ANSI/AAMI/ IEC 80601- 2-58:2014 pdf download – Medical electrical equipment – Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery.
201 .7.9.2.2 Warning and safety notices Addition: The instructions for use shall additionally include the following warning and safety notices: a) a warning to use only recommended TUBING SET (s); b) if an electrically adjustable ophthalmic IRRIGATION solution support pole is used, a warning not to modify pole height or manually force the pole height because this could cause incorrect indication of bottle height and PATIENT injury; c) a warning never to intentionally modify HANDPIECES or TIPS (e.g. do not bend, cut, or engrave them) as they could break or malfunction; d) a warning to the OPERATOR not to touch an activated ultrasonic HANDPIECE TIP , as injuries could occur; e) if applicable, warnings related to lamp replacement (e.g. RISK of injury, ratings of lamp, damage to lamp, damage to machine, etc.); f) if applicable, a warning to the OPERATOR that care should be taken to avoid concentrating the output of an illumination module on a small area of the retina for unnecessarily prolonged periods of time due to the potential for PHOTORETINITIS and serious permanent PATIENT injury; g) if applicable, a warning to the OPERATOR that inadvertent activation of functions that are intended for PRIMING or tuning HANDPIECES while the HANDPIECE is in the eye can create a HAZARDOUS SITUATION that could result in PATIENT injury; h) where gravity is relevant to performance, the ophthalmic IRRIGATION solution source shall be at or above the PATIENT ’s eye level; i) a warning to the OPERATOR to ensure sufficient volume of IRRIGATION solution for the PROCEDURE . The level should be monitored during the PROCEDURE ; j) if applicable, a warning to the OPERATOR to ensure that the maximum capacity of the DRAIN CONTAINER is not exceeded as this could cause a HAZARDOUS SITUATION to the PATIENT .
201 .7.9.2.1 3 Maintenance Addition: The instructions for use shall provide the OPERATOR or RESPONSIBLE ORGANIZATION with a recommendation to inspect all HANDPIECE cables and any cords on a regular basis and a recommendation as to the action to take if damage (e.g. exposed wire, nicks in the insulation, deformation, etc.) is observed. 201 .8 Protection against electrical HAZARDS from ME EQUIPMENT Clause 8 of the general standard applies. 201 .9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS Clause 9 of the general standard applies. 201 .1 0 Protection against unwanted and excessive radiation HAZARDS Clause 1 0 of the general standard applies. 201 .1 1 Protection against excessive temperatures and other HAZARDS Clause 1 1 of the general standard applies, except as follows: 201 .1 1 .1 .2 Temperature of APPLIED PARTS 201 .1 1 .1 .2.1 A PPLIED PARTS intended to supply heat to a PATIENT Replacement: H ANDPIECES for DIATHERMY , PHACOFRAGMENTATION , LASER and LIQUEFACTION are considered to be APPLIED PARTS intended to supply heat to a PATIENT . The temperature or clinical effects shall be determined and documented in the RISK MANAGEMENT FILE . 201 .1 1 .6.7 Sterilization of ME EQUIPMENT and ME SYSTEMS Addition: The packaging for terminally sterilized ACCESSORIES for LENS REMOVAL DEVICES and VITRECTOMY DEVICES shall comply with the requirements of ISO 1 1 607-1 :2006. Validation requirements for forming, sealing, and assembly processes for this packaging shall be consistent with ISO 1 1 607- 2:2006.
201 .1 2.1 .1 01 Additional accuracy of controls and instruments requirements NOTE Additional requirements for accuracy of controls and instruments are detailed in subclauses 201 .1 2.1 .1 01 .1 to 201 .1 2.1 .1 01 .5 and 201 .1 2.1 .1 01 .7 to 201 .1 2.1 .1 01 .9. 201 .1 2.1 .1 01 .1 Accuracy of static IRRIGATION pressure Static IRRIGATION pressure output shall not deviate from the indicated setting on the LENS REMOVAL DEVICES and VITRECTOMY DEVICES by more than ± 20 % or ± 1 0 mmHg (± 1 .3 kPa) whichever is greater for a specific device in a defined configuration (see 201 .1 2.4.1 01 .1 for hazardous output limit). Compliance is checked by applying the relevant test method(s) 1 and/or 2: a) Test method 1 (Gravity fed IRRIGATION ) 1) Set the test environment temperature to 25 °C ± 5 °C. 2) Install the TUBING SET ( S ) AND PRIME THE DEVICE IN ACCORDANCE WITH THE MANUFACTURER ’ S INSTRUCTIONS FOR USE . 3) Zero the pressure meter reading. Connect the pressure meter to the end of the IRRIGATION tubing and position the pressure meter within ± 2.5 cm of the simulated PATIENT eye level, see Figure 201.101. 4) Initiate the flow of fluid in accordance with the MANUFACTURER ’s instructions for use. 5) Set the gravity feed reservoir height to 0 cm or the lowest setting and record the pressure meter reading after 5 s. 6) Increase the reservoir height by 20 cm and wait for 5 s and record the pressure meter reading.