OPTMCM-01[[Rev07]

Manual of Operator
Contents
Overview .........................................................................................................................................................................................3
Chapter 1- General Information ......................................................................................................................................................4
1.1. Intended Use...................................................................................................................................................................4

1.2. Device Description...........................................................................................................................................................4
1.3 Materials ........................................................................................................................................................................5
1.4 How Supplied ..................................................................................................................................................................5
1.5 Indications ......................................................................................................................................................................5
1.6 Contraindications............................................................................................................................................................5
1.7 General Warnings, Precautions and Cautions..................................................................................................................6
1.8 Applications ....................................................................................................................................................................8
1.9 Shelf Life .........................................................................................................................................................................9
1.10 Available Product Sizes and Ref Numbers ........................................................................................................................9
1.11 Packing and Labelling ...................................................................................................................................................15
1.12 Storage .........................................................................................................................................................................15
1.13 Return...........................................................................................................................................................................15
1.14 Disposal ........................................................................................................................................................................15
1.15 Inspection and Handling................................................................................................................................................16
1.16 Reprocessing Instructions..............................................................................................................................................16
1.16.1 Limitations on Reprocessing for Non-Sterile .........................................................................................................16
1.16.2 Manual Cleaning...................................................................................................................................................16
1.16.3 Automated Cleaning .............................................................................................................................................17
1.17 Cleaning Inspection .......................................................................................................................................................17
1.18 Wrapping......................................................................................................................................................................17
1.19 Sterilization...................................................................................................................................................................17
Chapter 2- lllustrations..................................................................................................................................................................18
Chapter 3 - Operative System .......................................................................................................................................................20
3.1 System Start Up ............................................................................................................................................................20

3.2 Ultrasonic Piezo Handle Assembly .................................................................................................................................25
3.3 Handle Disassembly .................................................................................................... Hata! Yer işareti tanımlanmamış.
3.4 Important .....................................................................................................................................................................27
3.4.1 Handle Position .............................................................................................................................................................27
 Correct Position .................................................................................................................... Hata! Yer işareti tanımlanmamış.

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3.5 Generator .....................................................................................................................................................................28
3.5.1 Receptacles, Controls and Indicators ........................................................................................................................28
Chapter 4 – Troubleshooting.........................................................................................................................................................29
4.1 General Troubleshooting...............................................................................................................................................29
Chapter 5 -Cleaning, Disinfection, Preventive Maintenance .........................................................................................................33
5.1 Electrical Safety Check ..................................................................................................................................................34

5.2 Cleaning and Disinfection Instructions...........................................................................................................................34
Follow Standards for Decontamination, Cleaning and Sterilization ........................................................................................34
5.2.1 Clean and Disinfect/Sterilize Reusable Items ............................................................................................................34
5.2.2 Touchscreen Cleaning ...............................................................................................................................................36
5.2.3 Expected Life, Reusable Components .......................................................................................................................36
5.2.4 Deviations from Decontamination, Cleaning and Sterilization Instructions ...............................................................36
5.2.5 Technical Assistance .................................................................................................................................................36
Chapter 6- Service, Repair and Technical Correspondence ...........................................................................................................37
6.1 Repair, Service and Replacement Parts .........................................................................................................................37

6.2 Important Notice...........................................................................................................................................................37
Mavera Medical Devices, Inc.........................................................................................................................................................37
Chapter 7-Appendices ...................................................................................................................................................................37
7.1 Markings on the Front and Rear Panel of the Generator................................................................................................37

7.2 Symbols for the Product Labels .....................................................................................................................................38
7.3 Technical Specification ..................................................................................................................................................39
7.4 EMC Statement .............................................................................................................................................................40
7.5 Electromagnetic Interference ........................................................................................................................................40
7.5.1 TABLE I .....................................................................................................................................................................40
7.5.2 TABLE II .........................................................................................................................................................................41
7.5.3 TABLE III ........................................................................................................................................................................41
7.6 Electrical Safety Statements ..........................................................................................................................................42
7.7 Environmental Statements ............................................................................................................................................42
7.8 General Safety Statements ............................................................................................................................................42
7.9 Conventions Warning and Cautions ..............................................................................................................................43
7.10 Disclaimer .....................................................................................................................................................................43
7.11 Contact .........................................................................................................................................................................43
7.12 Trademark Information.................................................................................................................................................43
Limited Warranty ..........................................................................................................................................................................44
Limited Liability .............................................................................................................................................................................44

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Overview
Please read all information carefully.
Failure to properly follow the instructions may lead to serious surgical consequences. This manual contains important
information for operation of the Macadam™ Ultrasonic Surgical Cavitation System.
It should be kept where it may be referenced during usage , especially for screen translations. Print or copy
pages as necessary to keep nearby.
Important: This manual is designed to provide instructions for use of the Macadam™ Ultrasonic Surgical Cavitation
System. It is not a reference to surgical techniques.
CAUTION:
This Operator Manual of the Macadam™ Ultrasonic Surgical Cavitation System is not a guarantee or warranty. It is
intended only as an operational guide. For additional information and questions, please contact Mavera Medical
Devices representative at +90 312 341 50 27 and info@maveramedical.com.tr.
In order for the Macadam™ Ultrasonic Surgical Cavitation System to provide safe, reliable, and proper performance,
the following conditions must be met. Failure to comply with these conditions will void all pertinent warranties.
There are no user serviceable components at Mavera Medical Devices Inc. All assembly, operation, adjustment,
modification, maintenance, and/or repair must be carried out only by qualified personnel authorized by Mavera Medical
Devices.
The electrical installation of the room in which the device will be used complies with the appropriate national electrical
standards.
The product must be used in accordance with this manual and all associated labeling and the Instructions for Use.
Any device that does not function as expected must be returned to Mavera Medical Devices Inc.
Notice to Users:
CAUTION: As with any prescription medical device, failure to follow product instructions or changing settings and
performing therapy applications without the express direction and/or supervision of a trained clinical caregiver may
lead to improper product performance and the potential for serious or fatal injury.
Conventions on Warnings and Cautions
WARNING Denotes potentially dangerous situation that could result in death or serious injury to
patient, operator or staff.
CAUTION Denotes potentially dangerous situation that could result in moderate injury to patient, operator or
staff.
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Chapter 1- General Information
1.1. Intended Use
Macadam™ Ultrasonic Surgical Cavitation System is intended to be used in selectively fragmentation,

