Iec 60601 2 21 2016

The minimum safety req irements sp cified in this p rtic lar stan ard are con idered to provide for a practical degre of safety in the o eration of INFA T RA IA T WA MER eq ipment.. MEDI

Medical electrical equipment –

Part 2-21: Particular requirements for the basic safety and essential performance

of infant radiant warmers

Apparei s électromédicaux –

Partie 2-21: Exigences particul ères pour la sécurité de base et les performances

essentiel es des incubateurs radiants pour nouveau-nés

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Medical electrical equipment –

Part 2-21: Particular requirements for the basic safety and essential

performance of infant radiant warmers

Apparei s électromédicaux –

Partie 2-21: Exigences particul ères pour la sécurité de base et le

performances essentiel es des incubateurs radiants pour nouveau-nés

Warnin ! Mak e s re th t y ou o tain d this publc tion from a a thorize distributor

Ate tion! Ve i ez v ou a s rer qu v ou av ez o te u c te publc tion via u distribute r a ré

c lo r

insid

IEC 60601 -2-21

Editio 2.1 2 16-0

Medical electrical equipment –

Part 2-21: Particular requirements for the basic safety and essential performance

of infant radiant warmers

Apparei s électromédicaux –

Partie 2-21: Exigences particul ères pour la sécurité de base et les performances

essentiel es des incubateurs radiants pour nouveau-nés

CONTENTS

FOREWORD 3

INTRODUCTION 6

2 1.1 Sco e, o ject an related stan ard 7

2 1.2 Normative referen es 9

2 1.3 Terms an definition 9

2 1.4 General req irements 1

2 1.5 General req irements for testin of ME EQUIPMENT 12 2 1.6 Clas ification of ME EQUIPMENT an ME SYS EMS 12 2 1.7 ME EQUIPMENT identification, markin an doc ments 12 2 1.8 Protection again t electrical H ZA DS from ME EQUIPMENT 14 2 1.9 Protection again t MEC A ICAL HAZA DS of ME EQUIPMENT an ME SYS EMS 14 2 1.10 Protection again t u wanted an ex es ive radiation H ZA DS 16 2 1.1 Protection again t ex es ive temp ratures an other H ZA DS 16 2 1.12 Ac urac of controls an in truments an protection again t hazardou outputs 17 2 1.13 HAZA DOUS SITUATIONS an fault con ition 21

2 1.14 PROGR MMABLE ELECTRIC L MEDIC L SYS EMS (PEMS) 21

2 1.15 Con tru tion of ME EQUIPMENT 21

2 1.16 ME SYS EMS 2

2 1.17 * Electromag etic comp tibi ty of ME EQUIPMENT an ME SYS EMS 2

2 2 Electromag etic comp tibi ty – Req irements an tests 2

210 Req irements for the develo ment of ph siologic closed-lo p control ers

An exes 2

An ex AA (informative) Partic lar g idan e an rationale 2

Bibl ogra h 3

In ex of defined terms u ed in this p rtic lar stan ard 3

Fig re 2 1.101 – L yout of T S DEVICE 10 Fig re 2 1.10 – TE T DEVICE 1

Fig re AA.1 – Il u tration of the main req irements of this stan ard 2

Ta le 2 1.101 – Ad itional E S NTIAL P RFORMA CE req irements 12

INTERNATIONAL ELECTROTECHNICAL COMMISSION

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-21: Particular requirements for the basic safety and

essential performance of infant radiant warmers

1) Th Intern tio al Ele trote h ic l Commis io (IEC) is a worldwid org nizatio for sta d rdizatio c mprisin

al n tio al ele trote h ic l c mmite s (IEC Natio al Commite s) Th o je t of IEC is to promote

intern tio al c -o eratio o al q estio s c n ernin sta d rdizatio in th ele tric l a d ele tro ic fields To

this e d a d in a ditio to oth r a tivities, IEC p blsh s Intern tio al Sta d rds, Te h ic l Sp cific tio s,

Te h ic l Re orts, Pu lcly Av ia le Sp cific tio s (PAS) a d Guid s (h re fer refere to as “IEC

Pu lc tio (s)”) Th ir pre aratio is e truste to te h ic l c mmite s; a y IEC Natio al Commite intereste

in th su je t d alt with ma p rticip te in this pre aratory work Intern tio al g v rnme tal a d n

n-g v rnme tal org nizatio s laisin with th IEC also p rticip te in this pre aratio IEC c la orates closely

with th Intern tio al Org nizatio for Sta d rdizatio (ISO) in a c rd n e with c n itio s d termin d b

a re me t b twe n th two org nizatio s

2) Th formal d cisio s or a re me ts of IEC o te h ic l maters e pres , as n arly as p s ible, a intern tio al

c nse sus of o inio o th rele a t su je ts sin e e c te h ic l c mmite h s re rese tatio from al

intereste IEC Natio al Commite s

3) IEC Pu lc tio s h v th form of re omme d tio s for intern tio al use a d are a c pte b IEC Natio al

Commite s in th t se se Whie al re so a le eforts are ma e to e sure th t th te h ic l c nte t of IEC

Pu lc tio s is a c rate, IEC c n ot b h ld resp nsible for th wa in whic th y are use or for a y

misinterpretatio b a y e d user

4) In ord r to promote intern tio al u iformity, IEC Natio al Commite s u d rta e to a ply IEC Pu lc tio s

tra sp re tly to th ma imum e te t p s ible in th ir n tio al a d re io al p blc tio s An div rg n e

b twe n a y IEC Pu lc tio a d th c r esp n in n tio al or re io al p blc tio sh l b cle rly in ic te in

memb rs of its te h ic l c mmite s a d IEC Natio al Commite s for a y p rso al injury, pro erty d ma e or

oth r d ma e of a y n ture wh tso v r, wh th r dire t or in ire t, or for c sts (in lu in le al fe s) a d

e p nses arisin o t of th p blc tio , use of, or rela c u o , this IEC Pu lc tio or a y oth r IEC

Pu lc tio s

8) Ate tio is drawn to th n rmativ refere c s cite in this p blc tio Use of th refere c d p blc tio s is

in isp nsa le for th c re t a plc tio of this p blc tio

9) Ate tio is drawn to th p s ibi ty th t some of th eleme ts of this IEC Pu lc tio ma b th su je t of

p te t rig ts IEC sh l n t b h ld resp nsible for id ntifyin a y or al su h p te t rig ts

DISCLAIMER

This Con ol d te v rsion is not a of icial IEC Sta dard a d ha be n prepare for

us r conv nie c Only the c r e t v rsion of the sta dard a d its ame dme t s)

are to be considere the of icial doc me ts

This Consol date v rsion of IEC 6 6 1-2-21 be rs the e ition number 2.1 It consists of

the s cond e ition (2 0 -0 ) [doc me ts 6 D/7 5/FDIS a d 6 D/7 2/RVD], its

cor ig ndum 1 (2 13-0 ) a d its ame dme t 1 (2016-0 ) [doc me ts 6 D/13 6/FDIS a d

6 D/13 7/RVD] The te h ic l conte t is ide tic l to th ba e e ition a d its

ame dme t

In this Re l ne v rsion, a v rtic l l n in the margin s ows where th te h ic l conte t

is modifie by ame dme t 1 Addition are in gre n te t, deletions are in strik through

re te t A s parate Fin l v rsion with al c a ge a c pte is a ai able in this

publ c tion

International stan ard IEC 6 6 1-2-21 has b en pre ared by s bcommit e 6 D:

Electromedical eq ipment, of IEC tec nical commite 6 : Electrical eq ipment in medical

practice

This secon edition can els an re laces the first edition publs ed in 19 4 an its

Amen ment 1 (19 6) This edition con titutes a tec nical revision This edition of

IEC 6 6 1-2-21 was revised to stru tural y al g with the 2 0 edition of IEC 6 6 1-1

This publ cation has b en drafed in ac ordan e with the ISO/IEC Directives, Part 2

In this stan ard, the fol owin print typ s are u ed:

– Req irements an definition : roman typ

– Test sp ecificato s: ialc typ e

– Informativ material a p arin o tsid of ta les, su h as n tes, e amples a d refere c s: in smaler ty e

Normativ te t of ta les is also in asmaler ty e

– TERMS DE INED IN CLA S 3 OF THE GENER L S A D RD, IN THIS PA TICULA S A D R OR AS

NOT D: SMAL CAPITALS

In refer in to the stru ture of this stan ard, the term

– “clau e” me n one of the sevente n n mb red division within the ta le of contents,

in lu ive of al s bdivision (e.g Clau e 7 in lu es s bclau es 7.1, 7.2, etc.);

– “s bclau e” me n a n mb red s bdivision of a clau e (e.g 7.1, 7.2 an 7.2.1 are al

s bclau es of Clau e 7)

Referen es to clau es within this stan ard are preceded by the term “Clau e” fol owed by the

clau e n mb r Referen es to s bclau es within this p rtic lar stan ard are by n mb r only

In this stan ard, the conju ctive “or is u ed as an “in lu ive or so a statement is true if an

combination of the con ition is true

The verb l forms u ed in this stan ard conform to u age des rib d in An ex H of the ISO/IEC

Directives, Part 2 For the purp ses of this stan ard, the au i ary verb:

– “s al” me n that compl an e with a req irement or a test is man atory for complan e

with this stan ard;

– “s ould” me n that compl an e with a req irement or a test is recommen ed but is not

man atory for compl an e with this stan ard;

