ROCAMED MH01 User manual

MH01
2100 nm Holmium
30W Laser System
User Manual
NOTE-MH01-EN rev05

NOTE-MH01-EN rev05
Dear Customer,
Thank you for choosing a ROCAMED Medical Laser product.
In order to attain best results with ROCAMED Laser Systems and to avoid
risks of dangerous faults, please be sure that you carefully and completely
read this user manual before starting any operation.
Notice
No part of this manual may be reproduced or transmitted in any form or by any means without the
written consent of ROCAMED.
The information in this manual is subject to change without notice.
Disclaimer
ROCAMED provides this document in its commitment to help facilitate consistent, positive clinical
outcomes, and to reduce patient risk and injury. These guidelines are not, however, intended to in any
way replace or substitute a physician’s duty of care, professional responsibility, or professional
judgment, nor are they intended to provide any warranty, promise, guarantee, assumption of risk or
duty, release, or indemnity. Physicians shall at all times maintain responsibility for patient treatment and
outcomes, and 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.
ROCAMED

NOTE-MH01-EN rev05
For an optimal functioning of the equipment, and to ensure the
maximum safety of operators and patients:
•Verify that the treatment room temperature does not exceed 30°C (86 F)
•Keep the equipment away from walls, especially where fans are
positioned, ensuring the right ventilation
•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
CONTENTS:
1GENERAL INFORMATION ............................................................................................. 1
1.1 INTRODUCTION............................................................................................................. 1
1.2 PURPOSE OF THE MANUAL ............................................................................................... 1
1.3 SAFETY INSTRUCTION...................................................................................................... 2
1.4 SYMBOLS AND ABBREVIATIONS USED IN THIS MANUAL ............................................................ 3
1.5 MANUFACTURER........................................................................................................... 5
1.6 COMBINATIONS ............................................................................................................ 5
2LASER SAFETY ............................................................................................................. 6
2.1 GENERAL SAFETY .......................................................................................................... 6
2.2 CLASSIFICATION ............................................................................................................ 6
2.3 TRAINING OF THE MEDICAL STAFF ...................................................................................... 6
2.4 NOMINAL OCULAR HAZARD DISTANCE ............................................................................... 7
2.5 WORKING AREA ........................................................................................................... 8
2.6 EYE AND SKIN EXPOSURE ................................................................................................. 8
2.7 FIRE HAZARD................................................................................................................ 9
2.8 EMISSION OF PLUME .................................................................................................... 10
2.9 SAFETY MEASURES FOR THE ELECTROMAGNETIC COMPATIBILITY (EMC)..................................... 10
2.10 EMISSION OF TOXIC GAS OR VAPOUR .............................................................................. 10
2.11 WARNING AND INSTRUCTIONS FOR THE DEVICE DISPOSAL ..................................................... 10
2.12 LABELLING PLAN........................................................................................................ 11
3DEVICE DESCRIPTION ................................................................................................ 17
3.1 INTRODUCTION........................................................................................................... 17
3.2 GENERAL DESCRIPTION OF THE DEVICE............................................................................... 17
3.2.1 DEVICE FRONTAL VIEW........................................................................................................17
3.2.2 DEVICE BACK VIEW ............................................................................................................18
3.2.3 DEVICE LATERAL VIEW ........................................................................................................19
3.2.4 LASER AND ELECTRIC SYSTEM................................................................................................20
3.2.5 ELECTRICAL CONTROL .........................................................................................................20
3.3 ACCESSORIES ............................................................................................................. 21
3.3.1 OPTICAL FIBER ..................................................................................................................21
4ENVIRONMENTAL CONDITIONS AND INSTALLATION.................................................. 22
4.1 ENVIRONMENTAL CONDITION ......................................................................................... 22
4.1.1 WORKING AREA ................................................................................................................22
4.1.2 ELECTRICAL CONNECTION REQUIREMENTS...............................................................................22
4.1.3 TEMPERATURE AND HUMIDITY .............................................................................................22
4.1.4 MINIMUM SPACE REQUIREMENTS .........................................................................................22

