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Safety and Performance Information / Operator's Manual for IVD Reagents

Safety and Performance Information / Operator's Manual for IVD Reagents

This page provides the Safety and Performance Information of Nihon Kohden products as per the requirements defined in the Section 23.1 of Annex I of the EU MDR: Medical Device Regulation 2017/745/EU, and Section 20.1 of Annex I of EU IVDR: In Vitro Diagnostic Medical Device Regulation 2017/746/EU, as well as the Operator’s Manuals for IVD reagents. 
This Safety and Performance Information is an extract from the General and Safety Information sections of the most recent edition of the Operator's Manual or Installation Guide. Therefore, the contents of your Operator's Manual or Installation Guide may differ from those provided on this page. For detailed operating procedures, follow the instructions of your Operator's Manual or Installation Guide.  
Safety and Performance Information for IVD reagents can be found in the Operator’s Manuals for those products, which are provided on this page.  
Please note that the products marked (SKC) are manufactured by SHANGHAI KOHDEN MEDICAL ELECTRONIC INSTRUMENT CORPORATION, and the rest by NIHON KOHDEN CORPORATION.

※ Not all products sold in the EU are covered on this page. 
※ Products will be added upon issuance of a Declaration of Conformity under the Medical Device Regulation and In Vitro Diagnostic Medical Device Regulation.

A

ProductModelDownload PDF
AC AdapterSC-101V
AC CradleSC-170R
AdapterBM-300S
Additional Alarm Indicator UnitYS-098P1, YS-098P2
Adult cap-ONE BiteblockYG-227T
Adult cap-ONE BiteblockYG-227TW
Adult cap-ONE Mask, Large Adult cap-ONE MaskYG-272TW, YG-282TW
Adult cap-ONE Mask, Large Adult cap-ONE MaskYG-272T, YG-282T
Adult/Pediatric cap-ONE Nasal AdapterYG-220TW, YG-221TW, YG-230TW, YG-231TW
Adult/Pediatric cap-ONE Nasal AdapterYG-220T, YG-221T, YG-230T, YG-231T
Air HoseYN-980S, YN-981S
Airway AdapterYG-101T
Airway AdapterYG-111T
Airway AdapterYG-211T
AIRWAY SCOPE AWS-S200NKAWS-S200
Antenna BaseZA-019P
Automated Hematology and Clinical Chemistry AnalyzerMEK-1303
AUXOUT UnitQI-831V

B

ProductModelDownload PDF
Band Pass FilterZA-006P, ZA-007P, ZA-008P, ZA-009P, ZA-010P, ZA-011P, ZA-012P, ZA-013P, ZA-014P, ZA-015P
Battery ChargerSB-101V
Battery ChargerSB-205V
Battery ChargerSB-801V
Battery PackSB-121A
Battery PackSB-170P
Battery PackSB-201P
Battery PackSB-310V
Battery PackSB-330Z
Battery PackSB-470P
Battery PackSB-671P
Battery PackSB-831V
Battery PackSB-920P
Battery PackSB-950P
Battery PackSB-970P
Battery Pack(SKC)NKB-301V
Battery Pack(SKC)SB-301DC
Battery Pack(SKC)SB-752P
Battery Pack(SKC)SB-901DC
Bedside Monitor(SKC)BSM-2500 series
Bedside Monitor(SKC)SVM-7500 series
BISx Connection CableYJ-671P
Bluetooth® ModuleQI-832V

C

ProductModelDownload PDF
Camera Capture Unit (Analog)QI-120A
Camera Capture Unit (Digital)QI-120A
Capillary Adapter SetYZ-008B6
cardioCream (Paste for ECG)Z-101BC
CartKD-033A, KD-033AK
Celltac chemi CRP 4NCR-420W, CR-421W
Celltac chemi HbA1c NHA-420W, HA-421W
Celltac chemi Rinse solutionRN-410V
Central Monitor(SKC)CNS-9101
Chest Electrode ø3 (Silicon Rubber)9000-065141
Chest Electrode ø4 (Silicon Rubber)9000-065673
Chest Electrode with Logo (Child)NC-123D, NC-124D
CHM cleaning kitYZ-006B0
CLEANACMEK-520
CLEANAC•3MEK-620
CLEANAC•710MK-710W
CLEANAC•810MK-810W
Collodion ElectrodeBE-920P
Communication CableIF-912P
Communication CableIF-913P
Communication CableIF-914P
Communication CableIF-916P
Communication CableIF-917P
Communication CableIF-918P
Communication CableIF-919P
Communication CableIF-920P
Communication CableIF-922P
Communication CableIF-923P
Communication CableIF-925P
Communication CableIF-927P
Communication CableIF-928P
Communication CableIF-930P
Communication CableIF-931P
Communication CableIF-932P
Communication CableIF-933P
Communication CableIF-934P
Communication CableIF-935P
Communication CableIF-936P
Communication CableIF-937P
Communication CableIF-938P
Communication CableIF-939P
Communication CableIF-942P
Communication CableIF-943P
Communication CableIF-944P
Communication Cable IF-946P
Communication CableIF-948P
Communication CableIF-950P
Communication CableIF-951P
Communication CableIF-952P
Communication CableIF-953P
Communication CableIF-955P
Communication CableIF-956P
Communication CableIF-958P
Communication CableIF-960P
Communication CableIF-961P
Communication CableIF-966P
Communication CableIF-969P
Connection CableYS-108P8
Connection CableYS-112P7
CPR AssistCPR-1100
CRP CalibratorCR-CAL