– “may” is u ed to des rib a p rmis ible way to ac ieve complan e with a req irement or

test

An asterisk (*) as the first c aracter of a title or at the b gin in of a p ragra h or ta le title

in icates that there is g idan e or rationale related to that item in An ex AA

A l st of al p rts of the IEC 6 6 1 series, publ s ed u der the general title Medical ele ctrical

e u ipme t, can b fou d on the IEC we site

The commit e has decided that the contents of the b se publ cation an its amen ment wi

remain u c an ed u ti the sta i ty date in icated on the IEC we site u der

"ht p:/we store.iec.c " in the data related to the sp cific publcation At this date, the

IMPORTANT – Th 'colour in ide' logo on the cov r pa e of this publ c tion indic te

that it contains colours whic are consid re to be us ful for the cor e t

understa ding of its conte ts Us rs s ould therefore print this doc me t using a

colour printer

The minimum safety req irements sp cified in this p rtic lar stan ard are con idered to

provide for a practical degre of safety in the o eration of INFA T RA IA T WA MER eq ipment

This p rtic lar stan ard amen s an s p lements IEC 6 6 1-1:2 0 , Medical electrical

e u ipme nt – Part 1: G en ral re uirem ents for b asic safety a d e sse tal p e rform ance,

hereinafer refer ed to as the general stan ard

The req irements are fol owed by sp cification for the relevant tests

A general g idan e an rationale for the req irements of this p rtic lar stan ard are given in

An ex AA

It is con idered that knowled e of the re son for these req irements wi not only faci tate

the pro er a plcation of this p rtic lar stan ard but wi , in d e course, exp dite an revision

neces itated by c an es in cl nical practice or as a res lt of develo ments in tec nolog

However, this an ex do s not form p rt of the req irements of this stan ard

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-21: Particular requirements for the basic safety and

essential performance of infant radiant warmers

201.1 Scope, obje t and relate standards

Clau e 1 of the general stan ard

1)

a pl es, ex e t as fol ows:

2 1.1.1 Scope

Rep laceme t

This International Stan ard a pl es to the BASIC SAF TY an E S NTIAL P RFORMA CE of INFA T

RA IA T WA MERS as defined in 2 1.3.2 4, also refer ed to as ME EQUIPMENT

If a clau e or s bclau e is sp cifical y inten ed to b a pl ca le to ME EQUIPMENT only, or to

ME SYS EMS only, the title an content of that clau e or s bclau e wi say so If that is not the

case, the clau e or s bclau e a pl es b th to ME EQUIPMENT an to ME SYS EMS, as relevant

HAZA DS in erent in the inten ed ph siological fu ction of ME EQUIPMENT or ME SYS EMS

within the s o e of this stan ard are not covered by sp cific req irements in this stan ard

ex e t in 7.2.13 an 8.4.1 of the general stan ard

NOT Se also 4.2 of th g n ral sta d rd

This p rtic lar stan ard sp cifies the safety req irements for INFA T R DIA T WA MERS, but

alternate method of compl an e with a sp cific clau e, by demon tratin eq ivalent safety,

wi not b ju ged as non-compl ant, if the MA UFA TURER has demon trated in his RISK

MA A EMENT FILE that the RISK presented by the H ZA D has b en fou d to b of an

ac e ta le level when weig ed again t the b nefit of tre tment from the device

This p rtic lar stan ard do s not a ply to:

– devices s p lyin he t via BLA KE S, PA S or MAT RE S S in medical u e; for information

se IEC 8 6 1-2-3 ;

– INFA T IN UBATORS; for information se IEC 6 6 1-2-19;

– INFA T TR NS ORT IN UBATORS, for information se IEC 6 6 1-2-2 ;

– INFA T PHOTOTHER PY EQUIPMENT, for information se IEC 6 6 1-2-5

2 1.1.2 Obje t

Rep laceme t

The o ject of this p rtic lar stan ard is to esta l s p rtic lar BASIC SAF TY an E S NTIAL

P RFORMA CE req irements for INFA T R DIA T WA MERS as defined in 2 1.3.2 4, whic

minimize H ZA DS to PATIENT an OP R TOR, an to sp cify tests by whic compl an e with

the req irements can b verified

———— ——— ——

1)

Th g n ral sta d rd is IEC 6 6 1-1:2 0 , Medical elec tric al eq u ipme t – Part 1: Ge eral requ ireme ts for

2 1.1.3 * Col ateral sta dards

Ad i o :

This p rtic lar stan ard refers to those a pl ca le col ateral stan ard that are l sted in

Clau e 2 of the general stan ard an Clau e 2 of this p rtic lar stan ard

IEC 6 6 1-1-2 an IEC 6 6 1-1-10 a pl es as modified in Clau es 2 2 an 210 resp ctively

IEC 6 6 1-1-3 an IEC 6 6 1-1-10 do not a ply Al other publ s ed col ateral stan ard in

the IEC 6 6 1-1 series a ply as publ s ed

2 1.1.4 * Partic lar sta dards

Rep laceme nt

In the IEC 6 6 1 series, p rtic lar stan ard may modify, re lace or delete req irements

contained in the general stan ard an col ateral stan ard as a pro riate for the p rtic lar ME

EQUIPMENT u der con ideration, an may ad other BASIC SAF TY an E S NTIAL P RFORMA CE

req irements

A req irement of a p rtic lar stan ard ta es priority over the general stan ard

For brevity, IEC 6 6 1-1 is refer ed to in this p rtic lar stan ard as the general stan ard

Col ateral stan ard are refer ed to by their doc ment n mb r

The n mb rin of clau es an s bclau es of this p rtic lar stan ard cor esp n s to that of

the general stan ard with the prefix “2 1 (e.g 2 1.1 in this stan ard ad res es the content

of Clau e 1 of the general stan ard) or a pl ca le col ateral stan ard with the prefix “2 x”

where x is the final digit s) of the colateral stan ard doc ment n mb r (e.g 2 2.4 in this

p rtic lar stan ard ad res es the content of Clau e 4 of the 6 6 1-1-2 col ateral stan ard,

2 3.4 in this p rtic lar stan ard ad res es the content of Clau e 4 of the 6 6 1-1-3 col ateral

stan ard, etc.) The c an es to the text of the general stan ard are sp cified by the u e of

the folowin word :

"Re lacement" me n that the clau e or s bclau e of the general stan ard or a pl ca le

col ateral stan ard is re laced completely by the text of this p rtic lar stan ard

"Ad ition" me n that the text of this p rtic lar stan ard is ad itional to the req irements of

the general stan ard or a pl ca le col ateral stan ard

"Amen ment" me n that the clau e or s bclau e of the general stan ard or a pl ca le

col ateral stan ard is amen ed as in icated by the text of this p rtic lar stan ard

Subclau es, fig res or ta les whic are ad itional to those of the general stan ard are

n mb red startin from 2 1.101 However, d e to the fact that definition in the general

stan ard are n mb red 3.1 throu h 3.13 , ad itional definition in this stan ard are

n mb red b gin in from 2 1.3.2 1 Ad itional an exes are letered AA, BB, etc an

ad itional items a ), b ), etc

Subclau es, fig res or ta les whic are ad itional to those of a col ateral stan ard are

n mb red startin from 2 x, where “x” is the n mb r of the col ateral stan ard, e.g 2 2 for

IEC 6 6 1-1-2, 2 3 for IEC 6 6 1-1-3, etc

The term "this stan ard" is u ed to ma e referen e to the general stan ard, an a pl ca le

col ateral stan ard an this p rtic lar stan ard ta en together

Where there is no cor esp n in clau e or s bclau e in this p rtic lar stan ard, the clau e or

relevant, a ples without modification; where it is inten ed that an p rt of the general

stan ard or a pl ca le col ateral stan ard, althou h p s ibly relevant, is not to b a pl ed, a

statement to that ef ect is given in this p rtic lar stan ard

SKIN T MP RATU E S NSORS whic are a pl ed to o erate a BABY CONTROL ED R DIA T WA MER

in lu in the displayed value are con idered to b not a CLINIC L THERMOME ER in the sen e

of the p rtic lar stan ard ISO 8 6 1-2-5

201.2 Normative referenc s

Clau e 2 of the general stan ard a pl es, ex e t as fol ows:

IEC 6 6 1-1-2:2 0 , Me dical electrical e uip me t – Part 1-2: Gene ral re uireme nts for b asic

safety a d es e tal p erforma ce – Colateral sta dard: Ele ctromagnetc comp tb il y –

Re u ireme ts a d tests

Ad i o :

NOT Informativ refere c s are lste in th biblo ra h b gin in o p g 3

201.3 Terms and definitions

For the purp ses of this doc ment, the terms an definition given in the general stan ard

mode of o eration in whic the p wer output varies automatical y in order to maintain the

temp rature as me s red by a

SKIN T MP R TU E S NSOR ac ordin to the CONTROL

T MP R TU E set by the OP R TOR

2 1.3.2 2

CONTROL T MPERATURE

temp rature selected at the temp rature control

electrical y p wered device with a radiant he tin source inten ed to maintain the thermal

b lan e of an INFA T by direct radiation of energ in the infrared region of the electromag etic

2 1.3.2 5

MA UAL MODE

mode of o eration in whic the he ter output is either at a fixed level or a pro ortion of its

maximum output set by the OP RATOR

mode of o eration in whic the he ter output is maintained at a preset level (set by the

MA UFA TU ER) for the purp se of pre-warmin the INFA T R DIA T WA MER an maintainin

the level of warmth of the INFA T R DIA T WA MER prior to an INFA T b in placed on the

con ition whic is re c ed when the temp rature, me s red at the centre of the T S DEVICE

p sitioned on the mid-p int of the INFA T R DIA T WA MER matres , do s not vary by more

average temp rature re din ta en d rin a S EA Y T MP R TU E CON ITION at reg lar

intervals at the centre of a T S DEVICE

ar ay of five T S DEVICE u ed in a sp cified config ration (se Fig re 2 1.101) for

p rforman e tests of the INFA T R DIA T WA MER

201.4 Ge eral requirements

Clau e 4 of the general stan ard a pl es, ex e t as fol ows:

2 1.4.1 Con itions for appl c tion to ME EQUIPMENT OR ME S ST MS

Ad i o :

For ME EQUIPMENT or ME SYS EMS, whic combines alternative he t sources, for in tan e

in ub tors with integrated R DIA T WA MERS, devices s p lyin he t via BLA KE S, PA S or

MAT RE S S

etc safety req irements of other relevant p rtic lar stan ard s al b

con idered Further the safety req irements of this p rtic lar stan ard s al b fulfi ed with

the combination of the other eq ipment, whic is a proved by the MA UFA TU ER, as stated in

the A COMPA YING DOC MENT ac ordin to Clau e 16 (ME SYS EMS)

Compla ce is ch ck d b y th test of Clause 20 1.1 a d su b clause 20 1.15.4.2.1 of th

rele a t p artcu lar sta dards (e.g IEC 6 60 1-2-19 etc)

2 1.4.3 ES ENTIAL PERFORMA CE

Ad i o :

2 1.4.3.101 Addition l ES ENTIAL PERFORMA CE re uireme ts

Ad itional E S NTIAL P RFORMA CE req irements are fou d in the s bclau es lsted in Ta le

201.5 Ge eral requirements for testing of ME EQUIPMENT

Clau e 5 of the general stan ard a pl es, ex e t as fol ows:

2 1.5.3 * Ambie t temperature, humidity, atmospheric pre s re

If not otherwise sp cified in this p rtic lar stan ard, al tests s al b car ied out at an

ambient temp rature within the ran e of 21 °C to 2 °C

2 1.5.4 Other conditions

Ad i o :

If not otherwise sp cified, the CONTROL T MP R TU E s al b 3 °C ± 1 °C an s al alway

ex e d the ambient temp rature by at le st 3 °C

Clau e 6 of the general stan ard a pl es

201.7 ME EQUIPMENT identification, marking and documents

Clau e 7 of the general stan ard a pl es, ex e t as fol ows:

2 1.7.2 Marking on th outside of ME EQUIPMENT or ME EQUIPMENT parts

(se also Ta le C.1 of the general stan ard)

Ad i o al su b clauses:

2 1.7.2.101

*

Ox ge monitor

An INFA T RA IA T WA MER not eq ip ed with an integral ox gen monitor an whic provides

me n for ox gen administration s al b mark d in a prominent p sition with a text whic

states: "Use an ox gen monitor when ox gen is administered"

2 1.7.2.10 Dista c markin s

The

INFA T R DIA T WA MER without integral b d are s s al b p rmanently an cle rly

mark d with an in ication of the p rmis ible distan es b twe n the INFA T R DIA T WA MER

he tin s stems an an matres

2 1.7.4.2 Control d vic s

Ad i o :

Me n s al b provided for the cle r selection an in ication of CONTROL T MP R TURE on or

adjacent to the controls The me n provided s al al ow resolution at intervals not gre ter

than 0,2 °C

2 1.7.9.2.2 Warning a d s fety notic s

Ad i o :

The in tru tion for u e s al ad itional y contain:

a) a statement that in e en ent monitorin of the temp rature of the INFA T by the OP R TOR

c) in tru tion on the recommen ed p sition an method of u e an atac ment of the

temp rature sen ors provided for u e with the INFA T R DIA T WA MER;

d) for INFA T R DIA T WA MER with TYP B AP LIED PA T in whic the INFA T mig t not b

isolated from e rth, a warnin that p rtic lar care s al b ta en to en ure that ad itional

eq ipment con ected to the INFA T is electrical y safe;

e) if a pl ca le, a recommen ation to the OP R TOR to in p ct reg larly latc es an closin

devices of b r iers to prevent the INFA T fal n out;

f a statement of the maximum lo d whic can b a pl ed to al s p orts an mou tin

brack ts for A CE SORIE an an i ary eq ipment;

*g) information on the efects on the fu ctionin of the INFA T R DIA T WA MER of detac ment

of the SKIN T MP RATURE S NSOR from the PATIENT skin;

h) if a pl ca le, a statement that the ti tin of the mat res from its horizontal p sition relative

to the INFA T R DIA T WA MER he ter can af ect the p rforman e of the INFA T R DIA T

R (se 2 1.12.1.10 );

i) a statement that A CE SORIE , e.g for photothera y or he ted matres es, or s nl g t can

cau e an in re se in INFA T temp rature to dan erou levels

j) a statement that the INFA T R DIA T WA MER is not s ita le for u e in the presen e of

flamma le ana sthetic gases or other flamma le materials, s c as some typ s of

cle nin fluid ;

k) a statement that rectal temp ratures are not a pro riate for control n the he ter output

of the INFA T R DIA T WA MER;

*l) a statement that the INFA T RA IA T WA MER can ot diferentiate b twe n an in re se in

core temp rature with a cold skin ( ever) an a low core an SKIN T MP R TURE

(h p thermia), an a recommen ation to monitor the temp rature of the PATIENT;

m) a statement that en ironmental con ition (e.g air movement can afect the thermal

b lan e of the INFA T;

*n) a statement that an INFA T RA IA T WA MER s al b u ed only by a pro riately trained

p rson el an u der the direction of q alfied medical p rson el who are fami ar with

c r ently known RISKS an b nefits of radiant warmer u e;

o) a statement that an INFA T RA IA T WA MER can in re se the PATIENT’S in en ible water

los ;

p) con entration of carb n dioxide (CO

2): If the matres of an INFA T RA IA T WA MER is

wi oc ur in the COMPA TMENT d rin NORMAL CON ITIONS;

q) a statement that the INFA T R DIA T WA MER do s not adju t for PATIENT temp rature in

PREWA M MODE an that the mode s al b c an ed to MA U L MODE or BABY CONTROL ED

R DIA T WA MER (b by mode) immediately when the PATIENT is placed on the device The

The in tru tion for u e s al also contain

a) for e c mode of control, a detai ed statement des ribin the method by whic the amou t

of radiation is control ed an the temp rature of the b by is maintained;

*b) if BABY CONTROL ED R DIA T WA MER o eration is avai a le, a statement to explain wh the

If the source of radiation has a l mited l fetime, the MA UFA TU ER s al state, in the

A CO PA YIN DOC MENT , the time afer whic the source of radiation s al b re laced

201.8 Prote tion against electrical HAZARDS from ME EQUIPMENT

Clau e 8 of the general stan ard a pl es

201.9 Prote tion against MECHANICAL HAZARDS of ME EQUIPMENT and ME S ST MS

Clau e 9 of the general stan ard a pl es, ex e t as fol ows:

2 1.9.4.2.1 Instabi ity in tra sp rt position

Th INFANTR AD IANT WAR ME a d th mountn b rack ts a d sh lv s are pro ided wih th

most unfa ourab le comb in to ofde tach b le p arts a d ACC ES S OR IE a d are lo de d wih th

re comme ded ma imu m lo d

s al have a sou d level of at le st 6 dBA at a distan e of 3 m from

the front of the INFA T R DIA T WA MER in a reflectin ro m Other than the A DIO PA S D

sp cified in 2 1.12.3.10 , the au itory ALA M SIG AL may b adju ted by the OP R TOR to a

minimum lower level of 5 dBA

The sou d pres ure level of the ALA M SIGN L s al not ex e d 8 dBA on the mat res

If the freq en y of the au itory ALA M SIGNAL is adju ta le by the OP R TOR, these

req irements s al a ply to al the in ivid al selecta le freq en ies

Compla ce is ch ck d wih th microp ho e of a sou nd le e l meter comp lyin wih th

re qu ireme ts of IEC 61672-1 p laced 1,5 m ab ov th flo r a d 3 m from th fro t of th

INFANT R AD IANT WAR ME

Compla ce of th ma imum le vel is che ck d wih e ch alarm sou nd me ns actv te d, th

sound le vel b e in me s u red at a p oint 5 cm ab ov th ce tre ofth matres

Ensure th t th b ack round sou nd pres ure le el is at le ast 10 dBA b elow th me sure d

le vels

2 1.9.8 HAZA DS a sociate with s pport s stems

Ad i o al sub clause:

2 1.9.8.101 Supp rts a d mou tin bra k ts for A CES ORIES

Sup orts an mou tin brack ts for A CE SORIE s al b s ita le an of adeq ate stren th

for their purp se

Compla ce is ch ck d b y inspe cto a d b y th folowin te st

A gradu aly incre sin force is a p lied so as to act v rtcaly throu gh th ce tre of th

su p p orts and mountn b rack ts, e.g a AC C ESS OR Y sh lf in th e te ded p osi o wih a

MANUFAC TUR ER'S re comme ded lo d Th force is incre sed from zero in a 5 s to 10 s

interv l, unt i e uals thre tme s th re comme ded lo d a d is sustain d for a p eriod of

1 min The re sh l b e n e vide nce of damage to th iems u nder te st

2 1.9.8.3 Stre gth of P TIENT or OPERATOR s pport or s spe sion s stems

2 1.9.8.3.1 Ge eral

Ad i o :

The normal lo d for an INFA T is red ced to 10 kg

Ad i o al su b clause:

2 1.9.8.3.101 Bar iers

For INFA T RA IA T WA MERS with an integral b d are s ita le b r iers s al b provided to

prevent the PATIEN

T from fal n of the mat res Su h b r iers as inten ed to b o ened or

removed to alow ac es to the PATIENT s al latc in their closed p sition an s al remain

lock d u der the test con ition

Compla ce is ch cke db y insp ecto a d th folowin test Ap ply to al th b ariers (othe r

th n th se secured wih th use ofa TOOL) a ou tward h rizo tal force of 2 N to th ce tre

of e ach b arierfor5 s Th b arie rs sh l rem ain closed

201.10 Protection a ainst unwa ted a d exc ssiv ra iation HAZARDS

Clau e 10 of the general stan ard a pl es ex e t as folows:

total infrared sp ctrum

The maximum ir adian e level s al not ex e d 10 mW/cm

2

in the ne r infrared sp ctrum

(7 0 nm to 1 4 0 nm)

