Transtek Medical Electronics TMB1491BS Bluetooth Blood Pressure Monitor User Manual TMB 1491 BS FDA

Guangdong Transtek Medical Electronics Co.,Ltd Bluetooth Blood Pressure Monitor TMB 1491 BS FDA

TMB-1491-BS(FDA)

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Document ID3963893
Application IDHSgBJ9KftMJ05Mk2wgC2Tg==
Document DescriptionTMB-1491-BS(FDA)
Short Term ConfidentialNo
Permanent ConfidentialNo
SupercedeNo
Document TypeUser Manual
Display FormatAdobe Acrobat PDF - pdf
Filesize457.62kB (5720221 bits)
Date Submitted2018-08-15 00:00:00
Date Available2018-08-16 00:00:00
Creation Date2018-08-15 10:48:41
Producing SoftwarePDFCreator 3.2.0.11758
Document Lastmod2018-08-15 10:48:41
Document TitleTMB-1491-BS(FDA)
Document CreatorPDFCreator 3.2.0.11758
Document Author: ferry-al

FCC ID:OU9TMB1491BS
Ginny-1m mum Mule: Ebfllwmzi so. m
me a. M105 ,Dorwl moan-en mum mama,
DummnijMTlfiu-mnnlcnnl
Version:1.D
TRHNSTEK
User Manual
Blood Pressure Monitor TMB—1491—BS
Arm Type
- Thank you very much for selecfing TRANSTEK Blood Pressure Monitor
TMB»1491-BS
. Please do read me use! manual carelully and Ihoroughlly so as to ensure
me safe usage Mlhis wound. and keep me manual well «x funher
relerenoe in case you have pmblems.
AT LOGLIE CA LOGUE
Table of Contents
INTRODUCTION 2
. General Dessrrptlnrr
Imrcatlnrrs tor Use
Conhalnrtlcatlnns
Measurement Prtnotple
Satety Irrtormatrcn
LCD Drsplay Sronal
Mantle! Components
Llsl
BEFOREVOUSTART. .. . .. .. . .. .. . .. .. . .. .. . ... ... . .. .. .9
. The Cholce of Power Supply
. lrrstallrrru and Reptaerrru the Batteres
Selllnu Date, TIME and Measurement Unrt
Select the User
- Pair-up the Blood Pressure Monilor wlttr Your Devlce
MEASUREMENT. .........t5
' fiettreCutT
- Start the Measurement
DATAMANAGEMENT. ... . .. .. . .. ... ... . .. .. . ... ... . ..18
- Recall the Remus
- Delete the Records
INFORMATION FOR USER , 20
11min! moasummont
- Marmerlarrees
ABOUT BLOOD PRESSURE. . .. . . . . .. . .. .. . .. . . .. . .. .. . .. 22
- What are systolre pressure and dlaslcllt: pTessure’r'
- What Is the slandam blood pressure classtflcahnn’v'
rregular heartbeal eetemr
Why does my blood pressure ttuottrate throughout the new
' Why Ito lgel a dllletenl blood pressure at home mmparea to the haspllal’i
~ Is the result the sarrre If rrreasurtna on the natrt arrrr7
TROUBLESHOOTING 24
SPECIFICATIONS 25
AUTHORIZED COMPONENT 26
CONTACTINFORMATION. . . .. . . .. . .. . .. .. . .. .. . .. . . ..26
FCC STATEMENT , 27
coMPLlED EUROPEAN STANDARDS LIST . . .. . . .28
EM GUIDANCE 29
TRODUCTI TRC L‘CTiON
V General Description ' Safety Information
The signs below might be In the user manual. labeling or other component,
Thank you for selecting TRANSTEK arm type blood pressure monitor They me me requiremem D, 5.5mm and using.
