ROCAMED MH01 - General Laser Warnings; General Laser Precautions; General Laser Complications

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NOTE-MH01-EN rev05
6.2.1 General Laser Warnings
Warning
a) Incorrect treatment settings can cause serious tissue damage; therefore, it is
recommended that you use the lowest acceptable treatment settings until familiar with the
instrument’s capabilities.
b) Use extreme caution until the biological interaction between the laser energy and
tissue is thoroughly understood.
c) As with conventional endoscopic surgery, the possibility of complications and adverse
events, such as chills, fever, edema, haemorrhage, inflammation, tissue necrosis, or
infection may occur following treatment. In extreme cases, death may occur due to
procedural complications, concurrent illness.
d) Flash fire may occur. Flammable inhalation general anaesthetics must not be used.
Oxygen levels in the direct surgical area must not exceed 50%. The risks of combustion,
perforation, and laser-induced haemorrhage, any of which could cause death, must be fully
explained to the patient.
e) The flammability of methane gas must be considered when treating in or near the
perianal area.
f) There is a risk of infection and scarring associated with any surgical procedure.
Therefore, appropriate pre- and postsurgical care should always be practiced.
g) The laser should be used only on tissues that are fully observable. Do not use the laser
if the desired target is not visible.
h) Use of the laser on anatomical structures in proximity to known critical structures,
such as large arteries, veins, bowel, ureter, bladder, etc., should be performed carefully to
avoid inadvertent or unintended treatment of such structures.
i) There is an increased risk of back scatter (reflection) and forward scatter (penetration)
when using the laser if the laser is in non-contact mode.
6.2.2 General Laser Precautions
Caution
- Use caution with patients who have had difficulty with previous endoscopic
procedures.
- Blood vessels up to 1 millimetre in diameter can be effectively coagulated with the
Ho:YAG wavelength
- Electrocautery and/or suture (ligature) should be easily accessible in the event that a
bleeding artery or vein is larger than possible to control with the laser.
- Use caution when treating patients who have recently undergone radiotherapy. Such
patients may be at greater risk of tissue perforation or erosion.
- 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.
6.2.3 General laser Complications
- The potential complications encountered in endoscopic laser surgery are the same as
those normally encountered in conventional endoscopic surgery.
- Acute pain may occur immediately following laser therapy and may persist for as long
as 48 hours.