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4.2 DEVICE INSTALLATION................................................................................................... 22
4.2.1 TRANSPORTATION..............................................................................................................23
4.2.2 PACKAGING ......................................................................................................................24
4.2.3 INSPECTION ......................................................................................................................24
4.2.4 LABELLING CHECK ..............................................................................................................24
4.2.5 INSTALLATION PROCEDURE ..................................................................................................24
4.2.6 MAIN DEVICE CONNECTION..................................................................................................25
4.2.7 REMOTE INTERLOCK CONNECTION .........................................................................................26
4.2.8 FOOTSWITCH CONNECTIONS ................................................................................................27
4.2.9 OPTICAL FIBER CONNECTION ................................................................................................27
4.2.10 OPTICAL FIBER CHECK .......................................................................................................27
4.2.11 HYDRAULIC SYSTEM FILLING ...............................................................................................27
4.2.12 EMPTYING THE HYDRAULIC CIRCUIT .....................................................................................28
5INSTRUCTION FOR USE.............................................................................................. 29
5.1 START-UP PROCEDURE .................................................................................................. 29
5.1.1 RFID FIBER CONNECTION ....................................................................................................30
5.2 OPERATING INSTRUCTION .............................................................................................. 31
5.2.1 MAIN DISPLAY SCREEN ........................................................................................................31
5.2.2 CHANGE EMISSION MODE...................................................................................................32
5.2.3 LITHOTRIPSY MODE:..........................................................................................................33
5.2.4 TISSUE MODE:..................................................................................................................34
5.2.5 FREQUENCY......................................................................................................................34
5.2.6 ENERGY ...........................................................................................................................34
5.2.7 FIBER INFO .....................................................................................................................35
5.2.8 PILOT LASER .....................................................................................................................35
5.3 MENU .................................................................................................................... 36
5.3.1 FIBER ..............................................................................................................................36
5.3.2 PILOT LASER .....................................................................................................................36
5.3.3 DEVICE PARAMETERS .........................................................................................................36
5.3.4 USER MANUAL .................................................................................................................36
5.4 DEVICE PARAMETERS ............................................................................................. 36
5.4.1 SERVICE (ONLY FOR TECHNICAL SERVICE)...............................................................................37
5.4.2 DISPLAY...........................................................................................................................38
5.4.3 AUDIO.............................................................................................................................38
5.4.4 DEVICE INFO.....................................................................................................................39
5.4.5 LANGUAGE .......................................................................................................................39
5.5 LASER EMISSION.......................................................................................................... 39
5.5.1 READY /STANDBY .............................................................................................................40
5.5.2 READY MODE ...................................................................................................................40
5.5.3 MODE OF EMISSION...........................................................................................................41
5.5.4 POWER OUTPUT SETTINGS ...................................................................................................41
5.5.5 EMISSION.........................................................................................................................42
5.5.6 ALARM -FIBER CONSUMPTION.............................................................................................43
5.5.7 LASER PARAMETERS ...........................................................................................................43

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5.6 ALARMS AND WARNING DESCRIPTION ............................................................................... 44
5.7 SHUTDOWN PROCEDURE AND PROTECTION AGAINST UNAUTHORIZED USE ................................... 45
6CLINICAL APPLICATION.............................................................................................. 46
6.1 INTENDED USE ............................................................................................................ 46
6.2 GENERAL WARNINGS,PRECAUTIONS,AND COMPLICATIONS TO CONSIDER WHEN USING THE HOLMIUM
WAVELENGTH ..................................................................................................................... 46
6.2.1 GENERAL LASER WARNINGS ................................................................................................47
6.2.2 GENERAL LASER PRECAUTIONS .............................................................................................47
6.2.3 GENERAL LASER COMPLICATIONS ..........................................................................................47
6.3 UROLOGY INDICATIONS................................................................................................. 48
6.3.1 UROLOGY CONTRAINDICATIONS ................................................................................... 48
6.3.2 UROLOGY WARNINGS ............................................................................................... 48
6.3.3 UROLOGY PRECAUTIONS ............................................................................................ 48
6.3.4 UROLOGY COMPLICATIONS ......................................................................................... 48
6.3.5 UROLOGY CLINICAL PARAMETERS ................................................................................. 48
6.4 URINARY LITHOTRIPSY INDICATIONS ................................................................................. 49
6.4.1 URINARY LITHOTRIPSY CONTRAINDICATIONS ................................................................... 49
6.4.2 URINARY LITHOTRIPSY WARNINGS................................................................................ 50
6.4.3 URINARY LITHOTRIPSY PRECAUTIONS............................................................................. 50
6.4.4 URINARY LITHOTRIPSY COMPLICATIONS ......................................................................... 50
6.4.5 URINARY LITHOTRIPSY CLINICAL PARAMETERS ................................................................. 51
6.5 ENT –GENERAL SURGERY –GASTROENTEROLOGY –ARTHROSCOPY ........................................ 51
6.5.1 SPECIFIC CONTRAINDICATIONS ..................................................................................... 52
6.5.2 SPECIFIC LASER COMPLICATIONS ................................................................................... 52
7MAINTENANCE, CLEANING AND STERILIZATION......................................................... 53
7.1 DEVICE CLEANING ........................................................................................................ 53
7.2 LASER MAINTENANCE AND TECHNICAL CHECK ..................................................................... 53
7.3 SAFETY LABELLING CHECK............................................................................................... 53
7.4 WATER COOLING SYSTEM .............................................................................................. 53
7.5 CHECK OF THE LINE CABLE .............................................................................................. 54
7.6 OPTICAL FIBER MAINTENANCE......................................................................................... 54
7.6.1 FIBER MANAGEMENT (APPLICATION CYCLES)...........................................................................54
7.6.2 CHECK THE OPTICAL FIBER BEFORE OPERATION.........................................................................54
7.7 USE,CLEANING,DISINFECTION,STERILIZATION OF OPTICAL FIBERS ............................................ 55
7.8 BLAST SHIELD REPLACEMENT .......................................................................................... 55
8TROUBLESHOOTING .................................................................................................. 56
9CUSTOMER SERVICE .................................................................................................. 57
9.1 MANUFACTURER WARRANTY AND RESPONSIBILITY ............................................................... 57

