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f..aMED 0-Cure Series Oxygen Concentrator

Oxygen Thera

Standard Model: OC-S Series

~~.::r 3

~:;g:n10

c~::::~:~::le at all rated liter flows, ~~f .~eftlng;~;· function,Big LCD display Elapsed time and Running time,

Cabinet, Compressor & Bacterial Filters,

,':Et~~~)!lWW~,~!gt!lJR~f Pt~~~~k~~!~~~,~~rrJ~;lJ;!~~~~t~r~; Intelligent fault diagnosis-malfunction code display,

Maintenance reminder

**** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** Model w/purity alarm (Bar& Real time): OC-E Series

Oxygen concentration indicator (Low, rich, high bar display on the LCD)

Low oxygen purity alarm **** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** Model w/purity ala1m (Bar& Real time): OC-P Series

Oxygen concentration indicator (Low, rich, high bar & realtime concentration display on the LCD)

t•111{ Low oxygen purity alann , ~:,~, , **** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** ~-;· J!...*fl:._ * Optional function

p

·:!~9l)~!~~:~p.ni~i> P:~!>~Ui;~tLtre.a,t9).~P,f.~; Median Diamete~5 µm, Percent· ,<h-.,..~,::.:"'-· '..,\:;;~-,;:_: :···.:·:%;->;~.~·~·":-;::,._i.-,~--"-----·..::.......:.-;..='"· - - . .-_

Specifications I

I Model no. OC-SSO I OC-880 OC-5100 I

--- - -~~----~ ; ----- J

Operating System Timed Cycle/Rapid Pressure Swing

Power Consumption (W) 350 480

Electrical Requirement 220±22V 50±1 or Customize as demand

(V/HZ)

Flow rate (L/min) 1-5 1-8 1-10

Oxygen Concentration (%) 93±3% 90±3%

Outlet pressure (Mpa) 0.05-0.08

Sound level dB(A) S42 S50

Operating Environment 10-40

Ambient Temperature re) Humidity Range (%) :S80

Equipment Class & Type Class Ila

Status Display Sere.en Large scale LCD

Standard Accessories 2xSponge filter, 2xPaper filter, 2xNasal tube,

1xUser manual, 1xPower "~o.;t~1. ,~1,: ... ,t.

Dimension (mm) 3a1x341xss9~, .. ')~t~ \::;r;;~:· 1 unit/carto~'.~~;,~

~I

l-1~1!? Packing ~ ;. ·'a; ..... , f /,d j';-~:

flli7Ph l(\i F~.f~:(~ Net weight (kg) 25 <:l J . IJ

Gross Weight (kg) 27 ~-,,~ ~·1.

-...N'~'' ta-·· ·i-:' ~/':P

Carton MST (mm) 440X390X750 •iQhl~~

/ ,/' ,..

Pallet (mm) 1200x920x162 f~r,,1oad12)cs / / Certificates >P ,;y1~ L'~ r / CE0123; ISO 485; ee'S_ te ~

Warranty 4e~ ~ - ·- ·- • !I.I' 11 u o u·o1 rucrmn~'eHl

Model w/purity alarm (Bar) _ OC- E50/ EBO/ E100 ;

' '

Model w/purity alarm (Bar & Real Time) : OC- P50/ P80/ P100 i I • l

*Specifications subject to change without not e

SysMed (China) Co., Ltd

Tel: +86 24 24697305 Fax: +86 24 2469613

Website: www.sysmed.cn

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f;Vl:]MED Oxygen Concentrator User Manual

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TECHNICAL SPECIFICATION

1. Model and function definition

D-D D

L Item no.: OC series include 30, 50, 80, 100;

The corresponding rated flow: 3, 5, 8, 10Umin

Type name: S, E, P;

S: type with timer

E: type with timer & oxygen concentration indicator bar

P: type with timer, oxygen concentration indicator bar & reaJUme displaY,

f;Vl:]MED O:tygen Concentrator User Manual

Parameter setting comparison form

OC.S30 I OC-E30 OC-P30 OC.S50 oc~E50 OC-P50

350 350

1.59 1.59

220vmv 220V±22V 50HZ:t1HZ 50HZ±1HZ

1-3 1-5

93±3% 93±3%

93±3%

93±3%

0.05±0.005 0.05±0.005

~2 s.'.42

Class Ila Class Ila

Median Oiameters5µ, Percent 90% I Median Oiameters5µ, Percent 90%

oc.sao I OC-E30 I OC-P80 OC-P100 ---480 -2.25

2.20V±221/ 50HZ±1HZ

1-8

93±3%

93±3%

90±3%

0.05±0.005 :q;~0:005 • ,0 ~) ~o

Class Ila Class Ila

Median Diameters5µ, Percent 90%

27kg

oi~~'~i~~1 (mm) 381x347x689 38'1x347x689

Notice: The information contained in this manual is subject to change without notice.

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f3Y¢)MED \

·:-j. O:i:ygen Concentrator User l\Ianual f3Y¢)MED Qx}-gen Concentrator User l\.lamial

'.5 •. :.;,. PART NAME & FUNCTION

)

~ ·-~ components: 7.6 7.5

::~ ~

'; .. ; )..,

.. :

Main components of the concentrator include: compressor, filter, molecular sieve set, controlling panel, flow meter and humidifier. Additional optional parts: positive pressure outlet Accessories are not shown ..... . ; ~z., () ~ ~ ~ 188%~7.I

Main'*'- ..,.,.,..,,. low Rich Hlgt>

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1. Humidifying Bottle

It is also called Oxygen humidifier, and is ~1~ Ltl'- ~ .. used to humidify jhe Oxygen in order ~a~~~ lilPJ,, i>" the dry Oxygen doesn~t irritate the ~ ~ and nasal mucosa, and prevent lit • from drying. ~M~====================~ 2. Connecting Nut

3. Oxygen OutJet 4.HumidffierConnector ~-~n __- 8 8 8 8 8 I 5. Oxygen FIOW-filleter · ·~ o~.,_~Q'' ~ Fi 2 The bobber m side is a sign to show the 11IORLDW10"-"' ~ g · flow rate outlet from this concentrator 1 .1 xy~~pur1ty percentage (type OC-P)

6. Knob of the Fl()w-meter ~~,git purity indicator

1 £. . Rich purity indicator

7.4 Low purity indicator

abruptly, or the value spopl ~be 7 .5 Malfunction alarm broken. Tum on the valve ~ckwise 7 .6 Maintenance alarm

and tum out it dockwise. tv 0 J.7 Timed setting, Running time and Malfunction code display

7. LCD Display '11.J'a-'£1~~1 L U1 Cl n '9l'ilN Elapsed time It shows running time, elapsed time, qi

oxygen purity bar (type OC-E) , and realtime oxygen .purity (type OC-P) ; Malfunction code of higMow pressure

alarm, temperature alarm and other troubles alarm; And maintenance reminder icon etc;. Guiding the users use the machine in a more scientific and safer way. (See Fig. 2)

8. Power Switch 9. Adjusting Panel and Buttons.

10. Positive Pressure Outlet (See Fig. 1) 11. Model label

12 13

12. Over current protector

13. Power cord socket

14. Inlet filter access panel

15. Cabinet air intake filters (two sides)

14

15

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(§WSMED Oxygen Concentrator User :Manual

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TIMED SETIING TIMED SETIING SILENCE

FOR INCREASING FOR DECREASING

'"i:fa' ~.:?t~ 1;":tim~·,~~#imi~-~-~ttory·ig~'JJt~i:ea~tng). :

1l?r~~~)1!h~2bi.ltt()n;~nl';tif!!e'fo(-~~rn-i.!JUP ~;:;ijfii!ig~~$!no~~.~~-~.-t?~.~i;~r~~~-!n~ , -~r~~\b.,::pH~P,p: ~t'l8:'·ti"le;;fgr;;~Qmin:aowri "c(20'~ecrinds after tlme)setting·;·1twill star to counting mode automatically.)

3. Alarm Silence Button Press this button to stop the alarm sound when some trouble occurs.

Dispfayintro~uction

• I The OX)IQ9R ~wFi~ bar;- hour, minute and separator flicker at the same time. The LCD displaying as below:

Elapsed time 00003

~ rrv r u: r ~

~, ~=ij~ti~o 9 o o 3 ~-~· -·~. f'!1.0<j~ pc-s ~~s no., oxygen indicator

_ ~;) ¥.?J1ti.nu,~s o~~rati~~ ~~d~ . . _ . iI ~ :./\~~-:~- j. Un~r~~mod.?J!th~_:;_~cq indicates elapsed time and current running time as display :.• . ·-:~~ 1-ne#ow:"" ~ :::::./). _) l

~3·6--;~~\_;~-~(B~~- l~ ~1 ~-------------<0.· ~I('~'.~: ,-":;,; r') .--,,•

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(?) 0 :0 0 R.mrgtirre 00 :00

Model OC-E &OC-P w/oxygen indicator

00 :02 Elapsed time 00003

'---~----·-· ... ----·-·- -

~

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(§WSMEO Oxygen Concentrator User .Manual

3. Timed Setting mode:

To set the time by press the increase or decrease button, one time for 10min up or down. When setting finished, wait for 20seconds it will start. to count. the time automatically. The concentrator will stop working, till the time runs out.

limed setting Q Q : 1 Q

Elapsed time Q Q Q Q 3 ci 'ijen Parameters Oispla·

~8'ted flow, stated concentration should be achieved after initial warm-up period (less nan 30 minutes). High 92'Purity, Rich 02 purity, Low 02 purity, display as below:

'(~~~~~~- ·" :it.;,, .. "\~. /C ~OLOW~~~ 192

High

R.mrglirre 00 :08 Elapsed time 00003 -.,, 0 9"

'rU'i'iHl~1 L U1 tl n Ul'fl{l cu Oxygen purity is higher than 85%1 the high 02 purity bar is lighting, and the real figure

shown behind the sign.(Realtime concentration display only for type OC-P)

84~ Rich

Rmrgmre Q Q : Q 9 Elapsed time Q Q Q Q 2

Oxygen purity is higher than 73%, the Rich 02 purity is lighting, and the real figure shown behind the sign. (Realtlme purity display only for type OC-P) The concentrator buzzer will remind you as alarm.

-14-

f V'1

Fingertip Pulse Oximeter

Model :SON OSAT-FOS

SCOPE OF APPLICATION

(' ~1'li:t,~~t·! ~· 5;,)~ Morr~ i-k:!pp!rJ.i:S:s

il'.15.lil 1'$'.i•JS®YW1J!l!..fti~:fiiPll~~ .. fangw Kcnsl..n;J Homoc:iro Madical Equlpmanl Ca.,b:I. -.f.>t' :l:JS:ill~~l'f)1 :i;.L!U:al:;!;Hlnt.: ~ 1H"ltn 11w;- O:'*--HH!ll:;.7 !>OM rtt''*', re8S»Sl-1-6'03:11 ll."8 ti~'"l ~ infx;...,~·Can11m9.cam. JiU . WNMkanuut9.c::if'ft

