Sin1zo®

& �

\

•

Digital Infrared Thermometer

03/01/2020

Product Description ------

Overview

Quick Details

Type: Non-Contact Forehead Thermometer

Place of Origin: Guangdong, China

Instrument assification: Class II

After-sale Service: Free spare parts

Power supply: 2*AAA Batteries

Range: 34.0C0 -43.0C0

Packing: ____

Colour Box

Feature: Three-color backlit

Packaging Details lpc/color box; 60pcs/CTN (470*340*315mm)

- color box X 1(163*88*47mm)

- Infrared Thermometer X 1

- User Manual X 1

- AAA battery X 2

Slmza

Brand Name:

Model Number:

Warranty:

Display:

Accuracy:

Certificate:

SIMZO or OEM

HW-F7

1 year

LCD

Measurement mode:

+/-Q.2C0 /Q.4 F0

CE ISO FDA

Forehead type

Availble Sample:

Slmzo lntr,i«HI thtitmom 1,

""' II

Product Description

Device name

Model

Measurement mode

Power supply

Measuring range

Measuring accuracy

(At laboratory conditions)

Clinical repeatability

Resolution of display

Operation condition

Storage condition

Size

Weight

High body temperature hint

Grade of waterproof

Electric shock

Applied part

Non-Contact Forehead Thermometer

HW-F7

Object/ Body

D.C.3V, 2 AAA batteries

For forehead temperature: 34.0-43.0C0(93.2 F0 -109.4 F0

)

For object surface temperature: 0-93C0(32 F0-199.4 F0

)

For forehead temperature:

±0.2C0 /0.4 F0 during 34.0C0 -42.0C0

;

±0.3C0/0.5F0 during 42.1C0-43.0C0

•

Within ±0.3C0/0.5 F0

0.lC0/0.1F0

15°C-40°C(59.0 F0-104 F0 ),Relative Humidity<95%

-25°C-55°C(13 F0-131F0 ),Relative Humidity<95%

136mm* 76.5mm*38mm

About 75g

;:;:: 37.5C0(199.5 F0

) (Can be set)

IP22

Internally powered ME equipment

Type BF applied part, including the whole unit

Continuous operation

5 years

Mode of operation

Product life

Standard EN60601-1,EN 12470-5 ,ASTM E 1965-98

PRODUCT DESCRIPTION ----

Streamline design,beautiful and practical feel.

Measuring Probe --------

Product label

Measuring button

Left shell

Battery cover

Accurate measurement

Negative electrode

LCD

display

Voice prompt and

�C/°

F switch button

Query

memory

button

Object/body

temperature

setting button

Positive electrode

Powered by 2* AAA Batteries

Three-color backlight for easy reading

' --

' ,.:::::,;_ .�· .. ,··.· . •a\,'I •,. • .•

... __ '/' -.

Normal 34.0~37.4

°

( Green backlight

----

Have a fever 38.0~43.0

°

( Red backlight

When the temperature value is higher than 37.4 "C, the color of backlight turns Orange with an audible alarm.

PRODUCT APPLICATION ----

The product is suitable for all ages. It can also be used to measure object surface temperature.

Take temperature for kids Take temperature for the aged

--

Take temperature for milk bottle Take temperature for food

HOW TO USE?

-Open the battery storehouse,

distinguishing the positive and

Negative electrode then insert

The batteries.

Measurement button

-

® I;]

][H'c

JD.

m I;]

][H'c

JD.

----

>>

»

Select measurement mode,gently press the

Measurement button to start measurement.

@ [M]l;I @ !;I

5-BCM

-Align the thermometer probe at the

Center of the forehead and keep it

At distance of 5-8cm,be careful not

To touch the forehead directly.

@ [;]

1r n°c

JO.O

-After successful measurement,the LCD

screen displays the temperature value.

,r n

oc --+

JO.O ,r n

oc --+

JO.O

!;I

nrr LIi- ,-

OUR CERTIFICATES

U.S .. FODD & DRUA.DMll'U5111,Uto,N

December 6, 2018

Dcmggmm S™ZO Electronic Technology Co. Ltd. Mei 'Ian QAMa11ager

o.81, Tianxin Street) Chon1gko:n& Sbij&e To"WDDongguan, Guangdong, China

Re; K.173048

Trade.lDeviceNam.e: Non-con.tact Forehead Thermomek.--r .. Model:· -IW-2/HW-2 1HW-3JHW-4 IHW-4SfilW-3,02/

RW-303

Regulation Number. 21 CFR 880.29 J 0 Regulation ame; Clinical E]ectrom.o Thermometer Regulatory Clas!i:. Class Il Product Code: FLL Dated: October 22. 2018 Received: October· 25, .2018

Dear Mei Tan:

We. have reviewed your Section 5 l O(k) premarket notification ,ofinrent to market the d evwe refcmoed above and have determin.ed the device is substa:htially equi\13.J:ent (for the indications for use stated, in fhe enclomre) to Jo,gally marketed predlicate deviws marlteted in interstate commerce prior· to May 281 1976, the enactment date ofthe Medical Device Amemlments1 or to devices lllut have been rec::'lassUied in aoooniance with the provisions of the .Federal Food, Dmg, and Cosmetic Act (Act) that do not .require approval of a premarket approval application (PMA). You may� ther-dor-ej mariret the aevjce� subject to die gooe,al controls provisions of the Act� Although this letter refers to your product as a device, p t!ff.R. he awatie that some cleared products may instead be combination prodm:;ts. · The :S IO{k) Premarket Motificati.oo Database loct@d at ,n:m""'"" Q Iseri We ' identifies combinati.OD product submissions'. The gmeral controls ·pmvis.ions of the Act include requ,iirements fut atlllmal re,gistraticm, 1istmg of devices, good manumcrurlng p:ractice� labeling, and prohibitions against misbranding and ad

u

lteration. Please note: CDRH does 'Rot evamate inform111tkm related to contract r ability wananties. We remind you, how:evcrt that device labeling must be t'ruthful and J1ot misleading,

If your device is classified (see above) into either class II (Special Controls) or class Ill (PMA),, it may be .subject to additional oontm'ls. E,dsting, major tegJJlati.ons affecting your device can be found in the Cod,e of Fedenl Regulations, T:itie 21 � Parts 80010 :89'8. In adWtion, FDA ·01a:y pubUsb further announcements concerning your device in the .Fed .·

tl.S. r-ood ai !:llUII Acilmllmratb'I. 10903 tl.ew�A� � Spi'l!jQ, HD 2G9931

Kl73048- Mei Tu Page 2

Please be advised that FDA's · SSllBllce of a su.bstmt.ial equwa wee determination does not mean that .l-"DA has made a determination that your devioe oomplies with other requirements of the Am or any Federal statutes and regulations administered by olbe:r Fedcml ,age-ncia. You must com.ply with all tke Ae afs. reqn.irenumts, iinc-Judmg, bw: nol limited to: regimation an__d listing (21 CFR Part 8.07)� labeling (U CFR Part 801); m,ediical device :repming (rep-Oiti!lg of medicid devioe-telated adverse events) (21 CF'R 803) for devices oc pootmarketmg sa&My repqrtmg (21 CFR. 4� Subpart B) for combination proouots (see h t . s:/1 i:la. ovl bina.tion I G · _ e u u t ' omiati 597 4 ' 1 ; _g()Odl manmacruring: practice requinmums as set forth in the quality systems (QS) Ng1ll]ation. (21 CER. Part S.20) ·fm- dmces or cmient good manufacturing practices ,(21 CFR 4, Subpart A) for combination pmducts; and, ifapplicable, the el.ecironic product radiation control provisions (Sections 531-:542 of the Act)· 21 CPR 1000-1050.

AJso� p]ease :note the msu]ation eotitted.t "Misbranding by reference to premat'ket n.otm.catio11!1 (21 CFR Part 807. 97.), For questions regarding the reporting o•f adv:ene evenu under the MDR. regulation (21 CPR Part803); pl.ease .!Q· to h !I. w. fi a ov/M 001 11IDe 'C s fe, /R orta robl ml ti htm.

Sincerely,

GeetaK. Pamidlmu,kkai · a -S

for Tina Kiang, .PhD. Aetmg Director Division .of Anesth�logy:l"

General Hospital, Re1iJliratory� Infectian Control, and Dcmt.81 Devices

Office of Device livalwltion Center for Devices and .Radio1ogjcail Health

Certifcate CN14131163

Dongguan SIMZO Electronic Technology Co., Ltd.

No. 81, Tianxm S ee. Chongkou, Shijie Town. Dongguian City, GuanQdonQ Pro\liooe, 523290. P.R.Cl'lina

ISO 13485: 2016 EN ISO 13485:2016

.an.ufaCilure o1 l'.nfrar,ed ancl Clinical Digital rtiermo:m.eter us.ed for measwing body temperature

an u.facture of Nebullzer fo medical U$0

This certificate- is 'ol811id rrom 09 Oclobef 2017 unli 08 Qcllober 2020 a.nd remalns vahd subject to sa · ractoll)' surve· ance aud ts.

Re certmcatoo a dit due be ore 00 Septe ber 2020 Jssoo 3. Cer1ifi&d sir'IC:8' 09 Octobei 20-14

SGS �dOOlld R='1111111 hffis P.vt E:i!s'Ml'8 FO't Che$11� CH6$ 3e U

I ->44 (Q)151 ™ f � (0)1�1 3»6&JO l!MU!IS l'IIJ1

SGS 134M 2(116 0&17

�

� UKAS

MA EM£Nl

!i\l'STEMS

0005

1pc/color box(163*88*4 7mm)

-color box X1

-Infrared ThermometerX1

-User ManualX1

-AAA batteryX2

Simzo"

Simzo®

Cl l

tJi

Clf

mn

0!

><um>alood,->«rC--O#Ctm'F·l<M'FJ

()t,joct O'C•ll'C(l1,0�-1t!.4'f)

Wo,ti"ll«>ndltion =��?not-•nd"'

-• .. conditioo .::,.""oot'°""""''I)

_._,. d.<.JV,•-.--

Slmza• Non-C.Ontaet Forehud Thermometer

I 60pcs/CTN(L4 70*W340*H315mm)

N.W 6.6 KG (Without battery)

GW 7.4 KG (Without battery)

N.W 7.6 KG (With battery)

GW 8.3 KG (With battery)

NON-CONTACT

FOREHEAD THERMOMETER

MOOfl:

COLOR:

l!!l lfl [I] _,ts:-LOT: QTY: N.W.:

G.W.:

MEAS: C/NO.: