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

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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

Product Model Download PDF
AC Adapter SC-101V SC101V_20190402_OM_ENG.pdf
AC Cradle SC-170R SC170R_20190419_OM-C_ENG.pdf
AIRWAY SCOPE AWS-S200NK AWS-S200 AWS-S200_20190418_OM-B_ENG.pdf
AUXOUT Unit QI-831V QI831V_20190527_IG-B_ENG.pdf
Adapter BM-300S BM300S_20190411_OM-B_ENG.pdf
Additional Alarm Indicator Unit YS-098P1, YS-098P2 YS098P1_20190419_IG-A_ENG.pdf
Adult/Pediatric cap-ONE Nasal Adapter YG-220TW, YG-221TW, YG-230TW, YG-231TW YG220TW_20190625_OM_ENG.pdf
Adult/Pediatric cap-ONE Nasal Adapter YG-220T, YG-221T, YG-230T, YG-231T YG220T_20190625_OM_ENG.pdf
Adult cap-ONE Biteblock YG-227T YG227T_20190408_OM-B_ENG.pdf
Adult cap-ONE Biteblock YG-227TW YG227TW_20190402_OM-B_ENG.pdf
Adult cap-ONE Mask, Large Adult cap-ONE Mask YG-272TW, YG-282TW YG272TW_20190402_OM-C_ENG.pdf
Adult cap-ONE Mask, Large Adult cap-ONE Mask YG-272T, YG-282T YG272T_20190402_OM-D_ENG.pdf
Air Hose YN-980S, YN-981S YN980S_20201120_OM-C_ENG.pdf
Airway Adapter YG-101T YG101T_20190312_OM-L_ENG.pdf
Airway Adapter YG-111T YG111T_20190422_OM-H_ENG.pdf
Airway Adapter YG-211T YG211T_20190408_OM-G_ENG.pdf
Antenna Base ZA-019P ZA019P_20190419_IG-A_ENG.pdf

B

Product Model Download PDF
BISx Connection Cable YJ-671P YJ671P_20190419_OM-E_ENG.pdf
Band Pass Filter ZA-006P, ZA-007P, ZA-008P, ZA-009P, ZA-010P, ZA-011P, ZA-012P, ZA-013P, ZA-014P, ZA-015P ZA006P_20190419_OM-G_ENG.pdf
Battery Pack(SKC) NKB-301V NKB301V_20191230_OM_ENG.pdf
Battery Pack(SKC) SB-301DC SB301DC_20191230_OM-A_ENG.pdf
Battery Pack(SKC) SB-901DC SB901DC_20191230_OM-D_ENG.pdf
Battery Charger SB-101V SB101V_20190402_OM_ENG.pdf
Battery Charger SB-205V SB205V_20190527_OM-D_ENG.pdf
Battery Charger SB-801V SB801V_2019418_OM-D_ENG.pdf
Battery Pack SB-121A SB121A_20190606_OM-B_ENG.pdf
Battery Pack SB-170P SB170P_20190419_OM-E_ENG.pdf
Battery Pack SB-201P SB201P_20190419_OM-G_ENG.pdf
Battery Pack SB-310V SB310V_20190531_OM-B_ENG.pdf
Battery Pack SB-330Z SB330Z_20190423_OM_ENG.pdf
Battery Pack SB-470P SB470P_20190423_OM_ENG.pdf
Battery Pack SB-671P SB671P_20190423_OM-I_ENG.pdf
Battery Pack SB-831V SB831V_2019418_OM-B_ENG.pdf
Battery Pack SB-920P SB920P_20190419_IG-E_ENG.pdf
Battery Pack SB-950P SB950P_20210715_OM-G_ENG.pdf
Battery Pack SB-970P SB970P_20210715_OM-F_ENG.pdf
Bluetooth® Module QI-832V QI832V_20190529_IG-I_ENG.pdf