Spot-check applications in personal health and wellness, homecare, hospital and

clinics, outdoor activities

FEATURE -Anti-movement digital signal processing technology

-Accurate pulse oximetry measurements during motion and low perfusion

~qij~t~(:jlq(srQtEt.lstreendispfayPRfsf>o2,.·satgraphj sync:hronous·wavet0rm7heart

~~~t'mark..aod.·euts~beep; -Reliable accuracy and durability

-Simple operation, real-time spot-checks

-Low power indicator

-Automatic power-off

SPECIFICATIONS [)efault Alarm Setting

's,io2 Mc~~i.tterpeo~.raf\ge:()~100% Accuracy:+ 2%(70"'100%),0"'69% unspecified

Resolution:1%

'I ' '~

[~·--,·-=· ~-~---,,

Environment requirement

Operation Environment:

Temperature:S°C +40°C

Humidity: 15%"'95%

Storage Environment:

Temperature:-20°C + 60°C

Humidity:10%"'95%

Measurement range:25"'250 bpm

Accuracy:+ 2 bpm

Resolution:l bpm

P~?~~~~'~;,;§~t\Ml:·~,;,~;.~!~"'.".'"""·' .... _.,,,,. <, .. "''< •• •:. , •. Work voltage:DC2~5V~3V(1AAJS:'Batter{) Work current:<30mA Dimension:62(H)X35 (W) X31 (D) mm

Net Weight:60g(include batteries)

Accessories in standard

A hanging rope

A user manual

Optional colors

White,blue,orange

, .

.,'{,._.~/- , ....... . \.

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~- :.U!>'Ci:i!b-~l.f\J·1<s.;..x.111t1:11:n•J ~ ·n;~ lt!la O:t\f>·~tl·W.;'!1.i!l.i •!!:ill . .X<l!•Hl·~~!~ lrf4"'·' info:~':'(nn•un;a.·::im RU V.WN-l:'~"''""IJ·c:?m

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....... ·-·-· ··-·· .. -· ····~-···-·· , .. -··--·· B. Please read the measure value when the waveform on screen is equably and steady-going), the measure value is optimal

value, and the waveform at the moment is the standard one. C. The light (the infrared is invisible) emitted from the equipment is harmful to the eyes, so the user and the maintenance man should not look at.the light source.

--::.-. The pulse oxygen saturation is the percentage of Hb02 in the total Hb in the blood, so-callec;I the 02 concentrati.on in the blood. !tis an important bio-parameterfor respiration. A number of diseases relating to respiratory system may cause the decrease of Sp02 in the blood. furthermore, some other causes such as the malfunction of human body's self-adjustment, damages during surgery. and the injuries caused by some medical checkup would also lead to the difficulty of.oxygen supply in human body. And the corresponding symptoms would appear as a consequence, s1,1ch as vertigo, impotence, vomit etc. serious symptoms might bring danger to human's life. Therefore, prompt information of patients Sp02 is of greats help for the doctor to discover the potential danger, and is of great importance in the clinical of medical field.

.. ------·- -- -------------- ... ---____ ... ___ .... ---------------------. ---.... ----------------------------------- --------- .. -----------------• •The pulse sound are optional function. • *Only FS20A can switchthe display. directions.

~--- ............. -- -.-------- ~- ---- ..... ---·-----"!' ------------- .. ----- -........... --- -- -----... ---.. ------------------------------ .,. ____ ... ---------- ! ... -

Press the bottom -=- Insert the finger to open the pr~~;'.'."......,..._o:-,

.- _jtfF~ ii---' "'• .. <

·-----.!:~£?/"

"""""' Press lhe button to~~---

\ /" ,•

,/r ,...'

/;~;~E~~f .. :~. ~~\_..<"''

Figure 5. Operation Guide

4.2 Attention for Operation ~inciple

• le of the ox1meter is as follows : An experience formula of data process is established taking use of Lambert Beer cording to Spectrum Absorption Characteristic of Reductive hemoglobin ( Hb) and oxyhemoglobin ( Hb02) in

glow & near-infrared zones. Operation Principle of the device is : Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning Recording Technology, So that two beams of different wavelength of lights can be focused onto human nail tip through perspective clamp finger-type sensor. Then measured signal can be obtained by a photosensitive element , information acquired through which will be shown on screen through treatment

A. Before use check and confirm that the people or finger size were applicable;

in electronic circuits and microprocessor.

.. J . .. c::·.~?iyug111Emilhf1!10iodP.

B. Before use check and confirm that the environment should be non-combustible material. as well as to avoid high or low temperature and humidity, but also need to pay attention to the following:

_, a) To avoid glare and direct sunlight exposure; b) To avoid radiation infrared or ultraviolet radiation; c) Avoid contact with the organic solvent, mist, dust, corrosive gases;

C. The finger should be in a proper position, the patient should insert the finger into the probe deeply ···~;,,. • D. The equipment should not be used ata location or limb tied with arterial canal or blood pressure cuff or receiving

~~·· 9.- intravenous injection;

...... _.. .. • - J_~ ~-.,..., E. The equipment may not work normally on microcirculation barrier patients, Warm or rub the finger, or re-position ··1 '::·:~~1 -i.---Ptioiu D•h•ciur ' \II ,, )the equipment could improve the measurement .

~-~-~- F1n9e-r

.,,,,,.,.,::. " , F. Don't shake the finger and try to keep the patient still during the measurement; I_ ProboBcdv ... ,,_. ~u. i'he ray between photo detector and.light emitting diode should across patient's arteriole;

Figure 1. Ox1meter schematic diagram : 1 • f:f I. Avoid to insert a wet finger into the probe; tl• " • -~H. The patient should not use enamel or other makeup;

• 2 2 1 ·~- : r· 0 J. A flexible circ . connects the two halves. Do not drag or pull the flexible circuit or overextend the equipment's f . litfdduftlbff - . : ...,: _. • •t .I ~ Spring; 2.2.1 Intended Use 1 011. ~ e>.rf' K "'./" h 1 d f h · • fl "bl · · . hlfulse a,,1meter.is inurnded t measure functional arterial oxygen saturation (Sp02) and pulse rate of ad™til. ~A"'" · 0 not . ng t e a~yar r~m t e. eq~ipment. s ext _e c~rcui t, . . . · 0 Q. t 1'.bl 1'-l ~ r 0 ttL!)W1Q- L. Stog smg the equipment 1f the l1qu1d flows mto the inside of the equipment. and wait for the machine to dry.

·-~-~~-~-~~-t~~~-!~--- __ j_ ______ L-----------------.1--------------------------------------------------------------------------- . pulse.waveform is un-normalized waveform, which can be used for signal quality indicator indirectly. The w4RNIN4: ~ ~ : , · . . . . . pa ram readings may not reasonable when observed disturb~l~ pulse waveform from the pulse oximeter interface.

: • ~his pulse oxirrteter is tended for use o ly by clinical professionals or under thetr guidance. It t onl~ e . . . • usid b~ pi" so.n~; ha~e rece; d ad3. uate 'trai ing in its use. Anyone unauthorized or untrained m t not perfor111 r Spec1f1cations . ~ op ratio • it. . · : .,.,1 :'.\) '.£:_ __ ,,, 5.1 Classification

· _____ .. _ --- ~ - :- --~-- --·r:'~.:-·rj···- ----------------------------------------------- -------- ~; -- ---·-- -- Type of protection against electric shock: .................................. 11 Unternally powered equipment) ~TION ·. . '. ~ : ' .. :1 ~:~ . t . . . . . . --~---/ Degree of protection against electric shock ................................ Type BF-Applied part (non-defibrillation proof} • i;his pulse ox1m:eter 1s !nlendft~ for~:~e m1hosp1tal, cltnical 1nst1tut1on, healthcare mm~ . Operating mode ...................................................................... , ...... Spot checking

. • -~he puls~· . ter is ~OT de~.·.J1n f~~;ne1born and infant. For adults and children, i re mmende hat the Deg_ree of protection against hazards of explosion ................... ~rdina~y eq~ipment: Not protected fm!Je I! ss s I . twee~ 8·25.1lJ1m.2"" t Equipment type ...............................................•.............................. F1ngert1p ox1meter ···:- - • •• • --~- -- -- -:- - -----~---- - -i>::P,·-· -5-· -+·· ··-------·-----· ------· .. --------·-------· ·o.;;· ... ---···· -~---·····--·-· IV

2.~.2 .co~ nei)t.s : ! -;:f ·"°.). { . . 'i\Ji'B'3ft1L U1t'Jnfltfl·~t2 f\11,easur~mf!ntSpecifiq1tions Th~ oxtm~ter conr1sts -~~!:..~~~::i:~:~:~~c-~~l!®~~~f ~~-~~-'~-~l-~:.a.~~-~~~~:~~-~1~~~~~-~~:~~-------.----------------------------~- 4,.~ S~~g}lec:cire~ a~ccµrEI.%' / • -. , . ·.•···.·. < .. : ---.-------"'·---·-- •••• - • , '-'-IP ~. r R .. nge(cr ) .................................................................... 70~1L100%spo2 :t:2d1g1ls NQTES : i ! : ~'.~n 4! ! 0%- 69%: unspecified.

; • i:he probe is th• hole .if1 the ~~tllefj th1equipment to which the finger insert. · ... ·· ·.· ..... · .. ''.,R .. ,e .• s··.·o···.l·, ... u ..... t ... iQn·····.·.··.·.' .................................................................... l .. · 3. o .. •. ?*."" ~fl,.ro_be is the 1;.pph~d Part~ th~u1 ment. F>F}:d~i;:!ar.7daccuracy · . :· · .. ·.'; -~~:ft-.cm~~ "-~~-:~--~-'------ -~:::---- -i.;'.~-- -~~4--- -_ ------------------- · --- ------------- -- -------- · ---------------------------- ·R~oge(~~) .. ~ ............................................................... +2.s\2iw:~e·~ ±.~~!9-i~~" .· '2 .. ~J'. ~, 5{~,o~rri~i:;r is small in:y(Jllu~s. li~ht in weight and easy to carry. Resolution ...................................................................... l bpm

.~ a ... '::?..!~~ . ~:Wf!r CCSf!~UmP,tfon, ~ spot-cj1~cks on two AAA batteries. 5.3 Power Requirements , -<:A/l ... ~'t)u~rf a~'{asy tG.oper~ ~ Specification of alkaline batteries ....................................•......... Two AAA ' /l ~:·;· Ju:~Jt~.".':., tlHR 8 ~~~onds when ther.~~ is no signal. Operating current .......................................................................... Less than 30mA . 2 3 F t \ /" :--:: · .. ~ Run time ........................................................................................ ,.600 spot checks on two full power batteries at

• "'-- ron ·-, · >" ____ ,,.. / ;_; ~""~.,,,,.:· : ··\ Pulse rate value Power indication ambient temperature 25°C. • " -- · :~: /, l~: ":.; - · \ // 5.4 Environmental Specifications . -· "'-.........//~S.~ , <:. f - "·" - - ii ,..--e=.~-- -- ~/ / Pulse bar graph Temperature ~,,, I ~~~ .. ;;:..'l~,:.~~··~.-lfit ~~•-:.'.~---Power indication Sp02value ____ ~ ctff...-.-=-==;L?) )iv Operating ............... :···· ...................................................... +41:to+104:F/5°t~+40"C:,

.,~, --..','"' Jjif.:ooi'·:' 1~1 _·~OJ/ Storage/Transportahon ........................................................ -40 lo1-140F/-40 to-t-60C -'1?.Vj~i:.llar1tf"Ph-- -n-1s...I.JI 1+----Sp02 value 1i/s jgg ::.'§. 1,_--Button Humidity

:11 !---in · l il r..,._,._, - \\ Operating ......................................................................... 10-95%, noncondensing H ' "'1· ;-- Pulse rate value _...- r v v v "-"'-' '' • _ 0 1r "I 1 IUJ I f.' p 1 . f __J \_ ~h•"1 ''" m•"' Stor.>g&/Tra0<pon.a""·················-·················---··············· ' ' 95 •.oonoondan~ng 'I -·----....... ' use wave otm .......:

t,~---~"·" ,: '---===....::::;:=-=;;;;.; Atmosphere Pressure

Button----~~;:·-~o~~Y ~io~~l~~~;~~~;~~i~i"i~~:::~::::::::::::::::::::::::::::::::::::::::::::::::::.~~=~~~~::pa Figure2. Front View of FSlOA Figure3. Front View of FS20A

.3 ~':/

~ ~

°\

SYSMED (CHINA) CO., LTD.

1--t.iMED

Certificate of Training

No. SYSMED-1801

This is to certifies that

Mr. Thanarak Mapamo

OF ONI WORLDWIDE TRADING CO.,LTD.

ra~1 t;ij~~·~Qmpl~.t~dtlj~tjxyge1}'¢ql).~entrafoi trainiri.g' course for;·

Model OT and OC Component replacemen! t~4 §;viee ~·~~ ,.

On May 28, t01s ;.;,.: .~ • : j. • ... ' ,' e And is Awarded this Certificate t?:..:. 9

"''-'' : . '!.,,J . jjl' ··~."~

course Tutor (signaturjl: . JN;r., .. ·· ___ .@~ · Date: June 01, 20.18 '

/ n·;P'',· ., ·:~J~~~~WiCUJgn.ffl~ .~· ~ '···"-'~<1lf;·:: :c'l

1 ............................ ············ ······ ~. ;

2...... . . .. . ~ . . ' ·~ .:?:::;1~~~3:' ' .

.~' ~

L~!!!.oWIDE w ... vw.onlrne-dlc-Al.com

uslrn foa 1:>aGil:>dl rnsGl.cf\.'> ·~hn<il ONI WORLDWIDE TRADING CO •• L TD. 153/59 ny s Gi1uttO"ll)ns:w o"\1r'lOu"t1.>ns:m ~n5°GtUUrittg 11130 lS3/59 Moo 5 n,.,ng:kruAI B""ngkru.'\l Nonthnburl 11130 Th .. '1.Ullnd Tel r 0-2.8S0-6SSO. 0-2880-6551 F.,x ; 0-2880-6522 E-maH ! ont_wottdwldc@hoti'Y\dll.eo1'r'l, [email protected]!"I

4 ih.nfllJ 2562

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iru~\ILL~1'ufl1uri1viu~-rut11~nu affe:i 6.3 e.7L?f'IJe:l11fl1"il~i;le:i.:ivi1m1?ffl'ULVit1'UmlJR1lJ11'11~1'U?l1f1"1'lJB\ILfl~B\I 'W~BlJUbeJfl?111-rmu\IL'IJ1'1JG'i.:JlJBi.Jbfl~B\I

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1~'Vl1'lh.:icwtJ1u1'11eNrie:iu'1un11'1~6lie:ilJLL'lflJL'1~'1 vi~B'liBmnun11 3 i°l~.:i L1.i;)1eT-:it6ffm11lJ1~'1~i;le:i.:iLt1~tJu1.fl~v.:itvilJ1~ ~e:i 6.1 o 1lm1u11-:i-Sn~11~v bfl~B.:iVJn Lfl~B.:i"il~i;lv.:i 1~-rum1m1'1L ~flLL"~u1l~-rn~1'1mcw 1~t1'li1.:i~6111u1qie:ici1.:iue:it1VJn i -mu 6 1.~e:iui;)aB~6"qiqi1m1-r'UtJ1~nu1~tJ11lillii1ti~1t11~i