(ms-1591.35), The monitor features blood pressure measurement. pulse
rate measurement and the result storage. The design provides you with
. . WNW lor'THE OPERAYION - symbol Va! TYPE BF APFUED
Movearsofre'wb'emm _ , ® cucrnisrseseo- ‘R ems-
Readings taken by the TMB-1491-BS are equivalent to those obtained by a m m flwmwm
ed observer using the culf and stethoscope auscultation method. H mm MWUFWURER. #2,,an , Em. Wm
TII mlnull collh ns important Safety and car! informltion, and K wounds “wig "m “WSW 91
provides step by step Instructions tor using the product, W m .SEM WWW win hmnw Wine Pluses reis-
Read the manual thoroughly before using the product ‘3 W“ ' — gmmgsufliflgwwfil
Features: WNW oi-oiaecr cunaewi- mic.-
' wmmij mm Blue LCD wnh white backllghl F0, mm, use Only D 5mm 'm .0355 H Eqmpmem.
. Maximum GD records _
- 3rd technonoly: Measuring during inllation r1 T1AI250V ca E‘toccc 313:? 'W MANUFACTURE
(The updated technology in the world) 7
. Cannon These notes must
v Ind allons for Use & as observed to Never“ any €32 Symbol lav ‘Ret:yt:le“
The Transtek Blood Pressure Monitor is digital monitors intended lor use in “”9“ “’ ""3 “2“”
measuring blood pressure and heartbeat rate with arm circumference ranging nearest Dal is he license
. Symon! w. Eulvpein
im‘mv220mio 320m(-about B/ 12/ )ar220mto42cm(abou18/ 16/ ) a leotktfllrldusnyrflmdsd
It is intended ior adult indoor use only. We”. w, m...” m
packaging maleitals n
v Contraln a ns WWW“
1.The device is not sunaple lcr use on may be pregnant women oi pregnant women.
2.The davioa is not Suitable lar use on patients with implantadfilediical deViDas,
such as cardiac pacemakers. defibrillators. \—/
V Measurement Principle
Thls product uses lhe Dscillomeiric Measumlu method in detect blood pressure.
Eelcre every measurement, the unit establishes a 'zem pressure" equlvalenl to the air
pressure Then it stans rnllaring the arm cult, meanwhile, ltie unit detects pressure
oscillations generated by bechrbeal pulsatrle, which is used in determine the systolic
and diastolic pressure. and also pulse rate.
H'FC‘EU,T\O‘~J
— A CAUTION
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~ n. mp. n. um mhbh lav mum-w n. mm mm Mammy-n m m. «my my. m; n pu
um. dummy:
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‘Yh: 6w»: . m unnumq nur punk: use
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pm" mmmm
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upm me 795ml
mm k‘nkmncmmmn muunng w mm“ In uunnpnum. may :anlmmuiwnannwmm
an Wm"! pmmm 1mm“ MMM mm mm: szm
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my mu. hiltwumm .mu p. mu”, m .n. Amflwv-mmfi w; flu m Mu. m wflm
me gnu. M . mummmy
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u: camp-“um
‘On the we wu-upnn MI mu “Haw-y he mnu rem-n My Mum mum; measurement upw me an
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m. 3 mum zppu-u pp Kh- am many m up .u mhymi
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umnunnun
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‘Yh: 6w»: nmm be used m HF mam mun-«n .n we same line
‘Yh: Accowmvmc» Documzm um mm: mm the SPNVGMOMANUMEYER ms chmuw
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~ m u. p. n; wmamdhzhd npn my Mun. w my p. min-um a], a! n maul SAM-i pnmm
mm mm n... .M. a! m. awn" m 1m nm m mknwm
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punnuunsm mdfinger! mu umun-umanu muununaunuu punpnuauunu pw mum
'wmn MI m use 5w: m um um mu .uppnur m . dry mom Ind pnunun w wimsl ememe mum-u
um mm «mama». Wynn My mwnuunm me may: mu
‘Yms «mu may be um um nun me purpose mu p. m: mm m III-Mummy 12mm be held
nnupn. npn Hanna;- can: by mm appnmn.
'Wns «we :nmvnses ummve mppuunp and man be new www- umnun emu me mane and
cumming mum“ «mm p. pm pm
\HTFICOLM
r— A CAUTION
'0“ ”my...“ nu M. mm: mum,“ and um um,» Ml .u. n. m. mam nl . hymn.