C

Product Model Download PDF
CHM cleaning kit YZ-006B0 0614-907575A_YZ006B0_OM_secured.pdf
CLEANAC MEK-520 0614-907976_MEK520_OM_secured.pdf
CLEANAC•3 MEK-620 0614-907968_MEK620_OM_secured.pdf
CLEANAC•710 MK-710W 0614-907966_MK710W_OM_secured.pdf
CLEANAC•810 MK-810W MK810W_12langs_OM_0614-907990_secured.pdf
CPR Assist CPR-1100 CPR1100_20190516_OM-D_ENG.pdf
Celltac chemi Rinse solution RN-410V 0614-907557B_RN410V_OM_secured.pdf
Chest Electrode with Logo (Child) NC-123D, NC-124D NC123D_20190329_OM-C_ENG.pdf
Chest Electrode ø3 (Silicon Rubber) 9000-065141 Chest_Electrode_20190524_OM_ENG.pdf
Chest Electrode ø4 (Silicon Rubber) 9000-065673 Chest_Electrode_dia.4_20190524_OM_ENG.pdf
Collodion Electrode BE-920P BE920P_20190422_OM-F_ENG.pdf
Communication Cable IF-912P IF912P_20190422_OM_ENG.pdf
Communication Cable IF-913P IF913P_20190422_OM_ENG.pdf
Communication Cable IF-914P IF914P_20190422_OM_ENG.pdf
Communication Cable IF-916P IF916P_20190422_OM_ENG.pdf
Communication Cable IF-917P IF917P_20190422_OM_ENG.pdf
Communication Cable IF-918P IF918P_20190419_OM-G_ENG.pdf
Communication Cable IF-919P IF919P_20190529_OM-J_ENG.pdf
Communication Cable IF-920P IF920P_20190422_OM-F_ENG.pdf
Communication Cable IF-922P IF922P_20190422_OM_ENG.pdf
Communication Cable IF-923P IF923P_20190422_OM_ENG.pdf
Communication Cable IF-925P IF925P_20190422_OM_ENG.pdf
Communication Cable IF-927P IF927P_20190329_OM-C_ENG.pdf
Communication Cable IF-928P IF928P_20190422_OM-H_ENG.pdf
Communication Cable IF-930P IF930P_20190422_OM-F_ENG.pdf
Communication Cable IF-931P IF931P_20190329_OM-D_ENG.pdf
Communication Cable IF-932P IF932P_20190419_OM-E_ENG.pdf
Communication Cable IF-933P IF933P_20190329_OM-D_ENG.pdf
Communication Cable IF-934P IF934P_20190329_OM-D_ENG.pdf
Communication Cable IF-935P IF935P_20190422_OM-E_ENG.pdf
Communication Cable IF-936P IF936P_20190422_OM-E_ENG.pdf
Communication Cable IF-937P IF937P_20190422_OM-F_ENG.pdf
Communication Cable IF-938P IF938P_20190422_OM-F_ENG.pdf
Communication Cable IF-939P IF939P_20190314_OM-D_ENG.pdf
Communication Cable IF-942P IF942P_20190422_OM-F_ENG.pdf
Communication Cable IF-943P IF943P_20190422_OM-E_ENG.pdf
Communication Cable IF-944P IF944P_20190422_OM-D_ENG.pdf
Communication Cable IF-946P IF946P_20190422_OM-E_ENG.pdf
Communication Cable IF-948P IF948P_20190422_OM-F_ENG.pdf
Communication Cable IF-950P IF950P_20190422_OM-D_ENG.pdf
Communication Cable IF-951P IF951P_20190419_OM-E_ENG.pdf
Communication Cable IF-952P IF952P_20190422_OM-D_ENG.pdf
Communication Cable IF-953P IF953P_20190422_OM-C_ENG.pdf
Communication Cable IF-955P IF955P_20190329_OM-B_ENG.pdf
Communication Cable IF-956P IF956P_20190419_OM-C_ENG.pdf
Communication Cable IF-958P IF958P_20190419_OM-D_ENG.pdf
Communication Cable IF-960P IF960P_20190422_OM-B_ENG.pdf
Communication Cable IF-961P IF961P_20190422_OM-B_ENG.pdf
Communication Cable IF-966P IF966P_20190409_OM-B_ENG.pdf
Communication Cable IF-969P IF969P_20200804_OM_ENG.pdf
Connection Cable YS-108P8 YS108P8_20190312_OM-A_ENG.pdf
Connection Cable YS-112P7 YS112P7_20190312_OM-A_ENG.pdf
cardioCream (Paste for ECG) Z-101BC Z101BC_20190424_OM_ENG.pdf

