Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard patient monitor with various physiological parameter modules. There is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

No
The device is a patient monitor that measures and displays physiological parameters. It is intended for monitoring and alarming, not for treating or preventing a disease or condition.

Diagnostic

No.
The "Intended Use / Indications for Use" states that the device is intended for "monitoring, storing, and to generate alarms for, multiple physiological parameters". While it measures physiological parameters, its primary function is monitoring and alarming, rather than providing a diagnosis of a disease or condition. The "Device Description" also emphasizes its role in continuous monitoring and indicating alarms for abnormalities, allowing healthcare professionals to respond, but not to provide a diagnosis directly.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Patient Monitor" and describes various hardware components like screens, batteries, and parameter modules (SpO2, NIBP, etc.) that are integral to its function. It is a hardware device with integrated software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is performed outside of the body.
Device Function: The description clearly states that this device is a patient monitor that measures physiological parameters directly from the patient's body. It uses sensors and modules to monitor things like ECG, blood pressure, oxygen saturation, etc., which are all in-vivo measurements.
Lack of Specimen Analysis: There is no mention of the device analyzing samples or specimens taken from the patient.

Therefore, the function and intended use of this patient monitor fall outside the scope of In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The monitors are intended to be used for monitoring, storing, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended healthcare professionals in hospital environments.

The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), anesthetic gas (AG), bispectral index (BIS), respiration mechanics (RM) and impedance cardiography (ICG).

BIS is intended for use on adult and pediatric patients.

ICG monitoring is intended for use on adults only.

The arrhythmia detection and ST Segment analysis are intended for adult patients.

The monitors are additionally intended for use during patient transport inside hospitals.

The monitors are not intended for MRI environments.

Product codes (comma separated list FDA assigned to the subject device)

MHX, DSI, DRT, CBQ, DXN, DSK, CBR, DQA, NHO, CBS, NHQ, NHP, CCK, DSB, CCL, BZQ, BZK, DPS, FLL, DRG, MLD

Device Description

V series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time.
The V series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP(respiration), CO2, IBP, C.O. and AG(anesthetic gas), RM(respiratory mechanics), BIS(bispectral index) and ICG(impedance cardiography).
The above is the maximum configuration for V series Patient Monitor, the user may select different monitoring parameters in according with their requirements.
elite V5 configures with 12.1-inch color TFT touch screen , elite V6 and elite V8 with same screen except different sizes 15-inch and 17-inch separately. Three models are all build-in Lithium-ion battery, support software upgrade online and networking.

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

Adults, pediatrics and neonates

Intended User / Care Setting

Trained healthcare professionals in hospital environments.

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)

Non-clinical data:
Biocompatibility testing: The biocompatibility evaluation for the elite V5, elite V6 and elite V8 Patient Monitor were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for a duration of less than 24 hours. And the battery of testing included the following tests:

Cytotoxicity
Skin Sensitization
Skin Irritation

Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the elite V5, elite V6 and elite V8 Patient Monitor device, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1:2005/A1: 2012, IEC 60601-1-8: 2006, IEC 60601-2-25: 2011, IEC 60601-2-27: 2011, ANSI/AAMI EC57: 2012, IEC 80601-2-30: 2009, IEC 60601-2-34: 2011 , IEC 60601-2-49: 2011, ISO 80601-2-55: 2011, ISO 80601-2-56: 2009, ISO 80601-2-61: 2011 and ISO 81060-2: 2013 standards for safety and the IEC 60601-1-2:2007 standard for EMC. All tests passed.

Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

Clinical data: Not applicable.

Summary: Based on the non-clinical and clinical performance as documented in the system development, the subject devices were found to have a safety and effectiveness profile that is similar to the predicate device.

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.

K120173, K092449, K131971

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.

Not Found

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

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 22, 2016

Edan Instruments, Inc. % Doug Worth Edan Medical 1200 Crossman Ave. Suite 200 Sunnyvale, California 94089

Re: K160981 Trade/Device Name: Patient Monitor, models elite V5, elite V6 and elite V8 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, DSI, DRT, CBQ, DXN, DSK, CBR, DQA, NHO, CBS, NHQ, NHP, CCK, DSB, CCL, BZQ, BZK, DPS, FLL, DRG, MLD Dated: November 30, 2016 Received: November 30, 2016

Dear Doug Worth:

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. 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.

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

1

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mude Jellm
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K160981

Device Name

Patient Monitor, models elite V5, elite V6 and elite V8

Indications for Use (Describe)

The monitors are intended to be used for monitoring, storing, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended healthcare professionals in hospital environments.

The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), anesthetic gas (AG), bispectral index (BIS), respiration mechanics (RM) and impedance cardiography (ICG).

BIS is intended for use on adult and pediatric patients.

ICG monitoring is intended for use on adults only.

The arrhythmia detection and ST Segment analysis are intended for adult patients.

The monitors are additionally intended for use during patient transport inside hospitals.

The monitors are not intended for MRI environments.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510 (K) Summary

Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92

| 1. Submitter: | Edan Instruments, Inc
3/F - B, Nanshan Medical
Equipments Park, Nanhai Rd 1019#,
Shekou, Nanshan Shenzhen,
518067 P.R. China
Tel: +86(0755) 26858736
Fax: +1 (408) 418-4059 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Queena Chen |
| Preparing date: | March 30, 2016 |
| 2. Device name and
classification: | Device Name: Patient Monitor
Model: elite V5, elite V6, elite V8
Classification Name/ Product code:
870.1025 monitor, physiological, patient(with arrhythmia
detection or alarms)/ MHX
870.1025 Detector and Alarm, Arrhythmia/ DSI
870.1025 Monitor, ST Segment with Alarm/ MLD
870.2300 Cardiac monitor (including cardiotachometer and rate
alarm)/ DRT
870.1130 Non-Invasive blood pressure/ DXN
870.1110 Blood pressure computer/ DSK
880.2910 Clinical Electronic Thermometers-Temperature
Monitor with Probe/ FLL
870.2700 Oximeter, Pulse/ DQA
868.1400 Carbon Dioxide Gas Analyzer/ CCK
868.1500 Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic
Concentration)/ CBQ
868.1500 Analyzer, Gas, Desflurane, Gaseous-Phase
(Anesthetic Concentration)/NHO
868.1500 Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic
Concentration)/NHQ
868.1500 Analyzer, Gas, Sevoflurane, Gaseous-Phase
(Anesthetic Concentration)/NHP
868.1620 Halothane gas analyzer/ CBS
868.1700 Nitrous Oxide gas analyzer/ CBR
868.1720 Oxygen gas analyzer/ CCL |

4

| 3.Premarket Notification Class III Certification and Summary | 870.2770 Impedance plethysmograph/ DSB
868.1850 Monitoring spirometer/ BZK
868.2375 Monitor, Breathing Frequency/BZQ
870.2340 Electrocardiograph/DPS
870.2910 Radiofrequency physiological signal transmitter and receiver/ DRG
Regulatory Class: Class II
Not applicable, the subject device is Class II. |
|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4. Predicate Device(s): | 1) Edan Instruments, Inc. / Patient Monitor Model elite V8/ K120173
2) Shenzhen Mindray Bio-Medical Electronics Co., Ltd/ BeneView T8 /K092449.
3) Edan Instruments, Inc. / iM70/ K131971 |
| 5. Reason for Submission | Modification for previous product elite V8 and introduce two new models elite V5 and elite V6. |
| 6. Pre-Submission, IDE | Not applicable, there is no prior submission. |
| 7. Device Description: | V series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time.
The V series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP(respiration), CO2, IBP, C.O. and AG(anesthetic gas), RM(respiratory mechanics), BIS(bispectral index) and ICG(impedance cardiography).
The above is the maximum configuration for V series Patient Monitor, the user may select different monitoring parameters in according with their requirements.
elite V5 configures with 12.1-inch color TFT touch screen , elite V6 and elite V8 with same screen except different sizes |

5

15-inch and 17-inch separately. Three models are all build-in Lithium-ion battery, support software upgrade online and networking.

Intended Use: The monitors are intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended for use by trained healthcare professionals in hospital environments.

The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), anesthetic gas (AG), bispectral index (BIS), respiration mechanics (RM) and impedance cardiography (ICG).

BIS is intended for use on adult and pediatric patients.

ICG monitoring is intended for use on adults only.

The arrhythmia detection and ST Segment analysis are intended for adult patients.

The monitors are additionally intended for use during patient transport inside hospitals.

The monitors are not intended for MRI environments.

9. Predicate Device Comparison

The subject devices share the same characteristics in all items with the predicate device, concluding from using the same technology and principle. All the technological differences existed between the subject and predicate devices are only some performance parameters improvement, for example accuracy for RESP Module is better, minor differences on NIBP module, different measurement range, accuracy and Sample flow rate for CO2 module and different Warm-up time, Sample flow rate, measurement range, accuracy for AG module. Please refer to the following tables for details.

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Comparison to Primary Predicate elite V8

| Item | Proposed device
(elite V5, elite V6, elite V8) | Predicate device
(elite V8) | Justification | |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------|
| K# | Current Submission | K120173 | — | |
| Intended use | | | | |
| Description | The monitors are intended to be used for
monitoring, storing, and reviewing of,
and to generate alarms for, multiple
physiological parameters of adults,
pediatrics and neonates. The monitors
are intended for use by trained
healthcare professionals in hospital
environments.
The monitored physiological parameters
include: ECG, respiration (RESP),
temperature (TEMP), oxygen saturation
of arterial blood (SpO2), pulse rate (PR),
non-invasive blood pressure (NIBP),
invasive blood pressure (IBP), carbon
dioxide (CO2), cardiac output (C.O.),
anesthetic gas (AG), bispectral index
(BIS), respiration mechanics (RM) and
impedance cardiography (ICG).
BIS is intended for use on adult and
pediatric patients.
ICG monitoring is intended for use on
adults only.
The arrhythmia detection and ST
Segment analysis are intended for adult
patients.
The monitors are additionally intended
for use during patient transport inside
hospitals.
The monitors are not intended for MRI
environments. | The monitor monitors parameters
such as ECG (3-lead, 5-lead
selectable), Respiration (RESP),
Functional arterial oxygen saturation
(SpO2), Invasive or noninvasive
blood pressure (dual-IBP, NIBP),
Temperature (dual-TEMP), Expired
CO2.
The monitor is equipped with alarms
that indicate system faults (such as
loose or defective electrodes).
physiologic parameters that have
exceeded the limits set by the
operator, or both.
The arrhythmia detection and ST
Segment analysis are not intended for
neonatal patients. | Similar | |
| Intended patient
population | adult, pediatric and neonatal patients | adult, pediatric and neonatal patients | Same | |
| Intended
application
environment | Hospital environment. | Hospital environment. | Similar | |
| ECG monitor | | | | |
| Lead Mode | 3-Lead: I, II, III
5-Leads: I, II, III, aVR, aVL, aVF, V
12-leads: I, II, III, aVR, aVL, aVF, V1 to
V6 | 3-Lead: I, II, III
5-Leads: I, II, III, aVR, aVL, aVF, V
12-leads: I, II, III, aVR, aVL, aVF,
V1 to V6 | Same | |
| Lead Naming
Style | AHA, IEC | AHA, IEC | Same | |
| Display
Sensitivity | 1.25mm/mV (×0.125), 2.5mm/mV
(×0.25), 5mm/mV (×0.5), 10mm/mV
(×1), 20mm/mV (×2), 40mm/mV (×4),
AUTO gain | 1.25 mm/mV (X0.125), 2.5 mm/mV
(X0.25), 5 mm/mV (X0.5),
10 mm/mV (X1), 20 mm/mV (X2),
40 mm/mV (X4), Auto | Same | |
| Sweep | 6.25mm/s, 12.5mm/s, 25mm/s, 50mm/s | 6.25 mm/s, 12.5 mm/s, 25 mm/s, 50
mm/s | Same | |
| Measurement
Range | Neonate: 15 to 350 bpm
Pediatric: 15 to 350 bpm
Adult: 15 to 300 bpm | Neonate: 15 to 350 bpm
Pediatric: 15 to 350 bpm
Adult: 15 to 300 bpm | Same | |
| CMRR
(Common Mode
Rejection Ratio) | Diagnosis: >95dB
Monitor: >105dB
Surgery: >105dB | Diagnosis: >95dB (the Notch filter is
off)
Monitor: >105dB (the Notch filter is
on)
Surgery: >105dB (the Notch filter is
on) | Similar | |
| Accuracy | ±1 bpm or ±1%, whichever is
greater | ±1 bpm or ±1%, whichever is
greater | Same | |
| Resolution | 1 bpm | 1 bpm | Same | |
| Sensibility | 200μV | 200µV (lead II) | Same | |
| Differential Input
Impedance | >5MΩ | ≥5 MΩ | Same | |
| Leakage Current
of Patient | 95dB
Monitor: >105dB
Surgery: >105dB | Diagnostic mode: ≥90 dB the
Notch filter is off
Monitor mode: ≥105 dB the
Notch filter is off
Surgical mode: ≥105 dB the
Notch filter is off | Similar |
| Accuracy | ±1 bpm or ±1%, whichever is
greater | ±1 bpm or ±1%, whichever
is greater | Same |
| Resolution | 1 bpm | 1 bpm | Same |
| Sensibility | 200μV | 200μV (lead II) | Same |
| Differential
Input
Impedance | >5MΩ | ≥5 ΜΩ | Same |
| Leakage
Current of
Patient | Pace | | | | | |
| Pulse
Indicator | | Amplitude: ±2 mV to +700 mV
Width: 0.1 ms to2.0 ms
Ascending time: 10 µs to 100 µs | Amplitude: ±2 to +700 mV
Width: 0.1 to 2 ms
Rise time: 10 to 100 µs | Same | |
| Pulse
Rejection | | Amplitude: ±2 mV to +700 mV
Width: 0.1 ms to 2.0 ms
Ascending time: 10 µs to 100 µs | Amplitude: ±2 to ±700 mV
Width: 0.1 to 2 ms
Rise time: 10 to 100 µs | Same | |
| HR | | | | | |
| Measurement
range | | Neonate: 15 to 350 bpm
Pediatric: 15 to 350 bpm
Adult: 15 to 300 bpm | Neonate: 15 to 350 bpm
Pediatric: 15 to 350 bpm
Adult: 15 to 300 bpm | Same | |
| Accuracy | | ±1% or 1 bpm, whichever is greater | ±1 bpm or ±1%, whichever is greater | Same | |
| Resolution | | 1 bpm | 1 bpm | Same | |
| RESP monitor | | | | | |
| Principle of
Operation | | Thoracic impedance | Trans-thoracic impedance | Same | |
| Measurement
Range | | Adult: 0 to 120 rpm
Pediatric/neonate: 0 rpm to 150rpm | Adult: 0 to 120 rpm
Pediatric/neonate: 0 to 150 rpm | Same | |
| Accuracy | | Adult: 6 to 120 rpm: ±2 rpm, 0 to 5
rpm: not specified
Pediatric/neonate: 6 to 150 rpm: ±2
rpm, 0 to 5 rpm: not specified | 7 to 150 rpm: ±2 rpm or ±2%,
whichever is greater
0 to 6 rpm: Not specified. | Similar | |
| Resolution | | 1 rpm | 1 rpm | Same | |
| Waveform
bandwidth | | 0.2Hz to 2.5Hz (-3dB) | 0.2 to 2 Hz (-3 dB) | Similar | |
| Apnea Alarm | | 10s, 15s, 20s, 25s, 30s, 35s, 40s; | 10 s, 15 s, 20 s, 25 s, 30 s, 35 s,
40 s | Same | |
| NIBP monitor | | | | | |
| Principle of
Operation | | oscillation (EDAN, M3600, SunTech
NIBP ) | oscillation | Same | |
| Measurement
Range(mm Hg) | Adult
Systolic | EDAN NIBP
M3600
SunTech
NIBP | 40 mmHg
to 270
mmHg
60 mmHg
to 250
mmHg
60 mmHg ~
250 mmHg | 40 to 270 | Similar |
| ic | | to 215
mmHg | | | |
| | M3600 | 40 mmHg
to 200
mmHg | | | |
| | SunTech
NIBP | 30 mmHg ~
190 mmHg | | | |
| | Mean | EDAN NIBP | 20 mmHg
to 235
mmHg | 20 to 230 | |
| | | M3600 | 45 mmHg
to 235
mmHg | | |
| | | SunTech
NIBP | 40 mmHg ~
210 mmHg | | |
| | Pediatric | | | | |
| | | | | | |
| | Systolic
c | EDAN NIBP | 40 mmHg
to 230
mmHg | 40 to 200 | |
| | | M3600 | 60 mmHg
to 250
mmHg | | |
| | | SunTech
NIBP | 40 mmHg ~
230 mmHg | | |
| | Diastolic | EDAN NIBP | 10 mmHg
to 180
mmHg | 10 to 150 | |
| | | M3600 | 40 mmHg
to 200
mmHg | | |
| | | SunTech
NIBP | 20 mmHg ~
160 mmHg | | |
| | Mean | EDAN NIBP | 20 mmHg
to 195
mmHg | 20 to 165 | |
| | | M3600 | 45 mmHg
to 235
mmHg | | |
| | | SunTech
NIBP | 30 mmHg ~
175 mmHg | | |
| Neonate | | | | | |
| | Systolic
c | EDAN
NIBP | 40 mmHg to
135 mmHg | 40 to 135 | |
| | | M3600 | 40 mmHg to | | |
| | | | 120 mmHg | | |
| | | SunTech | 40 mmHg ~ | | |
| | | NIBP | 130 mmHg | | |
| | Diastolic | EDAN | 10 mmHg to | 10 to 100 | |
| | | NIBP | 100 mmHg | | |
| | | M3600 | 20 mmHg to
90 mmHg | | |
| | | SunTech | 20 mmHg ~ 90 mmHg | | |
| | | EDAN | 20 mmHg to | | |
| | | NIBP | 110 mmHg | | |
| | | M3600 | 30 mmHg to
100 mmHg | 20 to 110 | |
| | Mean | SunTech | 30 mmHg ~
100 mmHg | | |
| Accuracy | | Max mean error: ±5 mmHg,Max
standard deviation: 8
mmHg(EDAN,M3600, SunTech); | | Max mean error: ±5 mmHg
Max standard deviation: 8 mmHg | Same |
| Resolution | | | 1mmHg(EDAN, M3600, SunTech); | 1mmHg | Same |
| Overpressure
protection | Adult | 297±3mmHg(EDAN)
60rpm: ±12% or ±
4mmHg of reading, whichever is
greater
Respironics:
± 2 mmHg, 0 to 40 mmHg, ± 5 % of
reading, 41 to 70 mmHg, ± 8 % of
reading, 71 to 100 mmHg, ± 10 % of
reading, 101 to 150 mmHg, ± 12% of
reading, RR is over 80 rpm | 0 to 38 mmHg: ±2 mmHg
39 to 99 mmHg: ±5% of the
reading+0.08% of (the
reading-38) | Similar |

20

Resolution	1 mmHg	1 mmHg	Same
Sample flow rate	EDAN:70ml/min or 100ml/min, optional (±15ml/min)
Respironics :50 ±10 ml/min	$50_{-7.5}^{+15}$ ml/min	Similar
Apnea Alarm Delay	10s, 15s, 20s, 25s, 30s, 35s, 40s;	10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s	Same

CO2 Monitor ( Respironics CAPNOSTAT 5 CO2 ( Mainstream CO2 )

| Measure

Parameters	EtCO2, FiCO2, AwRR	EtCO2, FiCO2, AwRR	Same
CO2
Measurement
range	0 mmHg to 150 mmHg	0 to 150 mmHg	Same
AwRR
measurement
range	0 rpm to 150 rpm	0 to 150 rpm	Same
Accuracy	± 2 mmHg, 0 to 40 mmHg, ± 5 % of
reading, 41 to 70 mmHg, ± 8 % of
reading, 71 to 100 mmHg, ± 10 % of
reading, 101 to 150 mmHg	0 to 40 mmHg: ±2 mmHg
41 to 70 mmHg: ±5% of the
reading
71 to 100 mmHg: ±8% of the
reading
101 to 150 mmHg: ±10% of the
reading	Similar
Resolution	1 mmHg	1 mmHg	Same
awRR
measurement
accuracy	± 1 rpm	1 rpm	Same

AG Monitor(Phasein and Drager)

Technique		Infrared absorption		Infrared absorption
Warm-up time		Full accuracy mode: $10	Not
specified
			10 to
15vol%	±(0.3 vol% +
2% of
reading)
			15 to 25
vol%	±(0.3 vol% +
2% of
reading)
				Unspecified
	Drager		0 to
13.6
Vol%	±(0.43 Vol% +
8% rel.)
O
2	Phasein(S
idestream
)		0 to 100
vol %	±(1 vol% +
2% of
reading)	0 to 25
25 to 80
80 to 100	±1
±2
±3
	Drager		0 to 100
Vol%	±(2.5 Vol% +
2.5% rel.)
N
2
O	Phasein
(Sidestream
&Mainstream)		0 to 100
vol%	±(2 vol% +
2% of
reading)	0 to 20
20 to 100	±2
±3
	Drager		0 to 100
Vol%	±(2 Vol% +
8% rel.)
D
es	Phasein(S
idestream
&Mainstream)		0 to 22
vol %	±(0.15 vol% +
5% of
reading)	0 to 1
1 to 5
5 to 10
10 to 15	±0.15
±0.2
±0.4
±0.6
			22 to 25
vol %	Unspecified
	Drager		0 to 20
Vol%	±(0.2 Vol% +
15% rel.)	15 to 18

18 | ±1
Not
specified |
| S
ev | Phasein
(Sidestream
&Mainstream) | | 0 to 10
vol % | ±(0.15 vol% +
5% of
reading) | 0 to 1
1 to 5
5 to 8
8 | ±0.15
±0.2
±0.4
Not
specified |
| | Drager | | 0 to 10
Vol% | ±(0.2 Vol% +
15% rel.) | | |
| E
nf | Phasein
(Sidestream
&Mainstream) | | 0 to 8
vol % | ±(0.15 vol% +
5% of
reading) | 0 to 1
1 to 5
5 | ±0.15
±0.2
Not
specified |
| | Drager | | 0 to 10 | ±(0.2 Vol% + | | |

22


	Is
o	Phasein
(Sidestream
&Mainstream)	0 to 8 vol %
8 to 25 vol %	±(0.15 vol% +
5% of
reading)
Unspecified		0 to 1
1 to 5

5 | ±0.15
±0.2
Not
specified | |
| | H
al | Phasein
(Sidestream
&Mainstream) | 0 to 8 vol %
8 to 25 vol % | ±(0.15 vol% +
5% of
reading)
Unspecified | | 0 to 1
1 to 5
5 | ±0.15
±0.2
Not
specified | |
| | | Drager | 0 to 8.5 Vol% | ±(0.2 Vol% +
15% rel.) | | | | |
| | | Drager | 0 to 8.5 Vol% | ±(0.2 Vol% +
15% rel.) | | | | |
| ICG | | | | | | | | |
| Technique | Thoracic electrical bioimpedance | | | | | Thoracic electrical
bioimpedance (TEB) | | Same |
| Measurement
range | SV: 0 ml/beat250 ml/beat
HR: 40 bpm250bpm
C.O.: 0 L/min~30 L/min | | | | | SV: 5 to 250 ml/beat
HR: 44 to 185 bpm
C.O.: 1.4 to 15 L/min | | Similar |
| Accuracy | SV: Undefined
HR: ±2bpm
C.O.: Undefined | | | | | SV: Not specified.
HR: ±2 bpm
C.O.: Not specified. | | Same |
| BIS | | | | | | | | |
| Technique | Bispectral index | | | | | Bispectral index | | Same |
| Measured
parameters | EEG
BIS: 0 to 100 | | | | | EEG
BIS: 0 to 100 | | Same |
| Impedance
range | 0 to 999 kΩ | | | | | 0 to 999 kΩ | | Same |
| Sweep speed | 6.25mm/s,
50mm/s | | 12.5mm/s, | 25mm/s, | | 6.25 mm/s, 12.5 mm/s, 25 mm/s
or 50 mm/s | | Same |
| Noise (EEG
Waveform) | 10Hz | | | | | ≥30 Hz | | Similar |
| Flow | | | | | | | | |

23

Measurement
Measurement
range	Adult: 2.0 L/min to 180 L/min
Pediatric: 0.75 L/min to 100 L/min
Neonatal: 0.25 L/min to 30 L/min	Adult/pediatric*: ± (2 to 120) L/min
Infant: ± (0.5 to 30) L/min	Similar
Accuracy	Adult: 0.5 L/min or ± 3% of reading,
whichever is greater
Pediatric: 0.25 L/min or ± 3% of
reading, whichever is greater
Neonatal: 0.125 L/min or ± 3% of
reading, whichever is greater	Adult/pediatric*: 1.5 L/min or
±10% of the reading, whichever
is greater
Infant: 0.5 L/min or ±10% of the
reading, whichever is greater
Resolution	1.0 L/min	0.1 L/min
Paw(or Airway Pressure)
Measurement
range	-120 cmH2O to 120 cmH2O	-20 to 120 cmH2O	Similar
Accuracy	0.5 cmH2O or ± 2% of reading,
whichever is greater	±3%
Resolution	1 cmH2O	0.1 cmH2O
MVe/MVi
Measurement
range	Adult: 1 L/min to 30.00 L/min
Pediatric: 0.3 L/min to 20 L/min
Neonatal: 0.1 L/min to 3 L/min	Adult/Pediatric*: 2 to 60 L/min
Infant: 0.5 to 15 L/min	Similar
Accuracy	Adult: 0.1 L/min
Pediatric: 0.1 L/min
Neonatal: 0.1 L/min	±10%×reading
TVe/TVi
Measurement
range	Adult: 40 mL to 2500 mL
Pediatric: 6 mL to 750 mL
Neonatal: 2 mL to 100 mL	Adult/Pediatric*: 100 to 1500
ml
Infant: 20 to 500 ml	Similar
Resolution	1.0 mL	1 ml
Accuracy	Adult: ± 10.0 mL or ± 5% of reading,
whichever is greater
Pediatric: ± 3.0 mL or ± 5% of
reading, whichever is greater
Neonatal: ± 1.0 mL or ± 5% of
reading, whichever is greater	Adult/pediatric*: ±10% or 15
ml, whichever is greater
Infant: ±10% or 6 ml, whichever
is greater
RR (RM)
Measurement
range	2 rpm to 150 rpm	4 to 120 rpm	Similar
Accuracy	± 1 rpm	4 to 99 rpm ±1 rpm
100 to 120 rpm ±2 rpm
Safety Classifications

24

| Type of
protection
against electric

shock	Class I	Class I	Same
Ingress
Protection	IPX1	IPX1	Same
The degree of
RF	Group 1, Class A	Group 1, Class A	Same
The degree of protection against electric shock
ECG, RESP,
TEMP, IBP,
C.O.	CF	CF	Same
ICG, NIBP,
SpO2,	BF	CF	Similar
CO2, AG, BIS,
RM, ICG	BF	BF	Same
Electrical & Mechanical safety & Thermal safety Standards
General
Standards	IEC 60601-1:2005	IEC 60601-1:
1988+A1:1991+A2:1995	Similar
EMC
Standards	IEC 60601-1-2:2007	IEC60601-1-2: 2001+A1:2004
Alarm
Standards	IEC 60601-1-8:2006	IEC60601-1-8:2003
Biocompatibili
ty Standards	ISO 10993-1:2009	ISO 10993-1:2003
Software
Standards	IEC 62304:2006	IEC 62304:2006
Special Standards
basic safety
and essential
performance
for patient
monitor	IEC 60601-2-49: 2011	IEC 60601-2-49: 2001	Similar
ECG	IEC 60601-2-27: 2011
IEC 60601-2-25: 2011	IEC 60601-2-27:2005
IEC 60601-2-25: 1999
NIBP	IEC 80601-2-30: 2009
ISO 81060-2	IEC60601-2-30:2000
IBP	IEC 60601-2-34: 2011	IEC60601-2-34:2000
AG, CO2, RM	ISO 80601-2-55	ISO21647:2004
TEMP	ISO 80601-2-56
EN12470-4:2000	EN12470-4:2000
Power supply
AC power
Requirement	100-240V, 50/60Hz		100-240V, 50/60 Hz	Same
Battery
Rechargeable Battery	Yes		Yes	Same
	Operation characteristic
Installation and use	Portable Equipment
Fix Equipment (when the system is
installed on Wall Mounting Bracket)		Portable Equipment
Fix Equipment (when the
system is installed on Wall
Mounting Bracket)	Same
Working System	Continuous operation		Continuous operation	Same
	Physical Characteristics
Weight	elite V5 :