emulsification, resection, irrigation and/or aspiration of hard tissue (e.g. bone) and soft tissues including
subcutaneous fatty tissue.
The system addresses to adult patients of both sexes, ages from 18 and older. No clinical study presented and
consulted for pediatric patients, pregnant women and disabled persons, within the scope of this report. These
products are not directly intended to be used in pediatric cases, pregnant women and disabled persons.
1.2. Device Description
The Macadam™ Ultrasonic Surgical Cavitation Systems & Accessories are sterile, replaceable insert piece
connected to the handle of an ultrasonic surgical system, and contacts with the patient in surgical procedures
where fragmentation, emulsification and aspiration of soft and hard tissues. Surgical ultrasound generator is
a device that consists of electrical parts which in turn enables the action mechanism of handles through
delivery of ultrasound energy.
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1.3 Materials
Direct Contact Materials
Tips/Probes TI6AL4V and/or Stainless Steel
Flute Polyurethane and/or Polysiloxane Rubber
Indirect Contact Materials
Irrigation Tubing PVC Medical Grade
External Non-Tissue Contact Materials
Handle Body Anodized Aluminum Frame/Polyamide
Handle Gripper Polyurethane and/or Polysiloxane Rubber
Aspiration Tubing PVC Medical Grade
1.4 How Supplied
Product not made with natural rubber latex. It is a disposable, single-patient-use product. The Macadam™
Tip is provided STERILE using an ethylene oxide (EO) process.
1.5 Indications
Macadam™ Ultrasonic Surgical Cavitation System is indicated for use in surgical procedures where
fragmentation, emulsification resection and aspiration of soft and hard tissues are required in the following
surgeries: including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic
and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery,
Laparoscopic surgery and Thoracoscopic surgery. Gastrointestinal and Affiliated Organ Surgery - including
removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or
laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of
tissue during liver allotransplantation and donor hepatectomy. Urological surgery - including removal of renal
parenchyma during nephrectomy or partial nephrectomy. General Surgery - including removal of benign or
malignant tumors or other unwanted soft tissue in open or minimally invasive general surgical procedures.
Plastic and Reconstructive surgery- LipoSculpture (subcutaneous fatty tissue for aesthetic body contouring).
Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy
or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic
pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or
laparoscopic partial gastrectomy.
1.6 Contraindications
 The use of the generator and the attached instruments are contraindicated, when in the judgment
of the physician, ultrasonic surgery would be contrary to the best interest of the patient.
 It is the responsibility of the physician to determine whether any physical impairment of the patient
would contraindicate the use of this device.
 It is contraindicated for Central Circulatory System and Central Nervous system.
 It is contraindicated for patients with systemic infection or local infection in area of the procedure,
blood coagulation disorders or anticoagulant use.
 The system is not indicated for cardiac surgery or any procedure in the proximity of the heart.
 Patients with electric drives (e.g., pacemaker).
 Abdomen of pregnant women.
 Contraindicated for neonatal and neurovascular patients.
 The handle is not indicated for coagulation and dissection of vessels.
 The irrigation pump is contraindicated for the administration of parenteral fluids, infusion of drugs
or for any life sustaining purposes.
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 The handle is not indicated for coagulation and dissection of vessels.
 Laparoscopic procedures in women with known or suspected uterine sarcoma using devices that
fragment tissue may spread cancerous tissue. Also, there is no reliable method for predicting
whether a woman with fibroids may have a uterine sarcoma. Therefore, devices that fragment
tissue are contraindicated for use during laparoscopic hysterectomy or myomectomy for uterine
fibroid removal.
1.7 General Warnings, Precautions and Cautions
The operation area must be free of explosive gases or inflammable fluids and materials.
In order to avoid unwanted procedural delays, assure the system is fully operational prior to
administration of anesthesia.
This device must only be used by surgeons or medical staffs who are trained in the types of surgical
procedures that are to be carried out and - trained in the specific use of ultrasonic
surgical instruments.
The surgeon is to be thoroughly familiar with the equipment and the surgical procedure prior to
performing surgery.
It is recommended that prior to clinical use of the system; all operators of the device should be trained
in the proper use of the system. Mavera has developed a training program; contact
your local market representative for details concerning use of the device.
As with all surgical procedures, the system operator and other clinical personnel should follow the
universal precautions for infection control (including the use of surgical gloves, facemask that covers
the mouth and nose, protective eye goggles, protective clothing and anti-slip shoe
covers.
Carefully read all Instructions for Use prior to use and follow the hospital’s clinical practice guidelines
for ultrasonic surgery, ultrasonic, gynecology and laparoscopic procedures. Observe all warnings and
cautions noted throughout these instructions. Failure to do so may
result in complications. See product labels for recommended power settings.
Ignoring alarms on the device while continuing to use the system may result in injury to the patient
and/or surgical personnel, or equipment damage.
Single use devices are for single patient use only. Do not reprocess or re-use. Single use devices(s) is
(are) intended to be used for one procedure only. If reprocessed or re-used this may result in the
infection of patient (or patient specimen) through cross-contamination, as well as would incur the risk
of modifying the properties and performance of the device, and of increasing the likelihood of
complications and/or undesirable effects. Once used, devices
must be disposed of in accordance with hospital policies.
Do not re-sterilize sterile products. After re-sterilization, the sterility of the product is not guaranteed
because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead
to infectious complications. Cleaning, reprocessing and/or re- sterilization of the present medical device
increases the probability that the device will malfunction due to potential adverse effects on
components that are influenced by thermal
and/or mechanical changes.
Prior to use, carefully examine the unit to verify that the sterile package and contents have not been
damaged during shipment. Do not use if package is opened or damaged, or if seal is broken; contents
may not be sterile and may cause infection in the patient. If you believe a component to be faulty,
damaged or suspect, DO NOT USE and contact your local Mavera Medical Inc. representative. Replace
the handle if it becomes damaged or deformed in any
way either prior to or during use.
Ensure all connections and mating surfaces of handle, extension and ultrasonic probes, tips, blades and
catheters are clean and dry before assembly.
The devices are not to be repurposed in any way to be used for operations they are not intended for any
non-medical use. No modification of this equipment is allowed. Refer to package label for probe, tip,
blade, catheter shape or size. Do not attempt to manipulate or re - shape the probe, tip, blade, catheter
tip configurations. Handle the device with care. Damage or changes can affect the ability to attain
resonance and reduce the effectiveness of
the device. Do not use if damage is suspected.
Only use Mavera® handle and accessories with the system. Non-Mavera handle and accessories are not
supported. The use of accessories and cables other than those specified, with the exception of
accessories and cables sold by Mavera Medical Devices Inc. as replacement parts for internal
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components, may result in increased EMISSIONS or decreased
IMMUNITY of the ultrasonic console.
Ensure that electrical insulation or grounding is not compromised to avoid the risk of electric shock. This
equipment must only be connected to a supply main with protective earth.
Removal of outer covers may result in electrical shock.
Do not immerse ultrasonic console, handle, irrigation pump, remote footswitch or electric cables. These
items are not sealed against liquids and damage to equipment will result.
The system should not be used adjacent to or stacked with other equipment, and if adjacent
or stacked use is necessary, the system should be observed to verify normal operation in the
configuration in which it will be used
This device may cause electromagnetic interference with other devices when in use. Do not place
console near sensitive equipment when operating.
The Console contains no user-serviceable parts. Refer service to qualified personnel.
Touching of the tip of the handle by the operator, while the handle is powered on, can result in personal
injury.
Do not allow the device to contact tissue while not in use in case accidental activation should
occur. When you test the handle, do not allow the handle tip to contact anyone or anything during tip
activation. Contact may result in patient injury, user injury, or handle tip damage.
Care should be taken when operating in the vicinity of nerves.
When use ultrasonic handle and other instruments together, the probes, tips, blades, catheters and
accessories into the human body part must be checked if there are safety hazards caused by the rough
surface, sharp edges or protrusions; It must be strictly in
accordance with the operation manual, in order to avoid hazards due to inappropriate operation.
As with all energy sources (Electro-surgery, Laser or Ultrasound) there are concerns over
carcinogenic and infectious potential of the procedure by-products e.g. tissue smoke plume and
aerosols. Effective protective equipment should be used during procedures.
When the handle is powered on, contact of the tip with a hard surface (e.g. a metal
instrument, tray, staples, clips, instruments, etc.) may damage the tip of the handle and require
replacement before use.
Macadam tips utilize silicone flues. Compressing the flue against the side of the vibrating
surface along the length of the tip can cause excessive heating and potential hazard to adjacent tissue,
such as burns.
Excessive loading of Macadam tips at the surgical site can induce heating due to vibration and acoustic
power transmissions. Thermal management of the surgical site with the aid of the
appropriate irrigation and aspiration settings is essential.
Tip and irrigation fluid temperatures may exceed the tissue necrosis point if insufficient irrigation flow
rates are used. For hard tissue removal, set the irrigation flow rate to a setting no less than the
comparable vibration setting. For example, if the power setting is 70, a minimum flow setting of
70ml/mnt should be used. Additional external irrigation, e.g. by administering sterile saline with a
syringe over the distal tip portion, may be necessary for
removal of very dense, hard osseous structures
Avoid excessive lateral loading of Macadam tips.
Avoid contacting bone with the Macadam tips.
Use only Macadam™ accessories to assure compatibility.
To avoid product damage, NEVER hold the handle in your hand while using the torque tool to tighten or
loosen the tip.
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1.8 Applications
Select the tip of choice from the product range for the procedures. Remove the tip from its package and
Position the tip of choice onto the handle connecting body. Turn the tip until it is finger tight. Put the handle
in the tip torqueing base, so that the metal connecting body fits snugly in the metal end of the slot. Hold the
handle in place in the tip torqueing base. Rotate the wrench clock-wise until you feel and hear a click. Rotate
again until you feel and hear a second click. Remove the probe torque tool from the tip. Remove the handle
from the tip torqueing base.
Sterile irrigation fluid flows from a set to a variable speed Irrigation pump. The pump:
• Moves fluid at 1 to 200 ml/min per minute; Use the adjustment buttons (to increase or decrease the
irrigation flow.
• Accelerates to a Fast-Flush speed, pumping at greater than 25 ml/min. The Fast-Flush pedal on the
system footswitch activates the Fast-Flush feature. The accuracy of the irrigation flow is +/- 20% of setting or
+/-1 ml/min, whichever is greater.
The pump pushes the fluid through the manifold irrigation tubing to a flue, a sleeve surrounding the vibrating
tip. As the irrigation fluid passes through the flue, it cools the tip. When the fluid reaches the distal end of the
tip, as much as 99% of it passes through two pre-aspiration holes in the tip, eliminating fluid pooling in the
sterile field and continually clearing the suction system. Fluid that does not pass through the pre-aspiration
holes irrigates the surgical site and suspends fragmented tissue.
A vacuum pump in the console body provides up to 900 mm mercury maximum vacuum at sea level. The
suction, which produces an air stream moving toward the vacuum pump, pulls irrigation fluid, fragmented
tissue, and other materials through the distal end of the surgical tip. From the tip, the aspirated materials pass
through the manifold suction tubing into the suction canister. From the suction canister, the air stream
continues to flow through a contamination filter that filters any remaining particulate matter or moisture,
preventing them from entering the vacuum pump. A suction pinch valve on the front of the console opens
when the system is on, and closes to stop suction when:
• Priming the irrigation system
• Pressing the pedal
• Releasing the Vibration pedal in Run Status (in this case, the pinch valve closes for approximately one
second, then re-opens).
The piezo handle consists of a connector, a cable, a piezo handle body, and a connecting body. The connector
attaches the cable to the Macadam console. The cable contains:
• Cooling water tubes (deliver water from the console to cool the piezo handle)
• Electric wires (deliver electric power from console to drive the piezo handle)
The piezo handle body contains these working items:
• A piezo, which converts electric energy to mechanical motion
• Cooling water tubes; the water removes the heat generated by the piezo in the energy conversion.
The connecting body serves as the connecting point for the tip and transfers the vibrations from the handle
to the tip. Stages of handle packaging for sterilization:
1. Put the handle into the case first. Align the handle with the outline on the case bottom. Secure the
handle with the silicone strap.
2. Place the nosecone and flue with the tip cleaner in the handle compartment.
3. Close the protective cover over the handle.
4. Coil the cable and irrigation tubing (if attached) around the inside of the case.
5. Put the handle connector in the center compartment and secure it in place.
6. Put on the lid. Close and latch the case.
You also need a tip torqueing base and probe torque tool to assemble a handle. Irrigation tubing is sterile,
single use only. Discard the irrigation tubing after one use. You have two options for attaching the tubing to
the handle:
• Attach the irrigation tubing before sterilization
• Attach the irrigation tubing in the sterilization case.
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1.9 Shelf Life
• The expiration date is printed on the package.
• Do not use products if their shelf life is exceeded.
• To keep the kits sterile, store the product in its original packaging.
1.10 Available Product Sizes and Ref Numbers
Brand Description Ref#

