Carevature Dreal 3S45FU User manual

Refer to the Dreal™ system Instructions for Use (IFU) for
detailed instructions on motor and irrigation setup
drea ™
drea ™
OR Setup Guide
50cc
or larger
IV bag
Motor
handpiece
(foot operated)
Refer to Model Selection
Guide for advice on the
proper tip conguration.
Must be sterilized
prior to use.
Standard
Sterile tubing
Luer
lock
Roller-
clamp
Should be placed in the
sterile eld, within the
surgeon’s reach; Dripping
rate of ~1drop/sec
provides enough
irrigation to keep the tip
from heating and allows
debris to wash away.
Length should allow the
surgeon to work
conveniently or an
extension may be used.
The Dreal™ is intended to cut bone in neurosurgical and spinal applications.
Prior to use, the surgeon should refer to the product Instructions for Use (IFU)
for complete indications, warnings, precautions and contraindications. Official US Distributor

The Dreal™ system can be powered by electric or pneumatic motors compatible with an
ISO 3964 (‘micro’) connection or using appropriate adaptors. The motor system is not
included and not part of the device.
Refer to the IFU for instructions on motor preparation and setup.
Compatible driving systems cleared for Neuro and Spine surgery in the US include:
Stryker CORE/TPS with Micro Drill or Rem B handpieces
Medtronic® Midas REX Legend™ with Carevature Adaptor
DePuy Synthes Anspach™ Xmax, MicroMax Plus, eMax 2/eMax 2 Plus with Carevature Adaptor
Aesculap microspeed with GD678/679 handpiece
MKT010 R01
Carevature Medical Ltd. | 12 Eli Hurwitz Street, Rehovot, Israel
Customer Service phone: [phone] | Customer Service email: [e-mail]
www.carevature.com
Driving the Dreal™

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Instructions For Use
For DrealTM

INDICATIONS FOR USE
The Carevature Dreal™ is intended to be used with high-speed compatible electric and pneumatic motors.
When used with these motors, it is intended to cut bone by drilling, reaming, decorticating, shaping,
dissecting, shaving and smoothing for neurosurgical and spinal applications. Specic applications include
laminectomy/laminotomy and craniotomy/craniectomy/ skull base cuts < 1cm3.
General Operating Guidelines:
The Carevature Dreal™ is intended to be used with electric and pneumatic motors and acts as an interface
between the high-speed motors and the cutting accessories.
This symbol is used to alert the reader to important safety and precautionary information.
When displayed on the actual device or packaging, it refers the user to the instruction manual.
CAUTION
Federal (USA) law restricts this device to sale and use by, or on the order of a physician.
The words Warning, Caution and Note carry special meanings and should be carefully reviewed.
Important Safety Information
WARNING
• You must read carefully the entire instructions and warnings listed below prior to use.
• DO NOT use the DrealTM after the “Use By” date on the package label.
• DO NOT use the DrealTM with any motor other than one having the mentioned specications (See Motor
Selection and Handling section below)
• DO NOT use the DrealTM other than as a single patient, single use device. Reuse, reprocessing, or
re-sterilization of the device is strictly prohibited as reuse of the device can compromise the DrealTM
performance characteristics.
• DO NOT use the DrealTM without active irrigation to prevent tissues damage.
• DO NOT use the DrealTM without eyewear protection.
• DO NOT use the DrealTM if, after inspecting the DrealTM and its package, there is any overt damage. In
the event of damage to the sterile packaging, retain the package with the contents and notify your local
authorized representative.
• DO NOT use the DrealTM if damage is apparent or if the device does not function normally. The DrealTM
must be inspected prior to each use.
• DO NOT use excessive force which may bend the device’s shaft or cutter. This may cause the tool to
deform and may result in malfunction, injury to the patient, operator and/or operating room staff.
• The DrealTM should be used only by medical professionals familiar with powered surgical instrumentation;
this package insert is designed to assist in using the Dreal™ device and it is not a reference to surgical
technique. For information on surgical technique, please consult the medical literature.
• It is not recommended to use the Dreal™ continuously for more than 10 minutes.
• For any malfunctioning or damaged packages or devices, please contact your local authorized
representative
Potential Complications
• As in any rotatable devices, if not used properly or in case of inadvertent dislocation of the cutting tip
when active, an injury to the patient may occur.
Contraindications
• There are no known contraindications for devices with these indications.
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General description
• Figure 1 (a) and 1 (b) shows the Dreal™ and components;
Figure 2 shows two of the Dreal™ models (a Short 45o model and a Long 75o model):
Figure 1: (a) The DrealTM and (b) Magnied View of the Cutting Tip.
Figure 2: The upper is a Short 45omodel and the lower is a Long 75omodel.