Immune mnxnunu w. on wnnn mm a! nitrous om:
'Wam‘nv Nnume/munwunu mu. lhl ME Qumran-nu: u my
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mum: measullmwunms pnuumnpm mamndmnnmxlmw unnnmmapmuuunu magnum
nummuu. i‘vnz‘ m meal/Wm lailuanmnmaumi‘ma‘
1mm pressure mum. midlvlor .nmuwnm umupnunpn use pm" the plhemenwwflmem
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pampun ununnnnpu av mum. mulch
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summon: pm a mp thnan
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WWI Wm: npu p wow nm
w n, mnnmm mm n... punpunnm. ,nwu p. man my 2 y.“ "n m nmhmme .m
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mum
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clhbrllum pmmmpnu . nu rum In sum: «mm p. Dim rev-r
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pan‘puu pm .n .u «mm m dmm mm me mw‘y mm up “My mnnun. opununpu M ME
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munmnm mamas mm» pmmueu npum answen-ahy nuunnmmnupmnm
“mm“ 5mm;
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‘KeeP the mm w! an mun. nnn mm, war-u mum un pe's nu mu VIM-nun av uwunnmu mum-u
Pin: nn p fll'vww! w mu mun
lNTRODUCTlDN
A; CAUTION
' Be selelul lo slmrmuleuoll oue lo cables and rmees. pellleulelly llue |u exLeaell/e
lerlulll
' Al leesl an mlll lsoullell lol ME eoulpmelll le Wall" llem lrle rlllrulllulll sluleue
lelllpelelule llelweeu usee urlul ll ls leeuy lel ullelloeo use Al lede| 30 mm lsoullell lel
ML equlpmerll lo cool lrom lrle maxlmum sloraqe lemperalure between uses urllll ll ls
ledd‘] rel llllelloell use
' nus eoulpmelll lleells lo lle msulllell and pu| ln|u aelvlLB m eselllomlse Mlll llle
mlolmellell pleulueo lll llle ACCOMPANVING DOCUMENTS
' Mnlele.s eemlllulllullells euulumelll susll as wueless lleme nelwulk ueVlees lnublle
ullurles. soulless leleprlellee erlu lrlell vase sleuolls. walkle Idlklee sell afield lru.
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ollellle 4 ello Table 9 ol lEc 605m 1 2 2014‘ as dDDVuvlldle
. Plrav use l SSHRH s and flmanhahlc panes spsumsul sulrlurlsm by
MANUFACTURE muelwee ll may Lduae dam-sue lo lrle urul ol uelluel lo lrle
usellpellellls
A ”mm ls rul lurr um mnnL‘nan am uwd m lrlr oorlsllueuorl urlulurlg lm‘n‘ ls s
posslolllly Mel Mry mlghl be msownsmly mrmmm lu lrlueusssulsrllulo syslums
allowlnu alrlo he pumpeo mm a bum vessel
. Plrav use lhc flrvlor urlool Wm cnvlmnmrm wmml ms prnvldt‘d m ms user manual
olrlelWlso mo prnnrmannc and lllollmo thr oouuse wlll no lmpamcfl and mousse
v LCD display slgn_al
DESCRI’IIOII
ll~lT DDUC‘HON
SYS
sysloue blood pressure
marl bland Dmssum
I) IA Dlemllc blood pressure Low blood pressure
pull”... Pulse dlspliy Pulse lrl beats v-r mlrlule
V Dellallorl symbol The olll ls oellallng
Memery
llloloele ll ls m me memoly mas and
wrlloll gmup ol memory ll ls
kPa
Measuremem Unllal ale ulooo pressure
mm Hg mqu Meesulemeul unll ol me blood plessule
fit a + B Low ballery Baluerles are low and need m be mvlam
M We“ mu, .s um“ m
‘7 Inwulzl hunted lnbflular hearlbaal durmfl msasuremam
3'31"sz we ueueeupeeueleel
Duvmm rlme
Year/ManWDiy. Hour/Mmule
Heanbeal
Blood pressure monllor le deleulng a
haanbaal alllmll mnsummm
User HUSH Gluser 2
Sun meesulemerll lol User l/user G/Llser2
alum mrl
nle hlueloom loorl mulls whet! ale
bluemulh ls womllg
lNTRC L‘CTlCN
v Monitor Components
Component list of
premre measuring system
1 Cu"
2 Air pipe
3 PCBA
curs ,,
smirrsrop BUI’ION
unirw cot/“mew
v List:
1.Blood Pressure Monitor
(ms-1491.55)
3. 4XAM alkaline batteries
Uflfll
2.l:uir (Type BF applied part)
(22em~32cm or 22cm~42ern)
(Plus: use WNGYEK
arr-mm em The an
m the mm mm ptme
rarer la the law an M
armed will
5' AC Adaptor
(BLJ06L060100F»U)
4.User manual
BEFORE
v The Choice of Power Supply
1 Battery powered mode:
avnc AxAAA alkaline batteries
2A0 adaptor powered mode:
sv = IA
(Please only use the recommended AC
adaptor model).