Compla ce is ch cke d b y me asureme ts

201.11 Protection a ainst ex essiv temperature and other HAZARDS

Clau e 1 of the general stan ard a pl es, ex e t as fol ows:

2 1.1 1.2.2

*

AP LIED P RTS not inte de to s pply he t to a P TIENT

Rep laceme nt

The temp rature of s rfaces ac es ible to an INFA T on the mat res s al not ex e d 4 °C

for metal s rfaces an 4 °C for other materials when the INFA T RA IA T WA MER is o eratin

u der S EA Y T MP RATU E CONDITION at its maximum CONTROLT MP R TU E

Un er con ition of warm-up to S EA Y T MP R TU E CONDITION or that of a SIN LE FA LT

CON ITION these s rfaces s al not ex e d 4 °C for metal or 4 °C for other materials

These req irements a ply u der NORN L CON ITION an SINGLE FA LT CONDITIONS in lu in :

– faiure of the he ter control circ it;

Compla ce is ch cke d b y me surem ent of th te mpe rature a db y p rformin th rigidiy test

as des rib ed in 15.3.2 of th gen ral sta dard Th he ater GUAR D sh l n t touch th he ater

M s al b so con tru ted that in the event of spi age

of water (ac idental wetin ) on the PATIENT s p ort or SKIN T MP R TU E S NSOR no H ZA D

s al res lt from the in res of water

Compla ce is che ck d b y th folowin te sts: Posi o th INFANT R AD IANT WAR ME or

ME S YS TEM in th le st fa ourab le p osi o of NOR MAL US E In th case ofa INFANT R AD IANT

WAR ME or ME S YS TEM wih B AB Y C ONTR OLLE R AD IANT WAR ME op e rato , th S KIN

T MP R ATURE S ENS OR sh l b e place d at th ce ntre ofth up pe r surface of th matres Pour

2 0 ml of isoto ic wate r (0,9 % saln ) ste diy o th ce tre of th matre ss o er a p eriod of

15 s

Afte r this test, th INFANT R AD IANT WAR ME or ME S YS TEM sh l m eet th die lectric stre gth

re qu ireme ts spe cified in 8.8.3 of th gen ral sta dard a d th INFANT R AD IANT WAR ME or

ME EQUIPMENT sh l fu ncto n rmaly

2 1.1 8 Inter uption of the p wer s pply / S P LY MAIN to ME EQUIPMENT

Ad i o :

The INFA T R DIA T WA MER s al b so desig ed that an inter uption an restoration of the

p wer s p ly up to 10 min tes do s not c an e the CONTROL T MP R TU E or other preset

values

Compla ce is ch cke d b y swichin th S UPPLY MAINS of a d th n swichin o , a d

insp ctn th INFANT R AD IANT WAR ME

201.12 Accura y of controls and instrume ts and protection a ainst

hazardous outputs

Clau e 12 of the general stan ard a pl es, ex e t as fol ows:

2 1.12.1 Ac ura y of controls a d instrume ts

Ad i o al su b clauses:

2 1.12.1.101

*

Ac ura y of SKIN T MPERATU E SEN OR

The temp rature me s red by the SKIN T MP R TURE S NSOR s al b contin ou ly displayed

an cle rly visible The temp rature displayed s al have an ac urac of ± ,3 °C If the

display is u ed to present an other p rameter, this s al only b o tained on deman , u in

a momentary action switc The ran e of displayed temp rature s al b at le st 3 °C to

4 °C

Compla ce is ch cke d b y inspe cto a d th folowin test

Immerse th

S KIN T MP R ATUR E SENS OR in a water b ath maintain d at 3 °C ± 0 ,1 °C Posi o

a calb rated th rmometer, ac urate to wihin ±0 ,0 °C, wih is b ulb adjace t to th SKIN

T MP R ATURE S ENS OR Th re din of th sta dard th rmometer sh l b e comp are d wih th

displa e d temp ratu re a d th ir dife re nce sh l n t e ce d 0 ,3 °C les th calb rated

POINT A ERA E T MP RATU

E an the

T S DEVICE A ER GE

T MP R TU E of an of the other devices comprisin the T S LOA s al not ex e d 2 °C

Compla ce is che ck d b y th folowin te st Pre are fiv T S T D VICES co sistn of

alu minium dis s e ch wih a m as of 500 g ± 10 g a d a diameter of 100 mm ± 2 mm D ri

5 mm diameter h les 5 mm ± 2 mm de p as sh wn in Figure 20 1.102 a d co t th e tre

dis su rface wih n n-reflectv b lack p int

NOT Th disc thic n s wi b a pro imately 2 mm

Su b ject th INFANT R AD IANT WAR ME to th folowin test in a ro m in which th ma imu m air

v lociy is 0 ,1 m/s a d th amb ie t te mpe rature is maintain d at 2 °C

± 2 °C

Place four individualy ide ntfied T S T D EVIC ES, mark d 1, 2, 3 a d 4 o th h rizo tal

matre ss at th ce tres ofe ch of four recta gle s formed b y b ise ctng th le gth a d width of

th matre ss as sh wn in Figure 201.101 Place a fifth T ST D VIC E marke d “M” o th mid-

p int of th matre ss Insert a temp erature se nsorin e ch of th fiv T S D EVIC E ce tres a d,

in th case of a INFANTR AD IANT WAR ME wih B AB Y C ONTR OLLE R AD IANT WAR ME o erato ,

atach th SKIN T MP R ATUR E S

NS OR to th ce ntre ofth up p er su rface of th

T S TDEVIC E

“M”, as urin a g od th rmal co ductv co tact (e.g th rmal p aste) In th case of a INFANT

R ADIANT WAR ME wih a B AB Y C ONTR OLLE R AD IANT WAR ME o e rato , set th tem pe rature

co trol to a C ONTR OL T MP R ATUR E of36 °C ± 0,1 ° a d o e rate th INFANT R AD IANT WAR ME

u nt a S TEAD Y T MP RATUR E C OND ITION is ob tain d In th case of a INFANT R AD IANT WAR ME

wih o ly a MAN AL MOD E, set th he ater ou tp ut so th t th T S T D EVIC E wi warm up to

ap p ro imate ly 36 ° u nder S TEAD Y T MPER ATURE C ONDITION Ta e at le st 2 re dings of

temp ratu re ofe ch T ST D EVICE at re u larinterv ls o er a 6 min p riod

Calcu late th fiv v lues ofth T ST D EVIC E AVER AG E T MP R ATUR E fore ch T S TD EVICE as

folows:

n

ttttt

T

n).(

1

14

13

121

1

++++

are th individual tem p erature re adings ta e of T S T D VIC E No 1 at re gu lar

interv ls durin th S TEAD YT MP R ATUR E C OND ITION;

n is th numb erof re din s durin th S TEAD YT MP R ATUR E C ONDITION

Calcu late th remainin T S D EVIC E AVER AGE T MP R ATUR ES T

2, T

3, T

2, T

3, T

Ac ura y of B BY CONTROL ED R DIA T WA MER operation

With the INFA T RA IA T WA MER workin in the BABY CONTROL ED R DIA T WA MER o eration

SKIN T MP R TU E S NSOR s al not difer from the CONTROL T MP R TURE by more than

If an ox gen control er forms an integral p rt of the INFA T RA IA T WA MER, then there s al

b in e en ent sen ors for monitorin an control of O

2

A vis al an au itory alarm s al b given if the displayed ox gen con entration deviates from

the set level by more than ± vol % O

2

Comp lia ce is che ck d b y th folowin test

Set th o yge n co trol to 35 v l % Wh n ste ady co di o h s b ee re ch d, decre ase th

conce trato qu ickly to les th n 2 v l % Verify th t th alarm actv tes at a displa e d

o y e co ce trato n le ss th n 30 v l %

Restore th o ygen co ce trato to 35 v l % O

2 Whe n ste dy co di o h s b ee re ch d,

incre ase th co ce trato quickly to more th n 41 v l % Verify th t the alarm actv te s at a

displa ed o yge n co ce trato n more th n 4 v l %

2 1.12.1.10

*

Weighin s ale

If a weig in s ale is s p l ed as an integral p rt of the INFA T R DIA T WA MER or as an

A CE SOR sp cificaly for u e with the INFA T R DIA T WA MER, the weig t displayed value

s al not dif er from the test weig ts by more than the MA UFA TU ER’S sp cification in the

A CO PA YIN DOC MENT when o eratin in an INFA T R DIA T WA MER with horizontal

matres orientation Eac value me s red s al remain latc ed on the s ale display at the

con lu ion of an in ivid al me s rement c cle an b retained u ti dis arded by the

OP R TOR If the s ale may b exp sed to an OX GEN RIC EN IRONMENT in u e, it s al

comply with 6.5 of the general stan ard

NOT De ic c lbratio ma b a le to b b th v rifie a d u d te b th OP RA O d rin usa e

Compla ce is che ck d b y th folowin test

Test me sureme ts sh l b e demo strate d usin v lu e s of 50 0 g (± 1 g) a d 2 000 g (± 1 g)

Te sts sh l b e co ducte d wih th ME EQUIPMENT o eratn at NOR MAL C OND ITIONS of use

Th ac uracy of th me surem ent te st sh l b e v rified wih th te st lo ds p osi o e d in

locato s M a d A through D in Figure 20 1.10 1

2 1.12.2 US BILITY

Ad i o al su b clause s:

2 1.12.2.101 US BILITY of control

Eac temp rature control, if it has a rotary action, s al b so ar an ed that a clockwise

rotation prod ces an in re se in temp rature

Compla ce is ch ck d b y inspe cto

2 1.12.2.10 U

S BILITY of mode of operation

In the case of an INFA T R DIA T WA ME

R whic can b o erated in variou modes of

o eration the mode of o eration s al b cle rly displayed

Compla ce is ch cke d b y inspe cto

an vis al alarm s al b given at le st every 15 min an the he ter de ctivated if the

maximum ir adian e at an p int of the matres are ex e d a total ir adian e level of

He t output le el at P EWA M MODE

Whi e o eratin in PREWA M MODE it s al not b p s ible for the OP RATOR to modify the he t

output level preset by the MA UFA TURER The level of he t when o eratin in the PREWA M

MODE s al b displayed

Comp lia ce is ch cke d b y inspe cto

2 1.12.3 Alarm s stems

Ad i o al su b clause s:

2 1.12.3.101 Inter uption of p wer s pply

Au ible alarm an visible in ication s al b provided to give warnin in the event of

inter uption of the p wer s p ly to the INFA T RA IA T WA MER

Compla ce is ch ck d b y dis o n ctn th p ower su p ply whie th INFANT R ADIANT WAR ME

The INFA T RA IA T WA MER s al b provided with an au itory an vis al ALA M SIGN L whic

o erates in the event of the SKIN T MP R TU E S NSOR havin o en circ it or s ort circ it

le d in the BABY CONTROL ED RA IA T WA MER o eration

Both o en an s ort circ it le d s al dis on ect the s p ly to the he ter

Compla ce is ch cke d b y sim u latn b oth fault co di o s a d ob servin th efect

2 1.12.3.10

*

AUDIO P USED of a ditory ALA M SIGN LS during MA UAL MODE

If the INFA T R DIA T WA MER in orp rates a MA U L MODE, the au itory an vis al ALA M

SIGN LS (se 2 1.12.2.10 ) s al o erate within 15 min of commen ement of u e in this mode

The au itory ALA M SIGN L s al b A DIO PA S D Fol owin an A DIO PA S D the au itory

ALA M SIGNAL s al o erate again within 15 min This seq en e s al contin e u ti the man al

Compla ce is ch ck d b y insp e cto , o e ratn th INFANT R AD IANT WAR ME a d tmin th

alarm

2 1.12.3.10 AU IO P U ED

With the ex e tion of the alarm sp cified in 2 1.12.3.101, it is al owa le for the au itory

ALA M SIGN L to b A DIO PA S D or switc ed to a lower sou d pres ure level by the

OP R TOR, but it s al revert automatical y to a ful value af er not more than 15 min The

vis al ALA M SIGN L s al contin e afer the au itory ALA M SIGNALS has b en A DIO PA S D

u ti the alarm con ition have b en cor ected

Compla ce is che ck d b y insp ecto , o eratn th INFANT R AD IANT WAR ME a d tmin th

alarm

2 1.12.3.10 Alarm function te t

Me n s al b provided for the OP R TOR

to c eck the o eration of au ible an vis al

alarms Su h me n s al b des ribed in the in tru tion for u e

Compla ce is ch cke d b y insp ecto

2 1.12.4.2 Indic tion of parameters rele a t to s fety

If the

INFA T R DIA T WA MER

is fited with a

COMPA TM

ENT that en loses the b by, the

MA UFA TU ER s al dis lose the value of CO

2con entration whic wi oc ur in the

CO PA TMENT u der NORMAL CON ITIONS

Compl an e is c eck d by the fol owin test:

A 4 % mixture of CO

2

in air s al b administered at a rate of 7 0 ml/min at a p int 10 cm

a ove the centre of the matres (se Fig re 2 1.101, mid le p int throu h an 8 mm

diameter tub in vertical direction from the matres to the to CO

2con entration at a p int

15 cm from the mid le p int s al b me s red afer 1 h

201.13 HAZARDOUS SITUATIONS and fault conditions

Clau e 13 of the general stan ard a pl es

201.14 PROGRAMMABL E ECTRICAL MEDICAL S ST MS (PEMS)

Clau e 14 of the general stan ard a pl es

example latc es an b r iers s al remain closed an an i ary eq ipment s p led by or

avai a le from the MA UFA TU E

R s al remain sec re

2 1.15.4.1 Con truction of conne tors

Ad i o al su b clause:

2 1.15.4.1.101

*

Temperature s nsors

Al temp rature sen ors (in lu in

Af er S EA Y T MP R TU E CON ITIONS have b en ac ieved, any sen ed temp rature

deviation ex e din ±1 °C comp red with the CONTROL T MP R TU E s al cau e an au itory

an vis al alarm to o erate, an the INFA T R DIA T WA MER he ter s al switc of when the

sen ed temp rature ex e d the CONTROL T MP R TURE by 1 °C

Compla ce is ch ck d b y inspe cto a d b oth of th folowin tests:

Test 1

Set th C ONTR OL T MPER ATUR E to 36 °C a d immerse th S KIN T MP RATUR E S ENSOR in a

waterb ath maintaine d at 36 °C ± 0,1 °C Posi o a calb rated th rmometer ac u rate to wihin

±0,

0 °C wih is b u lb adjace t to th S KIN T MP R ATUR E S ENS OR Aftera ste ady temp rature

indicato is achie e d a d maintain d for at le st 10 min, incre se th wate r b ath tem perature

control setin to 3 °C Re ort wh th r th audiory a d visual alarms op erate at a wate r

b ath temp e rature n t e ce din 37 °C ± 0 ,3 °C a d wh th r th INFANT R ADIANT WAR ME

0 ,1 °C Rep ort wh th r th audiory a d visual alarms op e rate

ab ov 35 °C ± 0 ,3 °C a d th INFANT R AD IANT WAR ME he ater remains in op erato

Ad i o to iem b ):

Th INFANT R AD IANT WARME sh l n t p rmi th S KIN T MP RATUR E ofth PATIENT to e ce ed

4 °C u nderNOR MAL C ONDITION a d e ach S ING LE FAULT C OND ITIO

Comp lia ce is ch cke d b y th folowin test Place a T S T D VIC E at th ce tre of th

matres , wih th INFANT R ADIANTWAR ME op e ratn u nder S TEAD Y T MP R ATURE COND ITIONS

at th ma imu m C ONT OL T MP R ATUR E, a d under a y S ING LE FAULT C OND ITION

Th

T S T

D EVIC E sh l n t e xce ed 4 °C wih u tth audiory a d visu al alarm s op eratn a d

th h ater b ein dis o n cted

2 1.15.4.2.2 Temperature s t ings

Ad i on l su b clause:

2 1.15.4.2.2.101 Ra ge of

CONTROL T MPER TU E

The ran e of the CONTROL T MP R TU E in the BABY CONTROL ED R DIA T WA MER o eration of

an INFA T R DIA T WA MER s al b from 3 °C or les to not more than 3 °C

Compla ce is ch cke d b y insp cto

201.16 ME SY T MS

Clau e 16 of the general stan ard a pl es

201.17 Ele tromagnetic c mpatibi ity of ME EQUIPMENT a d ME S ST MS

Clau e 17 of the general stan ard a pl es

202 Electroma netic compatibi ity – Requireme ts and te ts

IEC 6 6 1-1-2:2 0 a pl es, ex e t as fol ows:

2 2.8.9 IMMU ITY T ST L VE S

For radiated radio- req en y electromag etic field , the INFA T R DIA T WA MER an /or

− contin e to p rform its inten ed fu ction as sp cified by the MA UFA TU ER at a level up

to 3 V/m for the freq en y ran e stated in the col ateral stan ard for EMC

Annex AA

(informativ )

Particular guidance and rationale

AA.1 Requirements and the safety concept of this sta dard

Compl an e with the minimum safety req irements sp cified in this p rtic lar stan ard is

predominantly c eck d by me s rement of ph sical q antities s c as the temp rature In

most cases the sp tial location of the me s rin site or the temp ral develo ment of the

q antity is of interest Therefore, the exp rt group of this stan ard con idered it helpful to

provide a s no sis of the req irements of this stan ard Hen e, Fig re AA.1 i u trates the

req irements an their s hematic me s rin sites or exp cted temp ral develo ment The

req irements as given by their clau es are set in brack ts

Interu tio of p wer su ply alarm

Ov rtemp rature alarm

4 °C ( or oth r materials)

Ma imumsurfa e temp rature (sin le fa lt c n itio )

4 °C ( or metals)

4 °C ( or oth r materials)

Ev ry 15 min alarm in Ma u l Mo e for ira ia c le el

AA.2 Particular guidance

The fol owin are rationales for sp cific clau es an s bclau e in this p rtic lar stan ard, with

clau e an s bclau e n mb rs p ral el to those in the b d of the doc ment

Subcla s 2 1.1.4 – Partic lar sta d rd

It is the primary purp se of a BABY CONTROL ED RA IA T WA MER to maintain the temp rature

a pl ed to o erate a BABY CONTROL ED R DIA T WA MER in lu in the displayed value are

con idered to b not a CLINIC L THERMOME ER in the sen e of the p rtic lar stan ard

ISO 8 6 1-2-5 u les they are sp cifical y exten ed to me s re the b d temp rature

The term b dy temp rature is u ed for al other temp ratures of the h man b d ex e t SKIN

