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
Product | Model | Download PDF |
---|---|---|
AC Adapter | SC-101V | |
AC Cradle | SC-170R | |
Adapter | BM-300S | |
Additional Alarm Indicator Unit | YS-098P1, YS-098P2 | |
Adult cap-ONE Biteblock | YG-227T | |
Adult cap-ONE Biteblock | YG-227TW | |
Adult cap-ONE Mask, Large Adult cap-ONE Mask | YG-272TW, YG-282TW | |
Adult cap-ONE Mask, Large Adult cap-ONE Mask | YG-272T, YG-282T | |
Adult/Pediatric cap-ONE Nasal Adapter | YG-220TW, YG-221TW, YG-230TW, YG-231TW | |
Adult/Pediatric cap-ONE Nasal Adapter | YG-220T, YG-221T, YG-230T, YG-231T | |
Air Hose | YN-980S, YN-981S | |
Airway Adapter | YG-101T | |
Airway Adapter | YG-111T | |
Airway Adapter | YG-211T | |
AIRWAY SCOPE AWS-S200NK | AWS-S200 | |
Antenna Base | ZA-019P | |
Automated Hematology and Clinical Chemistry Analyzer | MEK-1303 | |
AUXOUT Unit | QI-831V |
B
Product | Model | Download PDF |
---|---|---|
Band Pass Filter | ZA-006P, ZA-007P, ZA-008P, ZA-009P, ZA-010P, ZA-011P, ZA-012P, ZA-013P, ZA-014P, ZA-015P | |
Battery Charger | SB-101V | |
Battery Charger | SB-205V | |
Battery Charger | SB-801V | |
Battery Pack | SB-121A | |
Battery Pack | SB-170P | |
Battery Pack | SB-201P | |
Battery Pack | SB-310V | |
Battery Pack | SB-330Z | |
Battery Pack | SB-470P | |
Battery Pack | SB-671P | |
Battery Pack | SB-831V | |
Battery Pack | SB-920P | |
Battery Pack | SB-950P | |
Battery Pack | SB-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 Cable | YJ-671P | |
Bluetooth® Module | QI-832V |
C
Product | Model | Download PDF |
---|---|---|
Camera Capture Unit (Analog) | QI-120A | |
Camera Capture Unit (Digital) | QI-120A | |
Capillary Adapter Set | YZ-008B6 | |
cardioCream (Paste for ECG) | Z-101BC | |
Cart | KD-033A, KD-033AK | |
Celltac chemi CRP 4N | CR-420W, CR-421W | |
Celltac chemi HbA1c N | HA-420W, HA-421W | |
Celltac chemi Rinse solution | RN-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 kit | YZ-006B0 | |
CLEANAC | MEK-520 | |
CLEANAC•3 | MEK-620 | |
CLEANAC•710 | MK-710W | |
CLEANAC•810 | MK-810W | |
Collodion Electrode | BE-920P | |
Communication Cable | IF-912P | |
Communication Cable | IF-913P | |
Communication Cable | IF-914P | |
Communication Cable | IF-916P | |
Communication Cable | IF-917P | |
Communication Cable | IF-918P | |
Communication Cable | IF-919P | |
Communication Cable | IF-920P | |
Communication Cable | IF-922P | |
Communication Cable | IF-923P | |
Communication Cable | IF-925P | |
Communication Cable | IF-927P | |
Communication Cable | IF-928P | |
Communication Cable | IF-930P | |
Communication Cable | IF-931P | |
Communication Cable | IF-932P | |
Communication Cable | IF-933P | |
Communication Cable | IF-934P | |
Communication Cable | IF-935P | |
Communication Cable | IF-936P | |
Communication Cable | IF-937P | |
Communication Cable | IF-938P | |
Communication Cable | IF-939P | |
Communication Cable | IF-942P | |
Communication Cable | IF-943P | |
Communication Cable | IF-944P | |
Communication Cable | IF-946P | |
Communication Cable | IF-948P | |
Communication Cable | IF-950P | |
Communication Cable | IF-951P | |
Communication Cable | IF-952P | |
Communication Cable | IF-953P | |
Communication Cable | IF-955P | |
Communication Cable | IF-956P | |
Communication Cable | IF-958P | |
Communication Cable | IF-960P | |
Communication Cable | IF-961P | |
