(312 days)
Star 65 multi-parameter Patient Monitoring system is intended to monitor a single Adult. Pediatric or Neonatal patient's vital signs at the bedside or during intra-hospital transport with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead), SpO2, and Respiration, Temperature, Invasive Blood Pressure (Systolic, Diastolic and Mean), Non-invasive Blood Pressure (Systolic and Mean), Capnography (CO2), Cardiac Output (CO) & AGM module. It can display the numeric values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, CO, EtCO2 and FiCO2, N2O, O2, EtAA and FiAA readings.
The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use. It shall be used only by trained clinicians.
In addition Star 65 got Arrhythmia and ST detection from 3L/5L ECG measurements. The Arrhythmia and ST analysis module is intended for use with Adult & Pediatric patients and is not intended for use with Neonatal patients(ST and Arrhythmia detection functionality is not available for U.S.A).
Star 65 is a multi-parameter modular patient monitoring system for continuous monitoring of the physiological parameters like ECG (3/5 lead), Respiration, NIBP, Temperature, SpO2, CO2, Cardiac Output (CO). & Anesthesia Gas Monitoring (AGM) Module (Optional). The modular parameters are IBP, CO and CO2.
Star 65 is a 8 channel monitor with 12.1" LED display with touch screen capable of displaying and monitoring ECG, Respiration, SpO2, CO2, IBP, and O2 digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic & Mean), Invasive Blood Pressure (Systolic, Diastolic & Mean), Temperature, EtCO2, FiCO2, IPI, CO, N2O, O2, EtAA, and FiAA readings.
Star 65 has 240 Hours tabular and graphical vital trend. Star 65 has a NIBP trend of last 240 readings. Star 65 has Alarm Recall facility with last 48 'Patient Alarms' details.
Star 65 has communication features like USB for Thumb drive, Printer, Bar code scanner interface, Ethernet for CNS & Bed to Bed connectivity, HDMI output for External monitor connectivity, External Port for AGM 55 interface, Wi-Fi for CNS, Bed to Bed & Network Printer connectivity. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals, high priority alarms are indicated by red colour, medium priority alarms are indicated by yellow colour & low priority alarms are represented by blue colour.
Star 65 has got Drug calculator software package to display drug dosage applied / to be applied for the standard Medicines.
The provided text describes the 510(k) premarket notification for the Skanray Technologies Pvt Ltd Star 65 patient monitoring system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.
Therefore, it is important to note that the document does not present a standalone clinical study to prove the device meets acceptance criteria. Instead, it relies on demonstrating that the subject device's performance, as measured through non-clinical (bench) testing against recognized standards, is comparable to its predicate devices, which are already legally marketed.
Here's an breakdown based on the request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the format of a clinical study outcome. Instead, it details the performance specifications of the Star 65 and compares them to predicate devices. The "reported device performance" is essentially the listed specifications for the Star 65, and "acceptance criteria" can be inferred as being equivalent to or meeting the performance of the predicate devices and relevant consensus standards.
Since a strict "acceptance criteria" table from a dedicated study is not available, I will present the performance specifications of the Star 65 as its "reported performance," and the "acceptance criteria" is implied to be that these specifications are within acceptable ranges, similar to the predicate devices, and comply with the listed consensus standards.