sDB 6.11 i1m1?18'UbVJtl'UlJ1m~1'Ubf01~B-:IVJflbfl~B-:ll.bfl~8f)flL'U-rm8\IL~BcJ1\IUBCJU"1~ 1 ri#\1 l'lflB~6"qiqi1-r'Ut11::nu1~t11ll~ ~1ti~1t11~i

~CJ~ "1\l'lftl ........................................................ .

( ... 4 ' ) 'IJ1-:im1nCJl'lru1 VllJ'IJ'J -:i~

SysMed (China) CO., LTD. Address: No.17, Wensu Street, Hunnan New District, Shenyang, China

Tel: +86-24-24697305 Fax: +86-24-24696137 E-mail: [email protected]

To Ministry of Health in Thailand

Doc No.: SYSTH-1601 Date: Feb. 18. 2016 . <""

r,~!\iJ Manufacture's Authorization Letter

We, SYSMED (CHINA) CO., LTD, a corporation having its principal place of business at

11-2-3 No.17, Wensu Street, Hunnan New District, Shenyang, CHINA, authorize

ONI WORLDWIDE TRADING CO.,LTD. 153/59 Moo 5, Bangkruai, Bangkruai, Nontfuburi 11130 THAILAND.

to act as one of our official distributors for OXYGEN CONCENTRATOR in Thailand. Should ONI 'VORLDWIDE TRADING CO.,LTD. be requested to give a commitment or to provide a guarantee on behalf of SYSMED (CHINA) CO., LTD.

ONI WORLDWIDE TRADING CO.,LTD. is authorized for Import, Marketing,

Retailing & Distribution of our above mentioned products. We allowed them t~.~~~~in

private/government Tenders within Thailand. ~//"~ .. ~~ 'sf: • . .. . --~·. f1

Signed: M~ t::~·TJ;~~<:l ~. ""'' .... .., ' ; ...... ;,. .

• .J <'IM!'~"~' 'l) ;: ~ ~ : ' ' ; .......

GMP ;B~ttl/lli ifllN• Confirmation Letter for GMP Audit

r.G) ... /",, ... "I\.·,······· ·. :.·· i "' IUV !

!... SOD· / .·

·, .

Japan

W§:M8.: Audited Facility

W§~ifiB : Audit conducted on

W:lt'811: Audit scope

W*ft-&-: Audit report No.

Wl:M!tl: : Audit result

SysMed (China) Co., Ltd. No 17, Wensu Street, New Hunnan District, Shenyang, 110171, P.R.China,

2013/08/11

JMDN 12873002 Oxygen concentrator for Medical Use

T AQ235011185A

ii~ I Passed

~ttrct ... lfIRt 16~·~~--~ M 169-itl=&?~ ... GMP il'B'~Ul:i!fiifi.~O)ab.f>•:tar=~?~-·~*" t.::SiHa!li v t: 1- L, ... l:Ja0)1fiitf::~'t .f>il~i-iillL 'f.:: L, ~ L, t:.a ~ O)iill•.lfltlrt!rct~1t1.Jiti-M'G ~1t lvo DllfctSl:a&•a- ~•ftl < t=. ~ L 'o TOV SOD Japan confirms that the audit was performed by an auditor/s authorized to audit according MHLW ordinance No. 169, 2004 and that the audit results were reviewed by TOV SOD J~PA~,L~\d. This letter has to be attached to the audit report. Please refer to the audit report for detai.lf·1~'!~ '9.f, ., ..

~/~· "~t

§!ft"B: 2013-11-19 ·111'!°.. ~· ·". · Date of issue ... 1 'ri f~ ~ ,! ... ,/. w• ::_l

/}J,u~ /!( \.~~'-~ 11r~A~; Jlz

7-.:::i. 7~- i:~~,<~•lt*tt Manager, Medical-Health-Services ..., o ~ TOV sOo Japan Ltd. fU'l'Et-3ft1L U1tln'91?1~

IU

.::;- .i? ~- ~~~ 1<:,,•it~ttrct .. ··~ CHB"135 ~~~- 145 ~) M 23 ~°' 6 M 1 Jl(])m~1::J: ~J ff&~*1.t:::llliEtlN "'(! i>."f> a

TOV SOD Japan Ltd. is a certification body registered by Ministry of Health, Labor and Welfare according to Japanese Pharmaceutical Affairs Law (1960 law No.145) Art~~!~,J3-6clause1. ... . _____ -~------~ ·-··-~----·

... .... g ...

EC Certificate Full Quality Assurance System Directive 93/42/EEC on Medical Devices (MOD), Annex II excluding (4) (Devices in Class Ila, fib or Ill)

No. G1 14 09 67884 006

Manufacturer:

EC-Representative:

Product Category(ies):

Valid from: Valid until:

Date, 2014-11-25

SysMed (China) Co., Ltd. No.17, Wensu Street Hunnan New District 110171 Shenyang PEOPLE'S REPUBLIC OF CHINA

Shanghai International Holding Corp. GmbH (Europe) Eiffestrafle 80 20537 Hamburg GERMANY

Oxygen Concentrator for Medical use, Non-invasive Ventilator (Continuous Positive Airway Pressure Units, Bi-Level Positive Airway Pressure Units).

Product Service

. :·

... -i 0

. 'l

Product Service

EC Certificate Full Quality Assurance System Directive 93/42/EEC on Medical Devices (MOD), Annex II excluding (4) (Devices in Class Ila, llb or Ill)·

No. G1 14 09 67884 006

Facility(ies ): SysMed (China) Co., Ltd. No.17. Wensu Street, Hunnan New District, 110171 Shenyang, PEOPLE'S REPUBLIC OF CHINA

I \

• t ".

ct> ,._,

Report No.: SET2015-02061

MOD TEST REPORT Report No.: SET2015-02061

Product: OXYGEN CONCENTRATOR

Model No.: OT-Pro3, OT-Pro5, OT-Pro6, OT-Pro8, OT-Pro10

OT-Star3, OT-Star5, OT-8tar6, OT-8tar8, OT-8tar10

OT-Elite3, OT-Elite 5, OT-Elite6, OT-Elite8, OT-Elite10

OC-P30, OC-P50, OC-P80, OC-P100

OC-830, OC-850, OC-880, OC-8100

OC-E30, OC-E50, OC-E80, OC-E100

M30,M40,MSO,M60,M80,M100

Brand Name: f.Tl#J M E D Applicant: SYSMED (CHINA) CO., LTD

CCIC Southern Electronic Product Testing (Shenzh~n) Co., Ltd. .. ·~~~1i;t Ln,.'1 ~"'

Building 28/29, Shigudong, Xiii Industrial Ares:t~~~

Issued by:

Lab Location: Nanshan District, Shenzhen, Guangdong,,

Tel: 86 755 26627338 Fax: 86 755 266

This test report consists of 36 pages in tota.LJi n:L~~ be duplicated completely for legal use with the

approval of the applicant. It should not be repro ·uced e;~~pt-.in'~~~~:~~i~houtthe-.w.~ofour laboratory. The client should not use it to claim • roduct endors~~~1it1 b~,;g-~1~~J;~~est resu[s~irf1~,r report only apply to the tested sample. The tes ;report sh II ~J ·invalidwtttlw11J~~~~f,~r~~~es of testin~ engineers, reviewer and approver. Any objecti ;ns rliust .r · ..... )? .. ~~.IC:S5J~~~;~~~il~Y's since thet

-···:··t>... · !". ~~r:~t~;-~\;~-~ _ l

w ;··; :~ .. ; ;~~ <~i ,, '~ ~


TEST REPORT IEC 60601-1-11

MEDICAL ELECTRICAL EQUIPMENT -Part 1-11: General requirements for basic safety and essential performance -

Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

·~

Compiled by(+ signature) ............. : Will. Chen

Reviewed by ( + signature) ............. : Bonnie. Nie

Approved by ( + signature) ............. :

Lian. Wu

Date of issue ............................ : 2015-03-13

Testing Laboratory ...................... : CCIC Southern Electronic Product Testing (Shenzhen) Co., Ltd

Address .......................................... : Building 28/29, Shigudong, Xiii Industrial Area, Xiii Street, Nanshan District, Shenzhen, Guangdong, China

Tel: 86-755-26627338 Fax: 86-755-26627238

Applicant's name ......................... :

Address .......................................... :

Test specification:

Standard ........................................ : IEC 60601-1-11: 2010

Test procedure .............................. : Test report only

Non-standard test method ........... : N/A

Test Report Form No ................... :

Test Report Form(s) Originator ..... :

Master TRF .................................... :

Trade Mark .................................... :

Test item description .................. : OXYGEN CONCENTRATQB o ni:..:\~ itl'a'a-!i~1t U1~ VI u

®

f.~MED

SET/T-1 (00)

Page 3of36

OC-E30 I OC-E50 I OC-E80 I OC-E 100

M30,M40,M50,M60,M80,M100

·'"ll' l I


For OT series, the last arabic number means oxygen flow rate (e.g. 3

means 3L/min), For OC series and M series, the last arabic numbers

mean oxygen flow rate (e.g. 30 means 3L/min).

Ratings ........................................... : 220V 60Hz 350W:

(J/ t,;~;:·····'. ··: '

including OT-Pro3, OT-Pro5, OT-Star3, OT-Star5, OT-Elite3, OTElite5, OC-P30, OC-P50, OC-830, OC-850, OC-E30, OC-E50, M30, M40, M50;

220V 60Hz 480W : including OT-Pro6, OT-Pro8, OT-Pro10, OT-Star6, OT-Star8, OT-8tar10, OT-Elite6, OT-Elite8, OT-Elite10, OC-P80, OC-P100, OC-880, OC-8100, OC-E80, OC-E100, M60, M80, M100;

•,·"'l

" .. , \Ir·

Page 2 of 36 Report No.: SET2015-02061

Copy of marking plate

1-~MED Oxygen Concentrator OT-Elite3

• Address: 11-2-~r~~w:~su(~2~:~n~~~,o~.~~henyang China I ec I REP I Shanghai International Holding Corp GmbH (Europe)

Address: Eiffestrasse 80, 20537 Hamburg Germany

Model: OT-Elite3

Working Voltage: 220-240V 50/60Hz

Rate Power: 350W

Oxygen Flow Rate: 3L/min

Output Pressure: 0.05Mpa

Oxygen Concentration: 2!90%

Overall Noise: ~42dB

Classification: Class Ila

1--i~MED Oxygen Concentrator OT-Elites

1.ul SysMed (China) Co., Ltd - Address: 11-2-3 No.17 Wensu Str., Hunnan New Dis., Shenyang China

IECIREPI Shanghai International Holding Corp GmbH (Europe) Address: Eiffestrasse 80, 20537 Hamburg Germany


Rate Power: 350W

Oxygen Flow Rate: SL/min

1--iTBJMED u.J SysMed (China) Co., Lt OJ 0 IV

- Address: 11-2-3 No.17 Wensu Str., Hunnan New Dis., Sheny§i9fijt1~1L U1\)n~l'M I Eel REP I Shanghai International Holding Corp GmbH (Europe)


Model: OT-Star6

SET/T-1 (00) /

{)/

_·. ,;..: i: .;,

Page 7 of 36 Report No.: SET2014-01546

1-TIBMED Oxygen Concentrator OC-S 100

u.ll SysMed (China) Co., Ltd - Address: 11-2-3 No.17 Wensu Str., Hunnan New Dis., Shenyang China

I Eel REP I Shanghai International Holding Corp GmbH (Europe) Address: Eiffestrasse 80, 20537 Hamburg Germany

Model: OC-8100


Rate Power: 480W

Oxygen Flow Rate: 1 OL/min

Output Pressure: 0.05Mpa

Oxygen Concentration: ~90%

Overall Noise: :S50dB

Classification: Class Ila

f.TIBMED Oxygen Concentrator OC-S80

i~il SysMed (China) Co., Ltd - Address: 11-2-3 No.17 Wensu Str., Hunnan New Dis., Shenyang China

IECIREPI Shanghai International Holding Corp GmbH (Europe) Address: Eiffestrasse 80, 20537 Hamburg Germany

em @] ( E f!l 1px1 :E: s N: II llll II I II I llll II I I I I I lllll I lllU~@. in~.--· 0123 - 301 ***********~ • \o) ~tV ;;;, •

~ l..)\','4'· Model: OC-S80 Output Pressure: 0.0 ':J ,. . .~ • ;~

Working Voltage: 220 -240 V 50/60Hz Oxygen Concentrati ·~~ ~.~, ~ J Rate Power: 480W Overall Noise: ~50d!:f'! ~ ·i--- ; , v

;: r. . . ., J:' Oxygen Flow Rate: BL/min Classification: Class Ila o;, .. ;i,~· ' '. ..._, ... v-<J" ,/

"•co ... o~ ~

l.1(l3MED Oxygen Concentrator Y~·~· · .ml SysMed (China) Co., Ltd V 77 - Address: 11-2-3 No.17 Wensu Str., Hunnan New Dis., Shenruq{i~i~lLU1rtn~'fM -, E-c-1 R-EP-1 Shanghai International Holding Corp GmbH (Europe) cu


em @] c E f!l 1PX1 :E: SN: 1111111111111111111111111111111111111 0123 - 301 ***************

Model: OC-850 Output Pressure: 0.05Mpa

Working Voltage: 220-240V 50/ ~--exygerreorrce11ttatio11. i!'.90%

Rate Power: 350W flf0~~aiFNdi1e~~4Wf3l~Ja Oxygen Flow Rate: 5Umin ~asSTfiliiiilOO:EitillsMJ,Riiiiln~

1 ............................................... 'Li"JS:::t!'~~ l<::' 11 '.J"l

~.(

rf11EiAJiJ IE~E:R ~M TESTING CNAS L 1659


EMC TEST REPORT

Report No.:

Product:

Model No:

Applicant:

Address:

Issued by:

Lab location:

Tel:

SET2017-00866

OXYGEN CONCENTRATOR

OT-Pro3, OT-Pro5, OT-Pro6, OT-Pro8, OT-ProlO, OT-Star3, OT-Star5, OT-Star6,

OT-Star8; OT-StarlO, OT-Elite3, OT-Elite 5, OT-Elite6, OT-Elite8, OT-ElitelO,

OC-P30, OC-P50, OC-P80, OC-PlOO, OC-S30, OC-S50, OC-S80, OC-8100,

OC-E30, OC-E50, OC-E80, OC-ElOO, M30, M40, M50, M60, M80, MIOO

SYSMED (CHINA) CO., LTD

11-2-3 No. 17 Wensu Street, Hunnan New District, Shenyang,

China

CCIC Southen1 Electronic Product Testing (Shenzhen)CO., Ltd.

This test report consists of 41 pages in total. It may be duplicated completely for legal use with the

approval of the applicant. It should not be reproduced except in full, without the written approval

of our laboratory. The client should not use it to claim product endorsement by CCIC-SET. The test results in the report only apply to the tested sample. The test report shall be invalid without all

the signatures of testing engineers, reviewer and approver. Any objections must be raised to

CC IC-SET within 15 days since the. __9ate when the report i$ received. It will not b~ taken into

consideration beyond this limit. · fl{;'lJ~ffJ~J.JflT'j~\ll~nn~a ~

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SET/T-1 (00)

Product .................................. :

Model No. . ........................... :

Brand Name .......................... :

Applicant ............................... :

Applicant Address ................ :

Manufacturer ........................ :

Manufacturer Address ......... :

Test Standards ...................... : {,.<

Test Result ............................ :

Tested by ............................. :

Reviewed by ......................... :

Approved by ......................... :

SET/T-1 (00)

Report No.: SET2017-00866(2017-02-24 XO)

Test Report

OXYGEN CONCENTRATOR

OT-Pro3, OT-Pro5, OT-Pro6, OT-ProS, OT-Pro10, OT-Star3, OT-Star5, OT-Star6, OT-Stars, OT-Star10, OT-Elite3, OT-Elite 5, OT-Elite6, OT-Elites, OT-Elite10, OC-P30, OC-P50, OC-PSO, OC-P100, OC-S30, OC-S50, OC-SSO, OC-S100, OC-E30, OC-E50, OC-EBO, OC-E100, M30, M40, M50, M60, MSO, M100

UISMED


11-2-3 No. 17 Wensu Street, Hunnan New District, Shenyang, China


11-2-3 No. 17 Wensu Street, Hunnan New District, Shenyang, China EN 60601-1-2:2007(1EC 60601-1-2: 2007) Medical

Signature, Date

Product Service