Communication Cable | IF-966P | |
Communication Cable | IF-969P | |
Connection Cable | YS-108P8 | |
Connection Cable | YS-112P7 | |
CPR Assist | CPR-1100 | |
CRP Calibrator | CR-CAL |
D
Product | Model | Download PDF |
---|---|---|
DC Adapter | SC-102V | |
Defibrillation Pads | P-511X | |
Defibrillation Pads | P-530 | |
Defibrillation Pads for Adult | P-531 | |
Defibrillation Pads for Child | P-532 | |
Disk Electrode | BE-910P | |
Disk Electrode | NE-136B | |
Display | VD-403B | |
Display Extension Board | YS-104P5 | |
Disposable Cuff | YP-840T, YP-841T, YP-842T, YP-843T, YP-844T, YP-845T | |
Disposable Electrode | NE-05 (NE-05IS3) | |
Disposable Electrode | Vitrode Bs (Bs-150, Bs-25) | |
Disposable Electrode | Vitrode F (F-150M, F-150S, F-150U3, F-150U5) | |
Disposable Electrode | Vitrode G (G-600) | |
Disposable Electrode | Vitrode L (L-150X) | |
Disposable Electrode | Vitrode M (M-150) | |
Disposable Electrode | Vitrode N (N-01IS3) | |
Disposable Electrode | Vitrode N (N-03IS3) | |
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) | |
Disposable Electrode for EEG | NE-09 (NE-090S1, NE-091S7) | |
Disposable Pads | P-511 | |
Disposable Pads | P-711, P-713, P-721 | |
Disposable Pads | P-730K | |
Disposable Pads | P-740K | |
Disposable Pads for Infant | P-513 |
E
Product | Model | Download PDF |
---|---|---|
ECG/BP Output Cable | YJ-910P, YJ-920P | |
ECG Connection Cord | JC-933P | |
ECG Electrode Lead | BC-112B | |
EEG Disk Electrode | NE-116A | |
EEG Disk Electrode | NE-117A | |
EEG Disk Electrode | NE-118A | |
EEG Ear Clip Electrode | NE-311A | |
EEG Electrode | NE-113A | |
EEG Electrode | NE-114A | |
EEG Electrode (Collodion) | NE-133A | |
EEG Electrode (Collodion) | NE-134A | |
EEG Electrode (Collodion) | NE-136A | |
EEG Electrode Set | BE-403A | |
EEG Electrode Set, Electrode G (with plastic holder), Earlobe Electrode | BE-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&EMG | ZV-401E, ZV-181E | |
Evoked EEG Electrode Kit | NE-132B | |
Evoked Potential Electrode Kit | NE-142B | |
Extension Cord | BM-09IS8 | |
Extension Cord | BM-918B | |
External Paddle Holder | DP-831VK | |
External Paddles Holder | DP-101V |
F
Product | Model | Download PDF |
---|---|---|
Fast Clip | NC-143E(937122) | |
Fastclip Ø3 Child, Fastclip Ø4 Child | NC-153E, NC-154E | |
Fast Clip Ø4 | NC-144E(937131) | |
Finger Electrode | NM-450S | |
Finger Electrode | NM-451B | |
Flow Adapter | TF-120P | |
Flow Adapter | TF-130P | |
Flow Tube | YF-120P |
G
Product | Model | Download PDF |
---|---|---|
GELAID | Z-101BA | |
Ground Electrode | NM-501B | |
Ground Electrode | NM-502B | |
Ground Electrode | NM-503B | |
Ground Electrode | NM-505B | |
Ground Electrode | NM-506B | |
Ground Electrode | NM-550B | |
Ground Electrode | NM-551B |
H
Product | Model | Download PDF |
---|---|---|
HA-410V CAL | YZ-005B1 | |
Headband for EEG | BE-090AS, BE-090AM | |
HEMATOLOGY CALIBRATOR | MEK-CAL | |
HEMATOLOGY CONTROL | MEK-3DL, MEK-3DN, MEK-3DH | |
HEMATOLOGY CONTROL+CRP | MK-3CL, MK-3CN, MK-3CH | |
HEMATOLOGY CONTROL for Reticulocyte | MK-RE1, MK-RE2, MK-RE3 | |
HEMATOLOGY CONTROL for WBC 5 part differential | MEK-5DL, MEK-5DN, MEK-5DH | |
Hemolynac•310 | MK-310W | |
Hemolynac•3N | MEK-680 | |
Hemolynac•5 | MEK-910 | |
Hemolynac•510 | MK-510W | |
Holder BD 0.5 mL | YZ-008B3 |
I
Product | Model | Download PDF |