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9.2 REPAIR AND MODIFICATIONS OF THE DEVICE ....................................................................... 57
9.3 SERVICE DEPARTMENT CONTACTS .................................................................................... 58
10 TECHNICAL SPECIFICATIONS .................................................................................... 59
10.1 GENERAL SPECIFICATION.............................................................................................. 59
10.2 LASER SOURCE SPECIFICATION ....................................................................................... 59
11 ACCESSORIES........................................................................................................... 60
12 TABLES (EMC).......................................................................................................... 61

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NOTE-MH01-EN rev05
GENERAL INFORMATION
1.1 Introduction
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. The manual describes the instrument, surgical procedures, a description of the various
inspections, routine maintenance and operator information for the use and care of optical
fibers used for the release of the laser radiation to the patient.
Medical people using the medical device MH01 must read this manual carefully. Professional
information regarding specific surgical specialties can be found in Chapter 6, "Clinical
Applications".
Like all surgical instruments, for a responsible and proper use is necessary practice. This
manual should be read and understood thoroughly before first use! For more information
regarding the installation, clinical applications, or other problems you may encounter, please
contact the company ROCAMED
1.2 Purpose of the manual
This manual contains essential information necessary for the installation, operation and
maintenance of the medical device MH01. The manual is intended to be used as a guide. This
manual contains instructions for operation and maintenance. These instructions were written
specifically for staff who are fully trained in laser and conventional surgery.
This manual contains information on the optional accessories supplied with the medical device
MH01, their cleaning and sterilization (Chapter 7, "Maintenance and cleaning").
This manual is not used as an alternative to surgical preparation. In addition, this manual does
not provide specific technical information regarding operations of the medical device MH01
assistance. For any information regarding the technical assistance contact the company.

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1.3 Safety instruction
The safety instructions in this manual are intended to prevent possible injuries, material
damage and operational faults. The fact that, before operating the laser for the first time, you
should read through this manual carefully and keep it for future reference, is also considered
to be part of the safe operation of this product.
In this manual a distinction is made between the safety instructions used to warn of possible
injury (DANGER) and instructions warning against operational faults (WARNING):
“Caution: Federal law restricts this device to sale by or
on the order of a physician/surgeon”
DANGER
:
Risk of injury! This instruction concerns the safety of patients, operators and
other persons, who are in the room, in which the laser is being operated or
maintained.
In this manual the following symbol is used to warn of the risk of injury from
laser radiation (Fig. 1):
Fig. 1: Symbol for Danger
WARNING
:
Danger of operational fault! Failure to follow this instruction can lead to damage
to the laser system, the applicator or the laser fiber.
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).
Fig. 2: Symbol for Warning