Macadam™ Ultrasonic Generator Integrated with a Peristaltic Pump (Non-Sterile Reusable) MCM-USG02-N
Macadam™ Ultrasonic Piezo Handle UPHS6 (Non-Sterile, Re-Sterilizable) MCM-UPHS6-N
Macadam™ Foot Switch Duo (Non-Sterile, Reusable) MCM-FTS02-N
Macadam™ Serum Hanger (Non-Sterile, Reusable) MCM-SHA01-N
Macadam™ Sterilization Case II (Non-Sterile, Re-Sterilizable) MCM-STE02-N
Macadam™ Standard Straight Tip for Soft Tissue II (Sterile, Single-Use) MCM-SSS02-S
Macadam™ Standard Straight Tip for Soft Tissue III (Sterile, Single-Use) MCM-SSS03-S
Macadam™ Standard Straight Tip for Soft Tissue IV (Sterile, Single-Use) MCM-SSS04-S
Macadam™ Standard Extended Straight Tip for Soft Tissue (Sterile, Single-Use) MCM-SESS01-S
Macadam™ Micro Straight Tip for Soft Tissue (Sterile, Single-Use) MCM-MST01-S
Macadam™ XS Straight Tip for Soft Tissue (Sterile, Single-Use) MCM-XSS01-S
Macadam™ XS Extended Straight Tip for Soft Tissue (Sterile, Single-Use) MCM-XSES01-S
Macadam™ Exact Extended Straight Tip for Soft Tissue (Sterile, Single-Use) MCM-EESS01-S
Macadam™ Thinner Tip for Soft Tissue (Sterile, Single-Use) MCM-TTST01-S
Macadam™ Long Straight Tip for Soft Tissue (Sterile, Single-Use) MCM-MLSS-S
Macadam™ Short Straight Tip for Soft Tissue I (Sterile, Single-Use) MCM-MSSSI-S
Macadam™ Short Extended Tip for Soft Tissue I (Sterile, Single-Use) MCM-MSESI-S
Macadam™ Small Conic Straight Tip for Soft Tissue (Sterile, Single-Use) MCM-SCSS-S
Macadam™ Standard Conic Straight Tip for Soft Tissue (Sterile, Single-Use) MCM-SCSSII-S
Macadam™ Standard Short Loft Tip for soft tissue (Sterile, Single-Use) MCM-SSLS01-S
Macadam™ Standard Long Loft Tip for Soft Tissue (Sterile, Single-Use) MCM-SLLS01-S
Macadam™ Laparoscobic Tip (Sterile, Single-Use) MCM-LAP01-S
Macadam™ Standard Straight Tip for Hard Tissue I (Sterile, Single-Use) MCM-SSH01-S
Macadam™ Standard Straight Tip for Hard Tissue II (Sterile, Single-Use) MCM-SSH02-S
Macadam™ Standard Straight Tip for Hard Tissue IV (Sterile, Single-Use) MCM-SSH04-S
Macadam™ Standard Straight Tip for Hard Tissue V (Sterile, Single-Use) MCM-SSHV-S
Macadam™ Standard Saw Long for Hard Tissue (Sterile, Single-Use) MCM-SSL01-S
Macadam™ Standard Saw Short for Hard Tissue (Sterile, Single-Use) MCM-SSS01-S
Macadam™ Standard Extended Straight Tip for Hard Tissue (Sterile, Single-Use) MCM-SESH01-S
Macadam™ Standard Extended Straight Tip for Hard Tissue II (Sterile, Single- Use) MCM-SESHII-S
Macadam™ Exact Straight Tip for Hard Tissue (Sterile, Single-Use) MCM-ESH01-S
Macadam™ Exact Extended Straight Tip for Hard Tissue (Sterile, Single-Use) MCM-EESH01-S
Macadam™ Ball Tip for Hard Tissue (Sterile, Single-Use) MCM-BTH01-S
Macadam™ Standard Blade Short for Hard Tissue (Sterile, Single-Use) MCM-SBS01-S
Macadam™ Standard Blade Long for Hard Tissue (Sterile, Single-Use) MCM-SBL01-S
Macadam™ Standard Straight Tip for Hard Tissue VI (Sterile, Single-Use) MCM-SSHVI-S
Macadam™ Standard Straight Tip for Hard Tissue III (Sterile, Single-Use) MCM-SSH03-S
Macadam™ Standard Curved Tip for Soft Tissue (Sterile, Single-Use) MCM-SCS01-S
Macadam™ Standard Curved Tip for Soft Tissue II (Sterile, Single-Use) MCM-SCS02-S
Macadam™ Micro Curved Tip for Soft Tissue (Sterile, Single-Use) MCM-MCT01-S
Macadam™ Macro Curved Tip I for Soft Tissue (Sterile, Single-Use) MCM-MCTI01-S
Macadam™ XS Curved Tip for Soft Tissue (Sterile, Single-Use) MCM-XSCS01-S
Macadam™ Standard Curved Tip for Hard Tissue III (Sterile, Single-Use) MCM-SCH03-S
Macadam™ Curved Ball Tip for Hard Tissue (Sterile, Single-Use) MCM-CBTH01-S
Macadam™ Standard Curved Tip for Hard Tissue V (Sterile, Single-Use) MCM-SCHV-S
Macadam™ Standard Curved Tip for Hard Tissue VI (Sterile, Single-Use) MCM-SCHVI-S
Macadam™ Exact Curved Tip for Hard Tissue (Sterile, Single-Use) MCM-ECH01-S
Macadam™ Irrigation Tubing Set (Sterile, Single-Use) MCM-IRTS-S
Macadam™ Aspiration Tubing Set (Sterile, Single-Use) MCM-ASTS-S
Macadam™ Aspiration Tubing Set II (Sterile, Single-Use) MCM-ASTSII-S
Macadam™ Flute Sleeve Short (Sterile, Single-Use) MCM-FLTS-S
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Ultrasonic Generator Integrated with a Peristaltic Ultrasonic Piezo Handle UPHS6
Pump (MCM-USG02-N) (MCM-UPHS6-N)
Foot Switch Duo Flute Sleeve Short

(MCM-FTS02-N) (MCM-FLTS-S)
Serum Hanger Sterilization Case II

(MCM-SHA01-N) (MCM-STE02-N)
Irrigation Tubing Set Aspiration Tubing Set

(MCM-IRTS-S) (MCM-ASTS-S) / (MCM-ASTSII-S)
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Standard Straight Tip for Soft Tissue II Standard Straight Tip for Soft Tissue III
(MCM-SSS02-S) (MCM-SSS03-S)
Standard Straight Tip for Soft Tissue IV Standard Extended Straight Tip for Soft Tissue
(MCM-SSS04-S) (MCM-SESS01-S)
Micro Straight Tip for Soft Tissue XS Straight Tip for Soft Tissue
(MCM-MST01-S) (MCM-XSS01-S)
XS Extended Straight Tip for Soft Tissue Laparoscobic Tip

(MCM-XSES01-S) (MCM-LAP01-S)
Thinner Tip for Soft Tissue Long Straight Tip For Soft Tissue
(MCM-TTST01-S) (MCM-MLSS-S)
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Short Straight Tip For Soft Tissue I Short Extended Tıp For Soft Tıssue I
(MCM-MSSSI-S) (MCM-MSESI-S)
Small Conic Straight Tip For Soft Tissue Standard Conic Straight Tip For Soft Tissue
(MCM-SCSS-S) (MCM-SCSSII-S)
Standard Short Loft Tip for soft tissue Standard Long Loft Tip for Soft Tissue
(MCM-SSLS01-S) (MCM-SLLS01-S)
Standard Straight Tip for Hard Tissue I Standard Straight Tip for Hard Tissue II
(MCM-SSH01-S) (MCM-SSH02-S)
Standard Straight Tip for Hard Tissue III Standard Straight Tip for Hard Tissue IV
(MCM-SSH03-S) (MCM-SSH04-S)
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Standard Straight Tip for Hard Tissue V Standard Saw Long for hard Tissue
(MCM-SSHV-S) (MCM-SSL01-S)
Standard Saw Short for hard Tissue Standard Extended Straight Tip for Hard Tissue
(MCM-SSS01-S) (MCM-SESH01-S)
Standard Extended Straight Tip for Hard Tissue II Standard Curved Tip for Hard Tissue V
(MCM-SESHII-S) (MCM-SCHV-S)
Standard Curved Tip for Hard Tissue VI Ball Tip for Hard Tissue
(MCM-SCHVI-S) (MCM-BTH01-S)
Standard Blade Short for Hard Tissue Standard Blade Long for Hard Tissue
(MCM-SBS01-S) (MCM-SBL01-S)
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Standard Straight Tip for Hard Tissue VI Curved Ball Tip for Hard Tissue
(MCM-SSHVI-S) (MCM-CBTH01-S)
Standard Curved Tip for Soft Tissue Standard Curved Tip for Soft Tissue II
(MCM-SCS01-S) (MCM-SCS02S)
Micro Curved Tip for Soft Tissue Macro Curved Tip I for Soft Tissue
(MCM-MCT01-S) (MCM-MCTI01-S)
XS Curved Tip for Soft Tissue Exact Curved Tip for Hard Tissue
(MCM-XSCS01-S) (MCM-ECH01-S)
Standard Curved Tip for Hard Tissue III