| Parameter | Acceptance Criteria (Implied: Meets Predicate Performance & Standards) | Reported Device Performance (Star 65) |
|---|---|---|
| ECG Heart Rate Range | 20-350 BPM | 20-350 BPM |
| ECG Accuracy | 2bpm or 2% whichever is greater | 2bpm or 2% whichever is greater |
| Respiration Rate Range | 0-150 breaths/min | 0-150 breaths/min |
| Respiration Accuracy | Up to 30: +/- 1bpm; 30-60: +/- 2bpm; >60: +/- 4bpm | Up to 30: +/- 1bpm; 30-60: +/- 2bpm; >60: +/- 4bpm |
| Temperature Range | 0°C - 50°C | 0°C - 50°C |
| Temperature Accuracy | ±0.2°C or ±0.4°F | ±0.2°C or ±0.4°F |
| NIBP Range | 20 - 250 mmHg | 20 - 250 mmHg |
| NIBP Accuracy | +/- 5mmHg with a standard deviation greater than 8 mmHg | +/- 5mmHg with a standard deviation greater than 8 mmHg |
| SpO2 Range | 1-100% | 1-100% |
| SpO2 Accuracy (Adults/Pediatric) | 70-100% +/- 3 digits; 1-69% unspecified | 70-100% +/- 3 digits; 1-69% unspecified |
| SpO2 Accuracy (Neonates) | 70-100% +/- 4 digits; 1-69% unspecified | 70-100% +/- 4 digits; 1-69% unspecified |
| IBP Accuracy | 2 mmHg or 2% whichever is greater | 2 mmHg or 2% whichever is greater |
| EtCO2 Range | 0-100mmHg | 0-100mmHg |
| FiCO2 Range | 0-20mmHg | 0-20mmHg |
| CO2 Accuracy (0-20mins, 0-38mmHg) | +/- 4mmHg | +/- 4mmHg |
| CO2 Accuracy (0-20mins, 39-99mmHg) | +/- 12% of reading | +/- 12% of reading |
| Cardiac Output Range | 0.1 liter/min to 20 liter/min | 0.1 liter/min to 20 liter/min |
| Cardiac Output Accuracy | +5% | +5% |
| AGM RR Accuracy | Up to 60 - +/- 1bpm; >60 unspecified | Up to 60 - +/- 1bpm; >60 unspecified |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of a patient-based study. The testing performed was non-clinical (bench testing), as stated in Section VII. "NON-CLINICAL STUDY." It refers to "Electrical, mechanical environmental safety and performance testing according to the following consensus standards" and "Performance testing- Accuracy, Environment cycling, Temperature Rise Test, wireless co-existence were performed according to Design Requirement specification and Validation plans."
Therefore, there is no patient sample size for a test set described. The data provenance is from bench testing results, not human data. The document does not specify the country of origin for the testing itself, but the device manufacturer (Skanray Technologies Pvt Ltd) is based in India.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. Since no patient-based clinical test set was used, there was no ground truth establishment by experts in that context. The "ground truth" for the non-clinical performance validation was the specifications and performance outlined in the relevant consensus standards (e.g., IEC, ISO standards).
4. Adjudication method for the test set
This section is not applicable. No patient-based test set requiring expert adjudication was conducted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any AI assistance in the provided document. The device is a patient monitoring system, not an AI-driven diagnostic tool that would typically involve human readers interpreting results with or without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable in the sense of an "algorithm only" performance for a diagnostic task. The "standalone" performance shown is the inherent performance of the integrated hardware and software system (Star 65) measuring physiological parameters, as assessed through bench testing against standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance testing, the "ground truth" was defined by the technical specifications and accuracy requirements set forth in the international consensus standards (e.g., IEC 60601 series, ISO 80601 series) to which the device was tested for compliance. For example, for NIBP accuracy, the ground truth standard is +/-5mmHg with a standard deviation greater than 8 mmHg.
8. The sample size for the training set
This section is not applicable. The document does not describe the use of machine learning or AI models that would require a "training set." The device is a traditional multi-parameter patient monitoring system.
9. How the ground truth for the training set was established
This section is not applicable, as there was no training set mentioned in the document.
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Image /page/0/Picture/0 description: The image contains 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. Underneath the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 25, 2018
Skanray Technologies Pvt Ltd % Parul Chansoria Regulatory Consultant Elexes 6494 Tralee Village Dr. Dublin, California 94568
Re: K172147 Trade/Device Name: Star 65 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm). Regulatory Class: Class II Product Code: MWI, DRT, DSJ, DXN, DXG, DSF, DRS, CCK, FLL, NHO, CBO, DQA, NHP, CCL, MNR, CBS, NHQ, CBR, KRB Dated: April 23, 2018 Received: April 27, 2018
Dear Parul Chansoria:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K172147
Device Name Star 65
Indications for Use (Describe)
Star 65 multi-parameter Patient Monitoring system is intended to monitor a single Adult. Pediatric or Neonatal patient's vital signs at the bedside or during intra-hospital transport with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead), SpO2, and Respiration, Temperature, Invasive Blood Pressure (Systolic, Diastolic and Mean), Non-invasive Blood Pressure (Systolic and Mean), Capnography (CO2), Cardiac Output (CO) & AGM module. It can display the numeric values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive (Systolic, Diastolic and Mean), Temperature, CO, EtCO2 and FiCO2, N2O, O2, EtAA and FiAA readings.
The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use. It shall be used only by trained clinicians.
