra-operative steps in a typical case from
the overall procedure processes. |
| 4. |
Sterile Single Use device
assisting in the prevention of surgical site infections. |
| 5. |
Factory calibrated – The
HemaClear® provides consistent pressure with
no reported case of tourniquet paralysis (compared
with incidence of 1:4200 using the pneumatic tourniquet). |
| 6. |
Reduces the volume of ischemic
tissue. The HemaClear® can be placed closer
to the surgical field (e.g. forearm for hand surgery,
instead of upper arm; calf instead of thigh for foot
and ankle procedures) thereby reducing the amount
of tissue under ischemic condition. |
| 7. |
Full Range of sizes from pediatric
to obese; Narrow design allows more operating space
on appendages and better patient comfort. |
| 8. |
The HemaClear® reduces
the amount of blood loss during surgery thus reducing
the
need for blood transfusions and blood disposal.* |
* Henderson M S. Exsanguinating tourniquet Assessed. Clinical
Services Journal 2006 Sept; 81-84.
|
| 8. |
How long
can the HemaClear® remain
on the limb?
As with any other tourniquet, the HemaClear® can
remain on the limb for up to 2 hours. If a procedure lasts
longer than two hours the HemaClear® should
be removed by safely cutting the ring. After a proper duration
of blood flow resumption a second HemaClear® can
be applied. The HemaClear® can safely be passed over
the surgical incision as it is a sterile device.
|
| 9. |
How much
pressure is applied by the HemaClear®?
The pressure applied by the HemaClear® ring on the
limb is dependent on the circumference of the limb at the
occlusion location and the distance from there to the tips
of the fingers or toes. It is also dependent on the model
(color) of the HemaClear® used. The ranges of pressure
are:*
* Levenberg E. S-MART® and A-TT® ring
pressure analysis: Finite element analysis of pressure
and displacement
inside a limb compressed by a circular ring.
|
| 10. |
The HemaClear® applies
a strong pressure in a small area. Can this not cause
damage to
the limb?
Over 70,000 HemaClear units have been sold and there have
been no reports of tissue damage following use of the HemaClear®.
The pressure developed inside the limb from the HemaClear® is
equivalent to the pressure developed by the pneumatic tourniquet.
Therefore, pressure occlusion levels that have been determined
to be safe with conventional tourniquet cuffs are also
safe with the HemaClear®.
|
| 11. |
It is known
that wider cuffs are better than narrow cuffs. The HemaClear® is
ultra narrow. Does this present a problem?
To stop blood flow, it is sufficient to occlude the artery
over a venues short segment, which is efficiently achieved
by the HemaClear®. Compressing a much larger volume
of tissue is not necessary and may actually be detrimental.
The lower pressure needed to occlude blood flow with a
wide cuff, relative to a narrow one, does not balance out
the more external tissue compression. Furthermore, the
wide cuff elongates the nerves which may cause telescoping
and damage.*
* Mittal P. et al. Effect of different cuff widths on the
motor nerve conduction of the median nerve: an experimental
study. Journal of Orthopedic Surgery and Research 2008;
9:3(1). |
