(234 days)
No
The document describes standard physiological parameter monitoring and analysis (like arrhythmia detection and ST segment analysis) using established algorithms, without mentioning AI or ML. The performance metrics are typical for traditional signal processing and measurement accuracy, not AI/ML model performance.
No.
This device is designed for monitoring physiological parameters and generating alarms, not for treating or providing therapy to a patient.
Yes
The device is intended for monitoring physiological parameters, including ECG, respiration, temperature, SpO2, pulse rate, NIBP, IBP, and CO2, and for generating alarms. While it doesn't "diagnose" in the sense of providing a specific disease name, the monitoring and analysis of these parameters are crucial for healthcare professionals to assess a patient's condition, identify abnormalities, and make informed diagnostic and treatment decisions, thus serving a diagnostic purpose by providing critical data for diagnosis. The mention of "ST Segment analysis" specifically points to its role in aiding in the diagnosis of cardiac conditions.
No
The device description explicitly states it is a "Patient Monitor System" that performs "long-time continuous monitoring of multiple physiological parameters" and can be used as an "independent monitor" or a "multi-measurement module." It also mentions "Electrical safety and electromagnetic compatibility (EMC)" and "Bench Testing" in the performance studies, which are typically associated with hardware components. The description of monitoring parameters like ECG, NIBP, SpO2, etc., implies the use of physical sensors and hardware to acquire these physiological signals.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "monitoring, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates." It lists parameters like ECG, respiration, temperature, SpO2, NIBP, IBP, and CO2. These are all measurements taken directly from the patient's body or breath, not from samples of bodily fluids or tissues in vitro (outside the body).
- Device Description: The description reinforces that the device performs "long-time continuous monitoring of multiple physiological parameters." It describes how it collects, stores, displays, and analyzes this data.
- Lack of IVD Characteristics: There is no mention of analyzing samples of blood, urine, tissue, or other bodily fluids. The device does not perform tests on these samples to diagnose conditions.
In summary, the iM20 Patient Monitor is a device used for monitoring vital signs and physiological parameters directly from a patient, which falls under the category of patient monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
iM20 Patient Monitor (hereinafter called monitor) is intended to be used for monitoring, 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), and invasive blood pressure (IBP), and carbon dioxide (CO2).
The arrhythmia detection and ST Segment analysis are intended for adult only.
The monitor is additionally intended for use during patient transport inside of the hospital environment.
The monitor is not intended for airplane, helicopter transport, home use and MRI environments.
Product codes (comma separated list FDA assigned to the subject device)
MHX, DSI, MLD, DRT, DXN, DSK, FLL, DQA, CCK, GXY, DPS, DRG
Device Description
The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring of multiple physiological parameters, including ECG, respiration (RESP), non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), temperature (TEMP), invasive pressure (IBP), Carbon Dioxide (CO2). The system capabilities include storing, displaying, analyzing and controlling such data afterwards. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. The system is intended to be used during patient transport inside and outside of the hospital environment.
iM20 can be utilized in two ways, as an independent monitor and as a module of V series Patient Monitor (including models elite V5, elite V6 and elite V8). When used as an independent monitor, it can simultaneously monitor, store, review several parameters data. And transfer patient data to V series patient monitor only under the transport mode. As a highly portable monitor, its compact design makes it particularly appropriate inside hospital and vehicle ambulance transport environments. When as a multi-measurement module, when the iM20 is directly connected to a V series patient monitor, it can provide the measurements, trends, and patient information. When connected, the V series Patient Monitor controls the connected iM20, including all alarm functionality. So no alarms are available on iM20 in such application and iM20 takes power from the V series Patient Monitor.
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. The arrhythmia detection and ST Segment analysis are intended for adult only.
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 iM20 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 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 iM20 Patient Monitor device, consisting of all the modules and accessories in the system complies with the IEC 60601-1:2005/A1: 2012 for safety and the IEC 60601-1-2:2007 standard for EMC.
Bench Testing: Bench testing was conducted on the iM20 Patient Monitor device, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1-8: 2006, IEC 60601-2-25: 2011, IEC 60601-2-27: 2011, 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 and ISO 80601-2-61: 2011 standards for performance effectiveness.
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:
Clinical testing required by FDA specific guidance on Non-Invasive Blood Pressure (NIBP) Monitor is conducted per ISO 81060-2: 2013 Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type.
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.
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
§ 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.
