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Table of Contents
Summary of Contents for ROCAMED MH01
- Page 1 MH01 2100 nm Holmium 30W Laser System User Manual NOTE-MH01-EN rev05...
- Page 2 ROCAMED further assumes no liability for patient treatment or outcome or for physician’s negligence, breach of duty of care, or malpractice. In no way does this or any of ROCAMED’s policies, procedures, training materials, guidelines, or instructions create an obligation for ROCAMED to perform any services. Products and services may be purchased from ROCAMED or Distributor Certified/Trained by ROCAMED.
- Page 3 • Use protective goggles, ALWAYS • Protect the patient from hazardous optical radiation • Protect any operator, using personal protection means and environment protection barriers • Please consult, in advance, the “Safety” session of this manual NOTE-MH01-EN rev05...
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Page 4: Table Of Contents
4 ENVIRONMENTAL CONDITIONS AND INSTALLATION ..........22 4.1 E ..................22 NVIRONMENTAL CONDITION ........................ 22 4.1.1 W ORKING AREA 4.1.2 E ................22 LECTRICAL CONNECTION REQUIREMENTS ..................... 22 4.1.3 T EMPERATURE AND HUMIDITY 4.1.4 M ..................22 INIMUM SPACE REQUIREMENTS NOTE-MH01-EN rev05... - Page 5 TANDBY 5.5.2 R ........................40 EADY ......................41 5.5.3 M ODE OF MISSION 5.5.4 P ....................41 OWER OUTPUT SETTINGS ......................... 42 5.5.5 E MISSION 5.5.6 A ..................... 43 LARM FIBER CONSUMPTION ......................43 5.5.7 L ASER ARAMETERS NOTE-MH01-EN rev05...
- Page 6 HECK THE OPTICAL FIBER BEFORE OPERATION 7.7 U ..........55 LEANING DISINFECTION STERILIZATION OF OPTICAL FIBERS 7.8 B ..................55 LAST SHIELD REPLACEMENT 8 TROUBLESHOOTING ....................56 9 CUSTOMER SERVICE ....................57 9.1 M ............... 57 ANUFACTURER WARRANTY AND RESPONSIBILITY NOTE-MH01-EN rev05...
- Page 7 EPAIR AND MODIFICATIONS OF THE DEVICE 9.3 S ..................58 ERVICE DEPARTMENT CONTACTS 10 TECHNICAL SPECIFICATIONS ..................59 10.1 G ....................59 ENERAL SPECIFICATION 10.2 L ..................59 ASER SOURCE SPECIFICATION 11 ACCESSORIES ......................60 12 TABLES (EMC) ......................61 NOTE-MH01-EN rev05...
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Page 8: General Information
Medical Device MH01 is a 30W Holmium Yag Laser with 2100nm wavelength which is used by physician as a tool in surgical procedure. The laser MH01 is the result of a long experience of ROCAMED in the field of medical laser equipment This manual contains important information regarding the safe use of medical device MH01. -
Page 9: Safety Instruction
In this manual the following symbol is used to indicate a possible operational fault and the damage to the laser system, which might result from it (Fig. 2). WARNING: Fig. 2: Symbol for Warning “Caution: Federal law restricts this device to sale by or on the order of a physician/surgeon” NOTE-MH01-EN rev05... -
Page 10: Symbols And Abbreviations Used In This Manual
Units, Joule for centimetre square Units, centimetre Optical Density Continuous laser according to EN207 Glasses protection degree Units, Kilovolt Units, Ampere for metro Vrms Effective supply voltage Units, Kilo Hertz Units, Giga Hertz WEEE Waste Electrical and Electronic Equipment Continuous laser pulses NOTE-MH01-EN rev05... - Page 11 T on Pulse duration laser on T off Pulse duration laser off Units, Pressure °C Units, Celsius degree Units, Kilogram Percentage A label that indicates the key switch off A label that indicates the key switch on Pushing Prohibited NOTE-MH01-EN rev05...