---|---|---|
IBP Interface Isolation Cable | JP-911P | |
Interface | QF-801P | |
Interface | QF-901P | |
Interface | QF-902P | |
Interface | QF-903P | |
Interface | QF-907P | |
Interface | QF-908P | |
Interface | QF-909P | |
Interface | QF-911P | |
Interface | QI-373P | |
Interface | QI-374P | |
Interface | QI-670P | |
INTERFACE(SKC) | QF-751P | |
Interface Unit | JA-920P | |
ISOTONAC•3 | MEK-640 | |
ISOTONAC•4 | MEK-641 |
K
Product | Model | Download PDF |
---|---|---|
KABEVETTE G Kit | YZ-008B2 |
L
Product | Model | Download PDF |
---|---|---|
Lithium Ion Battery | SB-121V | |
Lithium Ion Battery | SB-220V |
M
Product | Model | Download PDF |
---|---|---|
Mini Flat Junction Box | JE-125AK, JE-225AK, JE-226AK, JE-227AK, JE-228AK | |
Mini Junction Box | JE-922A, JE-922AG | |
Multi Interface Box | JJ-230B | |
Multi-link Cable | YS-096P5 |
N
Product | Model | Download PDF |
---|---|---|
Nasal Adapter | YG-120T, YG-121T, YG-122T | |
Nasal Adapter, Pediatric Nasal Adapter | YG-125TW, YG-135TW | |
Nasal Adapter, Pediatric Nasal Adapter | YG-125T, YG-135T | |
Nasal Adapter, Pediatric Nasal Adapter | YG-225TW, YG-235TW | |
Nasal Adapter, Pediatric Nasal Adapter | YG-225T, YG-235T | |
NCS Electrode | NM-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 Adapter | YG-213T, YG-214T | |
NIBP Cuff | YP-710T, YP-711T, YP-712T, YP-713T, YP-714T, YP-715T | |
NIBP Cuff, Adult | YP-503P, YP-504P | |
NIBP Cuff, Adult(SKC) | YP-723T, YP-724T | |
NKB-301V Battery Pack | YZ-024H9 | |
Nurse Call Cable | YJ-672P |
P
Product | Model | Download PDF |
---|---|---|
Paste for EEG | Z-101N | |
Patient Cable(SKC) | BJ-961D, BJ-962D | |
Pediatric Electrode Assy Ø 44 mm | ND-844V | |
Pediatric/Infant cap-ONE Mask | YG-232TW, YG-242TW | |
Pediatric/Infant cap-ONE Mask | YG-232T, YG-242T | |
Pulse Oximeter | OLV-4201, OLV-4202 |
R
Product | Model | Download PDF |
---|---|---|
Receiver | ZR-920P | |
Recorder Module(SKC) | WS-752P | |
Reticulonac | MK-110W |
S
Product | Model | Download PDF |
---|---|---|
Sampling Line (Adult, Neonate) | YG-310P, YG-311P | |
SARSTEDT Kit | YZ-008B1 | |
Shield Junction Cord | BM-090Y | |
skinPure | YZ-0019 | |
SOFTWARE KIT(SKC) | QS-251P | |
SOFTWARE KIT(SKC) | QS-901PK | |
SpO2 Connection Cord | JL-400T | |
SpO2 Connection Cord | JL-430U | |
SpO2 Connection Cord | JL-900P | |
SpO2 Connection Cord | JL-930P, JL-030U1, JL-030U2 | |
SSD Expansion Board | YS-116P0 | |
SSD Extension Kit | YS-105P0 | |
Stimulation Electrode | NM-413B | |
Straight T-Piece, Elbow T-Piece | YG-320P, YG-321P | |
Surface Electrode | NM-312S | |
Surface Electrode | NM-315S | |
Surface Stimulation Electrode | NM-410S | |
Surface Stimulation Electrode | NM-420S | |
Surface Stimulation Electrode | NM-422B | |
Surface Stimulation Electrode | NM-430S | |
Surface Stimulation Electrode | NM-983W |
T
Product | Model | Download PDF |
---|---|---|
Thermal Airflow Sensor | TR-190A | |
TL-260T Clip Adapter | YS-087P9 |
U
Product | Model | Download PDF |
---|---|---|
Unit Connection Cable | YS-096P2, YS-096P3 |
V
Product | Model | Download PDF |
---|---|---|
Visual Stimulator Adaptor | YL-104A | |
Vital Signs Monitor(SKC) | SVM-7100 series |
W
Product | Model | Download PDF |
---|---|---|
Water Trap (Adult, Neonate) | YG-300P, YG-301P | |
Wireless LAN Module(SKC) | QI-710P | |
WS-960R Power Supply | SC-611R |