(MCM-SCH03-S)
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1.11 Packing and Labelling
The single-use product come individually sterile blister packs. Inspect the product and the packaging for
damage prior to use. Confirm that the device is consistent with the package label. Discard and replace any
damaged devices. Store the products in a clean, dry place in accordance with the storage conditions.
1.12 Storage
Store sterile packaged instruments in a manner that provides protection from dust, moisture, insects, vermin,
and extremes in temperature and humidity. For sterile product; Temperature: 21 to +25°C; Relative humidity:
35 - 55%, non-condensing; Ambient pressure: 500 - 1060. For non-sterile product; Temperature: +5 to
+40°C; Relative humidity: 0 - 60%, non-condensing; Ambient pressure: 500 - 1060 hPa. Protect the Handles
from exposure to direct sunlight during storage. It is recommended to keep the handle in the original
packaging until use.
1.13 Return
Before returning the Macadam™ system or any individual components to the manufacturer, please ensure
that washing and sterilization have been carried out. All equipment must undergo a valid cycle. A certification
of decontamination must accompany the system or any individual components on their return.
The instructions provided above have been validated by the manufacturer as being capable of preparing a
medical device for re-use. It remains the responsibility of the processor to ensure that the processing is
performed using equipment, materials and personnel in the processing facility to achieve the desired result.
This requires validation and routine monitoring of the process. Likewise, any deviation by the processor from
the instructions provided should be properly evaluated for effectiveness and potential adverse consequences.
1.14 Disposal
The medical device or its components, packaging material and accessories must be disposed of in accordance
with any applicable country-specific regulations and laws.
Symbol Designation
A device marked with this symbol must be put into the separate waste collection
for electrical and electronic devices. Disposal is carried out free of charge by the
manufacturer within the European Union.
16
16
1.15 Inspection and Handling
 Reuse of this product, including after reprocessing and/or re-sterilization may cause a loss of structural
integrity which could lead to a failure of the device to perform as intended and may lead to a loss of
critical labeling/use information, all of which present a potential risk to patient safety.
 Do not use if the package is opened or damaged. If it is suspected that the sterility or performance of
the device has been compromised; the device should not be used.
 Store in a cool, dark, dry place.
 Use the system prior to the "Use By" date specified on the package.
 Do not use if the product is partially deployed in straight shape upon removal from the package, or
before starting the deployment procedure.
 Avoid contaminating the valve, as with any type of non-vascular implant, infection, secondary to
contamination of the valve, may lead to complications.
 Do not expose the delivery system to organic solvents.
 After use, dispose of product and packaging in accordance with hospital, administrative and/or local
government policy.
1.16 Reprocessing Instructions

Please ensure that following use the Single Use Handle has been removed from the Piezo and disposed of as
clinical waste. Reprocessing instructions have been validated by the manufacturer to ensure capability of
Macadam™ system reuse. Instruments should be sterilized prior to use using the following guidelines. It is
the responsibility of the user to ensure that reprocessing is performed in a controlled manner using validated
and calibrated equipment. Any deviation by the re-processor from these instructions should be evaluated for
the effectiveness and potential adverse consequences. All Handles are provided clean but not sterile. All
Handles have been inspected prior to shipment. Please contact your local dealer or Technical Service if further
information is needed. Handles can be autoclaved a maximum of 50 times.
1.16.1 Limitations on Reprocessing for Non-Sterile

 Follow instructions and warnings issued by the manufacturer for cleaning and equipment use.
 140ºC is NOT to be exceeded during the reprocessing steps.
 Do NOT use ULTRASONIC WASHING or CYDEX.
 Do NOT sterilize the Macadam™ generator.
 Care should be taken to remove debris or tissue that may collect on the Macadam™ generator.
 Piezo Handles can be autoclaved a maximum of 50 times.
 End life is generally determined by wear or damage in surgical case.
 Carefully inspect instruments between uses to verify proper functioning.
 Damaged instruments should be replaced to prevent potential patient injury and loss of metal fragments
into the surgical site.
 Immediately after use wipe down all components and remove any surplus body fluids and debris.
 Fit the attached end cap over the free end of the Handles cable. Push the cap until it clicks into place.
1.16.2 Manual Cleaning

 Prepare enzymatic cleaning solution (e.g. Gigazyme Plus) to manufacturer’s instructions.
 Soak soiled instruments in enzymatic solution for 5 minutes
 When cleaning, fully submerge the instruments in the cleaning solution. Brush with soft nonmetallic
bristle brush or cloth to remove all traces of blood and debris, concentrating on any crevices, seams,
or other surface discontinuities
 Clean holes and recesses using an appropriate brush ensuring that the full depth of the feature is
reached.
 Ensure instruments are visibly clean before progressing to the next step.
 Rinse instruments thoroughly with clean running water for 2 minutes.
 Ensure that blind holes and recesses are repeatedly filled and emptied with running water.
 Dry instruments immediately after final rinse. Do not exceed 140 ºC
17
17
1.16.3 Automated Cleaning
 Instruments may require manual cleaning prior to automate cleaning to improve the removal of
adherent soil. Brush with a non-metallic bristle brush in enzymatic cleaning solution.
 Load instruments such that crevices, seams, surface discontinuities, holes and recesses can drain.
 Clean using the “Instruments” cycle in a validated washer disinfector and a pH neutral cleaning agent
intended for use in automatic cleaning (e.g. Enzymatic Detergent). The cleaning cycle should
incorporate pre-rinse (minimum 3 minutes), wash (minimum 14 minutes), rinse (minimum 7 minutes),
thermal rinse (minimum 1 minute at 93ºC), and drying steps - Do not exceed 140 ºC).
 An alkaline cleaning solution such as, for example, Serchem pH Plus Detergent, with a pH up to 13.2
may be used instead of, or in addition to, an enzymatic solution.
1.17 Cleaning Inspection

 Inspect all instruments prior to sterilization or storage to ensure the complete removal of solid surfaces
 Visually inspect instruments, if soil is still present clean instruments again.
 Inspect cables for wear and damage, ensuring that no cracks, ears, or other damage is found.
 Report any damage found to the Macadam™ representative.
1.18 Wrapping
 Double wrap in accordance with local procedures, using standard procedures wrapping techniques such
as those described in ANSI/AAMI ST46-1993.
 Label contents of wrapped tray using indelible marker or other sterilization compatible label system.
1.19 Sterilization
 Piezo can be autoclaved a maximum of 50 times.
 Sterilization is best achieved on the day preceding the surgery, but must be at least one hour prior to
use to allow the equipment to cool and stabilize.
 Piezo handles are NOT to be submerged in water to expedite cooling.
 Do NOT sterilize the generator.
 These components have been validated for sterilization by the following method in a vacuum autoclave.
 The parameters for this being 134 - 137ºC for a minimum of 3 and a maximum of 4 minutes with a 5-
minute drying cycle (If national standards dictate autoclaving up to 18 minutes, this is possible but not
preferable.)
1.2 Operation, Storage and Transport

Operating conditions:
 Temperature: +13 to +35°C;
 Relative humidity: 20 - 90%, non-condensing
 Ambient pressure: 500 - 1060 hPa
 Duration: 20 minutes
Store the Piezo Handles in a clean, dry place in accordance with the storage conditions.
Storage conditions for sterile:
 Temperature: 21 to+25°C;
Protect the Piezo Handles from exposure to direct sunlight during storage. It is recommended to keep
the handle in the original packaging until use.
Storage conditions for non-sterile:
 Temperature: +5 to +40°C;
18
18
Chapter 2- lllustrations
Side View of the Macadam™ Generator Right Side View of the Macadam™ Generator Right
Perspective View of the Macadam™ Generator Right
Top View of the Macadam™ Generator Down View of the Macadam™ Generator
19
Front Panel of the Macadam™ Generator Back Panel of the Macadam™ Generator
Display/Touch Screen
Displays system information and serves as interface for adjusting controls and settings.
Power Cord Port Power On/Off Switch
Pedal Connector Handle Connector
Foot Switch Duo
Caution: The pedal and instruments plug socket must be solid and reliable otherwise it may not work properly.
20
Chapter 3 - Operative System
3.1 System Start Up
Power on, the touchscreen will appear the following interface:
System Start Up
1. Power From 0 to 100 %. It indicates percentage of a breakdown of watts at max 200

Watts % 100 value signifies value of power at voltage amper of power. % 1 signifies
0.8 Va value.
2. Irrigation The system is set for 200 ml per minute volume of whose value is 10ml as
increments intervals.
3. Vacuum From 0 to 100 % with 10% increments. Depending on the requirement of the
related surgery, this key is used to increase or decrease.
4. Probe Related Probes for the surgery type will be chosen.
5. Continuous or Predetermined 5 pulse modes are available. Depending on the tissue response, the
Pulse user may opt the best pulse required for the related indication.
6. Foot Switch You can manage the operation.
7. Return Screen goes back to start position.
8. Prime Priming is done and make sure the water comes from the tip of the nozzle.
9. Start Start the operation and stop it using the same key.
21
HOME SCREEN
LANGUAGE SELECTION
SYSTEM CHECKING
WORKING SCREEN
ERROR 10
Microcontroller – No Response (No connection between
HMI and PCB)
Service
ERROR 10
Error closed.
22
ERROR 20
Peristaltic Pump draws the excessive current.
(Improper placement of Peristaltic Pump Head)
See User Manual. If the problem is not resolved, Contact
an authorized service center.
ERROR 20
Error closed.
ERROR 21
Peristaltic Pump does not work (It does not rotate).
(Either software or mechanical oriented)
Check the pump head if it sits the place snaggly, unless
resolved, contact authorized service center.
ERROR 21
Error closed.
ERROR 22
Peristaltic Pump does not produce rotation enough in
harmony with the amount of fluid delivered. (Mismatch
of rotation and fluid amount)
Check the pump head if it sits the place snaggly, unless
resolved, contact authorized service center.
ERROR 22
Error closed.
23
ERROR 41
Out of Resonance Wrong Selection of Tips
ERROR 41
Error closed.
ERROR 42
Mismatch of target and applied frequency
ERROR 42
Error closed.
ERROR 43
Output Voltage Failure
ERROR 43
Error closed.
24
ERROR 50
Perception of overcurrent
ERROR 50
Error closed.
NOTIFICATION
Foot switch is connected.
NOTIFICATION
Foot switch connected confirmation.
NOTIFICATION
Foot switch is disconnected.
NOTIFICATION
Foot switch disconnected confirmation.
25
NOTIFICATION
Handle is disconnected.
NOTIFICATION
Handle disconnected confirmation.
NOTIFICATION
Handle is connected.
NOTIFICATION
Handle connected confirmation.
3.2 Ultrasonic Piezo Handle Assembly