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Page 12: Manufacturer
Via Acquedotto, 109 21017 Samarate (VA) ITALY www.quantasystem.com Combinations We recommend to use ROCAMED fibres in conjunction with MH01 Laser System. CAUTION! Products may be incorrectly combined! Injury of the patient, user or others as well as damage to the product are possible. -
Page 13: Laser Safety
It is recommended that all operators and support personnel are adequately trained on laser safety standards. (This device must only be used by adequately qualified and trained medical personnel with experience in Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery NOTE-MH01-EN rev05... -
Page 14: Nominal Ocular Hazard Distance
WARNING: Openings inside installation area that are transparent to laser radiation must be properly darkened. Doors equipped with a special interlocking system have to be made of a laser non-transparent material (glass, plastic, curtains, etc.) and windows have to be darkened by using appropriate laser non-transmissive systems. NOTE-MH01-EN rev05... -
Page 15: Working Area
Admission is strictly prohibited if there is no operator in the working area Eye and skin exposure The laser beam emitted by MH01 can cause sight loss. The laser operates at different wavelengths, visible and invisible. Any energy transmitted by the laser system that enters the eye will be focused directly on the retina. -
Page 16: Fire Hazard
· or disinfect Attention: endogenous gases can catch fire or explode. · WARNING! Equipment not suitable for use in the presence of flammable mixtures. NOTE-MH01-EN rev05... -
Page 17: Emission Of Plume
WARNING: Turn off mobile phones and similar devices while operating the device This device MH01 must be installed and used according to EMC information described in the tables reported in Attachment B. 2.10... -
Page 18: Labelling Plan
Labelling plan Label 1 Laser characteristics Label 2 Footswitch Connection Label 3.3 Emergency Stop Label 3.5 Laser Aperture Label 3.7 Warning Label of Maser Radiation Label 3.12 ON and OFF the key switch Label 3.13 Applied Part BF NOTE-MH01-EN rev05... - Page 19 Label 5 Interlock connector Label 6 Warning – High Voltage Label 7 Caution – Laser Radiation Label 8 Ground Label 9 Read Instruction For Use Label 10 Pushing Prohibited Label 14 Water Drain Connector Label 15 Water Fill Connector NOTE-MH01-EN rev05...
- Page 20 Label 16 Air Purge Connector Label 18 UDI label Label 19 Storage Conditions NOTE-MH01-EN rev05...
- Page 21 Frontal View NOTE-MH01-EN rev05...
- Page 22 Rear View NOTE-MH01-EN rev05...
- Page 23 Lateral View Left Side Right Side NOTE-MH01-EN rev05...
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Page 24: Device Description
2100nm, then in the infrared part of the EM spectrum. The maximum power of the device is 30W. For the release of laser radiation to the patient the medical device MH01 uses a quartz optical fiber with a diameter up to 1000μm (see Chapter 11 "Accessories") to be used for surgical applications mentioned in Chapter 6, "Clinical Applications". -
Page 25: Device Back View
3.2.2 Device Back view Hydraulic circuit loading connector Fiber Box support Fans Area Cord storage Interlock connector Power/mains switch Footswitch connector ROCAMED ENDOFLO®II/ROCAFLOW Connection Hydraulic circuit drain connector 10. Power supply cord 11. Bleeding 12. Blast Shield Access NOTE-MH01-EN rev05... -
Page 26: Device Lateral View
3.2.3 Device Lateral view Touch screen Display (control panel) Blast Shield Access Water Level Fiber Box support Cord storage Power supply cord Emergency red push button Key switch NOTE-MH01-EN rev05... -
Page 27: Laser And Electric System
Emergency red push button: The emergency red push button is designed for emergencies or when the operator must immediately turn off the device. To switch off immediately, press the button. To reset the emergency red push button turn the knob clockwise. NOTE-MH01-EN rev05... -
Page 28: Accessories
Before performing any laser emission, make sure that the probe is inserted, pay attention to the pointing direction WARNING: The use of fibers or other connections than those not supplied by the manufacturer, not original, does not guarantee the achievement of security requirements. NOTE-MH01-EN rev05... -
Page 29: Environmental Conditions And Installation