In addition Star 65 got Arrhythmia and ST detection from 3L/5L ECG measurements. The Arrhythmia and ST analysis module is intended for use with Adult & Pediatric patients and is not intended for use with Neonatal patients(ST and Arrhythmia detection functionality is not available for U.S.A).
| 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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SECTION 5. 510 (K) SUMMARY (AS PER 21 CFR 807.92)
I. SUBMITTER
Skanray Technologies Pvt Ltd, Healthcare division, #360, KIADB Industrial Area, Hebbal, Mysore - 570018, Karnataka, India.
Contact Person: Parul Chansoria, Regulatory Consultant, Elexes Telephone: 650-528-2445 E-mail: parul@elexes.com
Summary Prepared: May 23, 2018
FDA Establishment Number: 3002513440
II. DEVICE
Common/Usual Name: Patient Monitoring System Trade Name: Star 65 Regulation Description: Cardiac Monitor (including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Classification Panel: Cardiovascular Primary Product Code: MWI Regulation Number: 870.2300
| Product Code | Regulation Number | Regulation Description |
|---|---|---|
| DXN | 870.1130 | Noninvasive blood pressure measurement system |
| KRB | 870.1915 | Thermodilution probe |
| DRT | 870.2300 | Cardiac monitor (including cardiotachometer and ratealarm) |
| DQA | 870.2700 | Oximeter |
| DSJ | 870.1100 | Blood Pressure Alarm |
| DXG | 870.1435 | Single-function, preprogrammed diagnostic computer |
| DSF | 870.2810 | Paper chart recorder |
| DRS | 870.2850 | Extravascular blood pressure transducer |
| CCK | 868.1400 | Carbon dioxide gas analyzer |
| CBQ | 868.1500 | Enflurane gas analyser |
| NHO | 868.1500 | Enflurane gas analyser |
| NHP | 868.1500 | Enflurane gas analyser |
| NHQ | 868.1500 | Enflurane gas analyser |
| CBS | 868.1620 | Halothane gas analyser |
| CBR | 868.1700 | Nitrous oxide gas analyser |
| CCL | 868.1720 | Oxygen gas analyser |
Secondary Product Codes:
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| MNR | 868.2375 | Breathing frequency monitor |
|---|---|---|
| FLL | 880.2910 | Clinical electronic thermometer |
III. PREDICATE DEVICE
The Patient Monitoring System (Model: Star 65) is substantially equivalent to the following cleared device:
| Company | PredicatePriority | Product | 510(k)Number | ProductCode | RegulationNumber | RegulationDescription |
|---|---|---|---|---|---|---|
| SkanrayTechnologies Pvt.Ltd. | Primary | Star 90 | K150512 | MWI | 21 CFR870.2300 | Cardiac Monitor(includingCardiotachometerand Rate Alarm) |
| PhilipsMedizinSystemeBoeblingen GmbH | Secondary | MP50 | K161531 | MHX | 21 CFR870.1025 | ArrhythmiaDetector andAlarm (IncludingST-SegmentMeasurementand Alarm) |
| L&T Medical &Systems | Tertiary | Star 55 | K080173 | MWI | 21 CFR870.2300 | Cardiac Monitor(includingCardiotachometerand Rate Alarm) |
IV. DEVICE DESCRIPTION
Star 65 is a multi-parameter modular patient monitoring system for continuous monitoring of the physiological parameters like ECG (3/5 lead), Respiration, NIBP, Temperature, SpO2, CO2, Cardiac Output (CO). & Anesthesia Gas Monitoring (AGM) Module (Optional). The modular parameters are IBP, CO and CO2.
Star 65 is a 8 channel monitor with 12.1" LED display with touch screen capable of displaying and monitoring ECG, Respiration, SpO2, CO2, IBP, and O2 digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic & Mean), Invasive Blood Pressure (Systolic, Diastolic & Mean), Temperature, EtCO2, FiCO2, IPI, CO, N2O, O2, EtAA, and FiAA readings.
Star 65 has 240 Hours tabular and graphical vital trend. Star 65 has a NIBP trend of last 240 readings. Star 65 has Alarm Recall facility with last 48 'Patient Alarms' details.
Star 65 has communication features like USB for Thumb drive, Printer, Bar code scanner interface, Ethernet for CNS & Bed to Bed connectivity, HDMI output for External monitor connectivity, External Port for AGM 55 interface, Wi-Fi for CNS, Bed to Bed & Network Printer connectivity. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals, high priority alarms are indicated by red colour, medium priority alarms are indicated by yellow colour & low priority alarms are represented by blue colour.
Star 65 has got Drug calculator software package to display drug dosage applied / to be applied for the standard Medicines.
V. INDICATIONS FOR USE
Star 65 multi-parameter Patient Monitoring system is intended to monitor a single Adult. Pediatric or Neonatal patient's vital signs at the bedside or during intra-hospital transport with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead), SpO2, and Respiration, Temperature, Invasive Blood Pressure (Systolic and Mean), Non-invasive Blood
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K172147
Pressure (Systolic, Diastolic and Mean), Capnography (CO2), Cardiac Output (CO) & AGM module. It can display the numeric values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, CO, EtCO2 and FiCO2, N2O, O2, EtAA and FiAA readings.
The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use. It shall be used only by trained clinicians.
In addition Star 65 got Arrhythmia and ST detection from 3L/5L ECG measurements. The Arrhythmia and ST analysis module is intended for use with Adult & Pediatric patients and is not intended for use with Neonatal patients (ST and Arrhythmia detection functionality is not available for U.S.A).
VI. TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The monitoring of vital sign physiological parameters is the technological principle for both the subject and predicate devices. It is based on the use of modules and accessories that are either connected internally or externally to the monitors in order to monitor the specific physiological parameter.
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| Title | Subject | Primary Predicate | Secondary Predicate | Tertiary Predicate | Comments |
|---|---|---|---|---|---|
| Device | Star 65 | Star 90 | MP50 | Star 55 | --- |
| Indication For Use | Star 65 multi-parameter PatientMonitoring system is intended tomonitor a single Adult, Pediatricor Neonatal patient's vital signsat the bedside or during intra-hospital transport with theappropriate accessoriesmentioned / supplied with theunit. Vital signs parametersinclude ECG (3 lead /5 lead),SpO2, and Respiration,Temperature, Invasive BloodPressure (Systolic, Diastolic andMean), Non-invasive BloodPressure (Systolic, Diastolic andMean), Capnography (CO2),Cardiac Output (CO) & AGMmodule. It can display thenumeric values of HR/PR, SpO2,RR, Non-Invasive Blood Pressure(Systolic, Diastolic and Mean),Invasive Blood Pressure(Systolic, Diastolic and Mean),Temperature, CO, EtCO2 andFiCO2, N2O, O2, EtAA andFiAA readings. The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device | Star 90 multi-parameterPatient monitoring systemis intended to monitor asingle adult, pediatric orneonatal patient's vitalsigns at the bedside orduring intra- hospitaltransport along with theappropriate accessoriesmentioned / supplied withthe unit. Vital signsparameters include ECG(3 lead / 5 lead / 12 lead).Spo2, Respiration,Temperature andCapnography (CO2), IBP.It can also display thenumeric values of HR/PR,SpO2, RR, Non-InvasiveBlood Pressure (Systolic,Diastolic, and Mean)Temperature, IBP, EtCO2and FiCO2 readings. The user responsible to interpret the monitored data made available will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible | The monitors areindicated for use byhealth careprofessionals wheneverthere is a need formonitoring thephysiologicalparameters of patients.The monitors areintended to be used formonitoring andrecording of, and togenerate alarms for,multiple physiologicalparameters of adults,pediatrics, andneonates. The monitorsare intended for use bytrained healthcareprofessionals in ahospital environment. The MP50 monitors are additionally intended for use intransport situationswithin hospital environments. The monitors are only for use on one patient at a time. They are not | Star 55 multi-parameter PatientMonitoring systemis intended tomonitor a singleAdult, Pediatric orNeonatal patient'svital signs at thebedside or duringintra-hospitaltransport along withthe appropriateaccessoriesmentioned /supplied with theunit. Vital signsparameters includeECG (3 lead /5 lead/12 lead), SpO2,Respiration,Temperature,Capnography (CO2), & optional Gas module unit. It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean) | Same |
| Title | Subject | Primary Predicate | Secondary Predicate | Tertiary Predicate | Comments |