AC adaptor
Please unplug the adapior to depart train
the using urimy power.
ACAUTION
in order lo gel the besl retreat and protect your monrterplease use lhe rlgh
battery and special power aoaptor which cnmplles wrth local sarety stanoaro
- Open the battery cover.
- Install the batteries by matching
the correct polarity, as shown
- Replace the battery covert
Replace lhe baiierles whenever the below happen
shows
-The [a I:
.The dl
lDlA Mal
. 35:“. i , P“ '5'“
8 x , ,
v "MM "the data transmlsslon sumeeds, the Bluetoottl symbol wIll
I disappear.
,. lUIGE
Display and save the results.
The device will proceed to data
transmission after measurement.
The Bluetooth symbol blinks on
the LCD indicates data is tlansnlitling
U" sts
. 1
_ . m».
- - I Free: the “START/STOP" button
.- L RDA lo p0we( olf‘ otherwlse lt wlll tum
Ll _| , ml. olwmmm
H l 35m
l3 t
"was
16 17
v Recall the Records
1. When the monitor is off,
please press the “MEM” to
show lhe average value of
lhe Ialesl three recordsell
lhe records are less than
lhree groupsjt will display
lhs Iatasl record first,
2. Press lhe “MEM'
or “SET“ to gel the
record you want,
The dale and ltme *
nl me reoord E
will be shown
' Delete the Records
I! you old not get the correct measurement. you can delete all
resulls by following steps below.
l.l-lold pressing “MEM” M
fit
for 3 seconds when the » 1
monmr ls in the memory \ l
recall mode ,the ‘
flash display will J,
show.
2 Press “SET“ lo 5
confirm dalallng and
the monitor will turn
of! D)
3% you don‘t want to delete the
records press “START/STOP"
lo escape,
4 "there is no record,
‘ m Ne, e Nu; m ,1; m ,1; .l. m,- l ..
allemalely, ‘ “W H p M m DB 5:05? lsp ay Wl
K 7777777777777777
ACAUTION - - -
The most recent record (l) is shown first Each new measurement is ‘
assigned to the hrst (1) record All olher recurds are pushed back one
dlglt (e g r 2 becomes 3, and so on)‘ and the last record (50) is dropped
18 19
V Tlps for Measurement V Maintenance
Measurements may be Inaccurate It taken In the toIIowIng In order to get the best Peflormancer Please follow the
circumstances. Instructions below.
Avotu Ioucmncl water,
mean it wIIh a my math In case
Within 1 hour Immediate measurement
atter dinner or drinking atter tea coffee smoking
Avom intense shakmg Avoid dusty and unstable
and wlltslons temperature environment
Within 20 minutes X 9‘ ;
afler taking a ham when talkin or movin our fin ers Q
Ree 7,)
Uslng wet dams to remove dlrl Do not attempt to clean the reusable Gulf
wIth water and never Immerse the CW In
of 00 water
In a very cold environment >< When you want to discharge urine
20 21
'What are systolic pressure and diastolic pressure? . Why does my blood pressure
When ventricles oontract and pump blood out of the . . .
heart. the blood pressure reaches its maximum value fiffifm D'asw'm fluctuate throughout the
in the cycle‘ which is called systolic pressure When army "VI day?
the ventricles relax. the blood pressure reaches ils
minimum value in the cycle. which is called diastolic
pressure
1. Individual bland pressule valies
multiple times everyday. It is also attested
by the way you tie your cult and your
v What is the standard blood pressure classification? measurement position, so please take the
measurement under the same conditions.