0
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2016
Edan Instruments. Inc. % Doug Worth Sr. Dir. US RA/QA Edan Medical 1200 Crossman Ave. Suite 200 Sunnyvale, California 94086
Re: K152552
Trade/Device Name: Patient Monitor, model iM20 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, MLD, DRT, DXN, DSK, FLL, DQA, CCK, GXY, DPS, DRG Dated: March 22, 2016 Received: March 28, 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
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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.
Mitchell Stein
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) K152552
Device Name Patient Monitor, model iM20
Indications for Use (Describe)
iM20 Patient Monitor (hereinafter called monitor) is intended to be used for monitoring, 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), and invasive blood pressure (IBP), and carbon dioxide (CO2).
The arrhythmia detection and ST Segment analysis are intended for adult only.
The monitor is additionally intended for use during patient transport inside of the hospital environment.
The monitor is not intended for airplane, helicopter transport, home use and MRI environments.
| 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) |
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3
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 22, 2015 |
| 2. Device name and
classification: | Device Name: Patient Monitor |
| | Model: iM20 |
| | 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 |
| | 882.1320 Cutaneous electrode/GXY |
| | 870.2340 Electrocardiograph/DPS |
| | 870.2910 Radiofrequency physiological signal transmitter and
receiver/ DRG |
| | Regulatory Class: Class II |
| 3.Premarket
Notification Class III
Certification and
Summary | Not applicable, the subject device is Class II. |
| 4. Predicate Device(s): | 1) Philips Medizin.Systeme Boeblingen GmbH IntelliVue MP2 cleared under K102562. |
| | 2) Edan Instruments, Inc. iM70/ K131971 |
| 5. Reason for
Submission | Introduce new device iM20 |
| 6. Pre-Submission,
IDE | Not applicable, there is no prior submission. |
| 7. Device Description: | The iM20 Patient Monitor System (hereinafter called iM20) can
perform long-time continuous monitoring of multiple
physiological parameters, including ECG, respiration (RESP),
non-invasive blood pressure (NIBP), oxygen saturation of the
blood (SpO2), pulse rate (PR), temperature (TEMP), invasive
pressure (IBP), Carbon Dioxide (CO2). The system capabilities
include storing, displaying, analyzing and controlling such data
afterwards. When necessary, alarms will be produced so that
doctors and nurses can manage patient care appropriately. The
system is intended to be used during patient transport inside and
outside of the hospital environment.
iM20 can be utilized in two ways, as an independent monitor
and as a module of V series Patient Monitor (including models
elite V5, elite V6 and elite V8). When used as an independent
monitor, it can simultaneously monitor, store, review several
parameters data. And transfer patient data to V series patient
monitor only under the transport mode. As a highly portable
monitor, its compact design makes it particularly appropriate
inside hospital and vehicle ambulance transport environments.
When as a multi-measurement module, when the iM20 is
directly connected to a V series patient monitor, it can provide
the measurements, trends, and patient information.
When
connected, the V series Patient Monitor controls the connected
iM20, including all alarm functionality. So no alarms are
available on iM20 in such application and iM20 takes power
from the V series Patient Monitor. |
| 8. Intended
Use/Indications for
Use: | iM20 Patient Monitor (hereinafter called monitor) is 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 |
4
5
pressure (NIBP), and invasive blood pressure (IBP), and carbon dioxide (CO2).
The arrhythmia detection and ST Segment analysis are intended for adult only.
The monitor is additionally intended for use during patient transport inside and outside of the hospital environment.
The monitor is not intended for airplane, helicopter transport, home use and 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, detailed substantial equivalence discussion are included in the following tables.
| Item | Proposed device: iM20 | Predicate device:
IntelliVue MP2 | Compariso
n Result |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| 510(k)
Number | Current Submission | K102562 | |
| | Indications for Use | | |
| Intended Use | iM20 Patient Monitor is 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 to be used by trained healthcare professionals in a hospital environment. 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), and carbon dioxide (CO2). The arrhythmia detection and ST-segment monitoring are intended for adult only. Neonatal and pediatric | Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording of, and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The | Different |
| | | | |
| | patients are not clinically validated.
The monitors are indicated for use by
health care professionals or under their
direction whenever there is a need for
monitoring the physiological parameters
of patients.
The monitors are additionally intended
for use during patient transport inside
and outside of the hospital environment.