D

Product Model Download PDF
DC Adapter SC-102V SC102V_20200617_OM_ENG.pdf
Defibrillation Pads P-511X P511X_20190527_OM-B_ENG.pdf
Defibrillation Pads P-530 P530_20191018_OM-A_ENG.pdf
Defibrillation Pads for Adult P-531 P531_20191018_OM-A_ENG.pdf
Defibrillation Pads for Child P-532 P532_20191018_OM-A_ENG.pdf
Disk Electrode BE-910P BE910P_20190422_OM-F_ENG.pdf
Disk Electrode NE-136B NE136B_20190516_OM-D_ENG.pdf
Display Extension Board YS-104P5 YS104P5_20190419_IG-F_ENG.pdf
Disposable Cuff YP-840T, YP-841T, YP-842T, YP-843T, YP-844T, YP-845T YP840T_20190418_OM-C_ENG.pdf
Disposable Electrode NE-05 (NE-05IS3) NE05_20190423_OM_ENG.pdf
Disposable Electrode Vitrode Bs (Bs-150, Bs-25) Vitrode_Bs_20190424_OM-F_ENG.pdf
Disposable Electrode Vitrode F (F-150M, F-150S, F-150U3, F-150U5) Vitrode_F_20190416_OM-E_ENG.pdf
Disposable Electrode Vitrode G (G-600) Vitrode_G_20190411_OM-J_ENG.pdf
Disposable Electrode Vitrode L (L-150X) Vitrode_L_20200610_OM-J_ENG.pdf
Disposable Electrode Vitrode M (M-150) Vitrode_M_20190424_OM-H_ENG.pdf
Disposable Electrode Vitrode N (N-01IS3) N-01IS3_20190411_OM-F_ENG.pdf
Disposable Electrode Vitrode N (N-03IS3) Vitrode_N(N-03IS3)_20190513_OM-I_ENG.pdf
Disposable Electrode Vitrode 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) Vitrode_V_20190424_OM_ENG.pdf
Disposable Electrode for EEG NE-09 (NE-090S1, NE-091S7) NE090S1_20190411_OM_ENG.pdf
Disposable Pads P-711, P-713, P-721 P711_20190411_OM-H_ENG.pdf
Disposable Pads P-511 P511_20190527_OM-B_ENG.pdf
Disposable Pads P-730K P730K_20190411_OM-C_ENG.pdf
Disposable Pads P-740K P740K_20190219_OM-C_ENG.pdf
Disposable Pads for Infant P-513 P513_20190527_OM-B_ENG.pdf

E

Product Model Download PDF
ECG/BP Output Cable YJ-910P, YJ-920P YJ910P_20190419_OM-G_ENG.pdf
ECG Connection Cord JC-933P JC933P_20190405_OM-A_ENG.pdf
ECG Electrode Lead BC-112B BC112B_20190509_OM-E_ENG.pdf
EEG Disk Electrode NE-118A NE118A_20190312_OM-B_ENG.pdf
EEG Disk Electrode NE-116A NE116A_20190311_OM-C_ENG.pdf
EEG Disk Electrode NE-117A NE117A_20190311_OM-B_ENG.pdf
EEG Ear Clip Electrode NE-311A NE311A_20190311_OM-I_ENG.pdf
EEG Electrode NE-113A NE113A_20190311_OM-K_ENG.pdf
EEG Electrode NE-114A NE114A_20190311_OM-D_ENG.pdf
EEG Electrode (Collodion) NE-133A NE133A_2019056_OM-I_ENG.pdf
EEG Electrode (Collodion) NE-134A NE134A_20190516_OM-B_ENG.pdf
EEG Electrode (Collodion) NE-136A NE136A_20190516_OM-B_ENG.pdf
EEG Electrode Set BE-403A BE403A_20190516_OM-J_ENG.pdf
EEG Electrode Set, Electrode G (with plastic holder), Earlobe Electrode BE-413AG, BE-0005, NE-313AG BE413AG_20190410_OM-B_ENG.pdf
Electrode (with plastic holder) BE-0006 BE0006_20190516_OM-B_ENG.pdf
Elefix (Paste for EEG) Z-401CE, Z-181BE, Z-181JE Z401CE_181BE_181JE_20190411_OM-I_ENG.pdf
Elefix V Paste for EEG&EMG ZV-401E, ZV-181E ZV401E_ZV181E_20200415_OM-C_ENG.pdf
Evoked EEG Electrode Kit NE-132B NE132B_20190516_OM-B_ENG.pdf
Evoked Potential Electrode Kit NE-142B NE142B_20190516_OM-B_ENG.pdf
Extension Cord BM-09IS8 BM09IS8_20190424_OM_ENG.pdf
Extension Cord BM-918B BM918B_20190604_OM-A_ENG.pdf
External Paddle Holder DP-831VK DP831VK_20190527_OM-B_ENG.pdf
External Paddles Holder DP-101V DP101V_20190402_OM_ENG.pdf