The chan on the right is the ”Ma-'"MWVWWWWMWW'M WM“ 2.lt the person takes medicine, the
standard blood pressure classifi- more“. wry smile Diem pressure will vary more.
cation published by American "m" ' ”MM” 3.Wait at least 3 minutes for another
Heart Association (AHA). """"‘ W "' ‘7" '"‘ ”m“ ‘“ measurement.
aim. mm .a a...“ .o
awry-g.“ were a are ' Why do I get a different What you need to pay
disease.“ Wm a WW blood pressure at home aflengm’ when you ":35“
invasion—ileum . your pressure at ome:
“Meme” m Ngr-rm-ttm .nsii. manner In compared to the hospital? lllhe curt is tied properly
The blood pressure is diherent even " "is “I" is '00 “W 0"“ "me
A CAUTION Waugh” he day due .0 weamer ii tie on is red on he upper arm
, . I iryou reel anxious
Please consult a physician it your measuring result falls outside the range emotion, exercise 914:. N50. there Is the Taking 273 mp “am We”
Please note that only a physician can tell whether your blood pressure value “Mitts mat“ 2479:}. which means Flood mm...“ w." be barre, in, measuring
has reached a dangerous point. Pressure usually Inueases In dlnrcal Advioe Relax yourselrtorLfi
semis: minutes until you calm down
v Irregular Heartbeat Detector
All irregular heartbeat ls detected when a heartbeat rhythm varies whlle the uhlt to measuring ' Is the resu" the same
the systolic and diastolic blood pressure During eaoh measurement the monitor records all the if measuring on the
pulse intervals and calmlate the average V it there are two or more pulse intervals ,llre ditteienoe .
between each interval and the averaDe is more than the averaoe value ot x25% r or there are tour right arm?
or more pulse intervals sthe dtflerence between each Interval and the avefaue is more than the ‘
average value or xIS'Mhe irregular heartbeat symbol appears on the display when the It IS ok for both arms. but there
measurement results are appear will be some dirt‘erent results for
ditterent people, We suggest you
A CAUTION measure the same arm every time.
The appeaianoe otirie lHB ioon Indlmles that a pulse inogulanty oonsistentvnih an inegular heart
bealwas detected during measurement Usually this is NOT a cause tor oorioeiri. However, it the
symbol appears ohen, we reoomnierio you seek medical advioe Please note that the devioe does
22 riot replace a cardiac examination, but serves to detect pulse irregularities at an early stage 23
TROU LE OOTWG
T ls section Includes a list of error messages and frequently
asked questlons [or problems you may encounter wlth your blood
pressure monitor. littie products not operating as you think it
should, check here belore arranglng lor servlclng.
Z4
:PEC‘F‘C TlONs
Power supply
Battery pmred mode
(was rm altallnr halt-net
AC adaplor melted mode av =1 A
name only meme recantmerraett AC
adamant-ll
\—/
( Display mode Blue LCD wlllt whlle hadtllghl v A minimal) 5mm
PROBLEM SYMPTOM CHECK THIS REMEDY "lemme,“ mode “momma .65.” made
Batteries are exhaus1ed. Replace with new batteries Rated euii pmsure
Dlsplay wlll nct crnnlttc-zecrnrnngrcrre assure:
No power ‘ m Batten“ we men“ insert the batteries Measurement rznge Measurement ptessme'
‘“ "9 mwmny meaty svs- mnmttrrmmnalt atrem 7km
—— le mwtscrnmttg i5 aim-11 am.