26
Handle Assembly
Remove the front
Place Ultrasonic tip
Turn it Clockwise
Tighten the tip
Place the
protective sleeve
and front as
demonstrated
Handle Disassembly
Remove the Sleeve

and front
Turn it Anti
Clockwise
Loosen the tip
Remove from its

place
27
3.4 Important Considerations in Use

3.4.1 Handle Position
Correct Position
45°
Wrong Position
Wrong Position
28
3.5 Generator
3.5.1 Receptacles, Controls and Indicators
The handle receptacle is keyed in order to facilitate connection. The red dot on top of the receptacle must be
in line with the corresponding red dot on the handle cable.
Additional controls for ultrasound enable/standby and menu access are provided on the left of the display
panel. An ultrasound timer indicates the elapsed time, in which the ultrasound was on. The rear of the console
features receptacles for the power cord, fuses, footswitch cable and as well as a switch for mains power.
1 POWER
2 PERILSTATIC PUMP
3 PEDAL CONNECTOR
4 HMI PANEL SCREEN
5 ULTRASONIC CONNECTOR
1
PERILSTATIC PUMP
2
POWER SOCKET
3
ON/OFF SWITCH
4
FUSE
5
VACUUM PORT
6
AIRVENT
29
Chapter 4 – Troubleshooting
4.1 General Troubleshooting
The user interface for the generator has a number of informative screens to guide the efficient use of the
generator. Informative screens will maintain a consistent dark background to differentiate them from the
alarm screens shown below.
Condition Causes Recommended Action

No power at console AC Main Switch (on the rear Turn on the AC Main Switch (on the rear panel)
panel) off System Power Switch Turn on the System Power Switch (on the front
(front of console) off of the console)
Power cord not plugged in Plug the power cord into the wall receptacle.
Wall receptacle has no power Try another wall receptacle, or check the
available operating room circuit breakers.
Fuse blown in plug Change the fuse in the plug. This procedure
should be performed by the hospital technician.
Power interruption to the console Power cord becomes unplugged 1. Turn off the System Power Switch (on the
front of the console).
2. Plug the power cord into the wall
receptacle.
3. When power is restored, turn on the
System Power Switch.
4. When the Wait status indicator (flashing)
turns off, press the Prime button to make
sure the irrigation system is ready to use.
5. Adjust the Aspiration, Irrigation, Amplitude
and Tissue select settings.
6. Push the Status button to change to Run
mode.
Power interruption in the Facility power loss 1. Turn off the System Power Switch (on the
operating room front of the console).
2. When power is restored, turn on the
System Power Switch.
3. When the Wait status indicator (flashing)
turns off, press the Prime button to make
sure the irrigation system is ready to use.
4. Adjust the Aspiration, Irrigation, Amplitude
and Tissue Select settings.
No irrigation flow from the handle IV administration set roller Open the roller clamp.
flue; the handle tip gets hot clamp closed
Irrigation tubing not routed Route the irrigation tubing properly through
properly through irrigation pump the irrigation pump.
Manifold irrigation tubing not Connect the Luer fitting.
connected to the handle flue
tubing
Not enough time set at Prime to Press the Prime button, and wait until irrigation
allow fluid to pass through the fluid drips from the tip.
irrigation tubing
Irrigation tubing pinched or Remove the pinch or kink from the tubing.
kinked
Irrigation pump not turning Call Mavera for assistance.
Excessive misting at the handle Flue not lined up with tip pre- Adjust the flue position to line up
aspiration holes with the pre- aspiration holes in the
30
tip tip.
Too much irrigation Reduce the irrigation rate.

Low suction setting on the Increase the setting.
control panel
Low or no suction due to Verify that the manifold suction tube connects
suction tubing improperly properly to the nosecone by disconnecting, then
connected to handle reconnecting, the tubing and its clip.
Excessive misting at the handle Blocked tip 1. Verify that the manifold suction tube
tip-continued connects properly to the nosecone by
disconnecting, then reconnecting, the
tubing and its clip.
2. Use the tip cleaner to dislodge the blockage
in the tip. Continue to push the tip cleaner
into the tip until the cleaner becomes
visible in the tubing.
3. When you have cleared the blockage, verify
again that the manifold suction tube
connects properly to the nosecone.
4. If the suction remains low, disconnect the
manifold suction tube connector from the
nosecone. Use the tip cleaner to dislodge
blockage from the tubing, then reconnect
the tubing to the nosecone.
5. Immerse the handle tip in sterile irrigation
fluid briefly. This may clear the blockage
Blockage in the suction tubing 1. Immerse the handle tip in sterile irrigation
at the handle fluid briefly. This may clear the suction
tubing.
2. Press the Status button to change to
Standby mode. Use the sterile tip cleaner to
clean out the tip, then put the tip in
irrigating fluid to flush the tubing.
3. As necessary, disconnect, clean and
reconnect the suction tubing connector at
the handle.
A pinch or kink in the suction Straighten the tubing to remove a kink or
tubing remove anything that might pinch the tube.
A blockage in the suction 1. Examine the suction tubing along its entire
tubing between the handle and length for a blockage.
the suction canister. 2. Squeeze the blocked area to loosen it.
fluid briefly. This may clear the blockage
Suction canister full Replace the suction canister.
Excessive misting at the handle Suction connections at the 1. Remove any unused suction canister
tip-continued suction canister not seated “elbow” connectors.
properly 2. Reseat all connections.
Open port(s) on the suction Close any open ports on the suction canister.
canister
Suction canister improperly Refer to the canister manufacturer’s instructions
connected for connecting the canister.
Inside of the contamination 1. Disconnect the contamination guard fitting
guard wet and blocked from the suction canister tubing. If you feel
no suction at the end of the contamination
guard fitting, the guard is locked.
2. Replace the contamination guard.
Problem at the Macadam Remove the contamination guard and put a
System console suction port finger in the suction system port. If you feel no
suction, call Mavera for assistance.
31
Suction pinch valve not working Check the Lap mode indicator.
properly • If Lap mode is off, in Run mode the pinch
valve should be open.
• If Lap mode is on, in Run mode the pinch
valve should be open only when you
activate vibration.
If these conditions do not exist, call Mavera for
The Run mode status indicator System in Standby mode Press the Status button to switch the system to
does not illuminate when you Run mode.
activate vibration.
Little or no vibration or Excessive tip/tissue pressure 1. Verify that console settings are at desired
fragmentation (Amplitude set (stalling tip) levels.
point indicators may illuminate 2. Remove the tip from contact with tissue,
then reactivate vibration.
well below setpoint)
Note: When first activating vibration, make sure
that there is no tip/tissue pressure.
Blocked tip 1. Verify that the manifold suction tube
connects properly to the nosecone by
disconnecting, then reconnecting, the
tubing and its clip.
into the tip until the cleaner becomes
visible in the tubing.
again that the manifold suction tube
connects properly to the nosecone.
4. If the tip remains blocked, disconnect the
blockage from the tubing, then reconnect
the tubing to the nosecone.
fluid briefly. This may clear the suction
tubing.
Incorrect flue installed Install the correct flue.
Little or no vibration or Tip loose due to improper 1. Press the Status button to place the system
fragmentation (Amplitude set assembly in Standby mode.
point indicators may illuminate 2. Press the Test button to test the handle and
tip.
well below set point)–continued
3. If the Vibration alarm activates, do one of
the following:
If tip assembled in a non-sterile area:
• Remove the handle from the sterile field.
• Use the tip torqueing base and wrench to
tighten the tip.
• Test the tip by testing the handle.
• Sterilize the handle.
If sterile tip assembled to handle in the sterile
field: Use the sterilizable torque base and a
disposable sterile wrench to tighten the tip. Test
the tip by testing the handle.
Console not left in Run mode 1. Return to Standby mode.
for a minimum of two 2. Restart Run mode and wait for two minutes
continuous minutes (36 kHz before using the system.
handle only).
Little or no vibration or Damaged or cracked tip 1. Press the Status button to place the
fragmentation (Amplitude set system in Standby mode.
point indicators may illuminate 2. Press the Test button to test the handle
and tip.
32
well below set point)–continued 3. If the Vibration alarm activates, do one of

