(293 days)
No
The document describes a device that measures physiological responses to electrical stimulation and displays the data. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as monitoring relaxation, not as providing therapy.
Yes
The device is described as "monitoring the relaxation of the patient when neuromuscular blockades are administered" and detecting "the muscle's action potential." This involves assessing physiological states to provide information for medical decision-making regarding muscle relaxants and regional anesthetics, which falls under the definition of a diagnostic device.
No
The device description explicitly lists hardware components such as the NMT Module, Main Cable, Holder, and EMG Electrode, which are integral to its function of electrical stimulation and signal measurement.
Based on the provided text, the Smart Cable NMT Module and Accessories are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Intended Use/Device Description: The Smart Cable NMT Module and Accessories are described as being used for "monitoring the relaxation of the patient when neuromuscular blockades are administered." This is achieved by applying electrical stimulation to the ulnar nerve and measuring the muscle's action potential (EMG signals). This process involves interacting directly with the patient's body and measuring a physiological response, not analyzing a specimen taken from the body.
- Lack of Specimen Analysis: The text does not mention the analysis of any biological specimens. The device measures electrical signals and muscle responses directly from the patient.
The bedside monitors (Life Scope BSM-3000, BSM-6000, and CSM-1901) are also not IVD devices. They are used for monitoring various physiological parameters directly from the patient.
Therefore, the Smart Cable NMT Module and Accessories, as described, fall under the category of a physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Smart Cable NMT Module and Accessories are indicated for monitoring the relaxation of the patient when neuromuscular blockades are administered.
The Smart Cable NMT Module and Accessories are comprised of:
- · AF-201P NMT Module with Smart Cable
- Disposable Electrodes
- Main cable
- · Holder (optional)
The Smart Cable NMT Module and Accessories are intended to be used as a system that requires Nihon Kohden compatible electrodes and bedside monitoring systems. The Smart Cable NMT Module and Accessories are intended for use by medical personnel in clinical settings and are available by prescription only.
The Life Scope BSM-3000 Series Bedside Monitor is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate audible and/or visible alarms when an arrhythmia exists.
The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature,BIS, cardiac output (CO), oxygen concentration (O2), carbon dioxide concentration (CO2), EtCO2, respiratory rate, and inspired and expired anesthetic gases including N20. Halothane. Isoflurane. Enflurane. Sevoflurane, and Desflurane.
The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. The device may also be used to condition and transmit physiological signals via radio frequency. The device can interface to external equipment to display numerical and waveform data and alarms from the external devices. Supported external devices include CO2 monitors, BIS monitors, Anesthetic agents/gases detection system, Anesthesia machine, Ventilators, CCO monitors, TOF monitors, CCO/SvO2 Monitors, EEG monitoring device, tcPO2/tcPCO2 monitors, rSO2 monitors and external devices which output analog voltage signal.
The device will be available for use by medical personnel on patients within a medical facility on all patient populations.
The Life Scope BSM-6000 Series Bedside Monitor is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate audible and/or visible alarms when an arrhythmia exists.
The device is also intended to monitor heart rate, plood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature,BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2). EtCO2. respiratory rate, and inspired and expired anesthetic agents and anesthetic gases including N20, Halothane, Isoflurane, Enflurane, Sevoflurane, and Desflurane.
The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. The device may also be used to condition and transmit physiological signals via radio frequency. The device can interface to external equipment to display numerical and waveform data and alarms from the external devices. Supported external devices include CO2 monitors, BIS monitors, Anesthetic agents/gases detection system, Anesthesia machine, Ventilators, CCO monitors, TOF monitors, CCO/SvO2 Monitors, EEG monitoring device, tcPO2/tcPCO2 monitors, rSO2 monitors and external devices which output analog voltage signal.
The device will be available for use by medical personnel on patients within a medical facility on all patient populations.
The Nihon Kohden CSM-1901 Bedside Monitor is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N20, halothane, isoflurane, enflurane and desflurane. The device also displays patient data from external devices such as ventilators, TOF monitors, and EEG measuring unit.
The device may generate and audible and/or visual alarm when a measured rate falls outside preset limits.
The device will be available for use by trained medical facility on all patient populations. including adult, neonate, infant, child, and adolescent subgroups.
Product codes (comma separated list FDA assigned to the subject device)
MHX, KOI
Device Description
The Smart Cable NMT Module and Accessories are comprised of:
• AF-201P NMT Module with Smart Cable
• Disposable Electrodes
• Main cable
• Holder (optional)
The Smart Cable NMT Module and Accessories are intended to be used as a system that requires Nihon Kohden compatible electrodes and bedside monitoring systems. The Smart Cable NMT Module and Accessories are intended for use by medical personnel in clinical settings and are available by prescription only.
The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, Cardiac Output (CO), oxygen concentration (O2), CO2 and EtCO2, respiratory rate, BIS and inspired and expired anesthetic agents and gases including CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane. Anesthetic agents and gases are detected using the cleared AG-920RA Anesthetic Agent Detection System. The device can interface to external equipment to display numerical and waveform data and alarms from the external devices. Supported external devices include AG-920RA Anesthetic Agent Detection System, Ventilators, CO2 Monitors, TOF Monitors, BIS Monitors, CCO/SvO2 Monitors, EEG monitoring device, tcPO2 monitors, rSO2 monitors and external devices with output analog voltage signal and continuous NIBP Monitors. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. This device may also be used to condition and transmit physiological signals via radio frequency.
The Life Scope BSM-6000 Series Bedside Monitoring System is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, Cardiac Output (CO), oxygen concentration (FiO2), CO2 and EtCO2, respiratory rate, BIS and inspired and expired anesthetic agents and gases including CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane. Anesthetic agents and gases are detected using the cleared AG-920RA Anesthetic Agent Detection System. The device can interface to external equipment to display numerical and waveform data and alarms from the external devices. Supported external devices include AG-920RA Anesthetic Agent Detection System, Ventilators, CO2 Monitors, TOF Monitors, BIS Monitors, CCO/SvO2 Monitors and continuous NIBP Monitors. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. This device may also be used to condition and transmit physiological signals via radiofrequency.
The Nihon Kohden CSM-1901Series is a device which continuously monitors physiological information of a patient and is used in an operation room, a recovery room, general wards, ICU, CCU, HCU, NICU and an emergency room. This bedside monitor is placed near the patient and is intended to display patient's vital signs. This device can also be connected to other external patient monitoring devices. In addition, this device can communicate patient's data to a central monitoring station via network to monitor multiple patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The device will be available for use by medical personnel on patients within a medical facility on all patient populations.
The device will be available for use by trained medical personnel within a medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups.
Intended User / Care Setting
medical personnel in clinical settings
medical personnel in a medical facility
trained medical personnel within a medical facility
operating room, recovery room, or intensive care unit.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Smart Cable NMT Module and Accessories have been subjected to design verification and validation testing for electrical safety, electromagnetic compatibility, software V&V, operational performance, and operational and storage environmental performance. These tests verified and validated the proper operation of the system. Conformance to 21 CFR Part 898 Performance Standard for Electrode Lead Wires and Patient Cables was met with compliance to IEC 60601-1 3rd edition clause 8.5.2.3. Patient contacting accessories have demonstrated acceptable biocompatibility and where applicable, shelf life. Performance testing has been made for the TetraGraph which supports substantial equivalence between the TetraGraph and the predicate device.
The performance testing for the Smart Cable NMT Module and Accessories are summarized below:
Software performance testing Electrical safety (in accordance with IEC 60601-1) Electromagnetic compatibility (in accordance with IEC 60601-1-2 and IEC 60601-2-40) Biocompatibility testing (in accordance with ISO10993-1) Mechanical strength Environmental testing Usability testing Shelf life testing Performance testing of electrodes; including tensile testing as well as electrical performance (as specified in the ANSI/AAMI EC12:2000 standard) The performance testing shows that Smart Cable NMT Module and Accessories has met all the acceptance criteria and are equivalent or similar to the predicate device's specifications. Thus, the test data demonstrates that Smart Cable NMT Module and Accessories is as safe and as effective in monitoring the relaxation of the patient when neuromuscular blockade is administered as the predicate.
No clinical tests have been submitted, referenced or relied on in the premarket notification submission for a determination of substantial equivalence. The device and the components are not MR compatible.
The Life Scope BSM-3000 Series Bedside Monitoring System incorporated all software changes in the integration testing. The testing confirmed the operation of the device when the Smart Cable NMT software was integrated into the system. The results confirmed that the device performed within specifications. No clinical tests have been submitted, referenced or relied on in this premarket notification submission for a determination of substantial equivalence.
The Life Scope BSM-6000 Series Bedside Monitoring System incorporated all software changes in the integration testing. The testing confirmed the operation of the device when the Smart Cable NMT software was integrated into the system. The results confirmed that the device performed within specifications. No clinical tests have been submitted, referenced or relied on in this premarket notification submission for a determination of substantial equivalence
The Nihon Kohden CSM-1901 Bedside Monitoring System incorporated al software changes in the integration testing. The testing confirmed the operation of the device when the Smart Cable NMT software was integrated into the system. The results confirmed that the device performed within specifications. No clinical tests have been submitted, referenced or relied on in this premarket notification submission for a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.2775 Electrical peripheral nerve stimulator.
(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Nihon Kohden Corporation % Sunita Teekasingh Sr. Regulatory Affairs Consultant - GSA2 Group LLC Nihon Kohden America, Inc. 15353 Barranca Parkway Irvine, California 92618
Re: K201949
Trade/Device Name: Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series Bedside Monitors, Life Scope BSM 6000 Series Bedside Monitors, and Nihon Kohden CSM-1901 Bedside Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX, KOI Dated: March 30, 2021 Received: April 2, 2021
Dear Sunita Teekasingh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation -emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Todd Courtnev Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201949
Device Name
Smart Cable NMT Module and Accessories; Life Scope BSM-3000 Series Bedside Monitors; Life Scope BSM-6000 Series Bedside Monitors; and Nihon Kohden CSM-1901 Bedside Monitor
Indications for Use (Describe)
The Smart Cable NMT Module and Accessories are indicated for monitoring the relaxation of the patient when neuromuscular blockades are administered.
The Smart Cable NMT Module and Accessories are comprised of:
- · AF-201P NMT Module with Smart Cable
- Disposable Electrodes
- Main cable
- · Holder (optional)
The Smart Cable NMT Module and Accessories are intended to be used as a system that requires Nihon Kohden compatible electrodes and bedside monitoring systems. The Smart Cable NMT Module and Accessories are intended for use by medical personnel in clinical settings and are available by prescription only.
The Life Scope BSM-3000 Series Bedside Monitor is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate audible and/or visible alarms when an arrhythmia exists.
The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature,BIS, cardiac output (CO), oxygen concentration (O2), carbon dioxide concentration (CO2), EtCO2, respiratory rate, and inspired and expired anesthetic gases including N20. Halothane. Isoflurane. Enflurane. Sevoflurane, and Desflurane.
The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. The device may also be used to condition and transmit physiological signals via radio frequency. The device can interface to external equipment to display numerical and waveform data and alarms from the external devices. Supported external devices include CO2 monitors, BIS monitors, Anesthetic agents/gases detection system, Anesthesia machine, Ventilators, CCO monitors, TOF monitors, CCO/SvO2 Monitors, EEG monitoring device, tcPO2/tcPCO2 monitors, rSO2 monitors and external devices which output analog voltage signal.
The device will be available for use by medical personnel on patients within a medical facility on all patient populations.
The Life Scope BSM-6000 Series Bedside Monitor is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate audible and/or visible alarms when an arrhythmia exists.
3
The device is also intended to monitor heart rate, plood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature,BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2). EtCO2. respiratory rate, and inspired and expired anesthetic agents and anesthetic gases including N20, Halothane, Isoflurane, Enflurane, Sevoflurane, and Desflurane.
The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. The device may also be used to condition and transmit physiological signals via radio frequency. The device can interface to external equipment to display numerical and waveform data and alarms from the external devices. Supported external devices include CO2 monitors, BIS monitors, Anesthetic agents/gases detection system, Anesthesia machine, Ventilators, CCO monitors, TOF monitors, CCO/SvO2 Monitors, EEG monitoring device, tcPO2/tcPCO2 monitors, rSO2 monitors and external devices which output analog voltage signal.
The device will be available for use by medical personnel on patients within a medical facility on all patient populations.
The Nihon Kohden CSM-1901 Bedside Monitor is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N20, halothane, isoflurane, enflurane and desflurane. The device also displays patient data from external devices such as ventilators, TOF monitors, and EEG measuring unit.
The device may generate and audible and/or visual alarm when a measured rate falls outside preset limits.
The device will be available for use by trained medical facility on all patient populations. including adult, neonate, infant, child, and adolescent subgroups.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary – General Provisions 5.0
| Manufacturer Name: | Nihon Kohden Corporation | |
|---|---|---|
| Address: | 1-31-4 Nishiochiai, Shinjuku-Ku | |
| Tokyo 161-8560, Japan | ||
| General Provisions | Submitter Name: | Nihon Kohden America |
| Address: | 15353 Barranca Parkway | |
| Irvine, California, USA 92618 | ||
| Contact: | Sandra Gadeyne | |
| Sr. Director of Quality and Regulatory Affairs | ||
| Phone Number | 949-356-3401 | |
| Fax Number: | 949-580-1550 | |
| Sandra_Gadeyne@nihonkohden.com | ||
| Date of Preparation | 30Apr2021 |
5.1 Smart Cable NMT Module and Accessories
| Subject Device | Trade Name: | Smart Cable NMT Module and Accessories |
|---|---|---|
| Marketing Names | NMT Smart Cable TOF Pod; Smart Cable | |
| NMT Pod, with EMG Support; NMT Pod | ||
| TOF Pod; TOF Smart Pod; NMT Smart Pod | ||
| Common Name: | Electrical peripheral nerve stimulator | |
| Classification Name | Stimulator, Nerve, Peripheral, Electric | |
| Classification: | Class II | |
| Product Code: | KOI | |
| Regulation Number: | 21 CFR 868.2775 | |
| 510(k) Number | K201949 | |
| Predicate Device | Trade Name: | TetraGraph Neuromuscular Transmission |
| Monitor | ||
| Classification Name: | Electrical peripheral nerve stimulator | |
| Premarket Notification | Stimulator, Nerve, Peripheral, Electric | |
| Product Code: | KOI | |
| Device Classification: | Class II | |
| Regulation Number: | 21 CFR 868.2775 | |
| Manufacturer: | Senzime AB | |
| 510K number: | K190795 | |
| Reference Device | Trade Name: | ToFscan |
| Classification Name: | Electrical Peripheral Nerve Stimulator | |
| Premarket Notification: | Stimulator, Nerve, Peripheral, Electric | |
| Product Code: | KOI | |
| Device Classification: | Class II | |
| Regulation Number: | 21 CFR 868.2775 | |
| Manufacturer: | Idmed | |
| 510(k): | K172690 |
5
| Subject Device
Description | The Nihon Kohden Smart Cable NMT Module (NMT Module) and
Accessories is an optional accessory for the Nihon Kohden bedside
monitoring systems. The Smart Cable NMT Module and Accessories TOF
(Train of Four) are based on EMG technology. With this system, the user
can apply electrical stimulation on the ulnar nerve to detect the muscle's
action potential. The reaction to the electrical impulse can be visualized
on the connected monitoring system. The Smart Cable NMT Module and
Accessories can assist medical personnel to quantitatively determine the
level of muscle relaxation. This information can be used to determine the
dose of muscle relaxants and regional anesthetics when performing
anesthesia in a clinical setting. It is intended for use by medical personnel
in the operating room, recovery room, or intensive care unit. |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The NMT Module is a system comprised of NMT Module, Main Cable,
Holder, and EMG Electrode. The NMT module is connected to an
electrode via Main Cable. The electrode is a single-use electrode array
and each array includes two stimulating electrodes, two recording
electrodes, and one ground electrode. The NMT module can transmit an
electrical stimulation pulse to the patient and can receive EMG signals via
the electrode array. The captured data from the disposable electrode is
sent to the monitoring system via the Smart Cable interface connector.
The various stimulation settings are also sent to the monitoring system to
display. |
| | The AF-201P NMT Module is used to control the electrical stimulation
and to measure the response. The operational setting is controlled via
buttons on the module or a touch screen. |
| Indications for
Use and
Intended Use | The Smart Cable NMT Module and Accessories are indicated for monitoring
the relaxation of the patient when neuromuscular blockades are
administered. |
| | The Smart Cable NMT Module and Accessories are comprised of: |
| | • AF-201P NMT Module with Smart Cable
• Disposable Electrodes
• Main cable
• Holder (optional) |
| | The Smart Cable NMT Module and Accessories are intended to be used
as a system that requires Nihon Kohden compatible electrodes and
bedside monitoring systems. The Smart Cable NMT Module and
Accessories are intended for use by medical personnel in clinical settings
and are available by prescription only. |
6
| Characteristics | Subject Device:
Smart Cable NMT
Module and
Accessories | Predicate Device:
Tetragraph
Neuromuscular
Transmission Monitor
(K#190795) | Reference Device:
ToFscan Neuromuscular
Transmission Monitor
(K#172690) |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Panel | Anesthesiology | Anesthesiology | Anesthesiology |
| Classification Name | 21 CFR 868.2775
Electrical Peripheral
Nerve Stimulator | 21 CFR 868.2775
Electrical Peripheral Nerve
Stimulator | 21 CFR 868.2775
Electrical Peripheral Nerve
Stimulator |
| Regulatory Class | Class II | Class II | Class II |
| Product Code | KOI | KOI | KOI |
| Indications for Use | The Smart Cable NMT
Module and Accessories
are indicated for
monitoring the relaxation
of the patient when
neuromuscular
blockades are
administered.
The Smart Cable
Module and Accessories
are comprised of:
AF-201P NMT Module
with Smart Cable
Disposable
ElectrodesMain cableHolder (optional)
The Smart Cable NMT
Module and Accessories
are intended to be used
as a system that
requires Nihon Kohden
compatible electrodes
and bedside monitoring
systems. The Smart
Cable NMT Module and
Accessories are
intended for use by
medical personnel in
clinical settings and are
available by prescription
only. | The TetraGraph
Neuromuscular
Transmission (NMT)
Monitor is indicated for
monitoring the relaxation
of the patient when
neuromuscular blockade is
administered. | ToFscan is a
neuromuscular
transmission monitor for
monitoring the
neuromuscular block of a
patient in the operating
theatre, recovery room or
intensive care unit. The
effect of neuromuscular
blocking agents (NMBA) is
monitored by measuring the
acceleration of the muscle
movement
(acceleromyography) or by
visually observing muscle
contractions consequent to
electrical stimulation. The
ToFscan has a three-
dimensional acceleration
sensor (accelerometer) to
detect and quantify a
patient's thumb movement
(contracting adductor
pollicis). The sensor is
directly integrated into the
finger's splint, making it
possible to obtain its optimal
and reproducible positioning |
| Device Description | The Smart Cable
NMT Module and
Accessories are
comprised of:
• AF-201P NMT
Module with
Smart Cable
• Disposabl
e
Electrodes
• Main cable
• Holder (optional)
The Smart Cable NMT
Module and
Accessories are
intended to be used as
a system that requires
Nihon Kohden
compatible electrodes
and bedside monitoring
systems. The Smart
Cable NMT Module and
Accessories are
intended for use by
medical personnelin
clinical settings and are
available by
prescription only. | The TetraGraph
Neuromuscular
Transmission (NMT)
Monitor (TetraGraph) is a
portable, battery-operated
EMG-based neuromuscular
transmission monitor for
use perioperative and in
recovery and critical care
environments following or
during the application of
Neuromuscular block.
Neuromuscular
Transmission (NMT) is the
transfer of an electrical
impulse between a motor
nerve and its associated
muscle. The NMT is
blocked by neuromuscular
blocking agents ("NMBAs")
which cause transient
muscle paralysis preventing
the patient from moving and
breathing spontaneously.
Muscle relaxation is used
during general anesthesia
to enable endotracheal
intubation and mechanical
ventilation and to provide
optimal surgical
conditions. Muscle
relaxation may also be
used in critical care during
mechanical ventilation. In
these circumstances,
TetraGraph can be used
as an objective monitor of
neuromuscular
transmission. TetraGraph
undertakes this function by
electrical stimulation of the
peripheral nerve and
directly measuring the
evoked response of the
muscles (Muscle Action
Potential (MAP)), thus
providing a quantitative
and automatic
measurement of muscle
response to a stimulus
using electromyography
(EMG). The TetraGraph is
a prescription-only medical
device and is indicated for
use in hospitals.
TetraGraph supplements
the use of clinical
information/data obtained
from other monitors, such | The effect of
neuromuscular blocking
agents (NMBAs) is
monitored by measuring
the acceleration of the
muscle movement
(acceleromyography) or
by visually observing
muscle contractions
consequent to electrical
stimulation. The ToFscan
has a three-dimensional
acceleration sensor
(accelerometer) to detect
and qualify a patient's
thumb movement
(contracting adductor
pollicis). The sensor is
directly integrated into
the finger's splint, making
it possible to obtain it's
optimal and reproducible
positioning. |
7
8
| | saturation (SpO2), end-
tidal carbon dioxide
(ETCO2), as well as
clinical assessment, to
determine the adequacy of | |
|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | ventilation.
The level of
neuromuscular block is | |
| | routinely measured by
stimulating a peripheral
nerve, usually in the
forearm and by evaluating | |
| | the muscle response
typically in the thumb or
little finger. The
TetraGraph controls the | |
| | level of electrical
stimulation applied to the
nerve and monitors the
muscle response by the | |
| | use of Electromyography
(EMG) detected by
electrodes on the muscle. | |
| | TetraGraph consists of the
followingmain components | |
| | TetraGraph Monitor
The TetraGraph Monitor is
used to control the electrical
stimulation and to measure
the EMG- response. The
Monitor is controlled via a | |
| | touch screen and a power
button. The Senzime AB
Traditional 510(k)
Premarket Submission
TetraGraph Page 005- | |
| | 3TetraGraph Monitor is
connected to the electrode
via a cable (the TetraCord
Cable). The battery in the
TetraGraph Monitor is | |
| | charged via a
communication port
connected to a USB- supply
adapter. | |
| | TetraSens Electrode
The TetraSens Electrode is
a single-use electrode
array. Each array includes | |
| | two stimulating electrodes
(applied along the ulnar
nerve at the wrist) and two
recording electrodes | |
| | (applied on the hand). The
TetraGraph Monitor can
transmit stimulation pulses
to the patient and can | |
| | receive EMG signals via the
electrode array. The
electrodes are neither
supplied sterile nor
intended to be sterilized by | |
9
| Electrode for
Stimulation | Single-use
electrode array (5
electrodes on an | Single-use electrode array
(4 electrodes on an array) | Uses 3D Accelerometer
Sensor to measure thumb
movement instead of |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrode Connection | Reusable Cable | Reusable Cable | Reusable Cable |
| movement
detection
technology | (EMG) | | |
| Muscle | Electromyography | from the Tetragraph kit.
Rechargeable lithium-
polymer battery
A re-chargeable lithium-
polymer battery is included
in the TetraGraph, and also
available as spare part. The
rechargeable battery is
charged using the USB
power supply adapter.
USB power supply adapter
and USB cable
The rechargeable battery is
charged using the USB
power supply adapter. The
adapter is configured for
local power outlets and
connects to the TetraGraph
using a USB cable. Data
can also be transferred to a
PC via the USB-port by
using the
USB-cable.
Electromyography (EMG) | Acceleromyography |
| | | TetraGraph Pole Clamp kit
A Pole clamp kit is available
for mounting the
TetraGraph on a pole
stand. The kit includes a
mounting device and an
attachment to the
Tetragraph. The Pole clamp
kitis supplied separately | |
| | | TetraCord Cable
The TetraCord Cable is
connected to the
TetraGraph Monitor via a
portand is connected to the
TetraSens Electrode
via the cable connector at
the other end of the
TetraCord Cable. The
TetraCord Cable is supplied
in together with the
TetraGraph monitor as part
of the kit and can also be
sold separately as a spare
part. | |
| | | the user. The TetraSens
Electrodes are sold
separately from the
TetraGraph monitor and are
available in boxes of 20
pcs. | |
| | array) | | electrode |
| Electrode applied part | Total of 5:
Two stimulating
electrodes are applied
along the ulnar nerve at
the wrist and two
recording electrodes are
applied on the hand.
One grounding electrode
applied on the hand | Total of 4:
Two stimulating electrodes
are applied along the ulnar
nerve at the wrist and two
recording electrodes are
applied on the hand. | Not Applicable (Uses D
Accelerometer Sensor to
measure thumb
movement instead of the
electrode) |
| Stimulation Patterns | Single stimulation,
TOF (Train Of Four),
PTC (Post Tetanic
Count), TET (tetanic
stimulation), DBS
(Double Burst
Stimulation) | Single Twitch (ST),
Train-of-Four (TOF),
Post-tetanic Count
(PTC) | TOF (Train Of Four)
- PTC (Post
Tetanic Count) - ATP (Automated
TOF PTC) - DBS (Double
Burst) (3,3) (3,2) - ST (Single Twitch)
0.1 Hz and 1 Hz - TET (Tetanus) 50 Hz |
| Stimulating
Current Range | 10-60 mA | 10-60 mA | 0-60 mA |
| Stimulation Pulse Width | Square wave, constant
current: 200µs or
300µs | Square wave, constant
current: 200µs or 300µs | Constant current, 0-
60 mA, monophasic
200µsec
pulse width |
| Power source | Power is supplied from
the Monitoring
System. | Battery operated | AC Power Supply |
| Compatibility | Works only with
Nihon Kohden
Monitoring System:
BSM-6000, BSM-
3000 CSM-1901 | Tetragraph Neuromuscular
Transmission Monitor
consists of a monitor,
electrode, and other
components. | The ToFscan system is
composed of the monitor,
the hand sensor, and the
US AC power supply unit. |
| General Safety | IEC 60601-1, IEC-
60601-1-2, IEC 60601-2-
40 | IEC 60601-1, IEC-60601-
1-2, IEC 60601-2-40 | IEC 60601-1,
IEC 60601-1-2,
IEC 60601-2-10 |
| Intended Use | There are differences in the indications for use statement, but the
differences do not result in new intended use. | | |
| Technological
Characteristics | Both Smart Cable NMT Module and Accessories and the predicate device,
Tetragraph Neuromuscular Transmission Monitor, measure muscle
response based on electromyography (EMG) technology and have reusable
cables for the electrode connection. The electrode used for the stimulation
are single use. There are minor technological differences in number of
electrodes and stimulation settings. Both devices utilize two stimulating
electrodes which are applied along the ulnar nerve at the wrist and two
recording electrodes are applied on the hand. One grounding electrode
applied on the hand.
The Smart Cable NMT Module and Accessories incorporates the
stimulation patterns of both the predicate and the reference device. | | |
10
11
| Safety &
Performance
Tests | The Smart Cable NMT Module and Accessories have been subjected to
design verification and validation testing for electrical safety,
electromagnetic compatibility, software V&V, operational performance, and
operational and storage environmental performance. These tests verified
and validated the proper operation of the system. Conformance to 21 CFR
Part 898 Performance Standard for Electrode Lead Wires and Patient
Cables was met with compliance to IEC 60601-1 3rd edition clause 8.5.2.3.
Patient contacting accessories have demonstrated acceptable
biocompatibility and where applicable, shelf life.
Performance testing has been made for the TetraGraph which supports
substantial equivalence between the TetraGraph and the predicate device.
The performance testing for the Smart Cable NMT Module and
Accessories are summarized below:
Software performance testing Electrical safety (in accordance with IEC 60601-1) Electromagnetic compatibility (in accordance with IEC 60601-1-2 and IEC
60601-2-40) Biocompatibility testing (in accordance with ISO10993-1) Mechanical strength Environmental testing Usability testing Shelf life testing Performance testing of electrodes; including tensile testing as well as
electrical performance (as specified in the ANSI/AAMI EC12:2000
standard) The performance testing shows that Smart Cable NMT Module and
Accessories has met all the acceptance criteria and are equivalent or
similar to the predicate device's specifications. Thus, the test data
demonstrates that Smart Cable NMT Module and Accessories is as safe
and as effective in monitoring the relaxation of the patient when
neuromuscular blockade is administered as the predicate.
No clinical tests have been submitted, referenced or relied on in the
premarket notification submission for a determination of substantial
equivalence. The device and the components are not MR compatible. |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
Substantial
Equivalence | The device comparison and the results of the safety and performance tests
indicate that the Nihon Kohden Smart Cable NMT Module and Accessories
is substantially equivalent to the predicate device, the TetraGraph
Neuromuscular Transmission Monitor. |
12
Life Scope BSM-3000 Series Bedside Monitoring System 5.2
| | Trade Name: | Life Scope BSM-3000 Series Bedside
Monitoring System |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Subject Device | Common Name: | Bedside Monitor, Patient Monitor, Cardiac
Monitor, Vital Signs Monitor and Anesthesia
Monitor |
| | Classification Name | Monitor, Physiological Patient Monitor with
Arrhythmia Detection and Alarms |
| | Classification: | Class II |
| | Product Code: | MHX |
| | Regulation Number: | 21 CFR 870.1025 |
| Predicate Device | Trade Name: | Life Scope BSM-6000 Series Bedside
Monitoring System |
| | Common Name: | Bedside Monitor, Patient Monitor, Cardiac
Monitor, Vital Signs Monitor and Anesthesia
Monitor |
| | Classification Name | Monitor, Physiological Patient Monitor with
Arrhythmia Detection and Alarms |
| | Classification: | Class II |
| | Product Code: | MHX |
| | Regulation Number: | 21 CFR 870.1025 |
| | 510(K): | K080342 |
| Device Description | The Life Scope BSM-3000 Series Bedside Monitoring System is intended
to monitor, display and record physiological data to provide cardiac and
vital signs monitoring within a medical facility. The device is intended to
produce a visual record of the electrical signals produced by the heart and
monitor the electrocardiogram to generate visible and/or audible alarms
when an arrhythmia exists. The device is also intended to monitor heart
rate, pulse rate, blood oxygen saturation (SpO2), non-invasive blood
pressure (NIBP), invasive blood pressure (IBP), body temperature,
Cardiac Output (CO), oxygen concentration (O2), CO2 and EtCO2,
respiratory rate, BIS and inspired and expired anesthetic agents and
gases including CO2, O2, N2O, Halothane, Isoflurane, Enflurane,
Sevoflurane and Desflurane. Anesthetic agents and gases are detected
using the cleared AG-920RA Anesthetic Agent Detection System. The
device can interface to external equipment to display numerical and
waveform data and alarms from the external devices. Supported external
devices include AG-920RA Anesthetic Agent Detection System,
Ventilators, CO2 Monitors, TOF Monitors, BIS Monitors, CCO/SvO2
Monitors, EEG monitoring device, tcPO2 monitors, rSO2 monitors and
external devices with output analog voltage signal and continuous NIBP
Monitors. The device may generate an audible and/or visual alarm when
a measured rate falls outside preset limits. This device may also be used
to condition and transmit physiological signals via radio frequency. | |
| Indications for Use
and Intended Use | The Life Scope BSM-3000 Series Bedside Monitor is intended to monitor
display and record physiological data to provide cardiac and vital signs
monitoring within a medical facility. The device is intended to produce a
visual record of the electrical signals produced by the heart and monitor
the electrocardiogram to generate audible and/or visible alarms when an
arrhythmia exists.
The device is also intended to monitor heart rate, pulse rate, blood
oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive
blood pressure (IBP), body temperature, BIS, cardiac output (CO),
oxygen concentration (O2), carbon dioxide concentration (CO2), EtCO2,
respiratory rate, and inspired and expired anesthetic agents and
anesthetic gases including N2O, Halothane, Isoflurane, Enflurane,
Sevoflurane, and Desflurane.
The device may generate an audible and/or visual alarm when a
measured rate falls outside preset limits. The device may also be
used to condition and transmit physiological signals via radio
frequency. The device can interface to external equipment to display
numerical and waveform data and alarms from the external devices.
Supported external devices include CO2 monitors, BIS monitors,
Anesthetic agents/gases detection system, Anesthesia machine,
Ventilators, CCO monitors, TOF monitors, CCO/SvO2 Monitors, EEG
monitoring device, tcPO2/tcPCO2 monitors, rSO2 monitors and
external devices which output analog voltage signal. | |
| | The device will be available for use by medical personnel on patients
within a medical facility on all patient populations. | |
| Technological
Characteristics | The BSM-3000 Bedside Monitoring System was a letter to file to the
BSM-6000 Bedside Monitoring Systems. The dimensions and weight
of the monitoring systems are different, but the performance,
technological features are the same. The difference between the
systems are that the BSM-3000 has an integrated input system, and
BSM-6000 has a interchangeable input unit. Each of the monitoring
systems measure the same parameters and interface with the same
accessories. There have been no significant hardware changes. | |
| | The indications for use statement/intended use statement have been
updated to include the interface with other external devices. There
have been software updates to the system to integrate the Smart
Cable NMT Module and accessories. The performance of the device
is listed in Section 5.5 of this document. | |
| Safety &
Performance Tests | The Life Scope BSM-3000 Series Bedside Monitoring System
incorporated all software changes in the integration testing. The
testing confirmed the operation of the device when the Smart Cable
NMT software was integrated into the system. The results confirmed
that the device performed within specifications. No clinical tests have
been submitted, referenced or relied on in this premarket notification
submission for a determination of substantial equivalence. | |
13
14
5.3 Life Scope BSM-6000 Series Bedside Monitoring System
| | Trade Name: | Life Scope BSM-6000 Series Bedside
Monitoring System |
|------------------|---------------------|-----------------------------------------------------------------------------------------------------|
| | | |
| Subject Device | Common Name: | Bedside Monitor, Patient Monitor,
Cardiac Monitor, Vital Signs Monitor
and Anesthesia Monitor |
| | Classification Name | Monitor, Physiological Patient Monitor
with Arrhythmia Detection and Alarms |
| | Classification: | Class II |
| | Product Code: | MHX |
| | Regulation Number: | 21 CFR 870.1025 |
| Predicate Device | Trade Name: | Life Scope BSM-6000 Series Bedside
Monitoring System |
| | | |
| | Common Name: | Bedside Monitor, Patient Monitor,
Cardiac Monitor, Vital Signs Monitor and
Anesthesia Monitor |
| | Classification Name | Monitor, Physiological Patient Monitor
with Arrhythmia Detection and Alarms |
| | Classification: | Class II |
| | Product Code: | MHX |
| | Regulation Number: | 21 CFR 870.1025 |
| | 510(K): | K080342 |
15
| Device
Description | The Life Scope BSM-6000 Series Bedside Monitoring System is
intended to monitor, display and record physiological data to provide
cardiac and vital signs monitoring within a medical facility. The device is
intended to produce a visual record of the electrical signals produced by
the heart and monitor the electrocardiogram to generate visible and/or
audible alarms when an arrhythmia exists. The device is also intended
to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non-
invasive blood pressure (NIBP), invasive blood pressure (IBP), body
temperature, Cardiac Output (CO), oxygen concentration (FiO2), CO2
and EtCO2, respiratory rate, BIS and inspired and expired anesthetic
agents and gases including CO2, O2, N2O, Halothane, Isoflurane,
Enflurane, Sevoflurane and Desflurane. Anesthetic agents and gases
are detected using the cleared AG-920RA Anesthetic Agent Detection
System. The device can interface to external equipment to display
numerical and waveform data and alarms from the external devices.
Supported external devices include AG-920RA Anesthetic Agent
Detection System, Ventilators, CO2 Monitors, TOF Monitors, BIS
Monitors, CCO/SvO2 Monitors and continuous NIBP Monitors. The
device may generate an audible and/or visual alarm when a measured
rate falls outside preset limits. This device may also be used to condition
and transmit physiological signals via radiofrequency. |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use and
Intended Use | The Life Scope BSM-6000 Series Bedside Monitor is intended to
monitor, display and record physiological data to provide cardiac and
vital signs monitoring within a medical facility. The device is intended to
produce a visual record of the electrical signals produced by the heart
and monitor the electrocardiogram to generate audible and/or visible
alarms when an arrhythmia exists.
The device is also intended to monitor heart rate, pulse rate, blood
oxygen saturation (SpO2), non-invasive blood pressure (NIBP),
invasive blood pressure (IBP), body temperature, BIS, cardiac output
(CO), oxygen concentration (FiO2), carbon dioxide concentration
(CO2), EtCO2, respiratory rate, and inspired and expired anesthetic
agents and anesthetic gases including N2O, Halothane, Isoflurane,
Enflurane, Sevoflurane, and Desflurane.
The device may generate an audible and/or visual alarm when a
measured rate falls outside preset limits. The device may also be used
to condition and transmit physiological signals via radio frequency. The
device can interface to external equipment to display numerical and
waveform data and alarms from the external devices. Supported
external devices include CO2 monitors, BIS monitors, Anesthetic
agents/gases detection system, Anesthesia machine, Ventilators, CCO
monitors, TOF monitors, CCO/SvO2 Monitors, EEG monitoring device,
tcPO2/tcPCO2 monitors, rSO2 monitors and external devices which
output analog voltage signal.
The device will be available for use by medical personnel on patients
on all patient populations. |
| Technological
Characteristics | The indications for use/intended use statement have been updated to
include the interface with other external devices. There are no hardware
changes compared to the predicate devices. There have been software
updates to the system to integrate the Smart Cable NMT Module and
accessories. |
| Safety &
Performance
Tests | The Life Scope BSM-6000 Series Bedside Monitoring System
incorporated all software changes in the integration testing. The testing
confirmed the operation of the device when the Smart Cable NMT
software was integrated into the system. The results confirmed that the
device performed within specifications. No clinical tests have been
submitted, referenced or relied on in this premarket notification
submission for a determination of substantial equivalence |
| Summary of
Substantial
Equivalence | The Life Scope BSM-6000 Series is equivalent to the Life Scope BSM-
6000 Series. The indications for Use have been updated to include the
interface with other external devices. The BSM-6000 and the BSM-
6000 Bedside Monitoring System can measure oxygen concentration,
the BSM-6000 when connected to an external device, can also
measure fractionated oxygen. |
16
5.4 CSM 1901 Bedside Monitoring System
| | Trade Name: | Nihon Kohden CSM-1901 Bedside
Monitor |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Subject Device | Common Name: | Bedside Monitor, Patient Monitor,
Cardiac Monitor, Vital Signs Monitor
and Anesthesia Monitor |
| | Classification Name | Monitor, Physiological Patient Monitor
with Arrhythmia Detection and Alarms |
| | Classification: | Class II |
| | Product Code: | MHX |
| | Regulation Number: | 21 CFR 870.1025 |
| | 510(K): | K151080 |
| Predicate
Devices | Trade Name | Nihon Kohden CSM-1901 Bedside
Monitor |
| | Common Name: | Bedside Monitor, Patient Monitor,
Cardiac Monitor, Vital Signs Monitor and
Anesthesia Monitor |
| | Classification Name | Monitor, Physiological Patient Monitor
with Arrhythmia Detection and Alarms |
| | Classification: | Class II |
| | Product Code: | MHX |
| | Regulation Number: | 21 CFR 870.1025 |
| | 510(K): | K151080 |
| Device
Description | The Nihon Kohden CSM-1901Series is a device which continuously
monitors physiological information of a patient and is used in an operation
room, a recovery room, general wards, ICU, CCU, HCU, NICU and an
emergency room. This bedside monitor is placed near the patient and is
intended to display patient's vital signs. This device can also be connected | |
17
| Indications for
Use and Intended
Use | to other external patient monitoring devices. In addition, this device can
communicate patient's data to a central monitoring station via network to
monitor multiple patients.
The Nihon Kohden CSM-1901 Bedside Monitor is intended to monitor,
display and record physiological data to provide cardiac and vital signs
monitoring within a medical facility. The device is intended to produce a
visual record of the electrical signal produced by the heart and monitor the
electrocardiogram to generate visible and/or audible alarms when an
arrhythmia exists. The device is also intended to monitor heart rate, pulse
rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP)
invasive blood pressure (IBP), body temperature, BIS, cardiac output
(CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2),
EtCO2, respiratory rate, inspired and expired anesthetic agents and
anesthetic gases including N2O, halothane, isoflurane, enflurane,
sevoflurane and desflurane. The device also displays patient data from
external devices such as ventilators, TOF monitors, CCO/SvO2 monitors,
and EEG measuring unit.
The device may generate and audible and/or visual alarm when a
measured rate falls outside preset limits. The device will be available for
use by trained medical personnel within a medical facility on all patient
populations, including adult, neonate, infant, child, and adolescent
subgroups. |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | There are no hardware changes to the predicate devices. Both the
predicate and the subject device measure the same functions. Both
devices can measure Oxygen concentration but when connected to an
external adapter (JO-900P) can measure FiO2. The JO-900P is not been
validated on the BSM-3000. There have been software updates to the
system to integrate the Smart Cable NMT Module and accessories. |
| Safety &
Performance
Tests | The Nihon Kohden CSM-1901 Bedside Monitoring System incorporated al
software changes in the integration testing. The testing confirmed the
operation of the device when the Smart Cable NMT software was
integrated into the system. The results confirmed that the device
performed within specifications. No clinical tests have been submitted,
referenced or relied on in this premarket notification submission for a
determination of substantial equivalence. |
| Summary of
Substantial
Equivalence | The Nihon Kohden CSM-1901 Series is equivalent to the Nihon Kohden
CSM-1901 Series. There have been no changes on the indications for
use. The software was updated to incorporate the Smart Cable NMT
Module and Accessories |
5.5 Bedside Monitoring Systems Technological Specifications
The compatible bedside Monitoring systems features were unchanged as a result of the incorporation of the Smart Cable NMT Module and Accessories. See table below for the product features and technological specifications.
18
| Life Scope BSM-6000 Series
Bedside Monitoring System | Life Scope BSM-3000 Series
Bedside Monitoring System | Nihon Kohden CSM -
1901 Bedside
Monitoring System | |
|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | The Life Scope 6000 Series
Bedside Monitoring is intended to
monitor, display, and record
physiological data to provide
cardiac and vital signs monitoring
within a medical facility. The
device is intended to produce a
visual record of the electrical
signals produced by the heart and
monitor the electrocardiogram to
generate visible and/or audible
alarms when an arrhythmia exists.
The device is also intended to
monitor heart rate, pulse rate,
blood oxygen saturation (SpO2),
non-invasive blood pressure
(NIBP), invasive blood pressure
(IBP), body temperature, Cardiac
Output (CO), oxygen
concentration (FiO2), CO2 and
EtCO2, respiratory rate, BIS and
inspired and expired anesthetic
agents and gases including CO2,
O2, N20, Halothane, Isoflurane,
Enflurane, Sevoflurane, and
Desflurane. Anesthetic agents and
gases are detected using the
cleared AG-920RA Anesthetic
Agent Detection System. The
device can interface to external
equipment to display numerical
and waveform data and alarms
from the external devices.
Supported external devices
include AG- 920RA Anesthetic
Agent Detection System,
Ventilators, CO2 Monitors, TOF
Monitors, BIS Monitors, CCO/SvO
2 Monitors and continuous NIBP
Monitors. The device may
generate an audible and/or visual
alarm when a measured rate falls
outside preset limits. This device
may also be used to condition and
transmit physiological signals via
radio frequency | The Life Scope BSM-3000
Series Bedside Monitoring
System is intended to
monitor, display and record
physiological data to provide
cardiac and vital signs
monitoring within a medical
facility. The device is
intended to produce a visual
record of the electrical
signals produced by the
heart and monitor the
electrocardiogram to
generate visible and/or
audible alarms when an
arrhythmia exists. The
device is also intended to
monitor heart rate, pulse
rate, blood oxygen saturation
(SpO2), non-invasive blood
pressure(NIBP), invasive
blood pressure (IBP), body
temperature, Cardiac Output
(CO), oxygen concentration
(O2), CO2 and EtCO2,
respiratory rate, BIS and
inspired and expired
anesthetic agents and gases
including CO2, O2, N2O,
Halothane, Isoflurane,
Enflurane, Sevoflurane and
Desflurane. Anesthetic
agents and gases are
detected using the cleared
AG-920RA Anesthetic Agent
Detection System. The
device can interface to
external equipment to
display numerical and
waveform data and alarms
from the external devices.
Supported external devices
include AG-920RA
Anesthetic Agent Detection
System, Ventilators, CO2
Monitors, TOF Monitors, BIS
Monitors, CCO/SvO2
Monitors, EEG monitoring
device, tcPO2 monitors,
rSO2 monitors and external
devices with output analog
voltage signal and
continuous NIBP Monitors.
The device may generate an
audible and/or visual alarm
when a measured rate falls
outside preset limits. This | The Nihon Kohden
CSM-1901 is a device
which continuously
monitors physiological
information of a
patient and is used in
an operation room, a
recovery room,
general wards, ICU,
CCU, HCU, NICU and
an emergency room.
This bedside monitor
is placed near the
patient and is
intended to display
patient's vital signs.
This device can also
be connected to other
external patient
monitoring devices. In
addition, this device
can communicate
patient's data to a
central monitoring
station via network to
monitor multiple
patients. |
| | Life Scope BSM-6000 Series
Bedside Monitoring System | Life Scope BSM-3000 Series
Bedside Monitoring System | Nihon Kohden CSM -
1901 Bedside
Monitoring System |
| | | device may also be used to
condition and transmit
physiological signals via
radio frequency. | |
| Intended Use | The Life Scope BSM-6000 Series
Bedside Monitor is intended to
monitor, display and record
physiological data to provide
cardiac and vital signs monitoring
within a medical facility. The
device is intended to produce a
visual record of the electrical
signals produced by the heart and
monitor the electrocardiogram to
generate audible and/or visible
alarms when an arrhythmia exists.
The device is also intended to
monitor heart rate, pulse rate,
blood oxygen saturation (SpO2),
non-invasive blood pressure
(NIBP), invasive blood pressure
(IBP), body temperature, BIS,
cardiac output (CO), oxygen
concentration (FiO2), carbon
dioxide concentration (CO2),
EtCO2, respiratory rate, and
inspired and expired anesthetic
agents and anesthetic gases
including N2O, Halothane,
Isoflurane, Enflurane, Sevoflurane
and Desflurane.
The device may generate an
audible and/or visual alarm when
a measured rate falls outside
preset limits. The device may also
be used to condition and transmit
physiological signals via radio
frequency. The device can
interface to external equipment to
display numerical and waveform
data and alarms from the external
devices. Supported external
devices include CO2 monitors,
BIS monitors, Anesthetic
agents/gases detection system,
Anesthesia machine, Ventilators,
CCO monitors, TOF monitors,
CCO/SvO2 Monitors, EEG
monitoring device, tcPO2/tcPCO2
monitors, rSO2 monitors and
external devices which output | The Life Scope BSM-3000
Series Bedside Monitor is
intended to monitor, display
and record physiological
data to provide cardiac and
vital signs monitoring within
a medical facility. The device
is intended to produce a
visual record of the electrical
signals produced by the
heart and monitor the
electrocardiogram to
generate audible and/or
visible alarms when an
arrhythmia exists.
The device is also intended
to monitor heart rate, pulse
rate, blood oxygen saturation
(SpO2), non-invasive blood
pressure (NIBP), invasive
blood pressure (IBP), body
temperature, BIS, cardiac
output (CO), oxygen
concentration (O2), carbon
dioxide concentration (CO2),
EtCO2, respiratory rate, and
inspired and expired
anesthetic agents and
anesthetic gases including
N2O, Halothane, Isoflurane,
Enflurane, Sevoflurane, and
Desflurane.
The device may generate an
audible and/or visual alarm
when a measured rate falls
outside preset limits. The
device may also be used to
condition and transmit
physiological signals via
radio frequency. The device
can interface to external
equipment to display
numerical and waveform
data and alarms from the
external devices. Supported
external devices include
CO2 monitors, BIS monitors, | The Nihon Kohden
CSM-1901 Bedside
Monitor is intended to
monitor, display and
record physiological
data to provide
cardiac and vital signs
monitoring within a
medical facility. The
device is intended to
produce a visual
record of the electrical
signal produced by
the heart and monitor
the electrocardiogram
to generate visible
and/or audible alarms
when an arrhythmia
exists. The device is
also intended to
monitor heart rate,
pulse rate, blood
oxygen saturation
(SpO2), non-invasive
blood pressure
(NIBP), invasive blood
pressure (IBP), body
temperature, BIS,
cardiac output (CO),
oxygen concentration
(FiO2), carbon dioxide
concentration (CO2),
EtCO2, respiratory
rate, inspired and
expired anesthetic
agents and anesthetic
gases including N2O,
Halothane, Isoflurane,
Enflurane, Sevoflurane
and Desflurane. The
device also displays
patient data from
external devices such
as ventilators, TOF
monitors, CCO/SvO2
monitors, and EEG
measuring unit.
The device may
generate and audible
and/or visual alarm |
| | Life Scope BSM-6000 Series
Bedside Monitoring System | Life Scope BSM-3000 Series
Bedside Monitoring System | Nihon Kohden CSM -
1901 Bedside
Monitoring System |
| | analog voltage signal.
The device will be available for use
by medical personnel on patients
within a medical facility on all patient
populations. | Anesthetic agents/gases
detection system,
Anesthesia machine,
Ventilators, CCO monitors,
TOF monitors, CCO/SvO2
Monitors, EEG monitoring
device, tcPO2/tcPCO2
monitors, rSO2 monitors and
external devices which
output analog voltage signal.
The device will be available
for use by medical personnel
on patients within a medical
facility on all patient
populations. | when a measured
rate falls outside
preset limits.
The device will be
available for use by
trained medical
personnel within a
medical facility on
all patient
populations,
including adult,
neonate, infant,
child, and
adolescent
subgroups. |
| Display | | | |
| Type | TFT Color LCD, 10.4" (BSM-
6301A) TFT Color LCD, 12.1"
(BSM-6501A) TFT Color LCD,
15.0" (BSM-6701A) | TFT Color LCD, 12.1" (BSM-
35xx) TFT Color LCD, 15.0"
(BSM-37xx) | TFT Color LCD,
19.0" |
| Resolution | 800 x 600 (BSM-6301A/BSM-
6501A)
1024 x 768 (BSM-6701A) | 800 x 600 (BSM-35xx)
1024 x 768 (BSM-37xx) | 1680 x 1024, 1280
x 1024 |
| Number Of
Traces | 15 | 15 | 17 |
| Trace
Movement | Moving or fixed | Same | Same |
| Waveform
Display | ECG (12 leads), respiration,
SpO2, CO2, Cardiac output,
external input, O2, N2O,
anesthesia agents, EEG(BISx),
IBP (7) | ECG (12 leads), respiration,
Sp02, CO2, Cardiac output,
external input, O2, N2O,
anesthesia agents,
EEG(BISx),
IBP (2) (BSM-35xx)
IBP (3) (BSM-37xx) | ECG, respiration curve,
IBP waveform, SpO2
pulse waveform, CO2
partial pressure curve,
EEG waveform,
respiratory flow curve,
airway pressure curve,
respiratory volume
curve,
EEG waveform (BIS),
O2 concentration
curve, CO2
concentration curve,
anesthetic agent
concentration curve. |
| Numeric Data
Display | Heart Rate, Pulse Rate, VPC rate,
ST level (12 leads), Respiration
Rate, NIBP (sys/dia/mean),
Temperature (4), SpO2, EtCO2, | Heart Rate, Pulse Rate,
VPC rate, ST level (12
leads), Respiration Rate,
NIBP (sys/dia/mean), | Heart rate, VPC rate
(per minute), ST level,
respiration rate, NIBP
(Sys, Dia, MAP), |
| | Life Scope BSM-6000 Series
Bedside Monitoring System | Life Scope BSM-3000 Series
Bedside Monitoring System | Nihon Kohden CSM -
1901 Bedside
Monitoring System |
| | Anesthesia agents, BIS,
IBP (7) (sys/dia/mean) | EtCO2, Cardiac output, O2,
N2O, Anesthesia agents,
BIS,
IBP (2) (sys/dia/mean)
(BSM-35xx)
IBP (3) (sys/dia/mean)
(BSM-37xx) | SpO2, pulse rate,
temperature, cardiac
output (CO), cardiac
index (CI), injectate
temperature (Ti), blood
temperature (Tb), O2
concentration (02),
end tidal CO2 partial
pressure (ETCO2), BIS,
inspired/expired N2O
concentration,
inspired/expired CO2
partial pressure,
inspired/expired CO2
concentration, inspired/
xpired O2 concentration,
inspired/expired
anesthetic agent
concentration
(Halothane,
Enflurane, Isoflurane,
Sevoflurane,
Desflurane), minimum
alveolar concentration
(MAC),
peak airway pressure
(Ppeak), positive end
expiratory pressure
(PEEP),
mean airway pressure
(Pmean), minute volume
(MV), inspiratory tidal
volume (TVi),
expiratory tidal volume
(TVe), compliance (C),
airway resistance (R),
inspiratory airway
resistance (Ri),
expiratory airway
resistance (Re),
inspiration expiration
ratio (I:E),
90 or 95% spectral edge
frequency (SEF),
median frequency
(MDF), peak power
frequency (PPF),
total power (TP), power
of frequency (Abs δ,
Abs 0, Abs a, Abs ß,
Abs y),
power ratio of frequency
(% δ, |
| Alarm Display | Alarm sound, highlighted alarm
display, alarm lamp | Same | Same |
| | Life Scope BSM-6000 Series
Bedside Monitoring System | Life Scope BSM-3000 Series
Bedside Monitoring System | Nihon Kohden CSM -
1901 Bedside
Monitoring System |
| Alarm Suspend/
Silence Function | Yes | Same | Same |
| ECG | | | |
| Number Of ECG
Electrodes | 3, 6 or 10 | Same | Same |
| Defibrillation
Discharge
Protection | Yes | Same | Same |
| Electrosurgery
Interface filter | Yes | Same | Same |
| Pacing detection | Yes | Same | Same |
| Heart Rate
Counting Method | Average, instantaneous
(beat to beat) | Same | Same |
| Heart Rate
Counting Range | 0, 15 to 300 bpm | Same | Same |
| Counting
Accuracy | ±2 bpm | Same | Same |
| Alarm Limits:
Upper
Lower | 16 to 300 bpm, OFF
15 to 299 bpm, OFF | Same | Same |
| ST Level
Measuring Range | -2.5 to +2.5 mV | Same | Same |
| QRS Sync Tone | Yes | Same | Same |
| Arrhythmia Detection | | | |
| Detection Method | Multi-template software algorithm
Multi-lead analysis | Same | Same |
| VPC Counting
Range | 0 to 99 per min | Same | Same |
| Arrhythmia Alarm | Yes | Same | Same |
| Arrhythmia Recall | Yes | Yes | Yes |
| Number Of
Arrhythmia Recall
Files | Up to 72 hours | Up to 72 hours | 168 hours |
| | Life Scope BSM-6000 Series
Bedside Monitoring System | Life Scope BSM-3000 Series
Bedside Monitoring System | Nihon Kohden CSM -
1901 Bedside
Monitoring System |
| Number of
arrhythmia type | 23 | 23 | 25 |
| Arrhythmia
Graphic Trend | Yes | Same | Same |
| Respiration | | | |
| Method | Impedance, thermistor, CO2 | Impedance, CO2 | Impedance,
thermistor, CO2 |
| Respiration Rate
Display | 0 to 150 bpm | Same | Same |
| Alarm Limits:
Upper
Lower | 2 to 150 bpm, OFF
0 to 148 bpm, OFF | Same | Same |
| No breath time
Limit | 5 to 40 seconds, OFF | Same | Same |
| Waveform
Display | Yes | Same | Same |
| Connector
Insertion
Detection | Yes | Same | Same |
| Apnea Detection | Yes | Same | Same |
| SpO2 | | | |
| Probe Type | Nihon Kohden, Nellcor (NL) or
Masimo (MS) | Same | Same |
| Displayed Range
NK type | 0 to 100% | Same | Same |
| Displayed Range,
NL type | 1 to 100% | Same | Same |
| Displayed Range,
MS type | 1 to 100% | Same | Same |
| Declared Range,
NK type and
Accuracy with
sensor | 70 to 100% (with sensor)
80 to 100% ±2 %SpO2
70 to 80% ±3 %SpO2 | Same | Same |
| Declared Range,
NL type and
Accuracy with | 70 to 100%
70 to 100% ±2 digits(adult) | Same | Same |
| | Life Scope BSM-6000 Series
Bedside Monitoring System | Life Scope BSM-3000 Series
Bedside Monitoring System | Nihon Kohden CSM -
1901 Bedside
Monitoring System |
| sensor | 70 to 100% ± 3 digits (neonatal) | | |
| Declared Range,
MS type and
Accuracy with
sensor | no motion condition
70 to 100% ± 2 digits(adult)
70 to 100% ± 3 digits(neonatal)
motion condition
70 to 100% ± 3 digits(adult)
70 to 100% ± 3 digits(neonatal) | Same | Same |
| Pulse Sync Tone | Yes | Same | Same |
| Audible Indication
to SpO2 Variation | Yes | Same | Same |
| SpO2 Alarm
Limits:
Upper
Lower | 51 - 100%, OFF
50 - 99%, OFF | Same | Same |
| Pulse Rate Count
Range: | 0, 30-300 bpm (NK)
0, 20-300 bpm (NL)
0, 25-240 bpm (MS) | Same | Same |
| Non-Invasive Blood Pressure (NIBP) | | | |
| Measuring
Method | Oscillometeric | Same | Same |
| Pressure Data
Display | Systolic, Diastolic, Mean, Cuff
pressure | Same | Systolic, Diastolic,
Mean,
Cuff pressure,
Pulse Rate |
| Measuring Range
,Adult/ Pediatric | 0 - 300 mmHg | Same | Same |
| Measuring
Range, Neonates | 0 - 150 mmHg | Same | Same |
| Measuring
Accuracy | ± 3 mmHg ≤ 200mmHg
± 4 mmHg >200mmHg | Same | Same |
| Invasive Pressure (IBP) | | | |
| Measuring
Method | Pressure transducer | Same | Same |
| | Life Scope BSM-6000 Series
Bedside Monitoring System | Life Scope BSM-3000 Series
Bedside Monitoring System | Nihon Kohden CSM -
1901 Bedside
Monitoring System |
| Measuring Range | -50 to 300 mmHg | Same | Same |
| Measuring
Accuracy | ±1mmHg, ±1digit (-50 to 100 mmHg)
± 1%, ±1 digit (100 to 300 mmHg) | Same | Same |
| Connector
Insertion
Detection | Yes | Same | Same |
| Alarm Limits:
Upper
Lower | -48 - 300 mmHg, OFF
-50 - 298 mmHg, OFF | Same | Same |
| Pulse Svnc Tone | Yes | Same | Same |
| Pulse Rate Count
Range: | 0, 30 - 300 bpm | Same | Same |
| Temperature | | | |
| Number of
channels | Up to 4 | Up to 2 | Up to 8 |
| Measuring Range | 0 to 45°C | Same | Same |
| Display Units | °C or °F | Same | Same |
| Accuracy | ± 0.1 °C (25 to 45°C)
± 0.2 °C (0 to 25°C) | Same | Same |
| Connector
Insertion
Detection | Yes | Same | Same |
| Numeric Display | Yes | Same | Same |
| Alarm Limits:
Upper
Lower | 0.1 to 45°C,
0.2 OFF 0 to 44.9°C, OFF | Same | Same |
| Carbon Dioxide (CO2) | | | |
| Measuring
Method | Main Stream | Same | Main Stream, Side
Stream (when GF-210RA connected) |
| Response Time | Depends on CO2 unit
160msec (TG-900P) | Same | Same |
| | Life Scope BSM-6000 Series
Bedside Monitoring System | Life Scope BSM-3000 Series
Bedside Monitoring System | Nihon Kohden CSM -
1901 Bedside
Monitoring System |
| | 120msec (TG-920P/970P)