AC adaplnr is rnseneti Insentne AC adaptor rule. "In «(LfiSlDelllmlmnI
incorrectly mm, Accmcy Pressure
Law Display is arm or 5C40Cwllhln£0 AkPalSmmHgl
batterles show I“, , D Hal-em are low Reptace win new banerles Pulse value 5%
A temperature range or we to two
E 01 shows Eflgzgefs “3° "W °' mglzfmeum'fi: 3"; ‘ . ‘ A relative humidity range at 15% to 90%,
measure anal" Normal wolklllg Condllloll non-oondenstrig. but nol mulrlng a walervapour
E 02 snows The mom, dammed Filmill pressure greater Ihan so has
mummnm u. rm Relax tar ad An anncspnene pressure range at
muse ,s [on We, mggfifi‘eaa’aame" 700 We to 1060 We
wtrile measunng mange & “MW": Temperatureazmc to mow:
Error E 03 shows The measurement Loosen tire dnlltlng on the condition A ”‘3'“ WWW ”"99 M S 93% m"'°°"“°"5‘"9
message process does nut detect arm and lllen measure "as ‘ 3‘ zwa‘e'VEWW Press“ "P ‘0 5°"P2
"" “”99 W’B‘ 393‘" meme" "enmem About 22em~nern or 22em~41ern
of thumr arm
E 0,, mm Tne treatment citne Relax fur a moment and "El We'flh' Approxv1829tExv‘vdlng me dry WIS!
measurement railed tnen measure again External dimen ns Appmx 110mmx110mmx41mm
Attachment 4XAAA alkaline batterreswer manualAc adapter
fifiksrmenesifizenl Mode of operation Conunuous operation
EElot.shcws on A calibration errcr , -
me dIsvlay 0mm“ comm” Mam or w Degree or protection type BF appirea part
customer servloe _ IP21 it means ttre device could pmlecled
depaflmem to. runner Protection against against sciia icreign oblecls or 12 5mm and
assistance Rerar to ihe ingress of water greater, and protect against vemcaity railing
warranty lcr contact water drops
lnlormalmn and return Battery Powered Made
. . . lnternaiiy Powered ME Equipment
Warniri out of measurement Rem M a mmem Devroe Classmuuon AC “39‘“ Pm’e“ M0“
9 .0". r snows Rerasten the cull and then class H ME Emmy“
message Wine measure again iitire
problem pennant oonmm Somme Ver n Am
your physician
WARNING: Nu modmuatlurl or lhis equipment is allowed.
25
D CO PONENT
v Authorized Component
1. please use the TRANSTEK
authorized adapter.
by.
Amt»
rvnz: aiiosmmmuw
Input: tawwvsoewzu 2A Max
nnouu sv.— 1A
v Contact Information
For more lMomtalorl about our products, please vtshmmranttak cn you can get cusromer
servlcl. usual vroblems and dimmer download. transteir will serve you swim
usnuiasturad by: euangdong 1ranslzk Medical Eiecuonlcs ca, Ltd
Company: suanodono 1!:an Mldlizl Electronics Co . Ltd
Address: Zone 5. No ins .Dorrotr Road. Torch umlopmrnt Dismcl.
thgshnnfi2maleuangdmgphlnn
26
v FCC Statement
FCC IDzOU9TMB1491BS
This device complies with Part is oi the FCC Rules. Operation is subject
to the lollowing two conditions: (i ) this device may not cause harmiul
interterence. and 12) this device must accept any intelferenoe received.
including interterence that may cause undesired operation.
Caution: The user is cautioned that changes or modifications not
expressly approved by the party responsible tor compliance could void
the users authority to operate the equipment.
NOTE: This equipment has been tested and lound to comply with the
limits iora Class B digital device. pursuantto Pan 15 otthe FCC Rules.
These limits are designed to provide reasonable protection against
harmful interference in a residential installation. This equipment generates,
uses and can radiate radio irequency energy and. it not installed and used in
accordance with the instructions may cause harmful interference to
radio communications, However. there is no guarantee that interterence will
not occur in a particular installation.
"this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment oii and on.
the user is encouraged to try to correct the interierence by one or more
of the lollowing measures:
-- Rearient or relocate the receiving antenna.
-- Increase the separation hetween the equipment and receiver.
-- Connect the equipment into an outlet on a circuit diiterent trom that to
which the receiver is connected.
-- Consult the dealer or an experienced radio/TV technician for help.
FCC Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for
an uncontrolled environment.
This transmitter must not he co-located or operating in conjunction with
any other antenna or transmitter.