T MP R TU E as defined in IEC 6 6 1-2-19

Subcla s 2 1.3.2 7 – PREWA M MODE

INFA T RA IA T WA MERS req ire sig ificant time for the he ter to warm up an , s bseq ently,

for the matres are to warm up INFA T who are placed on INFA T R DIA T WA MERS are

of en cold stres ed from tran p rt or cold stres ed an wet from recent birth an can ot

tolerate contin ed co l n whi e waitin for the warmin device to he t up A MA U L MODE

level of he t b low 10 mW/cm

2

is not s ficient for prewarmin the INFA T R DIA T WA MER for

these cold stres ed INFA T These cold stres ed INFA T can ot tolerate the time for the

warmers to he t to a level a pro riate for their ne d without exp rien in further cold stres

The PREWA M MODE al ows the INFA T R DIA T WA MER to remain warmed to a level s ita le

for these INFA T so that the INFA T may immediately b gin warmin from a cold stres ed

con ition when placed on the INFA T R DIA T WA MER

Subcla s 2 1.3.212 – TEST LOA

With resp ct to ir adiation distribution of 2 1.12.1.10 , the aluminium 5 0 g T S DEVICE

were develo ed in 19 4 on the b sis that they were simple to re rod ce to sp cific

dimen ion , an they resp n to temp rature c an es d e to variation in warmer output

Diferent MA UFA TU ERS of INFA T warmers have con idered them to b a s ita le referen e

for tests of their prod cts Other T S DEVICE of this nature ten ed to b more compl cated to

re rod ce an more exp n ive

This T S LOA config ration is not inten ed to re resent a sp cific INFA T size, but only to

test the o eration of a radiant warmer

This T S LOA config ration is inten ed to demon trate the radiant warmer temp rature

control mec anism, an in icates the u iformity of he tin acros the matres

A mat black finis of the T S LOA s ould provide a hig emis ivity value for con istent test

data re rod ction

Subcla s 2 1.4.3.101 – Additional ES ENTIAL PERFORMA CE re uireme ts

The exp rts of the workin group have dis u sed an determined that these req irements are

the es ential req irements or es en e that a warmin thera y device (i.e in ub tor, warmer,

he ted matres , etc) mu t comply to

As an example, the inten ed u e of an in ub tor or warmer is to a ply he t to a b by an to

k e the temp rature sta le within a safe region The ac urac of the set temp rature to the

re l temp rature mu t b maintained within the ran e req ired by the stan ard an l sted as a

req irement in the E S NTIAL P RFORMA CE ta le If the temp rature varies b yon the ran e

l sted in the req irement then the device mu t s p ly an alarm

It s ould b noted that the time relation hip b twe n PATIENT an warmin thera y tre tment

was evaluated in the dis u sion to resolve es ential req irements These typ s of devices

(in ub tor/warmer) have re l me s ra le resp n e times bui t into most fai ure mode

activities as o p sed to venti ators or implantable devices Therefore it was con idered

a pro riate that combined with the req irement to define thermal p rforman e that a fai ure to

maintain this state if ac omp nied by an au ible alarm, whic would alow a clnician the

a pro riate mitigatin action , would b the total s mmation of es ential req irements for

these typ devices

Subcla s 2 1.5.3 – Ambie t temperature, humidity, atmospheric pre s re

INFA T R DIA T WA MERS are commonly u ed in are s where ambient temp ratures ran e

from 18 °C to 3 °C

INFA T R DIA T WA MERS are inten ed for u e in n rseries as wel as in la or an del very

ro ms, the lat er could b co ler than n rseries

Subcla s 2 1.7.2.101 – Ox ge monitor

INFA T req irin s p lemental ox gen are at ad ed RISK sin e their arterial ox genation is

not con idered adeq ate whi e bre thin ambient air Inadeq ate amou ts of s p lemental

ox gen may res lt in brain damage or de th, an ex es ive amou ts of s p lemental ox gen

have b en as ociated with an in re sed RISK of retino ath of prematurity (ROP) (retrolental

fibro lasia RLF) Whie known con entration of ox gen can ot b directly related to the

adeq ac of arterial blo d gas values, it is imp rtant that at en in p rson el b aware of

in pired con entration (as wel as other factors influen in arterial ox genation) in order to

b a le to determine the re son for o served c an es in the ph siologic state of the INFA T

Subcla s 2 1.7.9.2.2 – Warning a d s fety notic s

Subcla s 2 1.7.9.2.2, item g)

It is desira le that the INFA T RA IA T WA MER s ould b provided with an au itory alarm an

vis al in ication whic o erates when the SKIN T MP R TU E S NS

OR is detac ed from the

INFA T’S skin Tec nical y this has not b en rel a ly ac ieved an has therefore not b en

made a req irement of this stan ard

Subcla s 2 1.7.9.2.2, item l)

The

INFA T R DIA T WA MER

can ot dif erentiate b twe n an in re se in core temp rature

with a cold skin ( ever) an a low core an SKIN T MP R TU E (h p thermia) Therefore in al

situation it is recommen ed that the temp rature of the PATIENT b monitored se arately

Subcla s 2 1.7.9.2.2, item n)

It is in erent in

INFA T R DIA T WA ME

R desig an fu ction that in order for it to b ef ective

for one PATIENT, it may b p tential y harmful to another It is neces ary therefore, that

q al fied p rson el with the neces ary in ivid al PATIENT information an medical knowled e

b resp n ible for orderin al asp cts of INFA T RA IA T WA MER u e

Subcla s 2 1.7.9.2.9, item b)

An INFA T R DIA T WA MER in the MA U L MODE of o eration emits a preset amou t of energ

to the c i d contin ou ly, regardles of the temp rature of the INFA T If the he ter is set at

the maximum in order to warm up the INFA T ra idly, the skin of the INFA T can b come

dan erou ly hot It is therefore es ential to at en to

Subcla s 2 1.7.9.2.13 – Mainte a c

There have b en re orts of hot fragments (e.g metal oxide p rticles) from aged warmer

he ters fal n onto the mat res

Subcla s 2 1.9.6.2.1.101 – Au ible alarms sou d le el

Temp rary thres old s ifs of he rin in ad lts have b en as ociated with 8 h of sig ificantly

hig er sou d levels Whie data on INFA T is not avai a le, a lower value was c osen to

provide an ad ed margin of safety

6 dB(A) is a rather hig noise level in an inten ive care n rsery Recent improvements in

n rsin care practices red ce noise levels an PATIENT disturb n es to a minimum Therefore

the OP R TOR s ould have the o tion to red ce this sou d level

OP RATORS have req ested the o tion for adju tin freq en y of au itory alarms for b ter

identification of the p rtic lar radiant warmer whic is sou din the alarm

Reflectin ro ms re resent the acou tic situation in an inten ive care n rsery more

re l sticaly than non-reflectin or semi-anec oic ro ms that are very ofen u ed for sou d

pres ure me s rements However, reflectin ro ms are not wel defined an del ver les

re rod cible values d e to their varia le size an ge metry The more ide l zed reverb ration

c amb rs del ver very re rod cible res lts but are sometimes dif ic lt to get for tests

Hen eforth, the test can alternatively b p rformed in a semi-anec oic c amb r that is very

of en u ed to me s re o eratin sou d pres ure level Usin a semi-anec oic c amb r for

the me s rements, the thres old are lowered This ta es into ac ou t that reverb ration

c amb rs when comp red with semi-anec oic c amb rs o tain sou d pres ure levels that

are reflected mainly at the cei n whic can b con idered as low comp red to the typical

heig t of a device an to a minor extent by the lateral wal s For me s rements in a semi

-anec oic c amb r an with a me s rement distan e of 3 m, the thres old of 6 dB(A) an

5 dB(A) are lowered by 5 dB to 6 dB(A) an 4 dB(A), resp ctively

Furthermore, if in the semi-anec oic c amb r a distan e of 3 m b twe n the device an the

micro hone as req ired is not fe sible, the distan e can b decre sed to no les than 2 m

The thres old of 6 dB(A) an 5 dB(A) are then lowered by 1,5 dB to 6 ,5 dB(A) an 4 ,5

dB(A), resp ctively This ta es into ac ou t that the me s red sou d pres ure level is

in re sed by 3,5 dB, comp red to a test with a 3 m distan e (reciprocal distan e 1/r law)

Subcla s 2 1.10.6 – Infrare ra iation

INFA T R DIA T WA MERS provide thermal s p ort by directin in isible infrared l g t to the

INFA T’S b d The source of this infrared l g t is an overhe d he ter whose electrical p wer

input is l mited by desig , there y lmitin the amou t of infrared energ output that can b

directed at the INFA T

The l mits pro osed in this stan ard are b sed up n a review of l terature regardin the ef ect

of infrared radiation up n the eyes an skin of h man [1 to 14]

2)

Infrared me s rements can b made in the 7 0 nm to 1 4 0 nm wavelen th (IR-A region) as

wel as the 1 4 0 nm to 4 5 0 nm segment of the wavelen th IR-B an IR-C region

The IR-A region is as ociated with p tential for damage to the cry tal ne len of the eye

whic may le d to a cataract The IR-B an IR-C region are almost completely a sorb d by

the corne ( he outermost layer of the eyes) with a res ltin p tential for burn

From a review of the l terature the fol owin statements can b made:

a) There have b en no re orts from an sources des ribin an harmful efects of infrared

radiant energ on either the eyes or skin in INFA T n rsed u der INFA T R DIATION

WA MERS

Retrosp ctive examination sp cifical y lo kin for an eye efects have

prod ced no eviden e of harmful efects for either s ort term or lon - erm evaluation

The lon - erm evaluation were p rformed from 3 day to 6 ye rs af er the INFA T were

n rsed u der radiant warmers

b) Spectral ir adian e me s rements on several commercial y avai a le radiant warmers

s ow the a solute p a ir adian e that the INFA T could b exp sed to is les than

IR-A wavelen th region The ir adian e the INFA T would normal y b exp sed to at

maintenan e he t levels is mu h les than these levels Clnical re orts have doc mented

that the me n ir adian e ne ded to maintain a sta le SKIN T MP R TURE could b

an where from 12 mW/cm

2

to a proximately 2 mW/cm

2

for very smal INFA T Hig er

levels would b ne ded routinely d rin warming of cold INFA T an /or warmin newly

b rn INFA T with skin sti wet with amniotic fluid General y, the smal er premature