The monitor is not intended for airplane,
helicopter transport, home use or MRI
environments. | MP2, X2, MP5,
MP5T, MP20,
MP30, MP40, and
MP50 are
additionally
intended for use in
transport situations
within hospital
environments. The
MP2, X2and MP5
are also intended
for use during
patient transport
outside of a
hospital
environment. | |
| ECG Function | | | |
| HR Calculation | | | |
| Range | ADU: 15 bpm to 300 bpm
PED/NEO: 15 bpm to 350 bpm | Adult/pedi: 15 to
300 bpm
Neo range: 15 to
350 bpm | Different |
| Accuracy | $\pm$ 1% or 1 bpm, whichever is greater | $\pm$ 1% of range | Different |
| Resolution | 1 bpm | 1bpm | Same |
| Sensitivity | $\ge$ 300 $\mu$ VPP | $\ge$ 200 $\mu$ Vpeak | Different |
| PVC Rate | | | |
| Range | ADU: 0 to 300 PVCs/ min
PED/NEO: 0 to 350 PVCs/ min | 0 to 300 bpm | Different |
| Resolution | 1 PVCs/min | 1 bpm | Different |
| ST Numeric | | | |
| Range | -2.0 mV to +2.0 mV | -20 to +20 mm | Different |
| Accuracy | -0.8 mV to +0.8 mV: $\pm$ 0.02 mV or 10%,
which ever one is greater.
Beyond this range: not specified. | $\pm$ 0.5mm or 15%,
which ever one is
greater | Different |
| Resolution | 0.01 mV | 0.1mm | Different |
| Range of Sinus and SV Rhythm | | | |
| Brady | Adult: RR interval for 5 consecutive
QRS complex $\ge$ 1.5 s.
Pediatric/neonatal: RR interval for 5
consecutive QRS complex $\ge$ 1 s. | Adult: 15 to 60
bpm
Pedi: 15 to 80 bpm
Neo: 15 to 90 bpm | Different |
| Normal | Adult: 0.5s 100 bpm
Pedi: >160 bpm
Neo: >180 bpm | Different |
| Bandwidth
(-3dB) | Diagnosis: 0.05Hz to 150Hz
Monitor: 0.5Hz to 40Hz
Surgery: 1Hz to 20Hz | Diagnosis:
Adult/neo/pedi:
0.05 to 150 Hz
Monitor: Adult: 0.5
to 40 Hz
Neo/ped
i: 0.5 to 55 Hz
Filter Mode:
Adult/neo/pedi: 0.5
to 20 Hz | Different |
| CMRR
(Common
Mode
Rejection
Ratio) | Diagnosis: >95dB (the Notch filter is
off)
Monitor: >105dB (the Notch filter is on)
Surgery: >105dB (the Notch filter is on) | Diagnostic
mode: >86 dB
(with a 51 k $/$ 47
nF imbalance).
Filter mode: >106
dB (with a 51 k/47
nF imbalance). | Different |
| Differential
Input
Impedance | >5MΩ | >2 MΩ RA-LL
leads (Resp)
5 MΩ at all other
leads (at 10 Hz
including patient
cable) | Different |
| Input Signal
Range | ±10mVPP | ±5mV
(peak-to-peak
value) | Different |
| Electrode
Offset
Potential
Tolerance | ±500mV | ±500mV | Same |
| Auxiliary
Current
(Leads off
detection) | Active electrode: 300 mmHg (40
kPa) >2 sec | Different |
| Overpressure
protection | Pediatric | | 240 $\pm$ 3mmHg(EDAN)
300 mmHg (40
kPa) >2 sec | |
| | Neonate | | 147 $\pm$ 3mmHg(EDAN)
150 mmHg (20
kPa) >2 sec | |
| Measuring
interval in
AUTO Mode | 1/2/3/4/5/10/15/30/60/90/120/240/480
min(EDAN)
1/2/3/4/5/10/15/30/60/90/120/240/480
min(SunTech) | | | 1, 2, 2.5, 3, 5, 10,
15, 20, 30, 45, 60
or 120 minutes | Different |
| Continuous | 5min, interval is 5s | | | 5 minutes | Same |
| SpO2 Function (EDAN) | | | | | |
| Measuremen
t Range | 0-100% | | | 0 to 100 % | Same |
| Accuracy | Adult /Pediatric : $\pm$ 2 % (70% to 100%
SpO2), Undefined (0 to 69% SpO2)
Neonate : $\pm$ 3 % (70% to 100% SpO2),