The installation of the laser device must be performed by qualified technical personnel authorized by the manufacturer. This person should also carry out tests on the operation of the device after installation in the designated working area. NOTE-MH01-EN rev05... -
Page 30: Transportation
Figure A and B. Avoid pulling the device on sloping surfaces as shown in Figure C and D, the device could tip over. NOTE-MH01-EN rev05... -
Page 31: Packaging
Connect the laser device to the power supply Turn on the system Check the system and verify if alert messages are displayed Connect the RFID Fibers and wait that MH01 system recognizes type and the number of uses of employed fibers. NOTE-MH01-EN rev05... -
Page 32: Main Device Connection
Remove the interlock Remove the key Note: ROCAMED advises wrapping the device with a large quantity of protective plastics. Note: The shipment of device to the final destination of the customer is under the responsibility of the distributor. ROCAMED is not responsible for possible damage caused during this phase. -
Page 33: Remote Interlock Connection
Warning: Do not wrap the footswitch with any plastic (or other material) film or cover bag, unless authorized by the manufacturer. The unauthorized use of wrapping bags/films may block the pedal in pressed position and cause unwanted laser emission. NOTE-MH01-EN rev05... -
Page 34: Optical Fiber Connection
The device accepts fiber with SMA905 connector and with RIFD Recognizer System (only with ROCAMED internal code). The fiber connector has an additional ring which facilitates the clamping of the fiber to the connector on the device and enables automatic... -
Page 35: Emptying The Hydraulic Circuit
Insert the blue tube supplied in the water drain connector (1). Place a container to collect the water released from the tube. When the emptying is over remove the tube and push in red cap to close the Air Purge NOTE-MH01-EN rev05... -
Page 36: Instruction For Use
INSTRUCTION FOR USE This section describes the instructions for use of the device MH01. They include: Start-up procedure · Operating instruction · Description of possible Alarm messages · Shut down procedure and protection from unauthorized use · Start-up procedure Before proceeding with the start-up procedure of the device, verify the correct connection of... -
Page 37: Rfid Fiber Connection
Before starting the laser emission, please control that the optical fiber size coinciding with the indications impressed on the connector of the fiber. After a few seconds, the main menu will be present the main screen. NOTE-MH01-EN rev05... -
Page 38: Operating Instruction
Touch this area to change the laser treatment MODE Touch here to reset the energy/pulse counter Touch here to enter Ready Mode Touch here to enter in the Menu This icon appears to recommend the refurbishment of the fiber’s tip NOTE-MH01-EN rev05... -
Page 39: Change Emission Mode
5.2.2 Change Emission Mode When you insert a new optical fiber, MH01 will ask you to select the specific emission mode depending to the intended use of the laser system. Press MODE Area to change the treatment mode. Touch MODE Area... -
Page 40: Lithotripsy Mode
Use the Lithotripsy Fragmentation Mode in order to minimize the speed of lithotripsy but doing bigger size of fragments MH01 will suggest you a combination of energy pulse and frequency emission*, taking in consideration your selection and the connected fiber specifications. -
Page 41: Tissue Mode
If you select “Tissue” in the first mode emission selection (cap5.2.2) the following screen will appear: Select the type of laser action you need over the target tissue MH01 will suggest you a combination of energy pulse and frequency emission, taking in consideration your selection and the connected fiber specifications. -
Page 42: Fiber Info
5.2.7 Fiber INFO When a RFID ROCAMED fiber is connected and the RFID system is active, the system recognizes the type of the fiber and any of the previous uses. When the RFID System recognizes the fiber the Info Fiber Panel will appear. -
Page 43: Menu
Please see chapter 5.2.6 5.3.3 Device Parameters Please see chapter 5.4 5.3.4 User Manual The electronic version of this User Manual is consultable directly from this area by the MH01 Software. DEVICE PARAMETERS By selecting the Device Parameters from the sub Menu (Menu Functions 5.3), the Device Parameters Panel will appear. -
Page 44: Service (Only For Technical Service)