CERTIFICATE No. Q1N 15 09 67884 007

Holder of Certificate: SysMed (China) Co., Ltd.

Facility(ies ):

Certification Mark:

No.17, Wensu Street Hunnan New District

110171 Shenyang PEOPLE'S REPUBLIC OF CHINA

SysMed (China) Co., Ltd. No.17, Wensu Street, Hunnan New District, 110171 Shenyang, PEOPLE'S REPUBLIC OF CHINA

Scope of Certificate: Design,Development,Production and

Applied Standard(s ):

Distribution of Oxygen Concentrator for Medical use, Non-invasive Ventilator : ··~6:1:jrF n;· .. ~'~ (Continuous Positive Airway Pressure Units~ .• >'·"·.· (j\:_~.·.:·,,:·,1.:.::· Bi"Level Positive Airway Pressure Units). ;;/. 1 ~·t'~~.:; G'f~ . • ,._ EN ISO 13485:2012 + AC:2012 /~~:··.,_ " ~ ·~ Medical devices - Quality management systed(/ft;J.' ·· t" . d Requirements for regulatory purposes ·~ 0 .. .. ~: · ~0v (ISO 13485:2003 + Cor. 1 :2009) ~~· '1-. lf:i E ..,"'.,.'>" /' // DIN EN ISO 13485:2012 '°'"0 0

The Certification Body of TOV SOD Produc; Service GmbH certifies t~at the c pany me. tio~ ~ ' above has established and is maintaining a quality management system, wp1c11 m~~.,r ~ requirements of the listed standard(s). See also notes overleaf. (__,/ ~

CV 0 II

Report No.: BJ1599004 i1.l'i'ih1ft1l u1untn'tl'3

Valid from: Valid until:

2016-01"27 2018-12-29

--·--~-·------·-··· ....

AAR - Audit Findings List {Confidential) iP~6tJmjjV~ ( f¥1!) <nt '"l -S~D'", ·

Product Service

Auditee(s}, Client number(s)

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Audit date and time

${$< B J11t&rt1 ffiJ Client Response due date

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1 Terminology iftlt

Requirement:

Objective evidence:

Non-Conformity:

Audit Finding:

File: MED_F _09.61ECS-MR • 45640

(dJ "'·('.Yl~r·~~f <;:~ ,. r:bi)

Order no: BJ18990042 b·s'

-SysMed (China) Co., Ltd., No.17, Wensu Street, Hunnan New District, 110171, Shenyang, People's Republic of China (67884)

2018-09-26 - 2018-09-28, 4.9

2018-11-27

Need or expectation that is stated, generally implied or obligatory like:

Any part of a law, ordinance, decree or other regulation, which applies to the Quality Management System of an Organization involved. in one or more stages of the life-cycle of a Medical Device (e.g. EN ISO 13485, European Medical Devices Directives, European Regulations, Canadian Medical Device Regulations, etc).

Defined processes and documentation of the Auditee's Management System.

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Major Non-Conformity

Minor Non-Conformity:

Positive Aspects:

Grade 1 -5:

~~.& 1-5:

File: MED_F _09.61ECS·MR • 45640

A Non-Conformity that affects the capability of the management system to achieve the intended results. Required Actions for Client Response in case of NC's: Immediate correction, cause(s) analysis and corrective actlon(s) to prevent recurrence are needed. Objective evidence of effective implementation must be made available by the defined due date and approved by the audit team.

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A Non-Conformity that does not affect the capability of the management system to achieve the intended results. Required Actions for Client Response in case of MNC's: Cause(s) analysis, correction(s) and corrective action(s) plan is needed as a minimum. Objective evidence obtained to support the resolution of Non-Conformity is to be followed up during the next regular audit.

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Deadlines for response

to be defined

by the Audit Team:

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Order no: BJ 18990042

Europe (TOV SOD Product Service):

- 60 days max.

When J-QMS, CMDCAS, MDSAP or other criteria are involved, shorter response times apply

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CMDCAS I MDSAP (TOV SOD America): - define and communicate as documented on

"Checklist for Auditors for Audit Performance"

CMDCAS I MDSAP (T0V SOD ~~):

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If a comment for improvement is recorded which suggests non-compliance but does not lead to Nonconformity, it should be clear why no Non-Conformity was raised. When Non-Conformity is found, a record of this should be completed even if the auditee corrects the Non-Conformity during the audit. In such case, a record of taken action by the auditee should be described, too.

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Product Service

2018-09-28 Date

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2018-09-28 Date

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Mr. Dawei Hu

iff'J:£.FH.'E:

Mr. Bin Qiu

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Mr. Runze Wang

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The report may only be quoted in full. Any use for advertising purposes must be approved in writing.

~·fJHfli!T 9-fi~·nt.7t~·:H m? f.Ef0Ir~ 1!r ffl:ifil~,~9!-fJJti~iifHU:?W~ The report is confidential and the property of TOV SOD.

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AAR • Audit Findings List (Confidential) iji~~Jmj~- (

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Finding Number:

••.1:•n:~1 1


Finding Type: ••.1:m~m.1

NC D ±~:il'iH~

MNC lgJ <M~:if'·&t-r.!

Audit Team: Description of detected Non-Conformity MUST include: Requirement(s) (e.g., QMS·standard, QMS-document, contract), Non-Conformity Statement including Supporting Objective Evidence

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Grade~•= Grade 1 -5 GHTF SG3 N19:2012 ~fJ.l-5 GHTF SG3 N19:2012

~Hii!!.*= J!,j( CfOn. QMSjj?t. QMS;tft., *!iiJ) ~ iF*t&-lJh¥J~:lcti!Lmj:~ij!~~iiE-

Requirement:

ISO 13485:2016 7.3.9 Control of design and development changes

Product Service

NA

The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product in process or already delivered, inputs or outputs of risk management and product realization processes.

~*= 7. 3. 9 litt*17f~J!ek~~$d •tt~ff~~~~w•e~MM~~dB~~~~fi#~~~~~~~m~•~m~~~~tt•M•A~ !ftu 1:1:1 at/~ it ~J~ :!fl,jlfriHrti t'V-fft. £r,~ (1<1isiz * rrHf! &-fffnJ 16· ~r~ Jim (t-Jic>Kfi~Ff f#Hfy < ffi!.4. 2. s) .

Supporting Objective Evidence: :stt4f t1: ~ .l~ IiE ffiS: Design change: 81602031801001, ver. A/4

Records Reviewed:

t~:SRB'$ti<

Design change: 81602031801001, ver. A/4

Client Response: Cause Analysis, Correction and Corrective Ac ton (In case of extensive response it also may reference to attached document's)

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1... ••, • • ••" • • • • • • • • "• • • •,. , , , , ,. •, • •.,," ... , ~Lh ~; 'j"t \:1 i~ "J ~~.j f(: ~

File: MED_F -r·61ECS-AAR • 45640

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Finding Number: ·~~JJ\V~"'Js

Cause Analysis: mtlN7HJf:

1


Finding Type: ·-~i\~lli

NC D :t.~~ E:rt;t MNC ~

Grade•&t: Grade 1 -5 GHTF SG3 N19:2012 ~!il-5 GHTF SG3 N19:2012

~EfiW$~CI~~tt~EB~»*~~~~*' ~BE~-fi~~:

• Product Service

NA

The pre-change review was not eftectively integrated with engineering design change notice, resulting in a disjointed change process;

Cause(s): J.j[N:

~~fi~W$~"~-~~~~-~»BMW~. ffi*~<IW~tt~~~~»~~ffWfil; "Impact on existing products" hns been assessed in the pre-change review. However, it is not evaluated in the engineering design change notice;

Correction{s) to eliminate detected Non-Conformity Cin case MNC: only planl:

1i~l~/tJm(t1~-%:!*:tJHl<Jt4lE (!ltJ~J!:MNC: P-i?Hr~J) :

1!(t~ «I~~w~~im;;i:i» mtJ.E~Alsfi&*· JUn "-~Hm:t:r~r\-7.B'~frlJ111~ .. i¥1ftti~~~:

Completion date for implementation of Correction(s) I Corrective Action(s):

#1.fi~4 IE/~4 IEmtfl§~~.6X B ti~ : 2018.10.22 Audit Team: TOV SOD review of client response Describe evidence of implementation and effectiveness (for NC) (for Grade 2

~: TOV SOD ~~F [W~(l(J-J,lfl'Efi •itjl.ffJ,t::ff~~acJiiEif.! (tf"XIJ'NC) (~f&2-5)

Note Client Response receiving date by TUV SUD: 2018-11-22

The CA plan was submitted and reviewed by audit team, the effectiveness of plan would be verified during next audit.

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Finding Number: 'ft1•£RJ1:~, 2


NC D Finding Type: ·-~JJ\l,~lta MNC ~

Audit Team: Description of detected Non-Conformity MUST include: Requlrement(s) (e.g., QMS·standard, QMS-document, contract), Non-Conformity Statement Including Supporting Objective Evidence

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Grade.ti: Grade 1·5 GHTF SG3 N19:2012 ~~1-5 GHTF SG3 N19:2012

~~i!.*: :R'1t Cflflll, QMS~it. QMSX~. 1tfiil) , ~1tfa.3Ji9CJl!*~i!.~~1ititfr~YE-

Requirement:

ISO 13485:2016 7.4.1 Purchasing process

Product Service

NA

Records of the results of evaluation, selection, monitoring and re-evaluation of supplier capability or performance and any necessary actions arising from these activities shall be maintained (see 4.2.5).

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Supporting Objective Evtdence: x~rM:~AmiiE~:

Control of purchasing procedure: 110074001, ver. F/5 Qualified supplier list: 92800061801001, ver. A/O

Records Reviewed:

l2~8Efi't1<

Control of purchasing procedure: 110074001, ver. F/5 Qualified supplier list: 92800061801001, ver. A/O

File: MED_F _09.61ECS-AAR • 45640

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Finding Number: 'Eflf/{~Jj.~-iJs 2


Finding Type: $fJ(~JJ\l~lla

NC D ±.JFF&r-t1.l MNC 1:23 (X!Jf1'~t~

Grade••= Grade 1 -5 GHTF SG3 N19:2012 ~~1-5 GHTF SG3 N19:2012

Client Response: Cause Analysis, Correction and Corrective Action (In case of extensive response it al.so may reference to attached document's)

~ !ID._: J.ll~HHfi .. ~41E$~41EMMi <jo*f"lireJI:, iiIW.~IJHfi'f~~> Cause Analysis: ~lzHHfr·:

'~--~_··.·.: __ --____ -__ ·_: __ ' !~ Product Service

NA

Tai Zhou Zhong Guan Electronics Technology Co., Ltd has been manufacturing the compressor for more than 10 years. It was separated from SSIG, and reorganized after SSIG going bankrupt. After that most of R&D & QC engineers went to Tai Zhou Zhong Guan Electronics Technology Co., Ltd.

The SSIG had audited Quality Management System, the Audit report No.: 93600061610003. As the long-term cooperation, and considering the cost, we has not re-audited the Tai Zhou Zhong Guan Electronics Technology Co., Ltd

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Cause(s): )j!ffil:

5.2.1.1.1 in control procedure, the onsite audit should be implemented for supplier which provided class A material, and maintained audit records.

The company has increased the corresponding requirements in the program documents ~infJs'f.~4 2016. At present, only one person is responsible for the supplier audit in the company ~1.1;.w-r•u(~i~\..._ ~ ik~ work. The company has a large number of Class A raw materials, which are distribute~ o u 9 country. For cost reasons, it is basically carried out in a gradual review according to ttteo ,, z

division, so~ has not been reviewed. J'[jf-J ,., -~

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Finding Number: 'EJJti.l:iU,~: 2

Orderno:BJ18990042

Finding Type:

••.1:·~-.

NC D 1Affgot~

MNC ~ (j\~1' g.{:if

Grade.It: Grade 1 -5 GHTF SG3 N19:2012 ~t&l-5 GHTF SG3 N19:2012

Corrective Action(s) to eliminate cause(s) of detected Non-Conformity (in case MNC: only plan):

i~~JtJJ.iU1'1."if'1:1-~r~.mt~fJ'1~LliEt-i!nff! C!l!L~:i!MNC: RW.Hf·l!JJ> : ,

9 Product Service

NA

Organize a plan to prioritize the safety-related raw material suppliers (pending: 22) in the category A raw material suppliers (pending: 41 ), and the reliability raw materials are secondary (pending) : 19), to ensure that the supplier related to product safety is first reviewed and then gradually promoted to the next supplier.

(The list of plans has been completed and no attachments are provided due to the sensitivity of the supplier list)

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C*~··B~--~~. ~f~n~•~•~tt. ~~~-~ffl#Tl Completion date for implementation of Correction(s) I Corrective Action(s):

fJ:l,fi;4IE/;4JEmtnB~~i;X;13~ : 2018-10-22

Audit Team: TOV SOD review of client response Describe evidence of Implementation and effectiveness (for NC) (for Grade 2 - 5)

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Note Client Response receiving date by TUV SUD: 2018-11-22 , ~"~~i-..a-.....-.: ,;:' / ~ .. L...-:" ........ 11-1

The CA plan was submitted and reviewed by audit team, the effectivene~ · . lf'I ' during next audit. I ·1 .~ /1"' I' · . rj

ffiTOV S0Di2..if<LltliJ?6;ft@UUuEI !tfl: ~ .. ·, ~ ,,..~f I )-~.',jj '-··11 .. ,:'

Finding Number: $~.l;Jj\\1'~r 3

Finding Type: '4rfi~3l~ll1

NC ~

'•'vr,._..J .,·, .... ;..

Audit Team: Description of detected Non-Conformity !.l~cacih-------:---:=~ MUST include: Requirement(s) (e.g., QMS-standard, QMS-docume11!. contract) Non-Conformity Statement including Supporting Objectiv1revniefi"ce , o./ fl c=: c:: jj f\ 1 ~ f1 ';:;} \ "'nll1 Na~ .!Wi: ~ft~:tliltsfft~ f\LW"-' 1