F

Product Model Download PDF
Fast Clip NC-143E(937122) NC143E_20190524_OM-D_ENG.pdf
Fast Clip Ø4 NC-144E(937131) NC144E_20190524_OM-C_ENG.pdf
Fastclip Ø3 Child, Fastclip Ø4 Child NC-153E, NC-154E NC153E_20190624_OM-A_ENG.pdf
Finger Electrode NM-450S NM450S_20190514_OM-C_ENG.pdf
Finger Electrode NM-451B NM451B_20190516_OM-D_ENG.pdf
Flow Adapter TF-120P TF120P_20190402_OM-C_ENG.pdf
Flow Adapter TF-130P TF130P_20190312_OM-A_ENG.pdf
Flow Tube YF-120P YF120P_20190402_OM-D_ENG.pdf

G

Product Model Download PDF
GELAID Z-101BA Z101BA_20190411_OM_ENG.pdf
Ground Electrode NM-501B NM501B_20190515_OM-H_ENG.pdf
Ground Electrode NM-502B NM502B_20190515_OM-C_ENG.pdf
Ground Electrode NM-503B NM503B_20190515_OM-C_ENG.pdf
Ground Electrode NM-505B NM505B_20190516_OM-E_ENG.pdf
Ground Electrode NM-506B NM506B_20190516_OM-E_ENG.pdf
Ground Electrode NM-550B NM550B_20190516_OM-H_ENG.pdf
Ground Electrode NM-551B NM551B_20190516_OM-D_ENG.pdf

H

Product Model Download PDF
Headband for EEG BE-090AS, BE-090AM BE090AS_20190424_OM_ENG.pdf
Hemolynac•310 MK-310W 0614-907955_MK310W_OM_secured.pdf
Hemolynac•3N MEK-680 0614-907971_MEK680_OM_secured.pdf
Hemolynac•5 MEK-910 0614-907970_MEK910_OM_secured.pdf
Hemolynac•510 MK-510W 0614-907969_MK510W_OM_secured.pdf

I

Product Model Download PDF
IBP Interface Isolation Cable JP-911P JP911P_20190419_ENG.pdf
ISOTONAC•3 MEK-640 0614-907967_MEK640_OM_secured.pdf
ISOTONAC•4 MEK-641 0614-907972_MEK641_OM_secured.pdf
Interface QF-801P QF801P_20190312_OM-B_ENG.pdf
Interface QF-901P QF901P_20190422_OM_ENG.pdf
Interface QF-902P QF902P_20190422_OM_ENG.pdf
Interface QF-903P QF903P_20190422_OM_ENG.pdf
Interface QF-907P QF907P_20190422_OM_ENG.pdf
Interface QF-908P QF908P_20190422_OM_ENG.pdf
Interface QF-909P QF909P_20190422_OM_ENG.pdf
Interface QF-911P QF911P_20190422_OM_ENG.pdf
Interface QI-373P QI373P_20190312_IG-A_ENG.pdf
Interface QI-374P QI374P_20190312_IG-A_ENG.pdf
Interface QI-670P QI670P_20190419_OM-E_ENG.pdf
Interface Unit JA-920P JA920P_20190419_OM-D_ENG.pdf

L

Product Model Download PDF
Lithium Ion Battery SB-121V SB121V_20191204_OM-A_ENG.pdf
Lithium Ion Battery SB-220V SB220V_20190613_OM-C_ENG.pdf

M

Product Model Download PDF
Mini Flat Junction Box JE-125AK, JE-225AK, JE-226AK, JE-227AK, JE-228AK JE125AK_20190606_OM-D_ENG.pdf
Mini Junction Box JE-922A, JE-922AG JE922A_20200730_OM_ENG.pdf
Multi Interface Box JJ-230B JJ230B_20190604_OM-B_ENG.pdf
Multi-link Cable YS-096P5 YS096P5_20190419_OM-A_ENG.pdf

