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ROCAMED MH01 - Clinical Application; Intended Use; Wavelength

ROCAMED MH01
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46
NOTE-MH01-EN rev05
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.
6.1 Intended use
The 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,
vaporization, coagulation and hemostasis of soft tissue in use in medical specialties
including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, ENT
and General Surgery.
MH01 is a Class 4 laser emitting laser radiation at a wavelength of 2100 nm.
This particular wavelength is transmitted by a fiber optic wave guide (glass fiber) allowing
efficient treatment in conjunction with the application related preselected parameters with
at the same time minimum stress for the adjacent tissue
Only
WARNING!
MH01
Holmium lasers are intended solely for use by physicians trained in the
use of the Ho:YAG (2.1 μm) wavelength.
This device must only be used by adequately qualified and trained medical
personnel with experience
in Urology, Urinary Lithotripsy, Gastroenterology,
Arthroscopy, Discectomy, ENT and General Surgery.
NOTE!
Laser settings are guidelines only; always start with low settings and increase to achieve the desired
tissue effect. Energy delivered endoscopically in a fluid medium.
The Ho:YAG (2.1 •m) wavelength is indicated for use in specific surgical applications as detailed
in this chapter. Read and comprehend the following section, titled General Warnings,
Precautions, and Complications to Consider When Using the Holmium Wavelength, before
reading the sections that describe a particular surgical specialty.
Note
a. The use of a laser instrument for an application is at the physician’s discretion except in
cases where the indication has been contraindicated.
b. Physicians should frequently consult current literature and information provided in
advanced workshops to keep abreast of the most effective and up-to-date practices.
6.2 General Warnings, Precautions, and Complications to consider when using the
Holmium wavelength
The following warnings, precautions, and complications apply to all of the surgical specialties
described in this chapter. For important information specific to a particular surgical specialty, such
as Urology, read the corresponding section later in this chapter.

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