D

ProductModelDownload PDF
DC AdapterSC-102V
Defibrillation PadsP-511X
Defibrillation PadsP-530
Defibrillation Pads for AdultP-531
Defibrillation Pads for ChildP-532
Disk ElectrodeBE-910P
Disk ElectrodeNE-136B
DisplayVD-403B
Display Extension BoardYS-104P5
Disposable CuffYP-840T, YP-841T, YP-842T, YP-843T, YP-844T, YP-845T
Disposable ElectrodeNE-05 (NE-05IS3)
Disposable ElectrodeVitrode Bs (Bs-150, Bs-25)
Disposable ElectrodeVitrode F (F-150M, F-150S, F-150U3, F-150U5)
Disposable ElectrodeVitrode G (G-600)
Disposable ElectrodeVitrode L (L-150X)
Disposable ElectrodeVitrode M (M-150)
Disposable ElectrodeVitrode N (N-01IS3)
Disposable ElectrodeVitrode N (N-03IS3)
Disposable ElectrodeVitrode V (V-040M4, V-04IO4, V-04IP4, V-04PN4, V-04PO4, V-05IN5, V-05IO5, V-05PN5, V-060M6, V-06IO6, V-06IP6, V-06PN6, V-06PO6, V-090M3, V-09IO3, V-120S3, V-74001, V-74004, V-74006, V-74007, V-74009, V-74010, V-74011, V-74013, V-74014, V-74018, VS-04IN4, VS-04IO4, VS-04PN4, VS-05IO5, VS-06IO6, VS-06PN6, VS-12IO3)
Disposable Electrode for EEGNE-09 (NE-090S1, NE-091S7)
Disposable PadsP-511
Disposable PadsP-711, P-713, P-721
Disposable PadsP-730K
Disposable PadsP-740K
Disposable Pads for InfantP-513

E

ProductModelDownload PDF
ECG/BP Output CableYJ-910P, YJ-920P
ECG Connection CordJC-933P
ECG Electrode LeadBC-112B
EEG Disk ElectrodeNE-116A
EEG Disk ElectrodeNE-117A
EEG Disk ElectrodeNE-118A
EEG Ear Clip ElectrodeNE-311A
EEG ElectrodeNE-113A
EEG ElectrodeNE-114A
EEG Electrode (Collodion)NE-133A
EEG Electrode (Collodion)NE-134A
EEG Electrode (Collodion)NE-136A
EEG Electrode SetBE-403A
EEG Electrode Set, Electrode G (with plastic holder), Earlobe ElectrodeBE-413AG, BE-0005, NE-313AG
Electrocardiograph(SKC)ECG-2250
Electrocardiograph(SKC)ECG-3150
Electrocardiograph(SKC)ECG-3250
Electrocardiograph(SKC)ECG-3350
Electrode (with plastic holder)BE-0006
Elefix (Paste for EEG)Z-401CE, Z-181BE, Z-181JE
Elefix V Paste for EEG&EMGZV-401E, ZV-181E
Evoked EEG Electrode KitNE-132B
Evoked Potential Electrode KitNE-142B
Extension CordBM-09IS8
Extension CordBM-918B
External Paddle HolderDP-831VK
External Paddles HolderDP-101V

F

ProductModelDownload PDF
Fast ClipNC-143E(937122)
Fastclip Ø3 Child, Fastclip Ø4 ChildNC-153E, NC-154E
Fast Clip Ø4NC-144E(937131)
Finger ElectrodeNM-450S
Finger ElectrodeNM-451B
Flow AdapterTF-120P
Flow AdapterTF-130P
Flow TubeYF-120P

G

ProductModelDownload PDF
GELAIDZ-101BA
Ground ElectrodeNM-501B
Ground ElectrodeNM-502B
Ground ElectrodeNM-503B
Ground ElectrodeNM-505B
Ground ElectrodeNM-506B
Ground ElectrodeNM-550B
Ground ElectrodeNM-551B