the following:
If tip assembled in a non-sterile area:
• Remove the handle from the sterile field.
• Use the tip torqueing base and wrench to
replace the tip.
• Test the tip by testing the handle.
• Sterilize the handle.
sterile tip assembled to handle in the sterile
field:
• Use the sterilizable torque base and a
disposable sterile wrench to replace the tip. (See
Section 11: Assembling or Changing Tips in the
Sterile Field)
Test the tip by testing the handle.
Damaged Handle 1. Connect a new handle to the Macadam
console and test it.
2. If the new handle corrects the problem,
• Verify that the previous handle is correctly
assembled, and
• If it was correctly assembled, send it to
Mavera for repair.
Suction tube won’t assemble Nosecone not assembled to Align the dot on the nosecone with the dot on
correctly to handle nosecone handle correctly the handle.
Transducer is twisted inside Replace with a sterilized handle.
handle housing
Low suction at the handle tip Low suction setting on the Increase the setting.
control panel
System inadvertently in Lap Turn off the Lap mode by pressing the Lap
mode mode button.
Suction tubing improperly Verify that the manifold suction tube connects
connected to handle properly to the nosecone by disconnecting, then
reconnecting, the tubing and its clip.
Blocked tip 1. Verify that the manifold suction tube
connects properly to the nosecone by
disconnecting, then reconnecting, the tubing
and its clip.
into the tip until the cleaner becomes visible
in the tubing.
that the manifold suction tube connects
properly to the nosecone.
4. If the suction remains low, disconnect the
blockage from the tubing, then reconnect the
tubing to the nosecone.
fluid briefly. This may clear the blockage.
Blockage in the suction tubing 1. Immerse the handle tip in sterile irrigation
at the handle fluid briefly. This may clear the suction
tubing.
2. Press the Status button to change to Standby
mode. Use the sterile tip cleaner to clean out
the tip, then put the tip in irrigating fluid to
flush the tubing.
3. As necessary, disconnect, clean, and
reconnect the suction tubing connector at
the handle.
33
A pinch or kink in the suction Straighten the tubing to remove a kink, or

tubing remove anything that might pinch the tube.
Low suction at the handle tip– A blockage in the suction tubing 1. Examine the suction tubing along its entire
continued between the handle and the length for a blockage.
suction canister 2. Squeeze the blocked area to loosen it.
Immerse the handle tip in sterile irrigation
fluid briefly. This may clear the blockage.
Suction canister full Replace the suction canister.
Suction connections at the 1. Remove any unused suction canister “elbow”
suction canister not seated connectors.
properly 2. Reseat all connections.
Open port(s) on the suction Close any open ports on the suction canister.
canister
Suction canister improperly Refer to the canister manufacturer’s instructions
connected for connecting the canister.
Inside of the contamination 1. Disconnect the contamination guard fitting
guard wet, blocked, or both from the suction canister tubing. If you feel
no suction at the end of the contamination
guard fitting, the guard is blocked.
2.Replace the contamination guard.
Suction pinch valve working Check the Lap mode indicator
improperly • If Lap mode is off, in Run mode the pinch
valve should be open.
• If Lap mode is on, in Run mode the pinch
valve should be open only when you activate
vibration.
• If these conditions do not exist, call Mavera
for assintance.
The handle gets hot Surgeon holding handle at tip Hold the handle at the nosecone.
and flue
Handle damage due to tip Replace with a sterilized handle.
torqueing without the torque
base
Loss of cooling water at the Check the Cooling Water System. If problem
handle persists, return handle for service.
The nosecone is loose Large O-ring not installed Install the large O-ring in the proper position
correctly, or missing on the handle.
Nosecone worn Replace with a sterilized nosecone.
Electrical Fault Alert
Alert Type Alert Screen Alert Action
Electrical Fault Displays Electrical Fault Screen.

Permanently deactivates ultrasound
and irrigation. Requires recycling of
mains power switch to re-set.
Possible Cause Corrective Action
1. Handle not connected Turn console OFF.

Check handle cable connection. Restart
console
2. Defective Handle Turn console OFF.
Replace handle and restart console.If
problem persists replace console.
3. Defective console Turn console OFF.
Replace console.
Chapter 5 -Cleaning, Disinfection, Preventive Maintenance

34
5.1 Electrical Safety Check
The hospital is responsible for ensuring that the unit has an electrical safety check performed by qualified service
personnel at least once a year. Do not remove the cover of the generator. Removing the cover voids the generator
warranty.
5.2 Cleaning and Disinfection Instructions
Follow Standards for Decontamination, Cleaning and Sterilization
Follow ANSI/AAMI ST35, Good Hospital Practice: Handling and Biological Contamination of Reusable
Medical Devices (1991), or other such guidelines as may be directed by Hospital or Clinic GHP’s.
 All reusable handle parts and accessories must be properly decontaminated, cleaned and
sterilized before each use as per instructions contained in this manual. Failure to do so may
lead to infections, which can ultimately cause patient.
 The manufacturer has validated all cleaning and sterilization cycles given in this manual. It is
highly recommended that the procedures given in this manual for cleaning and sterilizing the
Macadam™ Ultrasonic Surgical Cavitation System and related accessories be followed. It is the
responsibility of the user of this device or any accessories used with it to validate procedures
for cleaning and/or sterilization if they differ from the procedures as outlined in this manual.
5.2.1 Clean and Disinfect/Sterilize Reusable Items

The following items are considered reusable items and should be cleaned as recommended:
 Ultrasonic Handle
 Surgical Tip SPR
 Probe Torque Tool
 Sterilization Case
 Generator Console
 Foot Switch
Cleaning of Probe Torque Tool and Sterilization Case
Wash & Brush Wash items with hot water mixed with enzymatic detergents according to
standard hospital protocol. Follow manufacturer’s directions for preparing
solutions.
Probe cover and wrenches may be fully immersed.
Brush all passages at least four (4) times from FRONT to REAR, rotating the
brushes during insertion and inserting the brushes fully. This ensures clearing of
debris from the internal passages.
Item’s exterior surface can be cleaned using a standard soft bristle cleaning
brush.
Rinse Rinse item under warm running water for a minimum of 1 minute to clear soap
residue.
Dry Dry item fully with absorbent towel or paper. Dispose of cloth or paper in
accordance with Hospital or Clinic practices for contaminated wastes.
Cleaning of Piezo Handle

35
Wipe cable with cloth or absorbent paper moistened with an enzymatic

Wipe Cable detergents. Follow manufacturer’s directions for preparing solutions.
Clean all surfaces of bloodstains and obvious signs of decontamination.
Wash and brush handle item with hot water mixed with an enzymatic detergent.
Wash & Brush Follow manufacturer’s directions for preparing solutions.
The handle cannot be immersed.
Brush all passages at least four (4) times from FRONT to REAR, rotating the
brushes during insertion and inserting the brushes fully. This insures clearing of
debris from the internal passages.
The item’s exterior surface can be cleaned using a standard soft bristle cleaning
brush.
Rinse Rinse item under warm running water for a minimum of 1 minute to clear soap
residue.
Dry Dry item fully with absorbent towel or paper. Dispose of cloth or paper in
accordance with Hospital or Clinic practices for contaminated wastes.
Inspect Inspect handle and cable and remove any item which shows signs of damages
(cracks, gouges, fractures etc.). Mark damaged items clearly to prevent future use
before disposal.
Use manual cleaning techniques only. Do not use ultrasonic cleaners or automated washers to clean the handle as
both methods could damage handle.
Be certain to clear debris from all internal passages by brushing. Failure to do so may hinder sterilization of unit during
autoclaving.
Do not immerse ultrasonic console, handle, irrigation pump, remote footswitch or electric cables. These items
are not sealed against liquids and damage to equipment will result.
Generator Console and Footswitch
Wipe Surfaces Wipe footswitch and console, including irrigation unit, with cloth or
absorbent paper moistened with an enzymatic detergent
Follow manufacturer’s directions for preparing solutions. Clean all surfaces

of bloodstains and obvious signs of decontamination.
Dispose of cloth or paper with contaminated waste.
Sterilizing by Steam Autoclave

Reusable, Autoclavable Components
 Ultrasonic Handle
 Surgical Probe SPR
 Probe Torque Tool
 Sterilization Case
Steam Sterilization Cycles

36
Validated Steam Sterilization Cycles
Sterilizer Type Pre-Vacuum at 132 °C Gravity at 134 °C
Preconditioning pulses 3 None
Minimum Temperature 132 °C 134 °C
Full Cycle Time 8 min 20 min
Minimum Dry Time 5 min 5 min
Cooling Time Allow items to cool gradually to room temperature prior use.
Sample configuration Wrapped Wrapped
Allow reusable, autoclavable items to gradually return to room temperature after steam sterilization and prior
to usage.
5.2.2 Touchscreen Cleaning
Clean the generator and the touchscreen following the hospital protocol. Before cleaning, turn the generator
main power off and unplug the power cord from the grounded electrical outlet.
5.2.3 Expected Life, Reusable Components
All handle components need to examined regularly, prior each use and be replaced if damaged.
The estimated sterilization life of handle components is listed below. All sterilization life estimates are
approximate and may be affected by rough handling, damage, wear due to vigorous cleaning, etc.
Estimated Sterilization Life

Item Number of Steam Sterilization Cycles
Handle with attached cable > 50 cycles

Probe cover > 300 cycles
Wrenches: > 300 cycles
Handle/counter wrench and T-wrench
The reuse life given takes into account wear and tear due to cleaning and sterilization only.
Damage or wear caused by actual use in treatments will affect life of components.
5.2.4 Deviations from Decontamination, Cleaning and Sterilization Instructions
The manufacturer has validated all cleaning, disinfection and sterilization cycles given in this manual. It is
highly recommended that the procedures given in this manual for cleaning and sterilizing the Macadam™
System and related accessories be followed. It is the responsibility of the user of this device or any accessories
used with it to validate procedures for cleaning and/or sterilization if they differ from the procedures as
outlined in this manual.
5.2.5 Technical Assistance