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1.4 Symbols and Abbreviations used in this manual
Symbol
Description
Read the enclosed documentation label
Symbol of applied part type BF
According to standard 60601-1 2° ED
Symbol indicating that the device cannot be disposed of as
municipal waste, but must be separated in accordance with the
WEEE (Waste Electrical and Electronic Equipment)
Manufacturing date
Serial Number
Manufacturer
NOHD
Nominal Ocular Hazard Distance
NOHZ
Nominal Ocular Hazard Zone
MPE
Maximum permissible exposure
µm
Units, micro meter
s
Units, Second
mrad
Units, milliradiant
w
Units, watt
J
Units, Joule
J/cm2
Units, Joule for centimetre square
cm
Units, centimetre
OD
Optical Density
D
Continuous laser according to EN207
L
Glasses protection degree
KV
Units, Kilovolt
A/m
Units, Ampere for metro
Vrms
Effective supply voltage
KHz
Units, Kilo Hertz
GHz
Units, Giga Hertz
WEEE
Waste Electrical and Electronic Equipment
CW
Continuous laser pulses

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Vac
Volt AC
A
Units, Ampere
T
Slow blow fuse
I
Electrical Protection Class
nm
Units, Nanometre
mm
Units, millimetre
EO
Sterilization Method
Ø
diameter
SMA
Optical Fiber connector type
mW
Units, milli Watt
T on
Pulse duration laser on
T off
Pulse duration laser off
Bar
Units, Pressure
°C
Units, Celsius degree
Kg
Units, Kilogram
%
Percentage
A label that indicates the key switch off
A label that indicates the key switch on
Pushing Prohibited

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1.5 Manufacturer
This device is a Medical Laser classified as Class 4 according to IEC 60825-1.
Distributed by:
ROCAMED S.A.M.
9 Avenue Albert II
98000 MONACO
[phone]
[email protected]
www.rocamed.eu
Manufactured by:
Quanta System S.p.A.
Via Acquedotto, 109
21017 Samarate (VA)
ITALY
www.quantasystem.com
1.6 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.
The different products may only be applied jointly if the intended
use and the relevant technical data, such as working length,
diameter, peak voltage, etc. are suitable.
Follow the instruction manuals of the products used in combination
with this product.

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2LASER SAFETY
2.1 General Safety
·For safety use of this device, it’s necessary to know all the safety standards.
·This manual contains important information about safety use of the device
·All people who works with this device must know the operation and safety instructions in
this manual.
·Only trained personnel with appropriate safety guidelines can work with this device.
·The laser must be closed. Only authorized personnel can open the external cover.
·Only the service staff can work on the electrical section of the device.
·This User Guide should be available in the operation area of the laser device.
·All warning labels must always be in good condition.
CAUTION
- Use of controls or adjustments or performance of procedures other
than those specified herein may result in hazardous radiation exposure
IMPORTANT!
For shipment and storage below +5°C, the cooling system must be emptied.
NOTE!
To prevent damage during transport or shipment of the products we recommend using the original
packaging material.
2.2 Classification
This device is a Medical Laser classified as Class 4 according to IEC 60825-1.
2.3 Training of the medical staff
The use of the laser device is restricted only to the specialist medical staff*: that, depending on
their experience and expertise, can make choices appropriate to achieve the desired
therapeutic effects.
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)

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2.4 Nominal Ocular Hazard Distance
Following the Standard IEC 60825-1, the MPE (Maximum Permissible Exposure), NOHD
(Nominal Ocular Hazard Distance) and OD (Optical Density) are calculated.
The formulas and the numerical coefficients are specified in Section 3, Chapter 13, Table 6,
Figures 1, 2, 5, 6, 7, 8 of IEC 60825-1 standard.
·The MPE level represents the maximum level to which an eye, or skin, can be exposed
without consequential injury, immediately or after a long time. The MPE is related to radiation
wavelength, pulse duration or exposure time, the tissue at risk and, for visible and near infrared
radiation in the 400-1400nm range, to the size of the retinal image.
·The NOHD is the distance at which the beam irradiance or radiant exposure equals the
appropriate corneal maximum permissible exposure.
·The OD of the protective goggles to be worn is defined as:
OD = log10 (H0/MPE)
Where H0is the expected unprotected eye exposure level.
Please, refer to previous section 2.6 for further details concerning the protection level in
googles.
Laser system has to be used in a closed area that does not allow the escape of direct, reflected
or transmitted laser radiation.
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.