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AAR - Audit Findings List (Confidential) -~~Jl\U~.€P (

f*~n e Product Service

Finding Number: $tl€!:JJi1'~f·

Requirement:

ISO 13485:2016

3


Finding Type: •~1:m~m,

NC

MNC D

Grade~t!: Grade 1 -5 GHTF SG3 N19:2012 ~f&l-5

i.X~1'~:ftt GHTF SG3 N19:2012

7.6 Control of monitoring and measuring equipment The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements.

~*= 7. 6 ~~~jl!J:i:li4a<J~$~

ffi~@·~~~~-·~&~-~~~~~···· ~F~R*M~~~*-~filMo Description of Non-Conformity:

NA

The inspection device "IR thermal imager" was not controlled as monitoring and measuring equipment.

:fif~Jff!tlli;ij!:

·~u& ti~ "gr :$1rtt.H& fl fX" *~1~ AJl{I tw. ftl W1tllt~ ·~i~ffJIL

Supporting Objective Evidence: :t1H:E ~~ill: t1.!i: End product inspection specification: 242020003, ver. A/4

Records Reviewed:

1c~BE13't~

End product inspection specification: 242020003, ver. A/4

Client Resoonse: Cause Analysis, Correction and Corrective Ac ·on {In case of extensive response it also may reference to attached document's)

1&-E l§Ul: .J.ij{mJ~H1f, ~4iE~~4.iEM»i (jn~:b""Jiielj(. PI!?J.~IJ'fHfHH~lt) IV 0 ...

Cause Analysis: cu

JllzHtHi·: 1. On June 16, 2017, the R&D Department revised 242020003 "Inspection Procedures for Bi-leve Ventilator Finished Products". In the A/4 version, the "Infrared Thermal lmager" was added to measure the heating plate temperature, but the operator trained for the new version file, and the finished product OQC inspector and the personel who is responsible for equipment did not carefully read the terms in the " Inspection Procedures for Bi-leve Ventilator Finished Products". OQC did not use the "infrared thermal imager" to measure during the inspection.

\ File: MED_F _09.61ECS-MR-45640

AAR - Audit Findings List {Confidential) f:ji~~mlift~ (

f*ID Product Service

Finding Number: t¥fi.&IU¥1J1 3


Finding Type:

••~•~m.

NC [81 ±:~.PF15f.~

MNC D

Grade~tl: Grade 1·5 GHTF SG3 N19:2012 ~fj.1-5 GHTF SG3 N19:2012

NA

'' gi:jrl·~~J! flt:~." W1HUJU 1~~~1HA.lt • fE! ;rJr fi* Ji: ftt* xHwdf-A.w nt tf!(i~ VII. l1ti.~ ift,OQCJYi ~~ .. ·W:·@. tf J.!~ *iA~ 00 i~ 0.VJ< :if ll'Jr!&f!LJiX;ift:i ~ g~~;filf~)) r:f'J a~~ *IA:' OQC{f. t&:}9!1J r:J:1 ;;t~·ftf.~ H tHH!~r& ·fl{)(" i& i-HHrwm ft o

2. "Infrared thermal irnager'' has been used as the monitoring and measuring equipment in the R&D department for maintenance and management. However, after the "infrared thermal imager" is prescribed in the new version of the finished product inspection procedure for Bi-level ventilator to measure the temperature of the heating plate, the equipment was not transferred to the quality management department for management.

2, i' tt :71· ~ 11~ il & " - ll 1:£t2: ifli llJf '/J:.1.i'lHt 7'J ll~:f.WjJm 1ii9: -~ . it xt ;tt~U~ 1P1 f*fif tr J:tl!, {fil ?'UJT Pi&* « )(X 7](-'f

~~mJiX;H~••~>~•~m "tt*~JiX;•&"••~~••&m. *~•~&5tt•~••• JmffB, i!Hr trnn D

Cause(s):

Ni!Z51: 1.The file dafted department did not carry out operation training for 242020003 N4 version of" Inspection Procedures for Bi-leve Ventilator Finished Products". L finitlt1BfH~Xl:t242020003 A/41~-* (XY{lj(JfU1f!&.:111.!5xifM~~~t;rul_~)) illlHwdl:i'{hJI].,

2. OQC did not use "infrared thermal imager" for product inspection; Therefore, it is not recorded into,\l)e monitoring and measurement equipment list, and it is not regularly maintained and managed. ~: .. ••' ••"• h!~" 2, ~r.~c)j)j ~~ ... *!till "tt~f !t.llilt i~1X • Jilll' Plt .11,u~, wr l:l *~;<!;i~ A* ~11 rlj~!ijfif itl.~~<

JEfif4tU.Pf\tH~ ~mi.a ·';; ~ •· _, .

CorrectiQn(s) to elimiaate detected Non-CQnformity Cln case MNC: only o!anl: '. ~ g ~l~l~~~S~~%ft}J~~{]~tliE r(mfi.Ui1~MNC: R~iHr]) :

/ df.f"'/f ' ,rf 1. The R&D Department revised "Inspection Procedures for Bi~leve Ventilator Finishe~duc~

1

~ ~...flis touched the heating plate in the humidifier, and judged that the heating plate was normcit··i th~\~§<~ous temperature rise compared with the cold state of the equipment; ··-~1\L0·,·,1.;,..-:. \

1. F 51. filf~tlll~i& rn 7.k-'l'll'f'~mPlt.?nM~'l'J!l'l\> I*! 'i1i': i!'illl:fil1t :m r<i a~ hn;, ~~'"rt~. R lfulfrY!tlilJ-~1J)E1JrJ:t~t\tI11=iE#i: /~ ~ ~-

2. Cancel the use of the far infrared tester. ~ 2, tallK~m~~Ijl-~UIJm&a~{~ffl Q f1J'3?l'1~1L U1tln~'il'1

qJ

3. The far infrared tester does not need to transfer to the quality management department for management.

~ilitt*ilM~tt~~MB~··~~illffW~"

File: MED_F _09.61ECS-AAR- 45640

(JI l

" of \,;;- .

AAR - Audit Findings List (Confidential) Qi~:&tU!il~ ( (~ti)


Finding Number: ·-~J.i)-1:~, 3

iJll. i=thJll~~·]g: 82802031811001.

Finding Type:

-~~ .. ~-= NC r&l

MNC D

Grade~fl: Grade 1 - 5 GHTF SG3 N19:2012 ~~1-5 GHTF SG3 N19:2012

Completion date for implementation of Correction(s) I Corrective Action(s}:

#tfi!41E/!4IEmbm89~.5JGBltJ3 : 2018.11.10 Audit Team: TOV SOD review of client response Describe evidence of Implementation and effectiveness (for NC) (for Grade 2 - 5)

(i) Product Service

NA

The client revised "Inspection Procedures for BHeve Ventilator Finished Products" (242020003, ver. NS) chapter 6.1. 7, the inspection method via touch to feel the heating works well, the "IR thermal imager" would be removed from the specification. Training of revised inspection specification for inspection staff was organized on 2018-11-05, training record (82802031811001, ver. NO) with paper test was maintained, inspection staff (e.g. Mr. Shuai Lu) was attended training and test. Based on the evidence submitted by client, the NC can be closed. $~ill1 TOV sOo X9"~F lfil~ff{)i,Sf'ifi Mii!ifl.ff&~~tt~JtiE!i <tt~NC) C~t&2-5)


rt!TOV SODieJR:tj1(flJ~r1 @1 }fWJ B J!J]:

Finding Number: -~~-J-1:-'J1 4

Finding Type: 'ilf fJ(&J.i~ll.1

NC D ::t:. ~'1' ,g.:j:~

MNC r&l

Audit Team: Pesc;riptiQIJ of d~tected Non-Conformity MUST include: Requlrement(s) {e.g., QMS-standard, QMS-document, contract), Non-Conformity Statement including Su pportlng Objective Evidence

~: ~~~}Jiff{JffQ~ ~;.Ji1!!.'$': •* (~lfQ:J, QMS~;it, QMS~-fll:, *fi41) , ~*~JJi1¥J~i!1!!.1ii.:ttftt

Requirement:

ISO 13485:2016 8.2.6 Monitoring and measurement of product The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at applicable stages of the product realization process in accordance with the planned and documented arrangements and documented procedures.

~*: 8. 2. 6 "fr-~(!<]~1J».~~-m~15.'L ~1 ;tt: ifli ~*~ t~ti:lt n uri. tm-tn ~91tl it, l;J-1J&il "ft: &b ~ * eAUIJ fJ!i ,~ o j!:fili fill :t~~-fu W11J mJ§Z * ~ ?frYJL~jf,JJcftJ:.- . ~~--1t (J{]~t4~fu.~:t·ft1:·1-t.Ef.Jfjtr¥. -t£Fifli~J&H:tt1£B~jfil:~ll1f¥Jt:itl:1-r~---~---·-~-

File: MED_F _09.61ECS-MR- 45640

(V (~!'}~"('":~'~ . :··~~),,)

AAR - Audit Findings List (Confidential) iP~~JroWi~ ( fill)

Finding Number: tlJtl{~~U?:~s 4

Description of Non-Conformity:


Finding Type: ••~m~m,

NC D ±.!~Pl' 15-~

MNC ~

Grade.It: Grade 1·5 GHTF SG3 N19:2012 ~~1-5 GHTF SG3 N19:2012

Product Service

NA

According to the requirements of clause 6.1. 7 in "Non-invasive ventilator end product inspection specification", inspection item of measurement of "heating control of humidifier'' was not involved in end product inspection record.

lf·g. ~rJJi tlliit: *Nt/ril ":XJl 71< ·1r l!SP r~ tll.n\G rfh ~ !!~};ll;f¥."6 .1. 7 ~ig ~ *' imtli{ " m ft~~ J1n¥Jifr:t~ fli1J " Bi :f&~~!tl rm 13 I :f& !Ht ic jJ{ q:i &: 1=1 ~!'£- 0

Supporting Objective Evidence: :tM=t1:~XW.i1Et/ri1: End product inspection specification: 242020003, ver. N4 End product inspection record: SN: 30220002770209001

Records Reviewed:

1c~BE¥l*P< End product inspection specification: 242020003, ver. Af 4 End product inspection record: SN: 30220002770209001

Client Response: Cause Analysis, Correction and Corrective Action (in case of extensive response It also may reference to attached document's)

$=/=' lfilj!: ~~7H1f, t4.iE*1t4.iEM~ ctm*f"~IID~. iiJ!?J,~lfflut#ffl~) Cause Analysis·

DitlzHH:IT: 1) The result record form of the test item "humidifier heating test" is not specifie rn 24202000 , e A/4

"finished product inspection procedures of Bi-level ventilator";

1_). 242020003 A14f«-"* "50r7.l<-Vllflim.1VtifMi~:mll!11M*ijijfdD "~~~LJfi~flffR~ ~*~~*~' ~

2) There is no such inspection item in the production scanning system; 2 > ::Ef=r-UIJM'/f 9:i ~J!t~:JJi~ ~ 1

3) The operators did not receive timely and accurate operation training for 242020003of the A/4" finished product inspection procedures of Bi-level ventilator".

3) ttX1242020003 AJ41Vi* ">OCll<-ifns'~m~~*~:AAl~". •fF~*~~~d.&.Rjff£fdDl¥JfF~:l:&vllo

Cause(s):

JIJEI: 1} The form of the final result records of each inspection item is not specified in 242020003of the A/4 "finished


l •• u.'·:· .. '.·.'._.: .. ·.·····'·-.··.,. . . . I

I

AAR - Audit Findings List (Confidential) ifi~~!M~Qi ( {j'1)

Finding Number: ••~mt~-if, 4


Finding Type: $fl{~JJ1~1!:

NC D .:t.~'.iG&rtit

MNC r81 IJ\~:iG*f.~

Grade$1t: Grade 1·5 GHTF SG3 N19:2012 ~til-5 GHTF SG3 N19:2012

2) The inspection item was not timely entered in the production scanning system; 2) ~F!=IM!i~tlti:?*~R>t~A~~~J.91 ~;

e Product Service

NA

3) The operator conducted the inspection of "humidifier heating test1' according to the requirements in 242020003of

the A/4 "finished product inspection procedure of Bi-level ventilator", but did not follow the required inspection

methods and equipment, and did not record in any form. 3) #lf1:::f~Jm24202oooa AJ4~* "~*~°'~mnuM~:3&~*i"H!a<J~>J<~ "~.ftffbllil*!Ji:" ~-t:J.91 ~i!fi7;ti~, fil*~H«~).J{~~/J~~'\i~, liiJll't*fta:fffPJ~j\:ff(J*EJ~ia~o

Correction(s) to eliminate detected Non-Conformity fin case MNC: only planl:

im~S:btf£A~:lf''8'~J'.9!89NiE <!mJ!hl!:MNC: RflHHtl) :

1) Clarify the record form of the final results of each inspection item in 242020003of the A/5 "inspection

procedures for finished products of Bi-level ventilator", and optimize the process for the inspection operation of

"humidifier heating test".

The record of test results is as follows:

EPAPpressure test Test pressure value (cmH~O)

6. 1. 4

6. 1. 5

6. 1. 6

6. 1. 7

6. 1. 8

Pressure delay rise test

Power failure alarm check Pipeline off alarm check Temperature test of humidifier Wave test

Test pressure record value when the initial value is set to 6cmH20 Test pressure record value when the initial value is set to 8cmH20 Set delay time to 5 minutes time record value

Set the delay time to the time record value of 20 minutes Set the delay time to 45 minutes when the time record value Is there an alarm sound and greater than 120 seconds (yes/no) Is there an alarm sound within 10 seconds (yes/no) Whether the heating plate has been heated (yes/no) Whether the data wavefonn is displayed by scrolling (yes/no)

t-;:---:-~-t-~~-;,::::;::::::~:::;;::i;--t-"MN~ew::fifi;;:;:le-;g;;;e:;:;-ne~r::::;a+;,tio~n~(;::ye~s-::'ijD~J)~J-_-~------=--_-1--=t:=====;:;::+- ~.-............... · .. 6. 1. 9 Data storage check

File: MED _F _09.61ECS·MR·45640 Revision: 10- status: released ·

AAR - Audit Findings List (Confidential) ifi~~lttll!~ ( f*I:)

Finding Number:

·-~-1'-il-i 4

6. 1. 10 Stop the purge check

6. 1. 11 Date setting check

6. 2 Software versioning

6.3 Appearance inspection

6.4 Key, display test

6.5 Breath synchronization test

6.6 Leakage current test

6. 7 Withstand voltage

test

6.8 Packing inspection


Finding Type:

·~~JJ«~m=

NC D :t.~1'15-~

MNC ~ (j(Jff15-~

Grade~ffl: Grade 1·5 GHTF SG3 N19:2012 ~~1-5 GHTF SG3 N19:2012

Stop after blowing for 10 minutes (yes/no)

Whether to produce the corresponding file

name (yes/no)

Consistent with the quality plan (yes/no}

Compliance with internal appearance inspection specification (yes/no)

Show if it is normal (yes/no)

Good synchronicity (yes/no)

Test leakage current (mA)

Whether the tester has alarm (yes/no)

Compliance with acceptance criteria (yes/no)

o .. · ... ·t·· i~ Product Service

NA

1) :tE24202oooa AJsNit* "~*~llfiam.QJG&ls~~m~"Jt~ i:p ~-~-t-~~J!ii EI •~HUf~(f<Jia~m ~. ~M#~ "IHt:H:bllli~~,, JJiiEf:tf~]Ji-f1:J:::i1UrI~1jt{.~o

1J1HJM~Utllii EI ~*1a~m~:!l1rf =

~~

6.1.5

6.1.6

6.1. 7

6.1.8 llRlf~ft:if\t&~ 6.1.9 il!tlil:f.Htt&~ 6.1.10 -{;fll.~j3f&~ 6. 1.11 8!i.Jl1~~t&~ 6.2 ~f* 6. 3 ~~i!.W.t& 6. 4

File: MED _F _09.61ECS-MR·45640

(V' (:' . '.' •.·. '1)

AAR - Audit Findings List (Confidential) EP~~J!\1~~ (

f*ll>

Finding Number: 'Efir4~JJ,~~r 4


Finding Type: •~~J.J«~m,

NC D :l:~PF~t/5-

MNC [gJ

Grade~tl: Grade 1 -5 GHTF SG3 N19:2012 ~iil-5 GHTF SG3 N19:2012

Product Service

NA