Motor Selection and Handling
(The motor system is not included and not part of the device)
The Dreal™ can be powered by an electric or pneumatic motors using a ‘micro’ adaptor as per ISO 3964;
however, it can rotate only clockwise (right-hand, or Forward).
NOTE: the Dreal™ was tested for compatibility with the following motor systems:
• Stryker Consolidated Operating Room Equipment (CORE)
Motor Disinfection
The motor handpiece comes in contact with the surgeon hence must be disinfected according to the
specic instructions of the motor manufacturer.
NOTE: Prior to any use make sure to disinfect the entire non-sterile motor handpiece (including cable and
electrical plug); after disinfection it must be placed on a sterile surface.
Micro motor
connection recess (a) (b)
Irrigation port Handpiece grip Shaft Tip Protective shield
(hood)
Cutter (drill-like burr) Cutter (drill-like burr)
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DIRECTIONS FOR USE
Initial Preparation
DrealTM setup
The DrealTM is supplied sterilized and you should treat it like any factory-sterilized item.
• Open the cardboard external box and take out the sterile packaging
NOTE: inspect the sterile pouch and look for any damage or aw; if you suspect the packaging is defected,
DO NOT use the specic unit, use another unit from a new package.
• Open the sterile packaging.
• Take out the stage and release the DrealTM unit.
• Carefully inspect the DrealTM unit, looking for any visible damage to the handpiece grip, shaft or tip;
NOTE: if you suspect the unit is defected, DO NOT use the specic unit, use another unit from a new
package.
Motor Setup
NOTE: Prior to use, make sure to read the motor Instructions for Use and be familiar with it.
• Place the control unit and footswitch on an even, non-slip surface; do not allow the operating range of
the device (including cable) to be compromised by limiting factors.
NOTE: the control unit and footswitch are NOT disinfected and should NOT be touched by the gloved
hand of the health-care provider. The system display must be fully visible at all times.
• The footswitch must be placed within stepping distance between the patient and the surgeon.
• It must be explicitly ensured that no objects can fall on the footswitch.
• The power (On/Off) plug of the device must be accessible at all times.
NOTE: the power (On/Off) plug on the control unit should NOT be touched by the gloved hand of the
health-care provider.
NOTE: make sure that the motor is set to clockwise (right-hand, or Forward) direction.
• Set the required speed according to the surgeon’s preference.
NOTE: the DrealTM was tested to operate at any speed in the range 10,000-40,000 RPM.
Irrigation Setup
Irrigation should be used at all times when the DrealTM is active, as with any other high-speed rotating
device; an Intravenous Set of physiological solution dripping by gravity can be used as normally a ow
rate of ~1 drop/sec is sufcient.
NOTE: the IV set and tubing are not supplied with the DrealTM.
NOTE: aspiration of uids during work is strongly recommended to allow clear visibility of the tip.
Motor and Irrigation Connection to the DrealTM
• Connect the disinfected motor handpiece to the DrealTM as you would do with any other device with such
adaptor.
NOTE: you should push the motor rmly into the connection recess until a ‘click’ is heard; if necessary,
apply gentle rotational moves.
• Verify the integrity of connection by holding the motor handpiece only with the DrealTM facing downwards;
the DrealTM should remain connected despite gravity.
NOTE: do this above a sterile surface so as not to contaminate the DrealTM in case of bad connection.
• Connect the irrigation tubing (not supplied with the DrealTM) to the irrigation port on the handpiece grip
as with any Luer Lock type of connection.
NOTE: it is advised to position the tubing tap/valve within the surgeon’s reach to allow easy control of the ow.
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Figure 3 shows the DrealTM with the motor connected to it (the segment of the motor is shown here only
for demonstration and it is not part of the device)
Figure 3: The DrealTM with the motor handpiece
Check Activation
Turn the control unit ‘On’ and shortly press the footswitch to activate the motor with the DrealTM held in the
air, away from the surgical eld, to ensure that the device is in proper working order including irrigation;
specically, pay attention to any excessive vibration or noise, slippage between the motor and the DrealTM
handle or any sign to breakage or other failure.
NOTE: make sure that the cutter rotates in a clockwise (right-hand, or Forward) direction.
NOTE: in case of irrigation malfunction, it can be added externally; Irrigation should be always running
when the Dreal™ is active.
NOTE: In any sign of DrealTM or motor malfunction, do not use the specic unit; use another unit from a
new package.
The DrealTM is now ready for use.
Surgical Guidelines and Safeguards: a step-by-step approach
Please refer to the “Indications for Use” section at the beginning of this document. In summary, the Dreal™
is intended to cut bone in procedures such as laminectomy/laminotomy and craniotomy/craniectomy/skull
base cuts < 1cm3. It is important to understand and apply the following guidelines and safeguards for
keeping the procedure effective and safe.
