References

_{Safety
The surgical platform has been manufactured in accordance with the state of the art and recognised technical safety rules. Nevertheless, dangers to life and limb of the user or third parties, damage to the surgical platform and other objects during its use cannot be ruled out.}

_{Intended use
The CataRhex 3 is used for surgical interventions in the anterior eye segment:}

<sub>- Irrigation and aspiration (I/A function)
- Ultrasound phaco (PHACO function)
- Bipolar diathermy for hemostasis and welding of the conjunctiva (DIA function)
- Diathermic capsulotomy (CAPS function)
- Operation of a vitrectomy instrument (VIT function)</sub>

_{The device may only be used with instruments recommended and supplied by Oertli Instrumente AG.}

_{Instruments and consumables used in conjunction with Oertli devices constitute a complete surgical system. Use of consumables and handpieces other than those manufactured by Oertli may affect system performance and create potential hazards.}

_{Indications
The surgical system (including the surgical platform and its accompanying instruments/accessories) facilitates and supports surgeries in the anterior eye segment, but has no specific indications.}

_{Contraindications
The following contraindication was identified based on the patient profile:}

_{- Patient unfit for the surgical intervention in the eye}

_{Risks and undesireable side-effects
Anterior eye segment surgery
The use of the surgical system in anterior eye segment surgery (e.g.: cataract surgery) could include the following risks and undesirable side-effects:}

<sub>- capsule rupture, vitreous loss, dropped nucleus
- tissue trauma (e.g. cornea, iris, zonula, ciliary body) and tissue haemorrhage (e.g. choroid, conjunctiva, iris) and descemet membrane detachment
- corneal endothelial cell loss and corneal oedema
- phaco wound burn
- inflammations (e.g. fibrin reaction, uveitis, scleritis, keratitis, endophthalmitis and toxic anterior segment syndrome (TASS)
- retained lens material
- changes in the sclera
- sticking of the instruments to tissue
- capsule less elastic than with continuous curvilinear capsulorhexis (CCC)
- radial capsule tear and posterior capsule rupture, vitreous loss, dropped nucleus
- IOL decentration or malposition
- corneal oedema (CE)
- choroidal / suprachoroidal / sub-choroidal haemorrhage / choroidal effusions
- intraocular pressure disorders (e.g. ocular hypotension)
- wound leakage (e.g. leaking sclerotomy)
- foreign body in patient</sub>

_{Potential misuse
WARNING! 
The CataRhex 3 device has not been evaluated for use in the treatment of glaucoma.
Diathermy features of the device are not intended to be used to remove trabecular meshwork tissue and/or treat glaucoma.}

_{The surgical platform is not suited for surgical interventions outside the eye. The surgical platform is not suited for surgical interventions in the posterior eye segment. Failure to comply with the intended use, alterations carried out without the approval of Oertli, or operation with unsuitable parameters are regarded as misuse of the surgical platform. Misuse of the surgical platform can have the following consequences:}

<sub>- Danger to patients and staff using the device
- Impaired functionality of the surgical platform</sub>

_{Oertli accepts no liability for damaged caused by use for purposes other than those for which the device was designed.}

_{Intended user
The surgical platform may only be used by trained medical personnel. The correct choice of instrument settings is the responsibility of the surgeon.}

_{Intended patients
The surgical platform may be used in the vicinity of the patient. The surgical platform can be used for all patients, regardless of their age, height and weight, assuming the physician considers an operation to be justified. The following potential dangers exist when using the DIA or CAPS functions in patients with heart pacemakers or pacemaker electrodes:}

<sub>- Impairment of pacemaker function
- Damage to the pacemaker</sub>

_{Ask the cardiology department for advice if you are unsure.}

_{Intended environment
The surgical platform may only be used in enclosed rooms. The surgical platform must not be used in rooms with inflammable anaesthetics or other combustible gases and materials. Where possible, only non-flammable cleaning agents and disinfectants should be used. Ensure that flammable cleaning agents and disinfectants have completely evaporated prior to HF application. There is a risk of flammable solutions collecting under the patient or in bodily depressions or orifices. Collections of fluids in these areas should be wiped up prior to using HF surgical devices. Be aware that due to spark formation which can occur during normal use of HF surgical devices, endogenous gases and oxygensaturated materials, such as cotton, wool and gauze, can ignite. Risk of fire and explosion!}