Press ESC to come back to the Main Screen. · Diagnostic Without the Service Password it is possible to access the Diagnostic Panel by pressing on the “Diagnostic” button in the Service Screen. Press “Esc” to exit to the Main Screen. NOTE-MH01-EN rev05... -
Page 45: Display
Also it is possible to activate or deactivate the Key sounds by the Key Sound button (1) . Sound level » Touching the button increase the energy displayed. « Touching the button decreases the energy displayed. When the Sound emission corresponds to your desire, press OK to confirm and exit to the main screen. NOTE-MH01-EN rev05... -
Page 46: Device Info
After setting the suitable values for the working parameters, the user can start the laser emission as follows. Laser Operation: Press the ready/standby button area or push the dedicate pedal of the double footswitch (optional), changing the status from standby to ready. NOTE-MH01-EN rev05... -
Page 47: Ready / Standby
WARNING! All the personnel present in the laser working area must wear all the protective items 5.5.2 Ready Mode When you change the system from standby to ready to the first time the Warning Safety Screen will appear: NOTE-MH01-EN rev05... -
Page 48: Mode Of Emission
5.5.4 Power output settings The values for energy and frequency can be changed, within the permissible limits, using the dedicated buttons. The selected values are displayed. Touch here to modify the Frequency output Touch here to modify the Energy output NOTE-MH01-EN rev05... -
Page 49: Emission
At the end of the treatment, release the footswitch and enter in the standby mode by pressing the Ready/Standby area on the display or the dedicated pedal of the double footswitch (optional). For starting a new treatment press Ready/Standby area on the display or the dedicated pedal of the double footswitch (optional). NOTE-MH01-EN rev05... -
Page 50: Alarm - Fiber Consumption
2.5 J 3.5 J 3 Hz 12,5 5 Hz 8 Hz 14,4 10 Hz 10 W 12 W 15 W 18 W 20 W 25 W 14,4 21,6 12 Hz 10,5 22,5 15 Hz 20 Hz 25 Hz NOTE-MH01-EN rev05... -
Page 51: Alarms And Warning Description
Fiber (Optical Interlock) alarm: the optical fiber is not connected or it’s connected in a · wrong way. Try to unplug and plug again the fiber in the proper way. Fiber expired: you are searching to use the connected fiber beyond the expected uses. · NOTE-MH01-EN rev05... -
Page 52: Shutdown Procedure And Protection Against Unauthorized Use
· Turn off the main switch on the rear panel and disconnect the power cable · Disconnect the remote interlock · Disconnect the footswitch · Keep the device and accessories in a dry and safe place. · NOTE-MH01-EN rev05... -
Page 53: Clinical Application
6 CLINICAL APPLICATION This section is provided to aid professionals in the use of the MH01 laser system. It adds to or reinforces information presented in the operator's manual concerning instructions for use, precautions and warnings necessary to reduce the risk of injury. All operators must read the entire operator's manual before reviewing this section and before operating the system. -
Page 54: General Laser Warnings
Discontinue laser treatment immediately if the patient develops any cardiopulmonary problems. ROCAMED has no clinical information concerning the safety of laser treatment on pregnant or nursing women. Refer to the appropriate delivery system instruction guide for use instructions. -
Page 55: Urology Indications
Read General Laser Complications (see Section 6.2.3) for a list of complications. 6.3.5 Urology Clinical Parameters The Ho:YAG wavelength provides effective hemostasis without damaging surrounding or non-target tissues. Coagulation can be effected by reducing the energy or power density incident on vascularized tissue in two ways. NOTE-MH01-EN rev05... -
Page 56: Urinary Lithotripsy Indications
Contraindications for Percutaneous Nephrolithotomy (PCNL): Acute proneness to bleeding, anticoagulation Untreated infections of the urinary passages Tumor in the access area Pregnancy Difficult access to the stone in the case of: Skeletal anomalies Renal anomalies Intestinal interposition Pleural interposition NOTE-MH01-EN rev05... -
Page 57: Urinary Lithotripsy Warnings
1 to 3%. Previous ureter perforations represent the key risk factor. Complications for Percutaneous Nephrolithotomy (PCNL): Typical are the following complications: Fever, sepsis Bleedings requiring transfusion Absorption of irrigation fluid Perforation of the intestine Lesion of the pleura NOTE-MH01-EN rev05... -