@ Since it is necessary to judge the ris.ing temperature of the heating plate when inspecting with the infrared imagcr, it can be judged that the internal heating platf~ connection of the device is normal and the heating plate works normally. This process requires not only a long working t:ime (about 1~2 minutes) but also there is the risk of operator accurate determination (the deviation of the front-end alignment din:cti.on of the device and the error in the judgment of the screen display color when using the infrared imag0r may affect the final result)

EB r .ffl tt?l-~Rlt-fl-&~~M flJ!*Otfi:bll~fA:~ll:f'f1£-.t71-~~;;tff~~ ~li4 ~ ~1t.Hiit~~ittl.iE# .&~fi:IfFIE1ft, Jltlifi~ffiWl!~*IRt C~1-27Hifi) ffiiJlXifr•fFAJJltl91liilt*Uffifi1£,fXt.,~ C*ffltt?~RJG-fl-&!lf1:Mli4ftr~~$1i~OO-ui~Mll~M¥llUR'9if5*'1lfit'.fJ~~~PJB~~lfiuil~~*

(19,,jjE) ; ® "Humidifier Temperature Control" has a description of the reason for not testing in the description of the non-test item. The "Humidifier Heating Test" item in the "Test Procedure for Finished Products of Bi-Level Ventilator" is an additional test item. It is to check the electrical connection of the internal heating plate connection line of the humidifier and the heating plate works normally. To achieve this purpose, it is only necessary to check whether the heating plate of the humidifier has temperature rise after the nonnal operation of the equipment, and the temperature rise is the most direct and effective way of body sense. Through the test, the equipment is turned on after setting. If the internal heating plate line is connected normally and the heating plate is functioning normally, there must be obvious temperature rise within 10s, and the human hand touch perception is obvious (normal people are not easy to misjudge after touching the heating plate, Compared with the infrared imager, the risk of error determination is significan~ly reduced), and the production efficiency is significantly improved (excluding the time of other operation, the inspection time of each device is about 5s), so the inspection method is changed to touch by a human hand to detennine whether the inspection item is meet the acceptance criteria. ® "1:11-t=BHlll~flid" 1£/F*llitl#. IYJ itr 13/F:i=!ff ;tt~,mt ~ OOffli :0i, "3N7J< Sf Pf IJ!l.mnlt iitU~l!fi" itr 00 "~.ftfi:hn~tt~" lJil § ~Jlrlf*llimOOtt~:gn El, § oo~:tt~m.ftB~ftlU1n~1i}ttl~filOOr:@.~ittl iE1itil:bo~m:I f'F.iE'lK', jgi&JtlJlt El 00.R i&~tt®:1i4 .iE11tI f1:FRm-fttt(J(J1Jn~ , w~~s 7Uil1i.tlif~~Ji~~f*So li~~icl\. W;-i-~J!JJ<U.fQRltJiUfm, ~ :~ :IH:bn~ ftlJJ~.iE'if, tE10sN1H'&1f!YJ1iHi7f-, A-=¥-timll~Jl!Jh'll C.iE~AlilM:M. ' d, *11 ~n~~~.1!1l-fUMtt~#IJ.iEP<l.P.it!YJB~~> , Wll~F~$1YHU!~ <~Jl; f2 4ff:tli: 4:fi~Jt-tJliJ~5s) , ~Jlt~~~/J~~£:19iliii:tA~ti!il*#l1.iE~~~J9j.:·. '· .... . .. q

Before the change of inspection method: (A , ! ry· . 8 Inspection method: The test device is connected as shown in Figure 1. Set tpe'"iij9 · , ntilator to

be tested to CPAP, the pressure setting value is 10cmH20, set the humidifierte~eJ.ur.~,·~ •. Jr._ . toyth gear, take out the humidification tank, start working, use infrared thermal imager measl.Warj\E:of~ll ature t heating plate, and an upward trend indicates that the heating plate is working properly. .

:{\i~jj~~J!fir: ~~~/Jr!-: W!~ D\~1Ut!H1HirJ 001 PJrffi. i5tif.1~~9!1Jr!.iyn,&;j;JLT·ft:t#!:rt:hC P. i }) rm .'.. 1'1 cmH20.

~4iJllHUHH~Jf~i&}l:f:E5.f~, If;Ull rmt~. fF;JJLTft:' FlH.L~H'f.~!i~U~ ~~W. "' LJ[l:!Kfnfi&LJI' ll1J:~Ltfh@#J :;l;;, - J.11a ;t~~ .R:l-I fl\: :-c ,,,g. .;oc/J\ ~ .... :tiiL r .Le m u iv 0 11

After the change of inspection method: 'itl'ill~~1L u1r1nR?l-3 Inspection method: The test device is connected as shown in Figure 1. The default working moct'e is to set the

humidifier temperature control switch to 5 steps, take out the humidification tank, start working, after 1 Os, touch the heating plate in the humidifier, and the device. When the cold state has a significant temperature rise, it can be determined that the heating plate is working normally.

*~7Jf!jf1!m: ~~ "JiH~: ~tl b\~ 1§'.i-~ t~ flu 001 rrr~, ~~ ·iJ.. :L f1: 1~ J:t; - ~~· t!fi!-:ft~7iWttt7f.*\~!T:tr:s-~r.--.lffm r~~ ·ftlf."-tF l'

t i 1 ........................... · · · · · --· · · · · · ·· · · · · · . ~p· ;9' H t1~r ~JJ ;, ··::; ~

~ve: 28 Feb 2018 .;•, ~~ L~ · .-~ ·>'' 0

28 l:·· File: MED _F _09.61ECS·MR·45640 Revision: 10 - status: release

2 ~' '"fl~ '~'---,•,.• ..... -..- ':

3 ........ ¥"'' ......... ;·~:~·~".'.~t:\:d'.i: .. 1~ t

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4 ......... ~··.iii1~~~~~~ ~;:-.. . ......................... > .. ,.,,.> ... '..:·/!. <f-:;.r~ .-M~ ~~·: Cf)~.~

··I · ,,.. \ I <'» . n,~~ t) 5 .............. 2. . ............ : . .:·.·.··•,,:_"''·' ...-,..,,.Jl)' d

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I ~~..s)

AAR • Audit Findings List {Confidential) ili~~lmil.Q1 ( {ill)

Finding Number: ·~~!3«1'~1 4


NC D Finding Type: •~~JR~ma MNC ~

Grade~•: Grade 1 -5 GHTF SG3 N19:2012 ~~1-5

1J\~1'g.fit GHTF SG3 N19:2012

2) Add "humidifier heating test" to the production scanning system. 2) tE~.Ft=IMt~~J:::ll:JJ11 "~.ft~:JJo~*u&" ~~~~J91~ o

:.O.······ .. ··· ...... ·, !~ Product Service

NA

3) The operator is required to carry out the inspection of242020003of the A/5 "humidifier heating test" in

accordance with the requirements in the "finished product inspection procedures of Bi-level ventilator" and make

relevant records at the same time. 3) J!)j<~Rd'F::f~.fttt242020003 A15ri* ">OC7J<.Iflllf!RtTLJVt&ii:ft@~.Ui"!l!~~)j<~ "t!HtfliJll~:t't!Jt" l! ~J9i~~~*~~~M~~~~~~o

Corrective Action(s) to eliminate cause(s) of detected Non-Conformity On case MNC: only plan):

1~~~*2.UW,l'f.J.1'-8-~!g!Jj~(f.J~LjIEt~M!i <!m31!!:Jf£MNC: Rff.Hf-1YD: For the "procedures for the inspection of finished products of bi-level ventilator" (file number: 242020003);Version:

A/5) training relevant operators. ttX?t ">OC7J<.IflllflllmJ£ii*Ui~~" Ot#%: 242020003: Wi*= AJs> ~~*31f'FA~~rr:ttfilllo

Completion date for implementation of Correction(s> I Corrective Action(s):

#1.fi!41E/~4IEm~B956PX BM : All the above corrective actions are expected to be completed by November 10, 2018.

PJ.J::JW :ff~ lEttUfiBi it :t1:201s:t¥11A 1 o B fir~$ .:fefflt o

Audit Team: TOV SOD review of client response Describe evidence of implementation and effectiveness (for NC) (for Grade 2 - 5)

'i.fi~il.: TOV SOD X!t~F IBJj(rlJi-Sf 'i.fi

Note Client Response receiving date by TUV SUD: 2018-11-22 ... . ~,,,.. · >-:.#~

The CA plan was submitted and re. viewed by audit team, the effectiveness of plan wcYaf~,~~#f~~·:-~. during next audit /.)_

EllTOV S0Di~'1ti&'-'J'.J§'.J"lillllllflBM: u /~ /

NC D Grade~•: Finding Number: Finding Type: ~I: ~~FFfr:f~ Grade 1 -5

·~~JJ\t1'~1 5 •~~m~ms MNC ~ GHTF SG3 N19:2012 NA ~~1-5

i:?\!?JPT~ir-t:~ GHTF SG3 N19:2012

File: MED_F _09.61ECS-MR • 45640

AAR - Audit Findings List (Confidential) iP'~~lm~51! ( f¥1D

Finding Number:

·-~Jl.1'-ifr 5


Finding Type: 'ilf•~JA~l!z

NC D ±~'!:;it¥!

MNC ~ (j\~"fit~

Audit Team: Description of detected Non-Conformity MUST Include: Requirement(s) (e.g., QMS-standard, QMS-document, contract), Non~Conformity Statement including Supporting Objective Evidence

·~£tl:/Fit#rJJi~fl'li~

Grade.fl: Grade 1 -5 GHTF SG3 N19:2012 ~~1-5 GHTF SG3 N19:2012

~~i!L*' J!'1( (fW:flll, QMSfj1t, QMS)C.pf, -ft!PJ) .. :iF*~JJi1¥J~iti!Lt.!i:~:t#tt~~iiE~

Requirement:

ISO 13485:2016 8.3.1 General

e Product Service

NA

The organization shall document a procedure to define the controls and related responsibilities and authorities for the identification, documentation, segregation, evaluation and disposition of nonconforming product. ~>R: 8. 3. 1 .(iJjltl

m~m••~~~*~~~~&•~~~~~m™.%#fil~-~•.w~~~-~~m~~*M•~« ~~ A<J f]iff * 1&x ftt- o


The nonconforming product "Portable filling circuit board" (701270164) in storage room nonconforming shelf did not have identification and description of nonconformity, which did not fulfill the requirements of control procedure clause 5.2.1.2.

~fr ;J-!:i:lJHtt i!: 1tJ$ fJM~ * ~Jfil.1' '8-t~ rfl1 "·f!:l'J~ J~Ht/BI~ U(" ,. .-~flw li*i FFJtitl:5. 2. 1. 28<J~>l<o

Supporting Objective Evidence: :tt~:fj:~~ A] ii1 :tm: Nonconforming Product Control Procedure: 110083001, ver. E/2

Records Reviewed:

12jft8'Ef.ft~

Nonconforming Product Control Procedure: 110083001, ver. E/2

Client Response: Cause Analysis, Correction and Corrective c 1 (in case of extensive response It also may reference to attached document's)

t-F !Ell:: llUil*tfi, ~4iE~t4iEttUi c~*f"lirID~. PIW.~IfUHl=~:it> Cause Analysis: Jif2HttlT:

When the quality department QC handled the non-conforming product in the production process, only the defective phenomenon of the portable charging circuit board {701270164) is recorded in the "Production Process Non-conformin Product Determination Form", but the raw material ctab · .. .cir.cuilboarcLis.not."-' .

File: MED_F _09.61ECS-AAR • 45640 Revision: 10- status: rel

(}/

. /'

AAR • Audit Findings List (Confidential) iji'~~mlfi$~ (

{~Hi)

Finding Number: ·

••£JA"~' 5


Finding Type: Efi~~JJ«~B!ls

NC D ::1::~1::,g.tif

MNC ~ (7\~'f'*·f~

Grade.ti: Grade 1-5 GHTF SG3 N19:2012 ~til-5 GHTF SG3 N19:2012

f~ ..... rnv.·.·· ... ··: !~ Product Service

NA

simultaneously attached the label for the description of the unqualified phenomenon, and is not identified according to 110083001 of the E/2 "non-conforming product control procedures" and the requirements of the regulations.

IP! f!$QC A ff.! (Ht J-]!:i: rte j:(Jfi~ r.~I a~ /F g. f& rf1r.11Pt • ,R t£ (( :i:;•'.!: ):U~Jf' ·~ :t.1hfb ~~IJ ii::~» r:j:t ·i.c j]{{iJ!J'J~ ~16 r:j~ f1}ti ,, ( 701270164) (-J~ ::f~ .g. :m JJH~t' m ~~fl] n1 t£ J}il IJ'HH! 1JU~ ft i:g ~HJ~ .Ur!i mti /f' 1.t ~~ tW, .~ t~i:i! (J<J ~j~ m,~. *f!i:110083001 E/2Jj&:<$: «Jf'ir'"t~5M~rMf~.J:f)) 2kiiJfil~>J(X1tU&tri~-8-:fMW.~fr:m1Jtltif.iRo Cause(s): HR~:

The QC of the quality department did not paste unqualified labels on all unqualified raw materials or their outer packing according to110083001of the E/2 "non-confom1ing product control procedures" and the regulations.

JJJHl:·~'fflQCA.9?!-*t1Z110083001 E/2 (/FS-:Jt1~fl~iWHiiif-Y.}) lZ.¥1.d~~>R. ·*X1fl/f"ff~S-tuu~·*;~E!JZJH~ 'E!.~l:ITTr.VFS-:tMW. ·~fif-iRITT~i o

Correction(s) to eliminate detected Non-Conformity lin case MNC: only plan):

1~~~.~JW,((.J~.g.mriJHM4IE ( !la*l!MNC: R~ii-~J) : On October 09, 2015, all records of "portable charging circuit board" (701270164) were found by ERP

"Production Process Non-conforming Product Determination Form". According to the description of unqualified phenomena in the records, the labels were pasted on unqualified products correspondingly.

2018.10. 098:ifilit-filifiJERP «1::1'-uf.!i!JFif:nfrfii~~IJYE~)) t~tB "{!JH1JJ.H~JtEl!~Hi" (701270164) fllff:f fil~. ~-IB~~M~ir'"•~•~m:i!. ~mm~~•M~~~m£~o

Corrective Action(s\ to eliminate cause(s) of detected Non-Conformity !in case MNC: o~(i.~~l\)1~~; ~· Y~~];~JffUl~Jf' f.t:filJ'.9i~~IEI (fJ~L!IE1·1=\'M!! c !m~l'!MNC: H 1f.JH·:\:JJ) : '-.:.v / . . _ .~"i..):~)'-

QC were trained on 110083001 of the E/2 "non-conforming product control proced~~~t;" m de the " realize that the fault that not to label non-conforming products affected the identification @f 15 ~"i subsequent disposal of procurement back to the factory. The training record is refered tor~;.~. 0. ~

X1QCA.!T.!.il.!:tf110083001 E/2 f/G1itllrf.l:i¥2fli~l'MH t'ifiJll. ·{~·f1P;ffJ:i~:i.HfU.lw:1~~~wv l . ' - )i filiJ: 005 ~ g. ~fJQ.j{ tif.1rf, !flJ ll(iij}§ ~;t ~jl~H!~J:~ }!:iX~'.:tI: ~$~ fil 1.9U1 (1~ ifH)tl , thff~~.-~··.1. -_2; ~~0 828000118100020 C..J;q ~'; ~·.'-... ,·q:~

"•Vt-ILi)'i~\\)':-

Completion date for implementation of Correction(s) I Corrective Action(s):

tJ:l.fi~4IE/~4IEni~a9~.6XBM : 2018.10.09 Audit Team: TOV SOD review of client response Describe evidence of implementation and effectiv~ness (for NC) (for Grade 2 - 5)

t~fi: TOV SOD ~~.P IEJ~a9i-S¥$ tli1.Ml1,mHf~tttroiiHI <-tf-~NC) C~a&2-5)



ruTOV SODicJJt~tx:~U~f1 @1~J<J 8 JV}:

File: MED_F _09.61 ECS·AAR • 45640 Revision: 10-status: releas d

·"(i.nrJ~r.:'"'4 ~,~~ it~'!.i~) \Jf:'·~- -:,";" :;~ : .. ' ~ ' . 'f'(l"j'~',·~~

AAR • Audit Findings List (Confidential) ili~4tltU~Q! ( {¥ii)

Finding Number: ·-~Jlf1$-ij,

Finding Number:

·-~Jl>'-if:

5

6


Finding Type:

·-~JI~~'

Finding Type: ••£Jl~B!:

NC D :I: ~1' g. t~

MNC ~ i.X~1'%11it

NC ±. !.lfif' .g. fft MNC D

Audit Team: Description of detected Non-Conformity MUST include: Requirement(s) (e.g., QMS·standard, QMS~ocument, contract), Non-Conformity Statement including Supporting Objective Evidence ••m., ~*•JJ11¥.Jtl~

Grade~#a: Grade 1·5 GHTF SG3 N19:2012 ~~1-5 GHTF SG3 N19:2012

Grade~#a: Grade 1 ·5 GHTF SG3 N19:2012 ~~1-5 GHTF SG3 N19:2012

