ANSI/AAMI/ IEC 60601-2- 16:2018 pdf download – Medical electrical equipment—Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafltration and haemofltration equipment.
201 .7.9.2 Instructions for use 201 .7.9.2.2 Warning and safety notices Addition: The instructions for use shall additionally include the following, if applicable: – a warning statement which draws the OPERATOR ‘ S attention to the precautions necessary to prevent any cross-infection between PATIENTS ; – a warning statement which draws the OPERATOR ‘ S attention to the HAZARDOUS SITUATION associated with connection and disconnection of the PATIENT ; – a warning statement which draws the OPERATOR ‘ S attention to the HAZARD s, including any HAZARDOUS SITUATIONS , arising from improper connections of the EXTRACORPOREAL CIRCUIT ; – a warning statement on the HAZARDS related to incorrect choice of DIALYSIS FLUID CONCENTRATE ( S ); – a quantitative description of the possible deviation of each component of the DIALYSIS FLUID in SINGLE FAULT CONDITION depending on the ALARM LIMITS of the PROTECTIVE SYSTEM ; – * a warning statement on the HAZARDS and underlying causes related to a possible transport of undesired substances from the DIALYSIS FLUID compartment to the blood compartment of the DIALYSER ; – for the PROTECTIVE SYSTEM employed according to 201 .1 2.4.4.1 04.1 a): • a warning statement that this PROTECTIVE SYSTEM reduces the RISK in part only and an explanation of the remaining RISK ; • a description of OPERATOR responsibility for further mitigation of residual RISK ; – a warning statement of the adequate OPERATOR action upon an ALARM CONDITION and associated HAZARD ( S ), if the ALARM CONDITION is repeatedly cleared without solving the underlying problem; – * a warning statement specifying that any narrow passages in the EXTRACORPOREAL CIRCUIT (such as kinks in the blood line or cannula that are too thin) may cause haemolysis and that this HAZARDOUS SITUATION may not be detected by the PROTECTIVE SYSTEMS ;
201 .7.9.2.5 M E EQUIPMENT description Addition: The instructions for use shall additionally include the following, if applicable: – a definition of TRANSMEMBRANE PRESSURE if the MANUFACTURER makes use of one different from that stated in 201 .3.21 7; – an explanation of the coloured markings on the DIALYSIS FLUID CONCENTRATE connectors; – information on the effective delivered blood flow rate in single-needle treatments; – information on the recirculation of blood in the EXTRACORPOREAL CIRCUIT in single-needle treatments; – the delay time after which an auditory ALARM SIGNAL is activated after interruption of the power supply; – for PHYSIOLOGIC CLOSED – LOOP CONTROLLER functions (see also the collateral standard IEC 60601 -1 -1 0): a) the technical working principle; b) the PATIENT parameters which are measured and the physiological parameters which are controlled; c) the methods by which these PHYSIOLOGIC CLOSED – LOOP CONTROLLER modes have been evaluated, including beneficial and adverse effects recorded during clinical evaluation; – for any data that is displayed or indicated by the HAEMODIALYSIS EQUIPMENT and that may be used for adjusting the treatment or measuring or confirming the treatment efficacy: a) a description of the technical working principle; b) if the measurement is indirect: information about the accuracy and possible influencing factors; c) * the method by which the technical working principle has been evaluated relative to standard medical care; – for HAEMODIALYSIS EQUIPMENT with APPLIED PARTS other than TYPE CF APPLIED PARTS information, whether this HAEMODIALYSIS EQUIPMENT can be used together with a central venous catheter whose tip is in the right atrium. If the HAEMODIALYSIS EQUIPMENT is not suitable for a central venous catheter whose tip is in the right atrium, associated HAZARD s shall be listed. Compliance is checked by inspection of the instructions for use.
201 .7.9.2.1 4 A CCESSORIES , supplementary equipment, used material Addition: The instructions for use shall additionally include the following, if applicable: – information on DIALYSIS FLUID CONCENTRATES , DIALYSERS and blood lines intended to be used together with the HAEMODIALYSIS EQUIPMENT . Compliance is checked by inspection of the instructions for use.