27
CO .lPLlED STAN
28
RD
v Complied Standards List
Risk management
EN tso rm new so term-2m lama-mes
wishes-ten nl yea mar-smart re mural auto“
Labeflng
EMl501522$12liSD1522112mo Madlul m
symhalxhh-usad whit Mimi melanin. health»; and
mummy-tn bewPPllbd vim General Nimmmsms
User manual
in «an 2m Inf-mum same: w the mlmm at medial
new.e
General Regu ements
for Safety
EN SWIM-1 was.” zmwtzc slum .1 mam 2m: Mental
must nulpmmtspatt Gmllal Mom-mam: mrhaxlcmfiy
Ind sewn: pent-name
EN seems llznlsrlic mitten zorsweaeleumr
eaulpnrnns m HI annual rum-mum in tune an, and
men Wuhan-r Salami mum mar-meme tar-meal
must Iquipmml aid mural marital iymm und in the ham.
Mum-l9 emrmm
Elam,“ Mic an enema 2015/ EC sternum. Mal new
9 NulpmeM-Fanl-Z oenealrequtemenslerssslssalarsm
compat lty mllalmmu Calamalmm El-ummavmuc
«more» Emmy-mam m min
Performance EN tso swam m Nun-lmnluxmnmummm . Pull
. Rewmum .na lea mam. ta nun-Illumlled msummsm type
"Hulmmems m mess momma Mental.rnrrrmommms
Pan 3 Saw-mummy teat-mm lot mememtast bland
mile "sesame system
tzc mm-z—snznwm 2n13l0m
2.30 no.“ rsrurrenane in me tun. surety and alumni
Mann-tee Mitt-um ran-men. ”Mum-lumen!
V EMC Guidance
l)This product needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided,
and this unit can he afieoted by portable and mobile RF oammunicat‘ians
equipment
2)- Do not use a mobile phone or other devices that emit electromagnetic
fields. near the unit. This may result in incorrect DDemtion althe unit.
sycamo . This unit has been thoroughly tested and inspected to assure
proper penonnanss and operation!
4)‘ Caution: This machine should not be used adjacent to air stacked with
other equipment and that it adjacent or stacked use is necessary. this
machine should be Observed ta verify normal Operation in the configuratian in
which it will be used.
clinical investigation
an momma uwmunsMramem-melsrs. mt rest
means. n Mame westernmost" vuwlqul-Ikllllbs‘l
nowhwailv- iwumflmn
lso MW 2m: Newmanwygmemammns PMQ
sins-l "id-Inn «truer-rm measurement was
EN mum-E 2»!an NIS/lECeDSm-I.51LHD~A11MS
Msas.lm..lsauwent. m «a General requirements tare-sis
- » snot meme emmmnmmm usability
UsabI'W IECmuImIst laws.“ restores
uaetnsmmnmaa ens.
Soflware life-cycle EN swims/Ac mm mm whom an; Meant
Jme‘m Wenenssen..ru.e,aemm
Bio-compatibl ily
lso lame! me sweet "alum: e4 meal um» pat
t Ewalnamn and mm; with e rlxk mama... Wis
lso tum—s ma Bdwul snlum at medial dema-
m 5 Int: tor in ms mommy
lso lam-WNW Win-l wimnnmmefinl are»...
m to use furmmnlnflshnsensllmnn
Table l
Graeme. and manlnacmm's aeslsram clnlmmunoflc onusslons
the rim ts tnenm Var use in tn. Mammal: envlmnmm swim eelew the custom or tn.
user on" «rice she-rte assure thrt ll is user: in sush an enhrenrmt
Emlsslons m Comnllamn Ehummawmlc onvllonmml - wtasns.
me name use. as enemy Wm M .ntanat
RF emisslms mncllml iterators. ns RF mlsswns are very low
as” " Gmup i one .mnt immense .ny mnerenee in Mllby
eleamnrs autumn
RF “M", n. am. .. .uraet. re. u.. in .r mum.