INFA T req ire more ir adian e to maintain their SKIN T MP R TU E b cau e they have a

relatively larger s rface-are - o-mas ratio that p rmits larger he t los es p r u it weig t

c) Wheldon an Ruter [2 ] ac urately re ort a solute ir adian e levels, o servin a

maintenan e ir adian e level of (5 ± 3) mW/cm

2

for INFA T averagin 1,6 kg

Simiar levels of ir adian e have b en u ed in ne natal inten ive care u its for at le st the

last 15 ye rs to provide thermal s p ort to premature INFA T

———— ——— ——

2)

No re orts have identified a corne l o acity or skin inflammation cau ed by the n rsin of

the INFA

T u der a radiant warmer

d) The recommen ation of AAMI is 6 mW/cm

2

Both cataracts and retinal lesion have b en doc mented as b in cau ed by IR-A

wavelen th Absorption of the infrared energ by the iris, whic in irectly he ts the len

(an forms o acities), has b en identified as the most l k ly cau e of infrared in u ed

cataracts INFA T R DIA T WA MERS p s es very l tle IR-A energ when comp red to

sources that have cau ed cataract formation

Retinal lesion have b en re orted to b cau ed primari y by s orter visible l g t

wavelen th an the actual IR-A comp nent may b a negl gible contributor to an retinal

damage that could oc ur

The pro osed radiant warmer thres old values put forth by the Emergen y Care Rese rc

In titute in 19 3 have b en o served an maintained by MA UFA TU ERS of radiant

warmers on the mark t today These lmits of les than 3 0 mW/cm

2

for the IR-B an IR-C

region an les than 4 mW/cm

2

for the IR-A region are b sed on data that have sin e

b en updated an re-evaluated an confirm their a pro riatenes

Photo iologists have not yet determined a solute maximum safe levels of in oherent

infrared l g t in the IR-A, B an C region It has b en pro osed that for IR-A wavelen th ,

a safe, c ronic exp s re level pro a ly is in the order of 10 mW/cm

IR-C region is the safe thres old l mit for c ronic exp s re of the corne Sin e the time

these l mits were pro osed, these authors have doc mented that more recent

in estigation in icate that infrared radiation may not b as hazardou as was on e

thou ht

Sin e no harmful ef ects from the ir adian e levels now present in radiant warmers have

b en re orted, these levels can serve as a maximum thres old l mit u ti further data are

made avaia le

Althou h further stu y of thres old levels could b u eful to further define l mits, the

actual b nefits derived from the u e of radiant warmers far outweig the p tential,

u re orted, an the retical RISKS as ociated with radiant infrared energ from INFA T

R DIA T WA MERS No re orts of an harmful infrared energ in u ed efects have b en

doc mented in the medical l terature af er ne rly 15 ye rs of cl nical u e

e) The sp ctral c aracteristic for h man eye an skin media have b en doc mented in the

l terature No stu ies of the ne natal eye sp ctral c aracteristic have b en re orted Only

the sp ctral c aracteristic of ne natal skin with resp ct to visible l g t have b en

re orted

Althou h the ne natal eye is not completely develo ed at birth, the sp ctral c aracteristic

are b l eved to b simi ar to those of an ad lt Examination of ne natal eyes af er b in

n rsed in radiant warmers have not s own an harmful efects from the level of IR-A

del vered by the radiant warmers

Ne natal ex ised skin sp cimen have b en s own to have simi ar sp ctral a sorption

c aracteristic to ad lt skin in the visible l g t region However, for the IR-A region the

skin a sorption can vary with the skin thicknes

Sin e the skin's reflectan e is gre test in the IR-A region , mu h of the in ident l g t wi

b reflected away, an only a smal p rtion of the total in ident l g t would actual y

p netrate the skin

Most infra-red energ is in the IR-B an IR-C region an is a sorb d by the to 1 mm to

2 mm of skin No harmful efect from a sorption of the radiant energ from a radiant

warmer has b en re orted Sin e infrared energ is not energetic enou h to enter into

photoc emical re ction with skin comp nents, the only ef ect of the a sorption of the

energ is he tin , whic is the primary re son the INFA T is u der a radiant warmer

f The as ociated HAZA DS from exp s re to infrared energ for h man an animals, u in

b th coherent an in oherent l g t have b en doc mented in the l terature [18 to 2 ] The

H ZA DS, re orted in the l terature, from exp s re of h man to in oherent infrared l g t

(cataracts), retinal lesion , an skin inflammation Recent re orts have s own that

the c tane u skin burn , corne l o acities an inflammation, an skin inflammation are

d e entirely to the IR-B an IR-C p rtion of the infra-red sp ctrum; b cau e the

outermost layer of the skin an eye a sorb al of the in ident radiation in the wavelen th

region , they do not tran mit any sig ificant p rtion of in ident energ b low this

outermost layer Skin p in thres old have b en doc mented at a proximately 4 °C

Several commercial y avai a le radiant warmers have SKIN T MP R TU E l mits to prevent

the

SKIN T MP RATU

E from ex e din 4 °C Corne l o acities have b en re orted in

ne nates, but u ual y are as ociated with other p thological con ition (in as ociation with

con enital glau oma, or as a res lt of an infection from either con enital rub la or herp s

viru )

Subcla s 2 1.1 1.2.2 – AP LIED P

RTS not inte de to s pply he t to a

PTIENT

The req irements of this clau e can b b sed up n the BSI publ cation [2 ] an the draf in

commite havin noted the p tential RIS

K of b bies u der warmers comin into contact with

hot metal c or other s rface; hen e the stated lmits

Subcla s 2 1.1 2 – Fire pre e tion

Durin the review of this doc ment, the commite was req ested to con ider ad in a

flamma i ty req irement to the INFA T

matres Becau e the commit e could fin no

eviden e to s p ort an ad ition of this typ , this brief rationale was ad ed to the clau e

Matres es or p d u ual y con ist of two materials whic serve two diferent fu ction The

fi er fu ction to s p ort or cradle the INFA T whi e the s rface material acts as a b r ier from

the in er material The primary req irement of the s rface material is to present no H ZA D to

the PATIENT whic could contact the PATIENT u der a s stem sin le fault fai ure In most

clnical a plcation the outer s rface has b en o served to b covered with ad itional

coverin s con istin of a natural fibre (coton or materials s p l ed by PATIENT’S p rent

b sed material whic is not sp cifical y flame retardant but fu ction to further red ce the low

a rasion q al ties of the p d’s cover with the ne nates skin The primary req irements of the

fi er material are to provide a comforta le s rface for lon - erm stay of the PATIEN

T

Sin e there is no source of ig ition in ide the b s inet of an INFA T R DIA T WA MER, the RISK

of fire ig ition in the are of the matres is l mited sin e the req irements of s bclau e 6.5 of

the general stan ard for an ox gen enric ed en ironment have b en met No in ident has

b en re orted con ernin fire ig ition in ide the b s inet of a warmer for man ye rs Also,

even with warmer matres es, ad itional con ern were dis u sed arou d the toxicity of

fumes that can b prod ced by materials that have b en tre ted with flame retardant

ad itives Therefore, with the ex e tion of elevatin (ac elerant the RISK of fire from the

cover material, no sp cific flamma i ty ratin is req ired of the p d cover an the in er fi er

Subcla s 2 1.12.1.101 – Ac ura y of SKIN T MPERATU E SENSOR

The SKIN T MP RATU E S NSOR in ication of temp rature er or is only a p rt of the total er or

as ociated with skin s rface temp rature meas rement Other er ors can b introd ced by

variation of the are of sen or contact, contact pres ure an he t ex han e b twe n the

sen or an its en ironment The ac urac is most imp rtant at 3 °C whic is arou d the

normal p tient SKIN T MP R TU E Ac urac to this degre is req ired to esta l s the b st

p s ible fu ction of the SKIN T MP R TURE S NSOR control s stem

Subcla s 2 1.12.1.10 – Ac ura y of distribution of ir a iation to the mat re s

L n exp rien e of b th the medical an tec nical req irements for INFA T R DIA T WA MERS

has s own that this level of p rforman e (2°C) is satisfactory in maintainin the temp rature

of the b by, an re di y ac ieva le tec nical y

Subcla s 2 1.12.1.10 – Ac ura y of B B CONTROL ED R DIA T WA MER o eration

The OP R TOR of the INFA T RA IA T WA MER mu t b confident that the temp rature that is

set wi b the actual temp rature ac ieved within ± ,5 °C

Subcla s 2 1.12.1.10 – Ox ge control

Relatively low ox gen con entration for the PATIENT may cau e brain damage Relatively

hig ox gen con entration for the PATIENT may cau e a Retino ath of prematurity In SIN LE

