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Safety and Performance Information

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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.

This Safety and Performance Information is an extract from the general and safety information sections of the most recent edition of Operator's Manual or Installation Guide. Therefore, the contents of your Operator's Manual or Installation Guide may differ from those of this Safety and Performance Information.  For detailed operating procedures, follow the instructions of your Operator's Manual or Installation Guide.

*Not all products sold in the EU are covered in this page.
*Products will be added upon issuance of the Declaration of Conformity under the Medical Device Regulation.

A

Product Model Download PDF
AC Cradle SC-170R SC170R_20190419_OM-C_ENG.pdf
Adapter DH-170P DH170P_20190419_OM-B_ENG.pdf
Adapter DH-171P DH171P_20190419_OM_ENG.pdf
Adapter DH-172P DH172P_20190419_OM_ENG.pdf
Adapter DH-270P DH270P_20190422_IG-B_ENG.pdf
Adapter DH-470P DH470P_20190423_OM_ENG.pdf
Adapter DH-693P DH693P_20190419_IG-C_ENG.pdf
Adapter DI-270P DI270P_20190419_IG-B_ENG.pdf
Adapter DI-370P DI370P_20190312_IG-C_ENG.pdf
Adapter DI-371P DI371P_20190312_IG-A_ENG.pdf
Adapter DI-630P, DI-650P DI630P_20190422_IG_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_20190412_OM-A_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
Antenna Isolator ZA-022P ZA022P_20190522_OM-B_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
Base DH-691P DH691P_20190419_IG-C_ENG.pdf
Base DM-191P DM191P_20190419_IG-B_ENG.pdf
Base Stand DM-190P DM190P_20190419_IG-C_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-470P SB470P_20190423_OM_ENG.pdf
Battery Pack SB-671P SB671P_20190423_OM-I_ENG.pdf
Battery Pack SB-920P SB920P_20190419_IG-E_ENG.pdf

C

Product Model Download PDF
Cart KC-013P KC013P_20190419_IG-F_ENG.pdf
Cart KC-170P KC170P_20190419_OM_ENG.pdf
Cart KC-470P KC470P_20190423_OM_ENG.pdf
Cart KC-600P KC600P_20190419_IG-L_ENG.pdf
Channel Writer QI-901PK QI901PK_20190417_OM-L_ENG.pdf
Collodion Electrode BE-920P BE920P_20190422_OM-F_ENG.pdf
Connection Cable YS-108P8 YS108P8_20190312_OM-A_ENG.pdf
Connection Cable YS-112P7 YS112P7_20190312_OM-A_ENG.pdf
Counter Top Mount KG-600P KG600P_20190422_IG-D_ENG.pdf

D

Product Model Download PDF
Disk Electrode BE-910P BE910P_20190422_OM-F_ENG.pdf
Display Extension Board YS-104P5 YS104P5_20190419_IG-F_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
Extension Cord BM-918B BM918B_20190604_OM-A_ENG.pdf

F

Product Model Download PDF
Flow Adapter TF-130P TF130P_20190312_OM-A_ENG.pdf

I

Product Model Download PDF
IBP Interface Isolation Cable JP-911P JP911P_20190419_ENG.pdf
Interface QF-801P QF801P_20190312_OM-B_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

M

Product Model Download PDF
Multi-link Cable YS-096P5 YS096P5_20190419_OM-A_ENG.pdf

N

Product Model Download PDF
NIBP Cuff, Adult YP-503P, YP-504P YP503P_20190422_OM-A_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
PVM-2700 Serial Cable YS-100P6 YS100P6_20190422_OM-B_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
Pouch for GZ-130P YS-112P5 YS112P5_20190419_OM-A_ENG.pdf
Pouch for GZ-140P YS-112P4 YS112P4_20190419_OM-A_ENG.pdf

Q

Product Model Download PDF
QI RGB Cable YS-080P3 YS080P3_20190508_OM-E_ENG.pdf

R

Product Model Download PDF
Receiver ZR-920P ZR920P_20190419_IG-A_ENG.pdf
Remote Controller RY-910PA RY910PA_20190419_OM-F_ENG.pdf

S

Product Model Download 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
Serial Cable YS-095P6 YS095P6_20190422_OM-B_ENG.pdf
Software Kit QS-100P QS100P_20190419_IG-A_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
Straight T-Piece, Elbow T-Piece YG-320P, YG-321P YG320P_20190312_OM-A_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
VL Cable Set (Main) YS-097P5, YS-097P6 YS097P5_20190419_OM-A_ENG.pdf
VL Cable Set (Second) YS-113P8, YS-113P9 YS113P8_20190513_OM-A_ENG.pdf

W

Product Model Download PDF
WS-960R Power Supply SC-611R SC611R_20190419_OM-D_ENG.pdf
Wall Mount Kit, Adapter KG-951P, DI-950P KG951P_20190312_IG-I_ENG.pdf
Water Trap (Adult, Neonate) YG-300P, YG-301P YG300P_20190312_OM-A_ENG.pdf

Z

Product Model Download PDF
ZS Holder DH-380P DH380P_20190402_OM-B_ENG.pdf
ZS Setup Application QP-601P QP601P_20190220_OM_ENG.pdf