Identify the anatomy
The thecal sac, brain tissue or nerve root should be condently identied prior to approaching the anatomical
sight with the tip, as you would do with any other surgical device; then, apply tactile feedback using the tip,
as you would do with any common probing tool, to reconrm the tip is in touch with the bone be cut, prior
to operate the device.
Maintain Direct Visualization with the tip
The DrealTM is designed to allow the surgeon a clear “line of sight” with its tip, while not obscuring the
neural element; the tip should be visible at all times.
NOTE: Make sure to use proper aspiration of uids before and during work to ensure clear visibility of the tip.
Figure 4: Tip visualization
Motor connection direction
Motor’s handpiece connected to the DrealTM
Line of sight Thecal sac
Tip and cutter
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Holding the device
Hold the device rmly as you would be using a standard high-speed drill. You may lean the vertical shaft
on the surrounding soft tissues as needed. Turn on the Dreal™ prior to engaging the bone to ensure
smooth acceleration to the desired RPM setting.
Safety considerations
When used in spine decompression procedures, it is advised to use another layer of protection between
the tip of the Dreal™ and the neural element; when applicable, place the tip near the bone edge to be cut,
keeping it above the ligamentum avum or other ligament. Bone can then be removed using a forward
advancement of the tip without deection of the underlying thecal sac or nerve root, minimizing the risk of
a compressive injury to the neural element. If needed, the ligamentum avum or other ligament can then
be resected in standard fashion following bone cutting.
Figure 5: Cavity is drilled without nerve root manipulation
In case where there is no ligamentum (e.g. in the cranium) or if it has been removed, retraction of the
neural structures may be done if necessary.
Tip Alignment
The DrealTM should be held so that its tip is parallel to the neural structure. Do not tilt the device and
do not angle the tip towards the thecal sac, brain or nerve root; exposure of the neural structures to
the rotating cutter is only possible when using the device in a nonparallel fashion. The tip can be angled
upward and away from the neural structure to allow additional bone cutting.
Figure 6: Tip alignment
Bone Cutting
The rotating cutter is shielded around its lower side from safety considerations; it is therefore important
to use a step-by-step approach when cutting bone, otherwise the shield may touch the surrounding bone
tissue and interfere with the tip advancement.
Figure 7: DrealTM Bone cutting
Bone
Nerve
Ligament
Cutter is facing the
structure below
(NOT recommended)
Shield is facing the
structure below
Up
Advance
Advance
Lateral
(b) (c)(a)
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a. Advance forward into the bone as explained above, then move the tip a bit laterally to widen
the cavity
b. Pull the Dreal™ upward and slightly enlarge the cavity
c. Repeat as required
When aligned properly, the Dreal™ will cut bone efciently and there is no need to apply excessive force
on its tip.
Precautions
a. Irrigation should be running while the Dreal™ is active; normally, a ow rate of ~1 drop/sec is
sufcient.
b. Pay attention not to operate the device when the cutter (drill bit) is in touch with any
surface other than the tissue to be removed, e.g. swab, surgical glove, etc.
After use
When use has been completed, detach the Dreal™ from the motor by simply pulling apart and discard the
Dreal™ per hospital routine.
How supplied
The Dreal™ is supplied sterile (by Gamma irradiation), in a double pack pouch. In any case of a breached
package or suspicion of loss of package integrity, the package shouldn’t be used and you should contact
your local authorized representative.
Packaging
The Dreal™ package is sterile as indicated by its label and you should verify the package integrity when
receiving the Dreal™ and before you open each Dreal™ package. Any breach of the package should be
considered as a breach of sterility of the product and the package should be removed and the contents of
the Dreal™ should not be used. In such case, contact your local authorized representative.
Operational Environment
• 10°C (50°F) to 40°C (104°F)
Storage and Transportation Environment
• 10°C (50°F) to 40°C (104°F)
Use of Original Products
The components of the Dreal™ are designed for specic use and to complement each other. No system
components may be replaced by a product from another manufacturer even if the other product or part
is comparable or identical to the original product in appearance and dimensions. The material used from
other manufacturers, any structural alterations resulting from use of products from another source and/or
impurities of the material as well as minor differences of adjustment between the Dreal™ and instruments
introduce unforeseen risks to the patient and user.
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Labeling
List of symbols on the DrealTM labeling:
Rx Only United States federal law restricts this device to sale by or on the order of
a physician
Batch code
Reference number e.g. serial number
Manufacturing date
Use by
Single use only
Do not re-sterilize
Do not use if package is damaged or opened
Sterilized by Gamma
Consult Instruction For Use enclosed with the DrealTM
Temperature limitation: upper and lower limits of temperature should be
indicated adjacent to the upper and lower horizontal lines.
Manufacturer
For additional product information, please contact:
Carevature Medical Ltd
12Eli Hurwitz St., Rehovot 7608801, Israel
T. [phone]
F. [phone]
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