~~~*= ~*C~~.QMS~m. QMSX~.*~),~*~~~~~~m~~tt~~iiEll Requirement:

7.2.2Reviewofrequirementsrelatedtoproduct 7.2.2 ~tr-rrbif 9Cf.J~~*f:f.JVY.$

Q Product Service

NA

NA

Theorganizationshall reviewth erequiremen ts related to product. Thisreviewsh,a.U ~~~ij~uct~d priortotheorganization'scom~i_tmenttosupplyproducttot~ecust~me~ . , .. '\.•·';r?·J ·\~~ _. lllt!l@i'l''iji £; i"'/i/,'.ffl ~rtJ-1!>~. W$"@l'Elllt!ll-Jili'.tft tlll>l\~t" Ii/, B'~»:il\' z~.Ll·l. -, . · ··'~,\~J

A.:' ,6. Mt !fit ¥.fl-~-:!:'- ( . .fflft~ ,~ Description of Non-Conformity: ·~- ~~~ "R-.•.. . ~.-; .. 'I' i=I ;IT:r :!lhlfl.U!: I II ;,: ' t;: .· rf !he samp~e.d co~t~act re~i?~ ~as ~e~orn:ied :n~:_t~~.?~g~nization sent th~J}9~~~·~ ,~%~' lfM;f (f.J S' ~if-$ :J:E1£ffi tR.tl ~~? B~ *=91~ ff ~-ZIP ;f U1: ff (J;J o L,. _ ··, 11 , ..- --~-~?

Suooortinq Objective Evidence: ,, "''-"i•cinft'' ./ /'

:t~t!~:AJi!iiEll: /~ / ~ Pl with <SIDROC Services LTD> (Contract No.: SYS-P0-18223, Date: 201,-eIB-OJ /r;r/~ ~ SIDROC Services LTD*~~Jff!f:'!. C%1i11tti'U%: SYS-P0-18223, EJJ:lJj: 20~~01) · ~ Contract review records (870 01081807223, Date: 2018-08-31); °""

0 .,

-8-lfi1Wrili2.jjt (870 01081807223, Date: 2018-08-31) 11J'i'fl\t~1LU1tlnfl'il\t IU

Pl with <PT. Mandiri Jaya Medika >(Contract No.: SYS-P0-18219, Date: 2018-07-11);

PT. Mandiri Jaya Medika ( g-fi1Jtfiii%: SYS-P0-18219, B WJ: 2018-07-11)

Contract review records (870 01081807219, Date: 2018-07-20);

13-~if-'itiliC.J"k (870 01081807219, B J!JJ: 2018-07-20);

File: MED_F _09.61ECS-MR- 45640

(li ._.

AAR - Audit Findings List (Confidential) iP~~imr,5~ (

f*ID

Finding Number: ·-~~J!:-'ji 6


Finding Type: tfiiUtJJ«~lla

NC ~ .±.~1'~m

MNC D &~1'8--f.~

Grade.ta: Grade 1 -5 GHTF SG3 N19:2012 ~~1-5 GHTF SG3 N19:2012

Client Response: Cause Analysis, Correction and Corrective Action (In case of extensive response it also may reference to attached document's)

~.ri@•: ~f1Htfi .. *~lE'*1~~1Enttit <m~f"JiUID1f, iiJW.ijJJDl!Af#mlt> Cause Analysis·

~l~HHfr:

e Product Service

NA

Most customers do not specify the delivery date in the PO. After the company has been evaluated, we will give the delivery date, and after the customer agrees to the delivery date, the Pl and contract will be signed.

:Xi'f1~5rJ®l'.g::(£POr-j:t*xtx.m: B JtJUtl:ff:JDil]E, ~t:Ef'5:i}ii'JVP.$' JF-i, q~jj~f.HHX:~ BWJ. 11.J®i?i~~i":X::bt Jtllfr5. ~}!Pl, '&t~o

Therefore, our company neglects that the PO must have a clear delivery date. The purpose of the review is to meet the customer's needs, and the customer needs include delivery, but we have no delivery date in the PO. Once there is a dispute, the customer may challenge our responsibility of not shipping or delaying delivery. We should place the review before makeing a commitment to provide the product to the customer, that is, first review, then sign the Pl and contract. and deliver the goods accurately according to the delivery date to avoid the risk.

~n~~-·7PO~~~~~-~-m. W$~§~~~7~£~-~~~·*· ffim3R*~M~ Jtfj, ff6~1iJ tEPO ~ ¥!Yf=f 3C1Ji: J!JJ • - .§. lt~ gq ~)} • J[ij)l '.{;~ f.iHe,~ fEI 793c:Jtfl l'til :Mi MI l1't jJ§ 'flA~1i * ~:P~ n.U!38 J.fi: ~IWSHL f~fflf'Z~~··.~Jj! $'rYil t±tJI tRftlJ !®l~ ft= tf:l t'f:fM'.c ~rrrl a~J)Rtft:Z. mn~ ff' ap %-1o/-'4i • ,.1?1.ftffi~1iR~,~G-O' NixttJH1Ufn=)(Jfc, il!kJ<lJ~o ~~~~1 ·\; i·

~ijtJ -.~ i~~e(s}: ' ;§1

The purpose of the review is to ensure that the product meets customer nee~~flf~:~J~,..,._s delivery. The customer and we did not pay attention to the delivery date when confJtming.t:ttl~,··e.<a; the customer's needs were not fully understood during the review. The review proceS's··~~M~!?§: ·;;(' conducted before the Pl and the contract is carried out. It shall be a review of whether the materials, production capacity and delivery time of o.ur company meet the requirements of t~~omer. i,$8~ § B'~n!:J'~7 ti= ~~f.j~iWJ1~li9i~fm;J<, fffi/F!i!~?ffl;J<~Mx!tif o l®i~·'=if~·ffl -flfUiAPO J~fj :R·"·3(_p~ -- ,

~JJ. 11fJW·'F.f3'El1X-1~l:i(t!)ftWJK.7k~(:J~fi::f7E%" W$J:Hli~·ffPL -8-lf.iJjtJ:fj·. 1ti11Hr·_ h'-~>(i~~ •~ff.~~~h&x1Ji:M&N•~~~~*OO~$. ~

Correction(s) to eliminate detected Non-Conformity (in case MNC: only plan): - 0 ....

ir1r-t.tl:J:!iU1~:if'.g.mJJ!a~~4:u: (JmJl.h~MNc: H~H-1:JJ> : 'i1.J'i'fl~~1L u1trntwe.N Modify110072001 "Product requirements review control program" upgrade to the F/O versio?i' and

modify the work-flow: 5.2.1 The Engineering Services Department or the International Trade Department is responsible for

identifying the product requirements. After receiving the customer PO (including the delivery date), the relevant departments are deployed for review, and then the Pl and contract are signed with the customer. 1~r&110012001 «fi=r.fbJf >J(VFrti' tl#i1Jf~f'f-)) fH'JkF /O/i&-*, ~-~&~L-(1= ¥/iif.fil:

5. 2. lI~n~~t':i1f,9XWiYrnB~ff:t:l1fi.Q5J~j''..!:~1~3J(. f:EqUU~f1 PO [email protected]:.VfB Jlfj) !§' !.fl~iHf:l;X:M.fJUttrVl~~-·· --·-.. -~ ... ..--.. ·-"'·'··"""'"'- -~-·------·

File: MED_F _09.61ECS-MR- 45640 Revision: 10- status: released

AAR - Audit Findings List (Confidential) ifi~~JlU}fiiP ( {i~)

Finding Number:

··~•>'"'Ji 6


Finding Type:

*•~Jl~m.

NC ~ ±.~JGg..m

MNC D {j\~1'&1-¥*

Grade~•: Grade 1-5 GHTF SG3 N19:2012 ~til-5 GHTF SG3 N19:2012

Corrective Action(s) to eliminate cause(s) of detected Non-Conformity (in case MNC: only plan):

~'i!ll~UtfJilB~:if'M~J.j!jjt~(t1t4iEt~Jiai <lm~Jl!MNC: Ht~iHID:

;~. · TlJV .... " ... •.·.·· •.··. '~ Product Service

NA

Training110072001of the F/O "Product Requirements Review Control Procedures" for all staff of the International Trade Department. Make the whole staff clear customer needs and review the customer PO requirements (including delivery date). The results of the review should meet the needs of the customer. If it does meet, they need to communicate with the customer again. After confirming the new requirements, look back to the original review form, conduct a re-assessment, and sign the Pl and contract after confirming that the customer's needs are fully met. Training records: 82800081811001.

xo.HHfitflH1Jf1f 1;X;ffHif iJ11110012001 F/OJ\&;* «;P=rfb;~3JHSV-$¥1rfitll~Jt)> , ·f~t~Jnam~~F1m>J<, M~F •*romHW$<~m~m). W$~-~N·~~f-'•*· ~-:if'-~. -~~~f-'N~~-.-~& A~1">1tJ§. if.il :±l ffiH~$' if!, jtffi<ifi-7,XW$, t£PffliA5lt~¥!Hi1~~f-' ~*fEi. ;&fJPL -&!iiJ o !=ff'iJll'i-cff<:.fil: 82800081811001

.. .. ! , (J Audit Team: TUV SUD review of client response \. ·,·;\ , !'.? Describe evidence of implementation and effectiveness (for NC) (for Grade 2 - 5) ~~,: ~:', · ', ~ The client revised "Products requirements reviewed control procedure" ( 11 oon'cfdt~~trrf \~~}'btapter 5.2.1, the review would be implemented before the final Pl/contract to make sure the products requirements of client could be fulfilled. The revised procedure was trained for relative staff on 2018- f .. 06, training record (82800081810001, ver. A/O) with paper test (e.g. Quan Zhang) maintained and submitted. Based on the evidence submitted according to CA plan, the NC ca e-clo d.

~: TUV sOo X9'~,Fzlfilj((J{Jl.Sf'i$f •Wlll.fT.&;ff~it~iiEti (tf-XIJNC) (~i&2-5)


Ef3T0V SODic*Ll:ilJtl~f1 @lfU~ El ftJl:

File: MED_F _09.61ECS-MR • 45640 Revision: 10 - status: released

! d ~.]··~)

.,, ~ti'a'tl~~·~ u1iJni9l't1~

AAR - Audit Findings List (Confidential) r:fi~~J!\1}15~ ( {~{!)

Finding Number: \tlfi~JJU,~r 7


Finding Type: ifffl(~JJA~IL1

NC D :t.~/F;5-f~

MNC 121

Audit Team: Description of detected Non-Conformity MUST include: Requirement(s) (e.g., QMS·standard, QMS-document, contract), Non-Conformity Statement including Supporting Objective Evidence

'ifi~m, ::f-€tf&JJii.19Mi:t

Grade~jt: Grade 1 - 5 GHTF SG3 N19:2012 ~til-5 GHTF SG3 N19:2012

~~t!.°1t: Jb~ (fVjp, QMS~~. QMSj:fj:., '$-pij) , ~'$--JJi(l(J~i!i!!.mj;fftf~Z\iliiE~

Requirement:

ISO 13485:2016 6.3 Infrastructure

Product Service

NA

The organization shall document requirements for the maintenance activities, including the interval of performing the maintenance activities, when such maintenance activities, or lack thereof, can affect product quality. Records of such maintenance shall be maintained (see 4.2.5).

Jf>1t: 6. 3 ~illi~:hlli

~~@•~--~~~~•~m~~~~~H~•"· m~~~-~~~~~**~~#.ftM•~m~ ATI~:W$o J~f!iH~ll:l:;~tfHfr·ie5rdJ\!.4. 2. 5).


Sampled "Circuit board pressure test fixture" and "humidification maintenance specification and records.

