ʻO ke kala ʻula Doppler Ultrasound no nā mea holoholona vDult T8 Kiʻi Hōʻike ʻia

ʻO ke kani ʻo Doppler Ultrasound no ka holoholona vDult T8

Huahana Huahana

ʻIkepili ʻenehana:

1:	ʻO ka hōʻuluʻulu o nā kikoʻī nui a me ka ʻōnaehana o ke kala kala Doppler ultrasound
1.1	Trolley type a pau kikohoʻe kala Doppler ultrasonic mainframe
1.2	Pūnaehana hoʻokele kani ultrasonic: ʻōnaehana hana Windows
1.3	Nā noi:ʻO ka ʻōpū, obstetrics, gynecology, naʻau, urinary system, nā ʻāpana liʻiliʻi, superficial, nā kīʻaha koko, nā pediatrics, nā keiki hānau hou, musculoskeletal.
1.4	Nānā:ʻImi convex, ʻimi Tran-vaginal, ʻimi Linear, ʻimi Micro-convex, ʻimi naʻau, 4D Volume.ʻimi
1.5	Nā noi a me ka hōʻike:ʻObdominal, OB, GYN, Cardiac, Urinary, Nā ʻāpana liʻiliʻi, Superficial, Vascular, Pediatrics, ʻO nā pūʻolo polokalamu ana kiʻekiʻe, hōʻike pūʻolo lako polokalamu, pūʻolo polokalamu hoʻokele hihia, etc.
☆1.6	ana mānoanoa o ke aʻa carotid (IMT)
☆1.7	Ana 'akomi spectral envelope
1.8	Ka hoʻouna kikohoʻe piha a me ka loaʻa ʻana o ka beam synthesizer
1.9	ʻO ke kiʻi Doppler kala (C)
1.10	Pulse Doppler Kiʻi (PW)
☆1.12	ʻO ke kiʻi ʻokoʻa ʻokoʻa (CCI)
1.12	Ke kiʻi Doppler hawewe mau (CW)
☆1.13	B/C/D ʻekolu kiʻi synchronous i ka manawa maoli
☆1.14	Ka mana Doppler imaging (PDI)
☆1.15	ʻO ke kiʻi kiʻi Doppler Power Direct (DPDI)
1.16	M mode kiʻi
☆1.17	Anatomic M mode kiʻi
☆1.18	ʻO ke kiʻi kala Doppler M mode
☆1.19	Elastography
☆1.20	Tissue Doppler imaging（TDI）
☆1.21	ʻO ke kiʻi kiʻi ʻana o ke ahonui (SRI)
1.22	ʻO ke kiʻi harmonic tissue（THI）
1.23	Fusion harmonic imaging (FHI)
1.24	Speckle Reduce imaging (SRI)
☆1.25	Kiʻi kiʻi panoramic
☆1.26	Kiʻi hoʻokaʻawale
☆1.27	Kiʻi trapezoidal
1.28	ʻO ka hoʻoponopono wikiwiki ʻana
☆1.29	3D lima kūʻokoʻa
1.30	Kiʻi 3D manawa maoli（3D/4D）
1.31	DICOM3.0
1.32	Nānā: ≥21.5 iniha, hōʻike ultrasonic wehewehe kiʻekiʻe
1.33	≥13.3 iniha paʻi pā
1.34	Pākuʻi kino: mālama i ke kiʻi ma ka ʻaoʻao hema o ka pale, hiki ke hoʻololi pololei a holoi ʻia paha.
1.35	Loaʻa i ka ʻōnaehana ka hana o ka hoʻonui ʻana ma ka wahi
1.36	Presupposition: no ka nānā like ʻole o ka viscera, hoʻonohonoho i nā kūlana nānā no ke kiʻi maikaʻi loa, e hoʻemi i ka hoʻoponopono ʻana o ka hana, a me ka hoʻoponopono maʻamau o waho a me ka hoʻoponopono hui.
