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DEVICE DETAILS

NAME OF DEVICEPULSE OXIMETER OLV-4201
ESTABLISHMENT NAMENIHON KOHDEN MALAYSIA SDN BHD
REGISTRATION NOGC95939699418
BRAND NAMENIHON KOHDEN (OLV-4201)
DESCRIPTIONTHE PULSE OXIMETER IS A COMPACT MONITOR WITH A 7-INCH DISPLAY AND IS DESIGNED FOR TOUCHSCREEN OPERATION AT THE PATIENT’S SIDE. THE PULSE OXIMETER IS INSTALLED NEAR THE PATIENT TO DISPLAY THE PATIENT’S VITAL SIGNS (SPO2, PULSE RATE, ETC.) ON THE DISPLAY AND GENERATE ALARMS. NEONATES, CHILDREN AND ADULTS CAN BE MONITORED WITH THIS PULSE OXIMETER. WHEN THE OPERATION MODE IS SET TO NETWORK MODE, THE PULSE OXIMETER CAN CONNECT TO A NIHON KOHDEN CENTRAL MONITOR NETWORK AND COMMUNICATE WITH CENTRAL MONITORS AND BEDSIDE MONITORS IN THE NETWORK.
INTENDED PURPOSETHE PULSE OXIMETER IS INSTALLED NEAR THE PATIENT TO DISPLAY THE PATIENT’S VITAL SIGNS (SPO2, PULSE RATE, ETC.) ON THE DISPLAY AND GENERATE ALARMS. THIS PULSE OXIMETER MUST BE USED BY QUALIFIED MEDICAL PERSONNEL WITH FULL KNOWLEDGE OF ITS FUNCTIONS AND OPERATIONS WITHIN THE ENVIRONMENT OF HOSPITALS SUCH AS CRITICAL CARE, ICU, HCU, OR, GCU, OUTPATIENT CLINIC, GENERAL WARD AND SO ON. IT IS NOT INTENDED FOR PATIENTS TO USE. IT IS NOT INTENDED TO USE OUTSIDE OR AT HOME, EITHER.
VALIDITY DATE OF REGISTRATION22-02-2018 - 21-02-2023

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Pulse Oximeter, OLV-4201OLV-4201
2Power cord NPower cord N
3Power cord ULPower cord UL
4Battery pack, SB-170PSB-170P
5Transmitter, ZS-900PGZS-900PG
6Transmitter, ZS-900PKZS-900PK
7Software kit, QS-007TAQS-007TA
8Software kit, QS-007TKQS-007TK
9SpO2 connection cable, JL-400TJL-400T
10SpO2 connection cable, JL-430UJL-430U
11SpO2 connection cable, JL-030U1JL-030U1
12SpO2 connection cable, JL-030U2JL-030U2
13HFAS switch, RY-420TRY-420T
14Site label, YS-113P0YS-113P0
15Ground lead, L913L913
16Cart, KC-170PKC-170P
17Adapter, DH-171PDH-171P
18Adapter, DH-172PDH-172P
19ZS holder, DH-380PDH-380P
20Finger probe, TL-201TTL-201T
21Finger probe, TL-630T3TL-630T3
22Finger probe, TL-600T0TL-600T0
23Finger probe, TL-630T1TL-630T1
24Finger probe, TL-631T1TL-631T1
25Finger probe, TL-631T3TL-631T3
26Finger probe, TL-601T0TL-601T0
27Multi-site probe, TL-220TTL-220T
28Disposable SpO2 probe, TL-271TTL-271T
29Disposable SpO2 probe, TL-271T3TL-271T3
30Disposable SpO2 probe, TL-272TTL-272T
31Disposable SpO2 probe, TL-272T3TL-272T3
32Disposable SpO2 probe, TL-273TTL-273T
33Disposable SpO2 probe, TL-273T3TL-273T3
34Disposable SpO2 probe, TL-274TTL-274T
35Disposable SpO2 probe, TL-274T3TL-274T3
36Disposable Multi-site Y probe, TL-260TTL-260T
37Disposable SpO2 probe, TL-051STL-051S
38Disposable SpO2 probe, TL-052STL-052S
39Disposable SpO2 probe, TL-061STL-061S
40Disposable SpO2 probe, TL-062STL-062S
41Disposable SpO2 probe, TL-535UTL-535U
42Attachment tape, P263P263
43Sponge attachment tape, P260AP260A
44Sponge attachment tape, P260BP260B
45Clip adapter, P256P256
46Fixing tape for disposable probes, P260CP260C
47Attachment tape, P264AP264A
48Attachment tape, P264BP264B
49Probe fastener, YS-093P2YS-093P2