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2.5 Working Area
This device is a laser of Class 4 and must be used in a specific working area defined and
delimited following the international standards IEC 60825-1.
IMPORTANT!
This device is certified to be used in the operating room
RULES OF ACCESS TO THE RESTRICTED AREA OF WORK
External staff and visitors should also:
·Be guided by staff
·Always wear laser goggles in the working area when the laser is switched on
·Be briefed by staff on the laser, electrical hazards and other risks associated with the
operation of the laser within the working area (the laser radiation, electric shock, etc.)
Admission is strictly prohibited if there is no operator in the working area
2.6 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. Direct absorption of laser energy by the retina can
result in temporary clouded vision, retina lesion, long term scotoma and long term
photophobia.
A danger exists in any case of:
·Direct laser radiation
·Reflected laser radiation
Diffused laser radiation.
WARNING!
All the personnel present in the laser working area must wear all the protective
devices.
Use protective goggles with the following specifications according national
standard:
2100 I LB2 for laser source Ho:YAG at 2100 nm
In addition, even if you wear goggles, never look directly into the laser beam.
IMPORTANT!
Within the range of the laser, every person must wear laser goggles.
Check the laser goggles for perfect condition before each use. The goggles must not be
mechanically damaged in any way
Before wearing goggles to make sure that the goggles cover glasses are in good condition.
The skin is generally able to withstand higher levels of laser radiation, but can also be burned to
a greater or lesser degree depending on the duration and intensity of exposure. If necessary,
wear suitable protective clothing.

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To avoid any mix-up, the laser goggles require adequate identification.
Laser goggles with a higher degree (or level) of protection (such as L3, L4, ...) or goggles featuring
a broad--band filter of protection stage L2 or higher also covering wavelengths of 2100 nm can
also be used.
If you suspect that you have received a laser damaged, now:
·Turn off the laser;
·Inform your supervisor and / or technical laser safety.
2.7 Fire hazard
The laser radiation of this LASER device is able to melt, to burn or to vaporize almost all
materials. The use of this LASER device is limited to the applications specified in this manual.
Fire hazard can occur due to the nature of the laser treatment. The absorption of emitted laser
energy, no matter how brief, may raise the temperature of any material. This phenomenon is
the basis of many useful medical and surgical applications; it is also the reason why these
applications often require precautions against the risk of igniting combustible materials in and
around the treatment area.
When this LASER device is used, the following precautions should be taken:
·Do not use any flammable substance, such as alcohol or acetone, in the preparation of the
skin for treatment. Use soap and water if necessary.
·Anaesthetics administered either by inhalation or topically must be approved as non-
flammable.
·Use particular care in the use of oxygen.
·Avoid using combustible material, such as gauze and drapes, in the treatment area. When
they are required, these materials must be made fire-retardant by keeping them moist with
water. Clothing should be kept away from the treatment area.
·Never use in presence of flammable anaesthetic gases or oxidant gases like oxygen or N2O
·Cotton wool and similar materials, when saturated with oxygen can catch fire due to high
temperature emitted by laser
·before using the laser let evaporate solvents or glues or flammable solutions used to clean
or disinfect
·Attention: endogenous gases can catch fire or explode.
WARNING!
Equipment not suitable for use in the presence of flammable mixtures.

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2.8 Emission of plume
Vapour/smoke plume
There is considerable concern about the biological plume created by electrocautery units, bone
saws and lasers. Current medical literature recommends that a smoke evacuator and in-line
filter be used to capture this plume. The plume should be regarded as a source of active
biological material and a possible carcinogen.
CAUTION!
Laser
plume may contain viable tissue particulates.
2.9 Safety Measures for the electromagnetic compatibility (EMC)
The device MH01 doesn’t include any type of direct connection with other external devices.
The device MH01 can be disturbed by the interference with external electromagnetic fields
generated by other electrical devices installed near to it.
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 Emission of toxic gas or vapour
The laser radiation of this LASER device is able to melt, to burn or to vaporize almost all the
materials. The use of this LASER device is limited to the applications specified in this manual.
2.11 Warning and instructions for the device disposal
At the end of the service life of the device, it has to be handle according to the National or Local
regulations for the disposal of waste electrical and electronic equipment
The device is subject to national standards which regulates the disposal of waste such as
electrical equipment. It is forbidden to dispose of the device as municipal waste but has to be
collected separately according to the WEEE Directive (Waste Electrical and Electronic
Equipment).
The penalties for violating the requirements of the law are severe.

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2.12 Labelling plan
L
abel 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

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Label 4
Product Label
Label
5
Interlock connector
Label 6
Warning
–High Voltage
Label 7
Caution
–Laser Radiation
Label 8
Ground
Label 9
Read Instruction For Use
Label 1
0
Pushing Prohibited
Label 14
Water Drain Connector
Label 15
Water Fill Connector

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Label
16
Air Purge Connector
Label 18
UDI label
Label 19
Storage Conditions