ANSI AAMI IEC 80601-2-58-2014 pdf free download – Medical electrical equipment – Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery.
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 notto modify pole height or manually force the pole height because this could cause incorrectindication 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 prolongedperiods 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 areintended for PRIMING or tuning HANDPIECES while the HANDPIECE is in the eye can create aHAZARDOus 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 lIRRIGATION solution for thePROCEDURE.The level should be monitored during the PROCEDURE;
j)if applicable, a warning to the oPERATOR to ensure that the maximum capacity of the DRAINCONTAINER is not exceeded as this could cause a HAZARDOUS SITUATION to the PATIENT.
201.7.9.2.8
Start-up PROCEDURE
Addition:
The instructions for use shall include instructions to perform functional checks of the systembefore first use of the day.
201.7.9.2.9
operating instructions
Addition:
The operating instructions shall additionally include:
a) if applicable，instructions regarding loading，PRIMING，changing，and reloading the TUBINGsET(s), and the TUBING SET(s)change interval to maintain the specified performance;
b) if applicable，instructions regarding the use of clamps on a TUBING SET,the avoidance of
ophthalmic lRRIGATION solution free flow conditions, and the PRoCEDURE to be followed whenchanging the ophthalmic lRRIGATION solution source;
c)instructions regarding securely attaching plugs，HANDPIECE cables and other connectors.201.7.9.2.12Cleaning, disinfection, and sterilization
Addition:
For parts that are resterilizable，the information for processing shall be in accordance withISO 17664:2004.This information shall be provided to the RESPONSIBLE ORGANIZATION or theOPERATOR.
201.7.9.2.13
Maintenance
Addition:
The instructions for use shall provide the oPERATOR or RESPONSIBLE ORGANIZATION with arecommendation to inspect all HANDPIECE cables and any cords on a regular basis and arecommendation 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 EQUIPMENTClause 8 of the general standard applies.
201.9 Protection against MECHANICALHAZARDs of ME EQUIPMENT and ME SYSTEMSClause 9 of the general standard applies.
201.10 Protection against unwanted and excessive radiation HAZARDSClause 10 of the general standard applies.
201.11 Protection against excessive temperatures and other HAZARDSClause 11 of the general standard applies, except as follows:
201.11.1.2Temperature of APPLIED PARTS
201.11.1.2.1APPLIED PARTs intended to supply heat to a PATIENTReplacement:
HANDPIECEs for DIATHERMY，PHACOFRAGMENTATION,LASER and LIQUEFACTION are considered to beAPPLIED PARTs intended to supply heat to a PATIENT.
The temperature or clinical effects shall be determined and documented in the RISK MANAGEMENTFILE.
201.11.6.7Sterilization of ME EQUIPMENT and ME SYSTEMSAddition:
The packaging for terminally sterilized ACCESSORIEs for LENS REMOVAL DEVICEs and VITRECTOMYDEVICEs shall comply with the requirements of lSO11607-1:2006. Validation requirements forforming,sealing, and assembly processes for this packaging shall be consistent with ISO 11607-2:2006.ANSI AAMI IEC 80601-2-58 pdf download.