37
Should the user wish further information or instructions regarding any aspect of cleaning or sterilizing
procedures, please contact Mavera or an Authorized Representative. Allow reusable, autoclavable items to
gradually return to room temperature after steam sterilization and prior to usage.
Chapter 6- Service, Repair and Technical Correspondence
Proper system grounding can only be ensured when an approved, hospital-grade receptacle and matching
power cord are used. Install plug and receptacles as per local regulations before operating the unit. Power
cord, plug and receptacle should be examined to verify that they are in good working condition before
connecting the console. Never pull on the power cord to remove it from the receptacle.
6.1 Repair, Service and Replacement Parts
All requests for repairs and replacement parts should be directed to Mavera or an authorized Mavera
representative. Always provide model and serial number of malfunctioning items.
When returning items include model, serial and as well as purchase order number on all documents. Always
prepay return shipping and specify method of shipment.
6.2 Important Notice
Please contact Mavera with any questions regarding the specifications, use, sterilization, limitations or maintenance of
the Macadam™ Ultrasonic Surgical Cavitation System:
Mavera Medical Devices, Inc.
Web www.maveramedical.com.tr
Email info@maveramedical.com.tr
Phone +90-312-341-5027
Fax +90-312-341-5026
Address YEŞİLBAYIR MAH. SAĞDUYU

CAD. NO:107/C
MAMAK / ANKARA / TURKEY
Zip Code 06270
By returning any material to Mavera the customer or the customer's agent must certify that any and all materials so returned are or
have been rendered free of any hazardous or noxious matter or radioactive contamination and are safe for handling under normal
repair shop conditions.
Do not return any material for which such certification cannot be made without prior approval from Mavera.
The correct return address should read as follows:
Mavera Medical Devices, Inc.
Phone +90-312-341-5027
Address YEŞİLBAYIR MAH. SAĞDUYU CAD. NO:107/C MAMAK / ANKARA / TURKEY

Chapter 7-Appendices
7.1 Markings on the Front and Rear Panel of the Generator
38
FRONT REAR
ON/OFF SWITCH POWER
FOOTSWITCH
PIEZO CONNECTION
7.2 Symbols for the Product Labels
SYM BOL SYM BOL NAME SYM BOL SYM BOL NAME
Lot Number Keep Dry
Serial Number See instruction manual
Caution Manufacturer
Contents
Catalogue Number
Do Not Re-sterilize
Sterilized by using ethylene oxide
Do Not Use If Package Is Use By

Damaged
Do Not Re-use Consult Instruction for Use
Humidity Limitation Type BF insulation
Dispose Electrical Electronic

Risk of Electric Shock
Equipment Correctly
EC Mark European Temperature Limitation

Conformity
Footswitch Shelf Life

39
Non-Pyrogenic Autoclavable
Life Cycle Keep away from sunlight
Temperature Limitation (for

Humidity Limitation (for non-sterile)
non-sterile)
Federal USA law restricts this

device to sale by or on the
order of a physician
7.3 Technical Specification
Generator Specifications
Power input 220-230 VAC, 0,35 Amp, 50/60Hz
Ground leakage current 300 µA (max.)
Output power 80 VA (max.)
Aspiration 900 mmHg
Irrigation Pump 0-200 ml per minute at max
Main Fuses 2A Fast Glass Tube
Operating Frequency 20-57 kHz unless otherwise stated
Output - Accuracy of ±1%
frequency display
Degree of Protection Type BF (applied part complying with IEC 60601-1)
Against Electric Shock
Generator
Class of Protection Class 1 (generator has a protective earth connection)
Against Electric Shock Type BF (patient applied parts are at earth potential)
Handset Class of Protection Type BF (applied part complying with IEC 60601-1)
Against Electric Shock
Ingress Protection Generator IP20 the device does not let some particles but it does not have any
water resistance Handle Autoclave Sterilization
Mode of Operation Continuous and Intermittent Wave
Controls  Mains Power on/off switch (rear panel)

 Foot-switch control for ultrasonic
 Ultrasonic Wave Setting
 Continuous or Pulse control
 Irrigation
 Language
 Operation timer
 Alert (sound)
40
 Keybord
Handle cable • 3.00 m
Footswitch cable • 3.00 m
Power cord • 3.00m
Operating conditions • Temperature +13-+35 °C

• Relative humidity 20-90% (non -condensing)
• Ambient pressure: 500-1060 hPa
Shipping/storage conditions Sterile:
Temperature : 21-25 °C
Relative humidity: 35-55% (non-condensing)
Ambient pressure: 500-1060 hPa
Non-Sterile:
Temperature: 5 to +40℃
Ambient pressure : 500-1060 hPa
Dimensions H 20cm, L 40cm, W 40cm
Weight 11.6 kg
7.4 EMC Statement
The Macadam™ Ultrasonic Surgical Cavitation System is designed and tested to comply with IEC EN60601-1-2: 2015
guidelines for EMC.
7.5 Electromagnetic Interference
Macadam™ Ultrasonic Surgical Cavitation System generates, uses, and emits ultrasonic energy. If this
equipment is not used in accordance with the instructions in manual, it may cause electromagnetic
interference. This device was tested and found conforming to acceptable limits for medical devices in
accordance with EN 60601-1-2 standard. If this device is used in accordance with the instructions in manual,
these limits indicate that the device provides acceptable protection against electromagnetic interference (EMC).
This device is designed and manufactured in accordance with the requirements of EN 60601-1-2 standard.
This device may be affected by portable. This device should not be stored with other equipment.
To be informed more about this device and see EMC tables:
7.5.1 TABLE I
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The Macadam™ Ultrasonic Surgical Cavitation System is intended for use in the electromagnetic environment
specified below. The customer or the user of The Macadam™ Ultrasonic Surgical Cavitation System should ensure
that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
The Macadam™ Ultrasonic Surgical Cavitation System uses RF energy only
RF emissions
Group 1 for its internal function. Therefore, its RF emissions are very low and are
CISPR 11
not likely to cause any interference in nearby electronic equipment.
41
RF emissions
Class B
CISPR 11
Harmonic
emissions IEC Class A The Macadam™ Ultrasonic Surgical Cavitation System is suitable for use in
61000-3-2 all establishments including domestic and those directly connected to the
Voltage public low voltage power supply network that supplies buildings used for
fluctuations/flicker domestic purposes.
Complies
emissions
IEC 61000-3-3
7.5.2 TABLE II
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

Macadam™ Ultrasonic Surgical Cavitation System is intended for use in the electromagnetic environment
specified below. The customer or the user of the Macadam™ Ultrasonic Surgical Cavitation System should ensure
Immunity IEC 60601 Compliance
test level Electromagnetic environment –guidance
test level
Electrostatic
Floors should be wood, concrete or ceramic. If floors
discharge ± 6 kV contact ± 6 kV contact
are covered with synthetic material, the relative
(ESD) ± 15 kV air ± 8 kV air
IEC 61000-4-2 humidity should be at least 30%.
± 2 kV for power
± 2 kV for power
Electrical fast supply lines
supply lines Mains power quality should be that of a typical
transient/burst ± 1 kV for
± 1 kV for commercial or hospital environment.
IEC 61000-4-4 input/output
input/output lines
lines
±1 kV line (s) to ±1 kV line (s) to
Surge line (s) line (s) Mains power quality should be that of a typical
IEC 61000-4-5 ±2 kV line (s) to ±2 kV line (s) to commercial or hospital environment.
earth earth
Voltage dips, <5 % UT <5 % UT
Mains power quality should be that of a typical
short (>95 % dip in (>95 % dip in UT)
commercial or hospital environment. If the user of
interruptions UT) for 0,5 cycle for 0,5 cycle
the Macadam™ System requires continued operation
and voltage <40 % UT <40 % UT
during power mains interruptions, it is recommended
variations on (>60 % dip in (>60 % dip in UT)
that the Macadam™ System be powered from an
power supply UT) for 5 cycles for 5 cycles
input lines <70 % UT <70 % UT uninterruptible power supply or a battery.
IEC 61000-4- (>30 % dip in (>30 % dip in UT)
11 UT) for 25 cycles for 25 cycles
<5 % UT <5 % UT
(>95 % dip in (>95 % dip in UT)
UT) for 5 s for 5 s
Power
frequency Power frequency magnetic fields should be at levels
(50/60 Hz) 30 A/m, 50Hz 30 A/m, 50Hz characteristic of a typical location in a typical
magnetic field commercial or hospital environment.
IEC 61000-4-8
NOT UT is the AC mains voltage prior to application of the test level.
7.5.3 TABLE III
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

Mavera Macadam™ Ultrasonic Surgical Cavitation System is intended for use in the electromagnetic environment
specified below. The customer or the user of the Macadam™ Ultrasonic Surgical Cavitation System should ensure
42
Immunity IEC 60601 test Compliance

Electromagnetic environment -Guidance
test level test level
Portable and mobile RF communications equipment
should be used no closer to any part of the Model 005,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Conducted RF 3 Vrms Recommended separation distance
IEC 61000-4-6 150 kHz to 𝒅𝒅 = 𝟏𝟏. 𝟏𝟏𝟏𝟏√𝑷𝑷
3V
80 MHz
𝒅𝒅 = 𝟏𝟏. 𝟐𝟐√𝑷𝑷 0,15 MHz to 80 MHz
3V
𝒅𝒅 = 𝟐𝟐. 𝟑𝟑√𝑷𝑷 80 MHz to 2.7 GHz
where P is the maximum output power rating of the

transmitter in watts (W) according to the transmitter
Radiated RF 3V/m 80 MHz to manufacturer and d is the recommended separation
3 V/m
IEC 61000-4-3 2,5 GHz distance in meters (m).
Field strengths from fixed RF transmitters, as

determined by an electromagnetic site survey, should
be less than the compliance level in each frequency
range.
Interference may occur in the vicinity of equipment

marked with the following symbol:
NOT 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOT 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the Macadam System is
used exceeds the applicable RF compliance level above, the Macadam System should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-
orientating or relocating the Macadam System.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
7.6 Electrical Safety Statements

