IEC 60601-2-13 pdf download -Medical electrical equipment – Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems

IEC 60601-2-13 pdf download -Medical electrical equipment – Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
ff) The instructions for use of ANAESTHETIC SYSTEM(s) and/or individual devices shall provide
information on the method of enabling the ANAESTHETIC SYSTEM or individual devicesincluding the MONITORING DEVICE(S)，ALARM SYSTEM(S) and PROTECTION DEVICE(s) requiredby this standard.
NOTE This information may form part of the pre-use chacklist.
gg)The instructions for use shall state the conditions (e.g. ambient temperature and pressure
saturated (ATPS), body temperature and pressure saturated (BTPS), standardtemperature and pressure dry (STPD)) under which the measured values are displayed.
hh)The instructions for use shall state whether the ANAESTHETIC SYSTEM or individual device is
suitable for use in a magnetic resonance imaging (MRI) environment and any relatedrestrictions.
*ii) The instructions for use shall contain a statement to the effect that, IEC 60601-1-1 applies
both for combinations of items of MEDICAL ELECTRICAL EQUIPMENT and for combinations ofat least one item of MEDICAL ELECTRICAL EQUIPMENT with one or more items of NON-MEDICALELECTRICAL EQUIPMENT，Even if there is no functional connection between the individualpieces of equipment, when they are connected to an AUXILLIARY MAINs sOcKET oUTLET theyconstitute a MEDICAL ELECTRICAL SYSTEM. lt is essential that oPERATORS are aware of therisks of increased leakage currents when equipment is connected to an AUXILLIARY MAINSsoCKET OUTLET.
i) The instructions for use shall contain a statement to the effect that FLAMMABLE
ANAESTHETIC AGENTS such as diethyl ether and cyclopropane shall not be used in theANAESTHETIC SYSTEM. Only anaesthetic agents which comply with the requirements forNON-FLAMMABLE ANAESTHETlC AGENTs as specified in Annex DD of this Particular Standardare suitable for use in the ANAESTHETIC sYSTEM.
kk) The instructions for use shall contain a list of ALARM SYSTEMs to be tested, the methods of
verifying their correct function，and the recommended frequency of verification. The listshall include, as a minimum, the ALARM SYSTEMs required by this standard.
NOTE 1 Risk analysis may determine the necessity of verifying any additional ALARM SYSTEMS.NOTE 2 The correct function of an ALARM SYSTEM may be checked by a builit-in self test.
ll) The instructions for use shall contain a statement to the effect that，if AUXILIARY MAINS
sOCKET OUTLET(S) are provided, the connection of EQuIPMENT to the AUXILIARY MAINSsOCKET OuUTLET(s) may increase the leakage currents to values exceeding the allowablelimits.
mm)The instructions for use shall contain instructions for testing for correct assembly and
connection of each gas supply.
nn)The instructions for use shall contain recommended methods of cleaning, disinfection or
sterilization prior to first use.
oo) The instructions for use shall contain a statement to the effect that independent means of
ventilation (e.g. a self-inflating manually powered resuscitator with mask) be availablewhenever the ANAESTHETIG sYSTEM is in use.
pp)The instructions for use shall disclose all alarm limit(s) that are factory pre-set,
qq) The instructions for use shall disclose the presence of all latex based components and
their location.
rr) The instructions for use shall disclose, any restriction on re-use for re-usable components.
ss) The instructions for use shall disclose risks related to disposal,and precautions to be
taken to avoid such risks.
tt) The instructions for use shall disclose configuration(s) and condition(s) under which
Clause 24 of the General Standard is met.
uu)The instructions for use shall disclose the location of and instructions relevant to any filter
elements to be replaced by the operator.
vv) The instructions for use shall contain a description of the functioning of the ANAESTHETIC
sYSTEM or individual device after interruption of the power supply,and where applicablethe functioning of the ANAESTHETIC SYSTEM or individual devices after a switch-over to areserve power supply.
ww) The instructions for use shall disclose, where applicable, all information necessary for the
connection to an ANAESTHETIC VENTILATOR recommended for use with the ANAESTHETICsYSTEM.
xx) The instructions for use shall disclose，if provided，the minimum detectable exhaled
volume, the accuracy of the indicated exhaled volumes and the resolution of the exhaledvolume monitor when tested according to 51.101.4.
yy)The instructions for use shall include the information required in item a) of 6.8.3 of the
General Standard.
zz) The instructions for use shall disclose， where applicable,the medical gas pipeline supply
pressure(s) at which the ANAESTHETIC SYSTEM will cease to deliver gas.
aaa)The instructions for use shall contain a statement to the effect that a malfunction of the
central gas supply system may cause more than one or even all devices connected to itto stop their operation simultaneously.
bbb) Manufacturers of ANAESTHETIC GAsS DELIVERY SYSTEM(S)，MONITORING DEVICE(S)，ALARM
sYSTEM(S) and PROTECTION DEVICE(s) intended for use in an ANAESTHETIC SYSTEM shallstate in the instructions for use that whoever assembles an ANAESTHETIC SYSTEM fromindividual devices or systems shall provide the checklist for the ANAESTHETIC SYSTEM.
ccc) Additions specific to the ANAESTHETIG GAS DELIVERY SYSTEM
The instructions for use shall contain the pressure and flow characteristics of any gaspower outlet(s) throughout the range of RATED inlet pressures.and at twice themaximum RATED inlet pressure.
The instructions for use shall contain specifications of the oxygen failure ALARMsYSTEM(S) and if applicable the associated gas cut-off device(s).
The instructions for use shall contain the range of pressures and flows for which anyGAS MIXER is designed. (See 107.2).
ddd) The instructions for use shall contain a statement to the effect that any anaesthetic gas
scavenging transfer and receiving system used with the anaesthetic system shallcomply with ISo 8835-3.
Unless the anaesthetic gas scavenging transfer and receiving system is integral to theanaesthetic gas delivery system,the manufacturer/supplier of the anaesthetic gasdelivery system shall provide information on how to connect an anaesthetic gasscavenging transfer and receiving system.