N

Product Model Download PDF
NCS Electrode NM-310Y, NM-314YL, NM-314YS NM310Y_20190514_OM-D_ENG.pdf
NCS Electrode (NM-31) NM-316Y NM316Y_20190514_OM-F_ENG.pdf
NCS Electrode (NM-31) NM-317Y3, NM-319Y NM317Y3_20190515_OM-L_ENG.pdf
NCS Electrode (NM-31) NM-318Y NM318Y_20190517_OM-B_ENG.pdf
NIBP Cuff YP-710T, YP-711T, YP-712T, YP-713T, YP-714T, YP-715T YP71xT_20190607_OM-C_ENG.pdf
NIBP Cuff, Adult YP-503P, YP-504P YP503P_20190422_OM-A_ENG.pdf
NKB-301V Battery Pack YZ-024H9 YZ024H9_20190527_OM-K_ENG.pdf
Nasal Adapter YG-120T, YG-121T, YG-122T YG120_20150422_OM-N_ENG.pdf
Nasal Adapter, Pediatric Nasal Adapter YG-125TW, YG-135TW YG125TW_20190422_OM-A_ENG.pdf
Nasal Adapter, Pediatric Nasal Adapter YG-125T, YG-135T YG125T_20190422_OM-F_ENG.pdf
Nasal Adapter, Pediatric Nasal Adapter YG-225TW, YG-235TW YG225TW_20190402_OM-A_ENG.pdf
Nasal Adapter, Pediatric Nasal Adapter YG-225T, YG-235T YG225T_20190402_OM-B_ENG.pdf
Neonatal/Infant Airway Adapter YG-213T, YG-214T YG213T_20190408_OM-J_ENG.pdf
Nurse Call Cable YJ-672P YJ672P_20190419_OM_ENG.pdf

P

Product Model Download PDF
Paste for EEG Z-101N Z101N_20190312_OM-A_ENG.pdf
Patient Cable(SKC) BJ-961D, BJ-962D BJ-961D_BJ-962D_20191106_OM-B_ENG.pdf
Pediatric Electrode Assy Ø 44 mm ND-844V ND844V_20190527_OM-A_ENG.pdf
Pediatric/Infant cap-ONE Mask YG-232TW, YG-242TW YG232TW_20190402_OM-B_ENG.pdf
Pediatric/Infant cap-ONE Mask YG-232T, YG-242T YG232T_20190402_OM-D_ENG.pdf

R

Product Model Download PDF
Receiver ZR-920P ZR920P_20190419_IG-A_ENG.pdf
Reticulonac MK-110W 0614-907977_MK110W_OM_secured.pdf

S

Product Model Download PDF
SSD Expansion Board YS-116P0 YS116P0_20190422_IG-B_ENG.pdf
SSD Extension Kit YS-105P0 YS105P0_20190419_IG-D_ENG.pdf
Sampling Line (Adult, Neonate) YG-310P, YG-311P YG310P_20190312_OM-A_ENG.pdf
Shield Junction Cord BM-090Y BM090Y_20190424_OM_ENG.pdf
SpO2 Connection Cord JL-400T JL400T_20190404_OM-A_ENG.pdf
SpO2 Connection Cord JL-430U JL430U_20190404_OM-A_ENG.pdf
SpO2 Connection Cord JL-900P JL900P_20190507_OM-B_ENG.pdf
SpO2 Connection Cord JL-930P, JL-030U1, JL-030U2 JL930P_20190425_OM-C_ENG.pdf
Stimulation Electrode NM-413B NM413B_20190516_OM-C_ENG.pdf
Straight T-Piece, Elbow T-Piece YG-320P, YG-321P YG320P_20190312_OM-A_ENG.pdf
Surface Electrode NM-312S NM312S_20201223_OM-G_ENG.pdf
Surface Electrode NM-315S NM315S_20201223_OM-C_ENG.pdf
Surface Stimulation Electrode NM-410S NM410S_20190514_OM-G_ENG.pdf
Surface Stimulation Electrode NM-420S NM420S_20190514_OM-C_ENG.pdf
Surface Stimulation Electrode NM-422B NM422B_20190514_OM-C_ENG.pdf
Surface Stimulation Electrode NM-430S NM430S_20190514_OM-C_ENG.pdf
Surface Stimulation Electrode NM-983W NM983W_20190419_OM_ENG.pdf
skinPure YZ-0019 YZ0019_20190411_ENG.pdf

T

Product Model Download PDF
TL-260T Clip Adapter YS-087P9 YS087P9_20190507_OM-G_ENG.pdf
Thermal Airflow Sensor TR-190A TR190A_20190402_OM-B_ENG.pdf

U

Product Model Download PDF
Unit Connection Cable YS-096P2, YS-096P3 YS096P2_20190401_OM-A_ENG.pdf

V

Product Model Download PDF
Visual Stimulator Adaptor YL-104A YL104A_20190606_OM-E_ENG.pdf

W

Product Model Download PDF
WS-960R Power Supply SC-611R SC611R_20190419_OM-D_ENG.pdf
Water Trap (Adult, Neonate) YG-300P, YG-301P YG300P_20190312_OM-A_ENG.pdf