Elm “ classa marmmmmmmaareanmaem
the we. WWII pawn 50pm mm M
morale. mum. med to. m imme-
Harmonie mlssklns
IEC 61009:»2 “‘5 ‘
Volt-a. luau-tenet
item msslms Emit“
IEC 610011733
29
E .IC GU‘DANCE
Table 2
EMC GU‘DANCE
ram. 3
“mm... mailman-":13 Damian-:muwluwmklmmmhy
m. m... . mm... 1.. .... m m. .mmam uw‘mmnml M. hm n. ...m.. u m.
u... .1... mm a... m... m n w. u... .. mm 2.. «MN...
n. m. h 1...»... m uu .. 0.. «mm...» mm...“ .W m m. cm... a m-
use! am. a... m... m... I... n .. user! m saw .. :mxmnmem
Ehammammk
\mrmnfly m win an... Cowman“ Ehuwm mvianmml , “4......
m hm level
5......“ R, 15...... mm... Mme-VIEWERmemmmm
H my,“ .. m mum mum“... “mun...” m... I.4.
av"... 3v»... .4... mm mm... mmn,manlh
av... n. Isu m... u. ISM mm... sec-much mum. rub-I‘M
.mm... m. Imllau a... m- ...m ”my... turAInIMm-MY
a... hands) um. mm on». mmmiter
m Am .. 1ka m n. a! mu Rmmnfled sec-mm mm...
.-n as.’ ,
«.1 2 p
mam-a nr “mm, mm- ... «M... m Am an m I: .. m m .. m... . I: m. ”a...”
Izcmnma mm: mm. d-v m mwmmmwwn-
ann w. w 2 7 a... «mum... .. w... M:
.-2 a}; m... .. m
mummy mmmu,
a a me mm...“
may..." mo: M
"Ma! t... new
mm. n... n... a;
mammal-n ..
«mm m ...
mmm. we
may. mm be kg:
m... m. my...“ w...
w. “a. luau-my ram-
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m. mm .1 «mm...
m... m m. HIM-1M
mm... mm...“ Wm... .,
WWW.-.“
M... MW mm... m...
WW... .5... mm... xflmfiwmg‘
m... Wm... mm»... M . _ M
mum-m mv aw .m...'i’.7...'f.."’mm...
mm... W...“ WW.-.
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mm... .......,... mm..-
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M... MM... ..................
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m..- 7......“
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mm m...
NOYE o. .s m. a 9 min; vome w a. wlulwn am: an we...
30
W,
(«5»)
m. ....-..........,.........-
.m M........... .m, M... WWW.
WWWWMMMWWM
- new m”... n... mm "mm, ”a. .. a... mm: a. um. (um... / wan!)
mm... n. ma mi: m... Imllwrnfin. AM m. m m... mam m. w many.
an... n. we“... «mmuw m buck-WY To “seam: mm"... mm"... a» m
m RF «um»... .. emu-um... we saw a»... be manned Ill»: mum. in:
5mm m m: m... .. Mm me am. ‘5 um mam": win... .7; mm... a...
.m. I... an... ms. .. Observed w mm mm... mm... w a...“ ram...» 5
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. Ova m. (mummy "we W) m; w w w. m 31mm: mm be la: .1... av».
31
32
Table 4
nmmmm wanna: alums mm" yummy and mhlh as mmmunkaum
lelnm-nl m m- mm,
m. m h mm m an m in mm .Mmmm n mm. M a; dilmhanm in
mm m mum: we. own: device an m pmerl emmm mama“: w
mum-mi . lmmrmm damn: w mm: .m mu: nr mmuml equxvmem
"mummies! m In: awn _ vauwlmwded new “mm m m: mm... mm Wan»:
mmmmm! :wwum
Wmmmmm mm «mm- mmwhmmwhmmm,
Madam...
AW}
mommaawu wummmwx wnMmeum
d w: 47 up mu;
:1 m n 12 u 12 m
N am a.» 07:
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mo .2 12 m
nu Mam mu m . "mum mm mm m m‘ we mmmmm mumm-
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minim! mmubcmnl
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"DYE 2 mm wie‘n: mly MIvv‘y m m mum E‘azlmmlimc lama-gm: x! mm w
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rams
mnmmm-.m.m..mm
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1., 17 m
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M 3 MN mm. m 29
m m
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m mm mm,
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33

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Keywords                        : 
Modify Date                     : 2018:08:15 10:48:41+01:00
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Format                          : application/pdf
Title                           : TMB-1491-BS(FDA)
Creator                         : ferry-al
Description                     : 
Author                          : ferry-al
Subject                         : 
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