FA LT CON ITION the u e of one sen or may cau e a H ZA D for the b by, therefore for this

o eration the sen ors are req ired to o erate in e en ently

Subcla s 2 1.12.1.10 – Weighin s ale

Weig t s ales u ed in p diatric medical eq ipment have u iq e req irements that difer

sig ificantly from those of weig t s ales u ed in general commercial or domestic weig in

a pl cation Absolute ac urac is imp rtant, however not to the degre of ac urac (1/10 0)

req ired by commercial s ales u ed for monetary tran action More imp rtant from a cl nical

a pl cation is the information provided by weig t tren s, demon tratin an in re se or

decre se tren in the weig t of the INFA T PATIENT Absolute ac urac is very dific lt at b st

d e to electrical le d , tubin , an other PATIENT care devices that can ot b completely

el minated from the me s rement

Becau e weig in an INFA T is a dific lt proces req irin b th han s of the OP R TOR in the

manipulation of the INFA T PATIENT, it is neces ary that the weig t re ding b held an

displayed u ti s c time as the OP R TOR has completed the PROCEDU E The weig t re din

s ould b displayed u ti the OP R TOR has recorded it or stored it, if electronic storage is an

o tion

An INFA T PATIENT ne d to b contained in a he ted, control ed en ironment for an exten ed

p riod of time Movin an INFA T for an re son can b harmful to the INFA T PATIENT’S wel

b in INFA T PATIENT of en remain in their control ed en ironment, IN UBATOR or INFA T

RA IA T WA MER, for 2 or more we ks Durin this time it is neces ary for the OP RATOR to

as ure the cal bration of the weig t s ale Ad itional y, it may b neces ary for the OP R TOR

to b a le to adju t the cal bration s ould the weig t s ale b out of cal bration without the

neces ity to remove the s ale or move the INFA T for cal bration

Subcla s 2 1.12.2.10 – Time a d ir a ia c l mits in the MA U L MODE

It is neces ary to have in the MA UAL MODE a mode of o eration without alarm fu ction on a

low he ter output level to k e the INFA T RA IA T WA MER previou ly warmed (as a stan -by

fu ction) or to provide only a smal pro ortion of he t to the b by (u ual y big er b bies) The

exp rts of this workin group an the p diatric doctors from the German National Commit e

are of the o inion that at a level of 10 mW/cm

2

there is no RISK to b bies u der radiant

warmers L n exp rien e with the u e of radiant warmers with low output levels confirms this

statement There are no known HAZA DS

Subcla s 2 1.12.2.10 – He t output le el at P EWA M MODE

The PREWA M MODE is not a pro riate for care of an INFA T af er the INFA T has b en placed

on the INFA T RA IA T WA MER Se 2 1.3.2 7

Subcla s 2 1.12.3.10 – AUDIO P U ED of a ditory ALA M SIGNALS during ma ual control

An INFA T R DIA T WA MER o eratin in the MA U L MODE contin ou ly emits a preset amou t

of energ to the INFA T regardles of his/her temp rature If this energ is at a maximum in

order to ra idly warm up the INFA T, the INFA T’S skin can b come dan erou ly hot A

INFA T’S temp rature It is therefore es ential to have a p riodic alarm o eration an the

con ition of the INFA

T u der the warmer as es ed at freq ent intervals

Subcla s 2 1.12.4.2.101 – CO

2conc ntration

It is con idered that a general test, a pl ca le to al INFA T R DIA T WA MERS, s ould b

pres rib d, givin definite p rforman e fe tures It was recog ized that mixin of CO

b administered, in te d

Subcla s 2 1.15.4.1.101 – Temperature s n ors

The resp n e of the rectal temp rature of the INFA T to en ironmental temp rature c an es is

slow an is not s ita le for control n the

Bibl ography

[1] BARKER, F.M Th tra smi a ce ofth Electromagnetc Sp e ctrum from 20 0 NM to 2 0 0

NM through th Op tical Tis ues of th Ey of th Pigm ented Rab b it, Master’s Thesis

(19 9), Col ege of Optometry, University of Hou ton

[2] BAUMGART, S et al Aten ation of Warmin an Co l n Cy les by Shieldin

Thermistor Pro es in Infants Nursed Un er Radiant Warmers Adv nces in The rap y,

19 4, 1 (1), p 19-2

[3] BAUMGART, S et al Efect of He t Shieldin o Co ve ctv a d Ev p ratv He at

Los es a d o Radia t He t Tra sfer in th Premature Infa t, The Journal of Pediatric ,

19 1, 9 : p 9 8-9 6

[4] BAUMGART, S an QUINN G Lo g Term Folow-u p for Pote tal Infrare d Radia t

Inju ry to th Ey in Cri caly i Premature Ne on te s: A Prelmin ry Rep ort, Unpubls ed

re ort, 19 5

[5] BAUMGART, S et al Radiant Warmer Power an Bod Size as Determinants of

In en ible Water L s in the Critical y i Ne nate Pediatric Rese arch, 19 1, 15:

p 14 5-14 9

[6] BOWIE, W.H Low Le el Infrared Iradia ce Ocu lar Efe cts, Final Re ort for U.S Army

Medical Rese rc and Develo ment Comman , Fort Detrick, Frederick Marylan ,

Contract No DAMD 1 7-7 -C-7 5 : Novemb r 19 8)

[7] DU, J.N.H an OLIVER, T.K The Ba y in the Del very Ro m: A Suita le Micro

En ironment JAMA, 19 9, 2 p 15 2-15 4

[8] ENGLE, W.D et al Ef ect of In re sed Radiant Warmer-Power Output on State of

Hy ration in the Criticaly i Ne nate Cri cal Care Medicin , 19 2, p 6 3-6 6

[9] FITCH, C.W et al Me s red Red ction to Radiant Energ Req ired in Sp cial He t

Shield Pediatric Re se rch, 19 0, 14: p 5 7 (Abstract No 10 0)

[10] HAM, W.T et al Sen itivity of the Retina to Radiation Damage as a Fu ction of

Wavelen th Ph toch mistry a d Ph tob iology, 19 9, 2 : p 7 5-7 3

[1 ] HAM, W.T et al Solar Retino ath as a Fu ction of Wavelen th: Its Sig ifican e for

Protective Eyewe r, in Th Efe cts of Consta t Lig t o Visual Proces es, edited by

The dore P Wi iams an B.N Ba er, Plen m Publ s in Corp 19 0,p 319-3 6

[12] JOHNS, A et al Ev luato ofth Efects of Infrared Radiato o th Ey s ofInfa ts

Unde r Radia t Warmers, Unpubls ed p p r

[13] MOSS, G.E et al B iolog ical Efects of Infrared Radiato , NIOSH Publ cation No 8

2-10 , 19 2

[14] PITTS, D.G et al Determination of Infrared Radiation L vels from Ac te Oc lar

Cataractogensis Albrecht Vo Gra fes Arch Kln Ex Opth mol 19 1, 217(4): 2

5-97

[15] SLINEY, D Biohazard of Ultraviolet, Visible an Infrared Radiation J u rn l of

Occu pato al Medicin , Marc 19 3, 2 : 3, 2 3-2 0

[16] SLINEY, D and WOLBARSHT, M Safety wih Lasers a d Oth r Optcal Sou rces,

[17] SLINEY, D an Fre sier, B Evaluation of Optical Radiation Hazard Ap led Optcs,

Jan 19 3, 12: 1

[18] TENGROTH, B.M et al Infrared Cataract in Furnacemen Cincin at Proceeding s of a

To ical Symp siu m, Nov 2 -2 , 19 0, p 16 -17

[19] UY, J et al Lig t Fi tration Durin Tran i umination of the Ne nate: A Method to

Red ce He t Bui d p in the Skin Pediatrics, Se t 19 7, 60: 3

[2 ] KANTO, W an CALVERT L Thermoreg lation of the Newb r AFP, 19 7, 16 (5):

15 -16

[21] Infant Radiant Warmers- He lh De ices, 3: 4, Nov 19 3

[2 ] He lth In u try Manufacturers As ociation's Infant Radiant Warmer Petition for

Reclas ification from Clas I I to Clas I (Submit ed to Fo d an Dru Administration,

Jan ary 19 6)

[2 ] PD 64 4:19 3, Medical informato o adu lt hu ma re c tio to skin contact wih h t

su rface, BSI 19 3

[2 ] WHELDON an RUTTER The he t b lan e of smal b bies n rsed in in ub tors an

u der radiant warmers Early Hum D ev 19 2, 6: 131-4

[2 ] IEC 6 3 5-2-2 :2 0 , House hold a d simiar e lectrical ap pla ces – Safety – Part 2-27:

Partcu lar re u ireme ts for ap p lia ces for skin e xp osure to ultra iolet a d infrared

radiato

[2 ] IEC 6 6 1-2-19, Medical ele ctrical e quipme nt – Part 2-19: Partcu lar re quireme ts for

th b asic safety a d es e tal p erforma ce of infa t incub ators

[2 ] IEC 6 6 1-2-2 , Medical ele ctrical e uipme t – Part 2-20 : Partcu lar re quireme nts for

th b asic safety a d es e tal p e rforma ce of infa t tra sp ort incub ators

[2 ] IEC 8 6 1-2-3 , Medical electrical e uip me t – Part 2-3 : Partcular re uireme ts for

th b asic safety a d es e tal p rforma ce of b la k ts, p ads a d matres e s inte ded

for h atn in medical use

3)

[2 ] IEC 6 6 1-2-5 , Medical electrical e uip me t – Part 2-50 : Partcu lar re quireme ts for

th b asic safety a d es e tal p erforma ce ofinfa t p hotothe rap y e uipm ent

[3 ] IEC 616 2-1, Ele ctro coustc – Sound le el meters – Part 1: Sp cificato s

[31] ISO 8 6 1-2-5 , Medical electrical eq ipment – Part 2-5 : Partic lar req irements for

b sic safety an es ential p rforman e of clnical thermometers for b d temp rature

me s rement

———— ——— ——

3)

Index of defined terms used in this particular standard

PCLCS (PH SIOLOGIC CLOS D-LOOP CONTROL SYS EM) EC 6 6 1-1-10:2 0 , 3.19

PH SIOLOGIC CLOS D-LOOP CONTROL ER (PCLC) IEC 6 6 1-1-10:2 0 , 3.2

PH SIOLOGIC V RIABLE EC 6 6 1-1-10:2 0 , 3.21