Page 58: Urinary Lithotripsy Clinical Parameters
Use the Lithotripsy Dusting Effect Mode in order to minimize the size of fragments. ENT – General Surgery – Gastroenterology – Arthroscopy MH01 laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation,... -
Page 59: Specific Contraindications
Read “General laser complications” for a list of additional complications. Complications for Arthroscopy Read “General laser warnings”, “General laser precautions”, and “General laser complications” earlier in this chapter for further information. NOTE-MH01-EN rev05... -
Page 60: Maintenance, Cleaning And Sterilization
LASER system. Service by non-authorized people will cause warranty to lapse Device cleaning The laser device MH01 doesn’t need special maintenance by the user. Clean the visible surfaces with a damp cloth and a caustic solution such as foam. Do not use alcohol or disinfectant solution, because they are highly flammable. -
Page 61: Check Of The Line Cable
Check of the line cable MH01 device has a line cable mechanically fixed to it. The cable has a length of 3m. The line cable can be subjected to deterioration over time and therefore, it is necessary to check periodically the status of the line cable. -
Page 62: Use, Cleaning, Disinfection, Sterilization Of Optical Fibers
4. Check the protective glass for any visible damage 5. In case of damage, substitute the whole blast shield paying attention not to touch the protective glass with hands. Close the protective door screwing well the doorknob. In case of assistance, please contact Service Department NOTE-MH01-EN rev05... -
Page 63: Troubleshooting
Fluctuations of the energy Wait some second until · the energy is stabilized If the energy always · fluctuates, Call service No correspondence Damage of the fiber · Change fiber between displayed · Call service energy and treatment effects NOTE-MH01-EN rev05... -
Page 64: Customer Service
MH01 is warranted against any defects in material and workmanship for a period of one (1) full year from its delivery. Repairs necessary as a result of natural disasters, accidents, electrical system faults, negligence, improper use or misuse of the appliance, or servicing or repairs carried out by persons not authorized by Manufacturer are not covered by warranty. -
Page 65: Service Department Contacts
ROCAMED offers its customers resolve problems through e-mail and telephone contact, in addition to training courses for clients in ROCAMED, repairs and maintenance. Please contact the Service Department of ROCAMED through the contacts listed below. Please keep to hand the serial number of your device. -
Page 66: Technical Specifications
Aiming Beam Diode laser, green, 532nm (<5mW, adjustable by software) Results of MPE, NOHD and OD calculations are reported in the table below: Wavelength 2100 nm Divergence 440 mrad Exposure time 100 s 1000 W/m NOHD 0.44 m NOTE-MH01-EN rev05... -
Page 67: Accessories
800μm and 1000μm frontal optical fiber sterile (available according to and reusable customer requirements) Fiber stripper 1 Fiber stripper for diameter 0,3-1mm Fiber stripper 2 Fiber stripper for diameter 0,1-0,4mm Fiber cutter Ceramic fiber cutter Safety Goggles Safety Goggles NOTE-MH01-EN rev05... -
Page 68: Tables (Emc)
Guidance and manufacturer’s declaration – electromagnetic emission MH01 is intended for use in the electromagnetic environment specified below. The customer or the end user of the MH01 should assure that it is used in such an environment Emission test compliance... - Page 69 IEC 60601-1-2 Table 202 Guidance and manufacturer’s declaration – electromagnetic immunity MH01 is intended for use in the electromagnetic environment specified below. The customer or the end user of MH01 should assure that it is used in such an environment IEC 60601 Electromagnetic...
- Page 70 To asses 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 MH01 is used exceeds the applicable RF compliance level above, MH01 should be observed to verify normal operation.
- Page 71 Recommended separation distances between portable and mobile RF communication equipment and MH01. MH01 is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of MH01 can help prevent electromagnetic interference...
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