Client Response: Cause Analysis, Correction and Corrective Action "' (in case of extensive response it also may reference to attached document's) f1J1''a.:Jd1L U1tlnt;t'tM ~Effili[r Jjf§?}~ .. t4lE~~4iEM~ <:bP*f"JHJ11:, iiJPHlflH##~~> cu Cause Analysis:

illtlzHHlf: Due to lack of profound learning and understanding of the110063001 of the F/2 clause 5.2.4 "equipment use,

cleaning, maintenance and repair" in the company's procedure document "infrastructure and environment control procedures", which led to the failure to timely improve the content of thedocument 12000041512003 "equipment use, deaning, maintenance and repairment operation instruction", resulting in the lack of maintenanca nrncecf.ui::es..... ., .... ~. · ., ,

File: MED_F _09.61ECS·MR·45640 Rev;s;on; 10- "'""' """'' \: l'

t-

i

~' ;:~ '\

AAR • Audit Findings List (Confidential) EPm~JmWUtt ( {i!D

Finding Number: tfl•~ll.1'-ila 7


Finding Type: ··~31~1h

NC D ±~1'g.t*

MNC [gl

Grade~#'A: Grade 1-5 GHTF SG3 N19:2012 ~tll-5

<7\~1'g.t~ GHTF SG3 N19:2012

Q Product Service

NA

rn=fx1i~"ffll¥f:f)C·ftfl10063001 F/2JI&* «~Tt:JH9Jfil_!:§~Jjif~rbtlf.iFH 5. 2. 4i&~MitJfL ~M, gftl:P .f.U~fld~~~(~>.l-~lll-!/~/F~7*~tl . .@~*&Bt%tt-12000041512003 «W:-iH~JfL ir1i7~, gi£:tNn~tidii~1\Ht=W

~m•>~#~~. ~d~~-~-~-cause<sl: ~IZSI:

The maintenance procedures of "PCB pressure test tooling" and "humidifier cup test tooling" were not added to the document 12000041512003"instructions on equipment use, Cleaning, maintenance and repairrnent operation", so the maintenance and records.of the above tooling were not performed.

*~4*Jf:l:~"!xi'M:!iffi,7Jf;U!IJI~" f.U "mHrt:f~:~~JI~ti'' a~~{Hp{*·JH!fill~·fl' fe¥1Jl2000041512003 «W:·l ~m, M~, -~~---~~~tl;¥»~~~. M~*~~~I·~--~~*Wfil~

Correctjon(s) to eliminate detected Non-Conformity Cin case MNC· only plan):

WJ~~J~~fJ::f-%*1-~A'.J~4iE < w:J~.Ji!!MNC: H~HHJJ) : 1. Learn according to 5.2.4 the use, cleaning, maintenance and repairment of equipment in the file110063001 of the F/2"lnfrastructure and Environmental Control Procedures" of Sysmed.

1, :Jj:filitt~B*JT:f2~B[fif-H1ff5tfiHfl~lH~T:i'Jf:!Eff:Jt{t1:110063001F/2ri* ((~1itlit5thl!U=iJ:1-Jl~}111J~~ff:)) 5. 2. 4 ~&~~ffl,M~--~W••*fi~>.lo

2. Improve the content of "instructions on equipment use, cleaning, maintenance and repaim1ent operation", execute and record according to the operation requirements. . , !'Jr!. :fl!i " 2, ~~12000041512003 ((·i&~f~ffl, 1itt¥~i, ~f£1:Pf11~tH~~i'P1'F-~IUtj~)) fl"JJ*J?6:, e-~fj~~~~:j2

>J('l . • 0-"l .. J' ··.· - ) l.~t ) ;i r:,,~ ~~ . ~~rre~tive Action s to elimi1nat_~ c~~se s of detected Non-Conformit in case M~t/~, - · -~ l~~~T;W.(f.PFi1";~)1J.il1j.tlzMl~J~qiEj'::JJj(k (!JI:JJ;ft~MNC: n;Vrn.~Jl : (l1f~~ '/, i ~J 1. Organize related personnel to learn and understand, and train the relevant pro'(!sions:C.· f..,;.· . J.a s . ,2'.4 equipment use, cleaning, maintenance and repairment in 110063001 of the F/2 "lnfras1rnttt.!re:·a , ).,..A. · tal Control Procedures" of Sysmed. .,,, .. :--,, ~ ·~ ~·,

1, i1lrR*t11cA.9:\ ?¥=3J flHJHv~.:tifUllttF>Bf.frt~l!ii~f f:l·tif*fMfl~~z~ft'j ti. ff)l:f't110063001 Flrill'i""<~•IBll!: / / !!-"ilf Jit~lM M » 5. 2. 4 W~ (I{] ~Ill. ~iffl. illlJJ" 1'1Hllili!i\ ;»; (f.J*1J 'J<J1ll;:E. J 2. Improve the content of 12000041512003 "instructions on equipment use, cleaning, majp ance a rppairm ' operation". supplement the "PCB pressure test tooling" and "humidifier cup tooling'Z' m infenance i~nuct'o d /' ~ implement the record. 2, 7t#l2000041512003 ((i9:.~f~fiL n~rnt ~lli:tf1fri~-OJF!f!w11:f'f~~J13~)) f.1~11(fi:, fJE"~~lmt.&~ ,; W!YI •"~"•~~~~IH"•~m~m~~fi. ~~-ill~o ~- - ~

Completion date for implementation of Correction(s) I Corrective Action(s): f1Jji).:Jft1L U1

fl M'iN #J,ff~4IE/~IEm~B9~~BM: qtn 2018.10.31

Audit Team: TOV SOD review of client response Describe evidence of implementation and effectiveness {for NC) {tor-Srade 9- 5~ ·

File: MED_F _09.61ECS·AAR • 45640 Revision: 10 - status: released

~-'> "" ' 1 -~ .;. ~- _. ·• .::_,

AAR • Audit Findings List (Confidential) Eii~~ll\Uft.Ql (

fiin Order no: BJ18990042

NC D Grade.fl: Finding Number: Finding Type: ±.~.ffg.t*-t Grade 1 .5

$tl~JJi.1'-iJ1 7 ··~J.i~ll.1 MNC ~ GHTF SG3 N19:2012 ~itl-5

<X~'f'iH~ GHTF SG3 N19:2012

~: TOV SOD ~gft@j(ti{Ji.3Fili Miitjll.ff Jt:ff~~~i.iElf ( tf"X!J'NC) (~fi2-5)

Note Client Response receiving date by TOV SOD: 2018-11-22

9 Product Service

NA


FJ3T0V S0Dicjf{!&:¥.tl'.~J~lfilfia~ BM:

Finding Number: tfl•~Jl>'~z 8

Finding Type:

·-~-~lls

NC D Grade~•: Grade 1·5 GHTF SG3 N19:2012 ~itl-5

NA MNC (jz~'f'g.m GHTF SG3 N1~~012~

0 !lo'

Description of Non-Conformity: it1'ci'a~~1b U1\}n~'i1'1 The sample size cannot be demonstrated through "incoming inspection report and material release certificate" (85300011808362, ver. B/2, lot no.: 0818201802011).

~ - --·· ... ----..--"''"""'__..,----______ ..... ~ ... ---·~·~~~· _. ... , .

File: MED_F _09.61ECS·AAR-45640 Revision: 10 - status: released

AAR • Audit Findings List (Confidential) EP~~Jmffl~ ( f*il)

Product Service

Finding Number: ••£•1'-iJi 8


Finding Type: 1¥tl£•~~.

NC D :l?. ¥M1' g. :!* MNC ~ ~j\~1'&~

Grade~IJ: Grade 1 - 5 GHTF SG3 N19:2012 NA ~tl!l-5 GHTF SG3 N19:2012

":ltt~~!~jfH!r.&J.U~·*tll~fi··ilE=f~" (85300011808362, ver. 8/2, lot no.: 0818201802011) 1-t-1 • :fibt!~ E1 illirt:i!!ffi.:~~icJJ'<x~liE~o

Supporting Objective Evidence: ;tltt-E ~x!lHiE th!: IQC of sampled material - air compressor: 85300011808362, ver. B/2, lot no.: 0818201802011

Records Reviewed:

113~ 8 '$ tf< IQC of sampled material - air compressor: 85300011808362, ver. B/2, lot no.: 0818201802011

Client Response: Cause Analysis, Correction and Corrective Action (In case of extensive response it also may reference to attached document's)

f;fl reJj[: JlfUHJT .. ~4.iE~j4.iEM»lli c:«ii~f"JH1.:. 1iJW.~111Jl!H'flt:m:tt> Cause Analysis: Jjf2H:Hfr:

The program documents do not stipulate the raw materials for the compressor, integral valve, blower, and power adapter. During the incoming random inspection, the factory number and the test data of each raw material shall be recorded, and the "purchase inspection report and raw materiftlS release certificate" does not reflect the factory number and test data of the raw materials tlffaJt.0~' ~~d the sampling test. It is impossible to identify which materials and test data that h av .. e{~S"etf~e ~cf~'-inspection. J''7 / ,r--.. ·• ~ .

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\ ·:· J .... ~(" '"""" / ·-.:i·

Cause(s): '=-'~.,~: ,·}, i _Ir·>~~ Eift.IZSI: ~ ... \,t,,..,,, .... 1. There is no requirement in the program document for raw materials related to compressor, integral valve,~blower and power adapter, and the factory number and test data of each raw material tested shall be recorded during th random inspection;

1. l~Jf:)(f'ftf:ti.~~ij!JE:x~lli~afJl, -f.iqfij, 11~mfMUJL, r:t!J.iiOHc~*ff!!JJMH;. tEJd~/~~J?·-jJt :l ,

:lllJ~ a{J 'fff. t- illlM *4LI:I1-rtm ~ & t.& ~~1u rx: {a rt~ ?Q ;J(:: /- 'tr! /

2. The raw material factory number and test data are missing in the record.

2. fil~~•&•M#l~MMLI:1r•~&~MftM0 ~ 0 ~ 'lt1'iiJ~~1L u1rin~'tN

Correction(s) to eliminate detected Non-Conformity (in case MNC: only plan): 'l.I

wmt~~tJ~~-&~~a~~4IE <9a.~hiMNc: fH11Ht~J) : 1. Modify the110082002 "monitoring and measurement control procedures of processes and product" lo E/5 revision.New! added 5.1.3 com ressor, inte rated valve, blower and ower ada ter are the ke raw materials of

File: MEO _F _09.61 ECS-MR - 45640 Revision: 10- status: released

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. -··· ···-····---·--..... ---···---·····~· ·----.~-·-""" •'

AAR - Audit Findings List (Confidential) ifi~6tJM~.€P ( fimn

Finding Number: ••JtJl!Ft:-if, 8

Orderno:BJ18990042

Finding Type: ··~JJil~ll1

NC

MNC

D Grade~it: Grade 1·5 GHTF SG3 N19:2012 ~tll-5

(jz~1'g.fi1t GHTF SG3 N19:2012

:.A./ru1.·:········i·· ="1fl Product Service

NA

the company's products. The quality management department shall fill in the "incoming inspection report and raw material release certificate (attached form)" with factory number and test data when the key raw materials are incoming inspected.The record number in the incoming inspection report and raw material release certificate (attached form) is consistent with the corresponding incoming inspection report and raw material release certificate of this batch.

1, ~ii3k:110082002 «J:ilj&t= 1Prl n~ lla"truf1.1~~1tliti~tti1J~r=r-» , 1t~BJ(Jl&.*J§~:A"Ef5o *1r !i5.1.3Bif1~tfL, -1* R~~•mm, ~•mEM~0ffl~~~-~MM.~~--ti-~A~M~~. ~--~fi·~~ ~<m•*•*~&~MM~fffil~<ffl•J».*~-~~B~~~ttM~~r·~~~ffi~~fiOO:: <.itttitti¥HES.~s&J.~HHlJ.:JJHr1iH~ Offf{) )) r.1=1 B~ic~tfiU-~_l~fMtUtlJ~Z tit!:§~tft~tHfH!r &mtt~ *4n!l:ffiiE4~)) f~-¥.Yo

2. From 2018.10.10, the incoming inspection will be recorded on the raw material compressor, integral valve, blower and power adapter. The record 859 "Incoming Inspection Report and Raw Material Release Certificate (attached form)" is recorded the factory number and test data. 2 . .M201a.10.10 a Pa, illJli'f:&!!tx'.t*~EiJ{H*·~ffiJ~ttt, -¥fc1£~, ~~~Tief>Q:tn., Ehi!iiUi!lifr:*f, ¥r±bit1c51~as9 (G:tHlf;fft!iftf~ i!r&JJi{#*!l·7i!!ff1iE4'5 (~f.t~i) )) ·ta*~B<:tm:f&mttt~4UJl~Wlk:f§g,~!tl~UL

Corrective Action(s) to eliminate cause(s) of detected Non-Conformity fin case MNC: only plan):

1f-1~~~J.W.8<J/f'S~tji!I*IEIA<J~4lE1~00! ((i!ltli!;f~MNC: R1/HHJJ) : . ;.,,.J Id

/;.• •IVI •n 1. On Oct, 09, 2018 quality QC personnel were trained on the modified E/5 version of 11P _, r. . and product monitoring and measurement control procedures, and the training records are refer~ 06 . cf~•. ~, 201~.~o:_09Mli1!:i:OCA..ITT:i1HH~~J§E/5filii*110082002 G1li&t'"rfll18~lKit~,~~~. · ~l'iFf1. (1 ~ VII. <:lfiVlliCilU J\!.82800011810001" .,, ~ , ~

Comoletion date for implementation of Correctionlsl I Corrective Actionls): ~ /111'; l;~} 1tl.fi14IE/~41H~Dffi~~.5XB•JJ: ~.··~rf / .;,,_~.y 2018.10.09 II •i~ .., ,\.:. ''

Audit Team: TOV SOD review of client response Describe evidence of implementation and effectiveness (for NC) (for Grade 2 - 5)

·~m,, TOV SOD ~~F [E]j((J(JW'ifi ~tU!jl.ffll*°~tttroiiEI! <tf"XIJ'NC) C~tl2-5)


The CA plan was submitted and reviewed by audit team, the effectivenes during next audit.

rt!TOV SODie~1J~W~P~1 lill }'[8~ B JYJ:

File: MED_F _09.61ECS-MR - 45640 Revision: 10 - status: released .

rv

AAR - Audit Findings List {Confidential) ilim~l'l!il.€P ( {~II)


Number Identification Description (I or P)*

!f-5 f/7'19'(1 Q,I(; P)* tl:i£

The Audit Team reviewed and accepted all Client Responses to the NC and MNC's.

• Product Service

There was sufficient evidence of effective implementation of corrective action plans for all NC's. Based on the evidence reviewed the audit team concludes that the company's Quality Management System is effective and conforms to the Audit criteria.

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~, ( The Audit Team now recommends: r¥t*ffi~~Atff [gl Issuance I continuation of certificates I

~;ftJ/~fE~fiE=t-5 I

D Suspension of Certificate ~·~iiE ~

D Withdrawal of Certificate J!@HiE ~

D Reduction of Certificate scope iJ~1J,i1E4J;fr!.l!EI

D

Mr. Wei Wang

'$ t~ ~J3:l~

TD Assessor (if applicable)

t1:;.i(Jt·ft~W$ ~ <:~rH!li:J=§H•J')

File: MED _F _09.61 ECS-MR • 45640

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Revision: 10- status: released

LGl£J

www.onim.edicalcom

BG620309

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