H

ProductModelDownload PDF
HA-410V CALYZ-005B1
Headband for EEGBE-090AS, BE-090AM
HEMATOLOGY CALIBRATORMEK-CAL
HEMATOLOGY CONTROLMEK-3DL, MEK-3DN, MEK-3DH
HEMATOLOGY CONTROL+CRPMK-3CL, MK-3CN, MK-3CH
HEMATOLOGY CONTROL for ReticulocyteMK-RE1, MK-RE2, MK-RE3
HEMATOLOGY CONTROL for WBC 5 part differentialMEK-5DL, MEK-5DN, MEK-5DH
Hemolynac•310MK-310W
Hemolynac•3NMEK-680
Hemolynac•5MEK-910
Hemolynac•510MK-510W
Holder BD 0.5 mLYZ-008B3

I

ProductModelDownload PDF
IBP Interface Isolation CableJP-911P
InterfaceQF-801P
InterfaceQF-901P
InterfaceQF-902P
InterfaceQF-903P
InterfaceQF-907P
InterfaceQF-908P
InterfaceQF-909P
InterfaceQF-911P
InterfaceQI-373P
InterfaceQI-374P
InterfaceQI-670P
INTERFACE(SKC)QF-751P
Interface UnitJA-920P
ISOTONAC•3MEK-640
ISOTONAC•4MEK-641

K

ProductModelDownload PDF
KABEVETTE G KitYZ-008B2

L

ProductModelDownload PDF
Lithium Ion BatterySB-121V
Lithium Ion BatterySB-220V

M

ProductModelDownload PDF
Mini Flat Junction BoxJE-125AK, JE-225AK, JE-226AK, JE-227AK, JE-228AK
Mini Junction BoxJE-922A, JE-922AG
Multi Interface BoxJJ-230B
Multi-link CableYS-096P5

N

ProductModelDownload PDF
Nasal AdapterYG-120T, YG-121T, YG-122T
Nasal Adapter, Pediatric Nasal AdapterYG-125TW, YG-135TW
Nasal Adapter, Pediatric Nasal AdapterYG-125T, YG-135T
Nasal Adapter, Pediatric Nasal AdapterYG-225TW, YG-235TW
Nasal Adapter, Pediatric Nasal AdapterYG-225T, YG-235T
NCS ElectrodeNM-310Y, NM-314YL, NM-314YS
NCS Electrode (NM-31)NM-316Y
NCS Electrode (NM-31)NM-317Y3, NM-319Y
NCS Electrode (NM-31)NM-318Y
Neonatal/Infant Airway AdapterYG-213T, YG-214T
NIBP CuffYP-710T, YP-711T, YP-712T, YP-713T, YP-714T, YP-715T
NIBP Cuff, AdultYP-503P, YP-504P
NIBP Cuff, Adult(SKC)YP-723T, YP-724T
NKB-301V Battery PackYZ-024H9
Nurse Call CableYJ-672P

P

ProductModelDownload PDF
Paste for EEGZ-101N
Patient Cable(SKC)BJ-961D, BJ-962D
Pediatric Electrode Assy Ø 44 mmND-844V
Pediatric/Infant cap-ONE MaskYG-232TW, YG-242TW
Pediatric/Infant cap-ONE MaskYG-232T, YG-242T
Pulse OximeterOLV-4201, OLV-4202

R

ProductModelDownload PDF
ReceiverZR-920P
Recorder Module(SKC)WS-752P
ReticulonacMK-110W

S

ProductModelDownload PDF
Sampling Line (Adult, Neonate)YG-310P, YG-311P
SARSTEDT KitYZ-008B1
Shield Junction CordBM-090Y
skinPureYZ-0019
SOFTWARE KIT(SKC)QS-251P
SOFTWARE KIT(SKC)QS-901PK
SpO2 Connection CordJL-400T
SpO2 Connection CordJL-430U
SpO2 Connection CordJL-900P
SpO2 Connection CordJL-930P, JL-030U1, JL-030U2
SSD Expansion BoardYS-116P0
SSD Extension KitYS-105P0
Stimulation ElectrodeNM-413B
Straight T-Piece, Elbow T-PieceYG-320P, YG-321P
Surface ElectrodeNM-312S
Surface ElectrodeNM-315S
Surface Stimulation ElectrodeNM-410S
Surface Stimulation ElectrodeNM-420S
Surface Stimulation ElectrodeNM-422B
Surface Stimulation ElectrodeNM-430S
Surface Stimulation ElectrodeNM-983W

T

ProductModelDownload PDF
Thermal Airflow SensorTR-190A
TL-260T Clip AdapterYS-087P9

U

ProductModelDownload PDF
Unit Connection CableYS-096P2, YS-096P3

V

ProductModelDownload PDF
Visual Stimulator AdaptorYL-104A
Vital Signs Monitor(SKC)SVM-7100 series

W

ProductModelDownload PDF
Water Trap (Adult, Neonate)YG-300P, YG-301P
Wireless LAN Module(SKC)QI-710P
WS-960R Power SupplySC-611R