Undefined (0 to 69% SpO2) | | | Philips Reusable
Sensors:
M1191A,
M1191AL,
M1191ANL,
M1191B, | Different |
11
12
| | M1192A,
M1192AN = 2 %
(70 % to 100 %)
M1193A,
M1193AN,
M1194A,
M1194AN,
M1195A,
M1195AN,
M1196A = 3 %
(70 % to 100 %)
M1191T, M1192T,
M1193T (Adult),
M1196T = 3%
(70% to 100%)
M1193T (Neonate)
= 4 % (70 % to
100 %) | | |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Resolution | 1 % | 1 % | Same |
| Pulse Rate | | | |
| Measuring
Range | 25 bpm to 300 bpm | 30 to 300 bpm | Different |
| Accuracy | ±2bpm | ±2 % or 1 bpm,
whichever is
greater | Different |
| Resolution | 1 bpm | 1 bpm | Same |
| SpO2 Function (Nellcor) | | | |
| Measurement Range | 1% to 100% | 1% to 100% | Same |
| Accuracy | DS-100A, OXI-A/N(Adult): ± 3% (70%
to 100% SpO2)
OXI-A/N(Neonate): ± 4% (70% to 100%
SpO2) | Philips Reusable
Sensors:
M1193A,
M1193AN,
M1194A,
M1194AN,
M1195A,
M1195AN,
M1196A = 3 %
(70 % to 100 %)
M1191T, M1192T,
M1193T (Adult),
M1196T = 3%
(70% to 100%)
M1193T (Neonate) | Same |
| | | | |
| | | | |
| | | = 4 % (70 % to
100 %) | |
| Resolution | 1 % | 1 % | Same |
| Pulse Rate | | | |
| Measuring
Range | 20bpm to 300bpm | 30 to 300 bpm | Different |
| Accuracy | ± 3bpm (20bpm to 250bpm) | ±2 % or 1 bpm,
which eve one is
greater | Different |
| Resolution | 1 bpm | 1 bpm | Same |
| Temperature Function | | | |
| Measuremen
t Range | 0 to 50°C | -1 to +49°C (30 to
113°F ) | Different |
| Accuracy
(not
including
sensor) | ±0.1 °C | ±0.1°C (±0.2°F ) | Same |
| Resolution | 0.1 °C | 0.1°C (±0.1°F) | Same |
| Average
Time
Constant | IBP Function | | | |
| Measurement
Range | -50 to +300 mmHg | -40 to 360 mmHg | Different |
| Accuracy (not
including
sensor) | ± 2 % or ±1 mmHg, whichever is
greater | 4 % of reading or
±4 mmHg (±0.5
kPa), whichever is
greater | Different |
| Resolution | 1 mmHg | 1 mmHg | Same |
| Transducer | 5 (μV/V/mmHg)300 to 3000 Ω | Load
Impedance:200 to
2000 ^ (resistive)
Output
Impedance:"3000
^ (resistive) | Different |
| Zero | Range: ±200 mmHg | ±200 mmHg (±26
kPa) | Same |
| Electronic Safety | | | |
| Anti-electrosh
ock type | Class II | Class II | Same |
| | | | |
| Working
system | Continuous operation equipment | Continuous
operation
equipment | Same |
| | Environmental Specifications | | |
| | Temperature Range | | |
| Operating | 0°C to +40°C | 0 to 40°C (32 to
104°F) | Same |
| Storage
including
transportation | -30°C to +70°C | -20 to 60°C (-4 to
140°F) | Different |
| | Humidity Range | | |
| Operating | 15% to 95% (non-condensing) | 15 % to 95 %
Relative Humidity
(RH) | Same |
| Storage
including
transportation | 15% to 95% (non-condensing) | 5 % to 95 %
Relative Humidity
(RH) | Different |
| | Altitude Range | | |
| Operating | 615hPa to 1060hPa (DC-DCpower
supply)(-400 m to 4000 m)
680hPa to 1060hPa (AC to DC power
supply)(-400m to 3000m) | -500 m to 3000 m
(10000 ft) | Different |
| Storage
including
transportation | 615hPa to 1060hPa
(-400 m to 4000 m) | -500 m to 4600
m(15000 ft) | Different |
| | Physical Characteristics | | |
| Weight | iM20 :