The Macadam™ Ultrasonic Surgery Cavitation System is designed and tested to comply with EN 60601-1.
7.7 Environmental Statements
This equipment consists of materials that may be recycled if disassembled by a specialized company. Please
observe local regulations regarding the disposal of packing materials and old equipment.
7.8 General Safety Statements
The Macadam™ system is an electro-mechanical device, which under certain circumstances could present an
43
electrical shock hazard to the operator and/or patient. Please read manual thoroughly and follow directions
stated herein to assure maximum safety during operation. This manual shall be kept in close proximity to the
system for easy referral when needed.
The Macadam™ system is intended to be used in various types of invasive, surgical procedures. There may
be indirect danger to the patient should the device fail during the procedure. It is recommended that the
facility follows its back-up equipment protocols.
7.9 Conventions Warning and Cautions
Please read this section of the manual carefully. This section highlights the definitions and such critical terms
Warning and Caution.
The user is advised to read the entire manual and operate the device only in accordance with all of the
instructions contained herein.
Servicing of this device should only be performed by qualified technicians authorized by Mavera.
There are no service controls accessible to the user.
7.10 Disclaimer
A surgeon should rely exclusively on his or her own professional medical/clinical judgment when deciding
which particular product to use when treating a patient. Mavera does not dispense medical advice and
advocates that surgeons be trained in the use of any particular product before using it in surgery. The content
presented is intended to identify the breadth of Mavera Medical product options. A surgeon must always refer
to the package insert, product label and/or instructions for use before using any Mavera Medical product.
Products may not always be available in all markets in a similar capacity due to the local regulatory and/or
medical practices. It is advised that you contact a Mavera Medical representative if you have questions about
Mavera Medical products.
Mavera Medical Inc. guarantees that the products are designed, manufactured and packaged on application
of the EN ISO 13485 certified quality management with all possible care, using the most suitable state-of-the-
art processes and applying the principle of integrating safety into its design and manufacture. This system is
designed to guarantee the safe use of device when it is employed under condition and for the purposes for
which it is intended, in accordance with precautions described in the operator’s manual and/or instructions for
use and to minimize the risks associated with the use of the device as far as possible, although they cannot
be totally eliminated. The device must only be used under the responsibility of specialist medical personnel,
taking account of the unavoidable risks and the possible side effects and complications of the treatment for
which, it is designed, including those referred to in other sections of these instructions for use.
7.11 Contact
Mavera Medical Devices Inc.
YEŞİLBAYIR MAH. SAĞDUYU CAD. NO: 107/C MAMAK / ANKARA / TURKEY
Phone: +90312 341 50 27
Facsimile: +90312 341 50 26
info@maveramedical.com.tr www.maveramedical.com.tr
7.12 Trademark Information
Macadam™ and Mavera® are registered trademarks of Mavera Medical Devices Inc, Ankara TURKEY.
44
Limited Warranty
Mavera Medical Devices warrants its Macadam™ Ultrasonic Surgical

Cavitation System (“Device”) to be free from defects in workmanship and
materials for a period of one (1) year from the date the Device is delivered
to the original purchaser (“Warranty Period”). This Limited Warranty is
extended only to the original purchaser and is non - transferable. Mavera
Medical Devices’ sole obligation under this Limited Warranty shall be, at its
sole discretion, to repair or replace a device which is defective in either
workmanship or material. This is the sole remedy of the Purchaser. This
Limited Warranty excludes the power plug and connection tubing. In
addition, this Limited Warranty does not cover any device which may have
been damaged in transit or has been subject to misuse, neglect, or accident;
or has been used in violation of Mavera Medical Devices’ instructions,
including, without limitation, the instructions contained in the Operating
Manual.
THERE ARE NO OTHER WARRANTIES THAN THOSE EXPRESSLY STATED HEREIN. TO

THE EXTENT PERMITTED BY LAW, MAVERA MEDICAL DEVICES DOES NOT MAKE
ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE AS TO ANY PRODUCT OR DEVICE, WHETHER OR NOT THAT PRODUCT OR
DEVICE IS COVERED BY ANY EXPRESS WARRANTY CONTAINED HEREIN.
IN NO EVENT SHALL MAVERA MEDICAL DEVICES BE LIABLE FOR ANY SPECIAL,
INCIDENTAL, CONSEQUENTIAL, OR INDIRECT DAMAGES ( INCLUDING, WITHOUT
LIMITATION, DAMAGES FOR LOSS OF PROFITS, USE OR TIME INCURRED BY
PURCHASER OR END USER). IN ADDITION, MAVERA MEDICAL DEVICES SHALL NOT
BE LIABLE FOR ANY EXEMPLARY OR PUNITIVE DAMAGES.
Limited Liability
THE LIABILITY OF MAVERA IS STRICTLY LIMITED TO REPLACING THE DEVICE IF IT

SHOULD PROVE DEFECTIVE AT THE TIME OF DELIVERY. UNDER SUCH
CIRCUMSTANCES, THE CUSTOMER SHALL DELIVER THE DEVICE TO MAVERA, WHICH
RESERVES THE RIGHT TO EXAMINE THE ALLEGEDLY FAULTY DEVICE AND ESTABLISH
WHETHER IT ACTUALLY PRESENTS MANUFACTURING DEFECTS. THE WARRANTY
SOLELY COVERS REPLACEMENT OF A DEVICE FOUND TO BE DEFECTIVE WITH
ANOTHER OF SAME OR EQUIVALENT TYPE MANUFACTURED BY MAVERA.
THE WARRANTY SHALL ONLY APPLY IF THE DEVICE IS RETURNED TO MAVERA, CORRECTLY
PACKED, TOGETHER WITH A DETAILED WRIITTEN REPORT ON THE DEFECTS COMPLAINED.
IF THE DEVICE IS FOUND TO BE FAULTY AND REPLACED, MAVERA WILL REFUND THE
COSTS DIRECTLY INCURRED BY THE CUSTOMER. MAVERA DECLINES ALL LIABILITY
IN THE EVENT OF FAILURE TO COMPLY WITH THE DIRECTIONS FOR USE OR
PRECAUTIONS SPECIFIED IN THIS INSTRUCTION BOOKLET, OR IN THE CASE OF USE
AFTER THE EXPIRY DATE MARKED ON THE PACK ING. MAVERA FURTHER DECLINES
ALL LIABILITY FOR THE CONSEQUENCES OF MEDICAL DECISIONS AND METHODS OF
USE OR APPLICATION OF THE DEVI CE, AND SHALL THEREFORE NOT BE LIABLE FOR
ANY MATERIAL, BIOLOGICAL OR NON -PECUNIARY LOSS OR INJURY OF ANY KIND
RESULTING FROM THE APPLICATION OF THE DEVICE.

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Manual of Operator

Chapter 1- General Information ......................................................................................................................................................4

1.1. Intended Use...................................................................................................................................................................4

Chapter 3 - Operative System .......................................................................................................................................................20

3.1 System Start Up ............................................................................................................................................................20

 Correct Position .................................................................................................................... Hata! Yer işareti tanımlanmamış.

4.1 General Troubleshooting...............................................................................................................................................29

Chapter 5 -Cleaning, Disinfection, Preventive Maintenance .........................................................................................................33

5.1 Electrical Safety Check ..................................................................................................................................................34

Chapter 6- Service, Repair and Technical Correspondence ...........................................................................................................37

6.1 Repair, Service and Replacement Parts .........................................................................................................................37

Mavera Medical Devices, Inc.........................................................................................................................................................37

Chapter 7-Appendices ...................................................................................................................................................................37

7.1 Markings on the Front and Rear Panel of the Generator................................................................................................37

Limited Warranty ..........................................................................................................................................................................44

Limited Liability .............................................................................................................................................................................44

Please read all information carefully.

pages as necessary to keep nearby.

Conventions on Warnings and Cautions

1.1. Intended Use

Macadam™ Ultrasonic Surgical Cavitation System is intended to be used in selectively fragmentation,

1.2. Device Description

Tips/Probes TI6AL4V and/or Stainless Steel

Flute Polyurethane and/or Polysiloxane Rubber

Indirect Contact Materials

Irrigation Tubing PVC Medical Grade

External Non-Tissue Contact Materials

Handle Body Anodized Aluminum Frame/Polyamide

Handle Gripper Polyurethane and/or Polysiloxane Rubber

Aspiration Tubing PVC Medical Grade

1.4 How Supplied

1.7 General Warnings, Precautions and Cautions

Brand Description Ref#

Foot Switch Duo Flute Sleeve Short

Serum Hanger Sterilization Case II

Irrigation Tubing Set Aspiration Tubing Set

XS Extended Straight Tip for Soft Tissue Laparoscobic Tip

Standard Curved Tip for Hard Tissue III

1.16 Reprocessing Instructions

1.16.1 Limitations on Reprocessing for Non-Sterile

1.16.2 Manual Cleaning

1.17 Cleaning Inspection

1.2 Operation, Storage and Transport

Storage conditions for non-sterile:

Perspective View of the Macadam™ Generator Right

Power Cord Port Power On/Off Switch

Pedal Connector Handle Connector

Foot Switch Duo

Chapter 3 - Operative System

3.1 System Start Up

Power on, the touchscreen will appear the following interface:

1. Power From 0 to 100 %. It indicates percentage of a breakdown of watts at max 200

6. Foot Switch You can manage the operation.

7. Return Screen goes back to start position.

3.2 Ultrasonic Piezo Handle Assembly

Remove the front

Place Ultrasonic tip

Tighten the tip

Remove the Sleeve

Loosen the tip

Remove from its

3.4 Important Considerations in Use

3.5.1 Receptacles, Controls and Indicators

4 HMI PANEL SCREEN