1.37	ʻImi ʻimi: 4
1.38	Pūnaehana Pākē a me Pelekāne, Pākē a me Pelekāne hoʻokomo, koho
1.39	Ka hohonu: ≥360mm；
1.40	Hoʻonui kiʻi
2:	ʻImis
2.1 ʻO ka ʻimi convex	Ka pinepine kumu:2.0MHz/2.3MHz/2.5MHz/3.0MHz/3.5MHz/4.0MHz/4.6MHz/5.0MHz/5.4MHz,Harmonic Frequency:4.0MHz/4.6MHz/5.0MHz，
2.2 ʻImi laina	Ka pinepine kumu: 4.0MHz/4.6MHz/5.0MHz/6.0MHz/7.0MHz/8.0MHz/9.2MHz/10.0MHz/12.0MHz/13.3MHz，Harmonic Frequency:8.0MHz/9.2MHz/10.0MHz,
2.3 ʻImi ʻauʻau	Ka pinepine kumu: 4.0MHz/4.6MHz/5.0MHz/6.0MHz/7.0MHz/8.0MHz/9.2MHz/10.0MHz/12.0MHz/13.3MHz，Harmonic Frequency:8.0MHz/9.2MHz/10.0MHz,
2.4 ʻImi micro-convex	Ka pinepine kumu:3.0MHz/3.5MHz/4.0MHz/5.0MHz/5.4MHz/6.0MHz/7.0MHz/8.0MHz，Harmonic Frequency: 6.0MHz/7.0MHz/8.0MHz，
2.5 Ka ʻimi naʻau	Ka pinepine kumu: 1.7MHz/1.9MHz/2.1MHz/2.5MHz/3.0MHz/3.4MHz/3.8MHz/4.2MHz/5.0MHz，Harmonic Frequency:3.4MHz/3.8MHz/4.2MHz，
2.6 4D Volume probe	Ka pinepine kumu:2.0MHz/2.5MHz/3.0MHz/3.3MHz/3.7MHz/4.0MHz/5.0MHz/6.0MHz，Harmonic Frequency: 4.0MHz/5.0MHz/6.0MHz，
3:	ʻano kiʻi kiʻi 2D
3.1	Loaʻa: 0－100， ʻAkahi 2 hiki ke hoʻololi
3.2	TGC: 8 māhele hiki ke hoʻololi
3.3	ʻO ke kiko kiko kiʻekiʻe loa: ≥7, hiki ke hoʻoneʻe ʻia i ke kaʻina holoʻokoʻa.
3.4	Ho'ēmi kiko: 0-5，5 pae
3.5	Ka Hoʻohui Mokuna: 0-2 ，2 pae （Liner probe: 3 pae ， naʻau naʻau: 0）
3.6	Dynamic:30-180，35 pae， ʻanuʻu 5 hiki ke hoʻololi
3.7	Ka laina laina: haʻahaʻa, waena, kiʻekiʻe, 3 pae
3.8	Ka pilina o ka papa: 0-4, 4 pae
3.9	Hoʻemi ka leo: 0-5，5 pae
3.10	Hoʻonui ʻili: 0-5，5 pae
3.11	Mana kani: 2-10, 9 pae
3.12	Kaulana hina: 0-67, 67 pae
3.13	Ka waihoʻoluʻu: 0-67，67 pae
3.14	Kaila kiʻi:Soft-Comparison，2 pae
	Loaʻa i ka pale ka hōʻike manawa maoli o ka mana leo, ka pinepine probe, ka laulā ikaika, ka waihoʻoluʻu pseudo, ka unahi hina a me nā ʻāpana ʻē aʻe 11 hiki ke hoʻoponopono ʻia.
4:	kalakalaDopplerImagingMode
4.1	Loaʻa i ke koko: 0-100, ʻAkahi 2
4.2	Hōʻike ʻia nā ʻāpana: Velocity, Variance
4.3	B-Kaohi（B/W kaohi）：0-7, 7 pae
4.4	Ka wikiwiki: 0-8, 8 pae
4.5	Helu laʻana: 6-24, 7 pae
4.6	Makemake ʻia ke kahe koko: 0-8, 8 pae
4.7	Kānana: 1-6, 6 pae
4.8	Mana kani: 2-6, 4 pae
4.9	Hoʻemi ka walaʻau: 0-4, 4 pae
4.10	Hana maʻalahi: 0-4， 4 pae
4.11	Ka pilina o ka papa: 0-6， 6 pae
4.12	Chromatography（Kahe koko）：0-37， 37 pae
4.13	Kaha laina: Haʻahaʻa-Middle-Kiʻekiʻe， 3 pae
4.14	Ka pinepine: 4 pae hiki ke hoʻololi
4.15	Ka wikiwiki: 0.4K ka liʻiliʻi loa, 40.5KʻImi hoʻopaʻa:0.4K-4.3K-38.5KʻImi laina:0.4K-14.7K-39.0K ʻO ka ʻimi noiʻi ʻana: 0.4K-7.8K-39.7K ʻImi nui:0.4K-4.2K-34.8K ʻImi micro-convex:0.4K-10.3K-40.5K ʻimi naʻau:0.4K-7.8K-39.7K
	PS: Hoʻololi ke alapine o ka ʻimi noiʻi a hoʻololi ka waiwai alapine
	PS: Hoʻololi ka pākuʻi me ka wikiwiki
5:	PulsenaluDoppler（PW）
1	Loaʻa: 0-100, KaʻAnuʻu 2
5.2	ʻO ka hana o ka spectrum envelope: ka manawa maoli i ka envelop spectrum, ka envelope spectrum manual, a me nā ʻano ʻē aʻe.Hoʻopili maʻalahi ka ʻōnaehana a hōʻike i nā ʻikepili like ʻole e like me PSV, EDV, RI, PI, S/D, ACC, HR a pēlā aku.Hiki ke ala a kokoke
5.3	Laʻana nui:0.5mm~30mm
5.4	ʻAnela koko: -75—75 degere, ʻanuʻu 5
5.5	Ka waihoʻoluʻu: 0-67 ， 67 pae
5.6	Ka laulā dynamic:20-40， 4 pae
5.7	Kānana: 0-9, 9 pae
5.8	Hoʻomaʻamaʻa maʻalahi: 1-4 ， 4 pae
5.9	Mana kani: 2-5, 4 pae
5.10	Volume: 0-100, 10 pae, ʻanuʻu 10
5.11	Kānana leo: 0-4 ， 4 pae
5.12	Laina kumu:-1.0~1.0,
5.13	Palapala 'āhinahina: 0-67， 67 pae
5.14	Ka wikiwiki scan: 100-500, 6 pae
5.15	PRF: 0.5K ka palena iki, 87.5KʻO ka ʻimi convex:0.5K-4.3K-63.3KʻImi laina:0.5K-14.5K-78.4K ʻO ka ʻimi ʻana i ka waha:0.5K-8.1K-78.4K ʻImi nui:0.5K-4.2K-53.8K ʻImi micro-convex:0.5K-10.3K-81.1K ʻimi naʻau:0.5K-4.3K-87.5K
5.16	Ka pinepine: 4 pae
	PS: Hoʻololi ke alapine o ka ʻimi noiʻi a hoʻololi ka waiwai PRF
	PS: Hoʻololi ke alapine o ka ʻimi noiʻi a hoʻololi ka waiwai alapine
6:	Nalu mauDoppler（CW）
6.1	Kākoʻo ʻimi: Cardiac probe
6.2	Hiki ke hoʻololi ʻia ka hoʻoponopono ʻana i nā ʻāpana mode B
6.3	Loaʻa: 0-100, KaʻAnuʻu 2
6.4	Hiki ke hoʻololi ʻia ke kūlana laina laʻana
6.5	PRF:0.9K~36.1K
6.6	Kumu:-1.0~1.0
6.7	Anela koko:-75~75 degere
6.8	Palapala 'āhinahina: 0-67
6.9	Ka wikiwiki o ka nānā 'ana: 100-300
6.10	Ka waihoʻoluʻu: 0-67
6.11	Laina ikaika: 20-40
6.12	Kānana: 0-9，9 pae
6.13	Hana maʻemaʻe: 1-4
6.14	Ka pinepine: 2.0MHz/2.3MHz/2.5MHz/3.0MHz, 4 pae hiki ke hoʻololi
6.15	Mana kani: 2-5
6.16	Volume: 0-100
6.17	Kānana leo:0-4
☆7:	Anatomical M imaging
7.1	Kākoʻo probe: Convex probe, Linear probe, Cardiac probe
7.2	Hiki ke hoʻololi ʻia ka hoʻoponopono ʻana i nā ʻāpana mode B
7.3	Loaʻa: 0-100, KaʻAnuʻu 2
7.4	M Hiki ke hoʻololi ʻia ka ʻānela laina laʻana
7.5	M Hiki ke hoʻololi ʻia ka lōʻihi o ka laina laʻana
7.6	Laina laʻana: 3, Hiki ke hōʻike ʻia a hūnā ʻokoʻa paha
☆ 8:	Kahe kokoM mode（MC）
8.1	Hiki ke hoʻololi ʻia ka hoʻoponopono ʻana i nā ʻāpana mode B
8.2	Loaʻa: 0-100，Step2
8.3	Hiki ke hoʻololi ʻia ka ʻānela laina MC Sampling
8.4	Hiki ke hoʻololi ʻia ka lōʻihi o ka laina MC Sampling
8.5	Ka pinepine: 4 pae
8.6	Helu laʻana: 6-24
8.7	Ka māmā holo: 0-8, 8 pae
8.8	Ka wikiwiki o ka nānā 'ana: 150-500
8.9	Ka pilina o ka papa: 0-6, 6 pae
8.10	Kānana: 1-6，6 pae
8.11	Makemake ʻia ke kahe koko: 0-8，8 pae
8.12	Hoʻomaʻamaʻa maʻalahi: 0-4,4 pae
8.13	Palapala ʻāina: 0-37, 37 pae
☆9：	Elastography
9.1	Hiki ke hoʻololi ʻia ka hoʻoponopono ʻana i nā ʻāpana mode B
9.2	Loaʻa: 0-100, KaʻAnuʻu 2
9.3	B/E， Hōʻike ʻelua manawa maoli ma ka pale like
9.4	Hōʻike ʻia ka pihi hoʻoneʻe ʻimi: I luna/Iho
9.5	Hōʻike pā hōʻike paʻi
9.6	Ka pinepine: 8-9 pae, hiki ke hoʻololi; e like me ka hōʻike hōʻike
9.7	Hoʻemi ka leo: 0-2, 2 pae
9.8	Ka pilina o ka papa: 0-3, 3 pae
9.9	Hoʻohālikelike: 0-13, 13 pae
9.10	Ka waihoʻoluʻu: 0-3 ， 3 pae
9.11	Mai kākoʻo i ka ʻimi naʻau
☆ 10:	KiʻiDopplerkiʻi (TDI)
10.1	Kākoʻo ʻimi: ʻimi naʻau
10.2	Hiki ke hoʻololi ʻia ka hoʻoponopono ʻana i nā ʻāpana mode B
10.3	Loaʻa: 0-100, ʻanuʻu 2
10.4	wahi ROI hiki ke hoʻololi
10.5	Helu laʻana: 6-24
10.6	Ka wikiwiki: 0.4K-8.0K
10.7	Ka pilina o ka papa:0-6，6级
10.8	Mea makemake ʻia: 0-7, 7 pae
10.9	Ka pinepine: 2.0MHz/2.3MHz/2.5MHz/3.0MHz
10.10	Kākoʻo i ka hoʻohuli kala
☆ 11:	ʻO ke kiʻi kiʻi ʻana
11.1	Kākoʻo ʻimi: ʻimi naʻau
11.2	Hiki ke hoʻololi ʻia ka hoʻoponopono ʻana i nā ʻāpana mode B
11.3	wahi ROI hiki ke hoʻololi
11.4	Loaʻa: 0-100, KaʻAnuʻu 2
11.5	Helu laʻana:6-24，6 pae
11.6	Axial awelika:1-4， 4 pae
11.7	Ka wikiwiki: 0.4K-8K
11.8	Ka pilina o ka papa: 0-6， 6 pae
11.9	ʻO ka hoʻonui ʻana i ka ʻili: 0-7，7 pae
☆ 12:	Kiʻi kiʻi panoramic
12.1	Kākoʻo probe: Linear probe
12.2	Ho'ēmi Speckle: 0-5, 5 pae
☆ 13:	Kiʻi hoʻokaʻawale
13.1	Kākoʻo probe: Linear probe
13.2	Hiki ke hoʻololi ʻia ka hoʻoponopono ʻana i nā ʻāpana mode B
13.3	Anela deflection: 8 pae
13.4	Ho'ēmi kiko: 0-5, 5 pae
13.5	Laki hoʻolalelale: 30-180 ， Kaʻanuʻu 5
13.6	Ka laina laina: haʻahaʻa-waena-kiʻekiʻe，3 pae
13.7	Hoʻopili ʻana i ka pā: 0-4， 4 pae
13.8	Ka waihoʻoluʻu: 0-67, 67 pae
13.9	Kaila kiʻi:Soft-Comparison，2 pae
13.10	Hoʻemi ka leo: 0-5, 5 pae
13.11	Hoʻonui ʻili: 0-5，5 pae
13.12	Mana kani: 2-10，8 pae
13.13	Palapala 'āhinahina: 0-67，67 pae
☆ 14:	Kiʻi trapezoidal
14.1	Kākoʻo ʻimi: ʻimi laina
14.2	Hiki ke hoʻololi ʻia ka hoʻoponopono ʻana i nā ʻāpana mode B
14.3	Anela deflection: 8 pae
14.4	Ho'ēmi kiko: 0-5, 5 pae
14.5	Laki hoʻolalelale: 30-180 ， Kaʻanuʻu 5
14.6	Ka laina laina: haʻahaʻa-waena-kiʻekiʻe，3 pae
14.7	Hoʻopili ʻana i ka pā: 0-4， 4 pae
14.8	Ka waihoʻoluʻu: 0-67, 67 pae
14.9	Kaila kiʻi:Soft-Comparison，2 pae
14.10	Hoʻemi ka leo: 0-5, 5 pae
14.11	Hoʻonui ʻili: 0-5，5 pae
14.12	Mana kani: 2-10，8 pae
14.13	Palapala 'āhinahina: 0-67， 67 pae
14.14	Ka Hoʻohui Mokuna: 0-2, 2 pae
☆15	Kiʻi kiʻi lima lima lima
15.1	Kākoʻo probe: convex probe, linear probe
15.2	Hoʻohālike hōʻike: 4 kiʻi
15.3	Hoʻololi Kiʻi X/Y/Z Axis
15.4	ʻIke ʻana i nā ʻāpana he nui
16	Kiʻi 4D manawa maoli
16.1	Kākoʻo probe: 4D volume probe
16.2	Hiki ke hoʻololi ʻia ka hoʻoponopono ʻana i nā ʻāpana mode B
16.3	Loaʻa: 0-100, KaʻAnuʻu 2
16.4	Hoʻohālike hōʻike: hoʻokahi kiʻi, ʻelua kiʻi, ʻehā kiʻi
16.5	Ka Loli Kiʻi:X/Y/Z Axis
16.6	ʻIke ʻana i nā ʻāpana he nui
16.7	Hoʻohuli ʻia ka mālamalama a me ka malu
16.8	Māmā: 0-4, 4 pae
16.9	Paepae: 0-129, ʻanuʻu 3
16.10	Mākaʻikaʻi: 1-509 ， KaʻAnuʻu 10
16.11	ʻAno hāʻawi: 4 ʻano, Surface, maximum, liʻiliʻi, hiʻohiʻona
17:	Hoʻonui Kiʻi
17.1	Loaʻa: 0－100, KaʻAnuʻu 2
17.2	TGC: 8 māhele hiki ke hoʻololi
17.3	ʻO ke kiko kiko kiʻekiʻe loa: ≥7, hiki ke hoʻoneʻe ʻia i ke kaʻina holoʻokoʻa.
17.4	Ho'ēmi kiko: 0-5，5 pae
17.5	Space Compound:0-2 ，2 pae （Linear probe: 3 pae ， ʻaʻole kākoʻo i ka ʻimi naʻau)
17.6	Laina hoʻolalelale: 30-180, 35 pae, ʻanuʻu 5
17.7	Laina haʻahaʻa: Haʻahaʻa, waena, kiʻekiʻe, 3 pae
17.8	Ka pilina o ka papa: 0-4,4 pae
17.9	Hoʻemi ka leo: 0-5，5 pae
17.10	Hoʻonui ʻaoʻao: 0-5，5 pae
17.11	Mana kani: 2-10, 9 pae
17.12	Palapala 'āhinahina: 0-67, 67 pae
17.13	Ka waihoʻoluʻu: 0-67，67 pae
17.14	Kaila kiʻi:Soft-Comparison，2 pae
17.15	Ka pae i hoʻonui ʻia: 72 pae kiʻekiʻeʻO ka ʻimi convex: 9 paeʻO ka huli ʻana o ka ʻōpū: 72 pae ʻImi micro-convex: 29 pae Ka ʻimi naʻau: 40 pae 4D Volume probe: 17 pae
	PS: Loaʻa i ka pale ka hōʻike manawa maoli o ka mana leo, ka pinepine probe, ka laulā ikaika, ka waihoʻoluʻu pseudo, ka unahi hina a me nā ʻāpana ʻē aʻe 11 hiki ke hoʻoponopono ʻia.
	PS: Ke piʻi ka nui o ka ʻimi ʻimi noiʻi i ka palena kiʻekiʻe loa, ʻo 0 ka wahi i hoʻohui ʻia.
18:	Hana ana a me ka nānā 'ana:
18.1	Ana maʻamau: Ka mamao, ʻāpana, ellipse, laina keʻa, kihi, ratio mamao, leo, Volume (ellipse), ratio ʻāpana, anawaena, huina hui
18.2	ʻO ka naʻau: ʻO ka envelope kikoʻī kikoʻī, LV, ʻO ke anawaena o ke aʻa Pulmonary Nui, RVEDd, RVEDs, LVM, LAV, HR, MVF, AO, AR, LVOT, TVF, Pulmonic valve, DOpplerV vein, Pulmonary vein, MVF, AO, AR, LVOT. 、 LVMI, AV
18.3	Vascular: carotid intima (IMT), ka lōʻihi stenosis ratio, area stenosis ratio, IMT (hope o ka paia), IMT (mua o ka paia)
18.4	OB: ʻO ka hana maʻamau Fetal, AFI, TW, GS, CRl, OFD, HL, ulna, NT, Fibula, Nbonel, Radial, Tibia
18.5	GYN: ʻōpū, ʻāʻā, corpus uteri/pūpū ʻōpū, ʻaʻa ovarian hema, ʻaʻa ovarian ʻākau, follicle nui, mānoanoa intima.
18.6	Urology: prostate, ke koena mimi, ka ʻāʻī hema, ka ʻāʻī ʻākau, ka ʻaʻa suprarenal hema, ka suprarenal ʻākau, ka ʻāʻī hema, ka ʻāʻī ʻākau, ka vesic seminal hema, ka vesic seminal ʻākau.
18.7	ʻOpu: ate, CHD, ʻāpana vein anawaena, cholecyst, CBD, pancreas, spleen, anawaena o loko o ka aorta ʻōpū, ʻōpū.
18.8	Nā ʻāpana liʻiliʻi: Thyroid
18.9	Pūʻolo lako polokalamu: pūʻolo ana, pūʻolo lako polokalamu, pūʻolo lako polokalamu mālama moʻolelo olakino
19:	Pūnaehana hoʻomalu kiʻi a me kikokiko
19.1	Kūkulu ʻia ka mea hoʻokipa ma 2 disk paʻa (SSD 120+1T), hoʻomaka wikiwiki a paʻa.
19.2	Pāʻani kiʻiʻoniʻoni: ≥1200 mau kiʻi
19.3	Pūnaehana hoʻokele ʻike waihona waihona: hiki ke hoʻopaʻa i ka helu maʻi, ka inoa, ka helu helu, ka lā nānā a pēlā aku, a hiki ke ʻimi a mālama ʻia e ka helu ʻana, helu helu, inoa a pēlā aku.
19.4	ʻO ke ʻano o ka hōʻike he 16
19.5	Hoʻokahi kī wikiwiki hōʻike kiʻi a me ka hoʻokele kikokikona
20:	Ikepili
20.1	ʻO ke kelepona USB: 4
20.2	Hoʻopili HDMI: 1
20.3	RJ-45 hoʻopili:1
20.4	Hoʻopili uea honua:1
20.5	DVD RW:1
21:	Hoʻonohonoho
21.1	ʻO Trolley ʻano piha kikohoʻe kala Doppler ultrasound ʻōnaehana diagnostic
21.2	Probe: convex array probe (maʻamau), linear probe (koho), Trans-vaginal probe (koho), cardiac probe (koho), 4D volume probe (koho)
21.3	≥13 nā kī hoʻoponopono wikiwiki
22:	ʻenehana, lawelawe ma hope o ke kūʻai aku a me nā koi ʻē aʻe
22.1	Ma hope o ka ʻae ʻia ʻana, manuahi ka palapala hōʻoia no ʻelua makahiki (E hāʻawi i ka palapala hōʻoia mea hana)
22.2	Loaʻa i ka mea hana ka palapala hōʻoia ISO13485 a me ka palapala hōʻoia EU CE.