| permits patient monitoring withadjustable alarm limits as well asvisible and audible alarm signals.The monitor is not intended forhome use. It shall be used only bytrained clinicians. | and audible alarm signals.The monitor is notintended for home use. | intended for home use.Not therapeuticdevices. The monitorsare for prescription useonly. | (Systolic, Diastolicand Mean),Temperature,EtCO2, FiCO2,N2O, O2, EtAA andFiAA readings.The user,responsible tointerpret themonitored datamade available, willbe a professionalhealth care provider.The device permitspatient monitoringwith adjustablealarm limits as wellas visible andaudible alarmsignals. The monitoris not intended forhome use. | ||
| In addition Star 65 gotArrhythmia and ST detectionfrom 3L/5L ECG measurements.The Arrhythmia and ST analysismodule is intended for use withAdult & Pediatric patients and isnot intended for use withNeonatal patients(ST andArrhythmia detectionfunctionality is not available forU.S.A). | |||||
| DISPLAY: | |||||
| Type | Colour TFT LCD display | Colour TFT LCDdisplay | Colour TFT LCDdisplay | --- | Same as Star 90 |
| Size | 12.1 inch | 15 inch | 12.1 inch | --- | Same as MP50 |
| Resolution | 1024 X 768 | 1024 X 768 | 800 X 600 | Same as Star 90 | |
| No. of traces | 8 traces | 10 traces | 6 traces | Similar to Star 90 | |
| Sweep (trace) speed | 12.5, 25, 50mm/Sec for ECG,SpO2, IBP1, IBP2, IBP3 & IBP4.6.25, 12.5, 25mm/Sec forRespiration, AGM &Microstream Capnography | 12.5, 25, 50mm/Sec forECG, SpO2 IBP1, IBP2,IBP3 & IBP4.6.25, 12.5, 25mm/Secfor Respiration, AGM& Microstream | --- | Same as Star 90 | |
| Title | Subject | Primary Predicate | Secondary Predicate | Tertiary Predicate | Comments |
| Capnography | |||||
| Waveformdisplay options | a) Standard Formats: 3b) User Formats: 4c) Auto Formatd) Quick ECG format | e)Standard Formats: 3f) User Formats: 4g) Auto Formath) Quick ECG format | --- | --- | Same as Star 90 |
| CONTROLS: | |||||
| Front Panel:1 switch for Unit ON / OFF.1 switch for AlarmAcknowledgment1 switch for NIBP start/stop1 switch for Freeze1 switch for Home1 switch for Recording1 switch for Pump on1 switch for to set Monitorin stand-by Mode1 switch for GOTO (Short cutKey)1 switch for Optical encoderwith switch.1 switch for IBP zeroing | --- | --- | Front Panel:1 switch for UnitON / OFF.1 switch forAlarmAcknowledgment1 switch for NIBPstart/stop1 switch for Freeze1 switch for Home1 switchforRecording1 switchfor Pumpon1 switch for toset Monitor instand-byMode1 switch forGOTO (Shortcut Key)1 switch forOptical encoder | Same as Star 55 | |
| Title | Subject | Primary Predicate | Secondary Predicate | Tertiary Predicate | Comments |
| ALARMS: | with switch.1 switch for IBPzeroing | ||||
| Notification | Audible & visual | Audible & visual | Audible & visual | Same as Star 90 | |
| Classification | 1. Patient Alarms :High Priority: Audio & Visual(flashing RED LED alarm) andmessage indication. Respectiveparameter values will behighlighted.Medium Priority: Audio &Visual (flashing YELLOWLED alarm) and messageindication. Respectiveparameter values will behighlighted2. Equipment Alarms: Audio &Visual (flashing BLUE LEDalarm) and message Indication3. Re-Alarm: 1 minute re-alarmprovided in case conditionpersists after alarmAcknowledgment. (With Userconfigurable Alarm Pauseduration). | 1. Patient Alarms :High Priority: Audio &Visual(flashingRED LED alarm) andmessage indication.Respective parametervalues will behighlighted.Medium Priority: Audio& Visual (flashingYELLOW LED alarm)and message indication.Respective parametervalues will behighlighted2. Equipment Alarms:Audio & Visual (flashingBLUE LED alarm) andmessage Indication3. Re-Alarm: 1 minute re-alarm provided in casecondition persists afteralarm Acknowledgment.(With User configurableAlarm Pause duration). | --- | --- | |
| Alarm Silencing / | Alarms Suspend: Continuous | Alarms Suspend: | --- | --- | |
| Title | Subject | Primary Predicate | Secondary Predicate | Tertiary Predicate | Comments |
| mute & Alarm suspend / pause | RED LED ON to indicate alarm suspend condition with crossed bell icon on Real Time Screen | Continuous RED LED ON to indicate alarm suspend condition with crossed bell icon on Real Time Screen | |||
| Volume | 10 steps (Low to High) | 10 steps (Low to High) | --- | --- | Same as Star 90 |
| ECG: | |||||
| Standard leads available | 3/5L | 3/5L/12L | --- | --- | Similar to Star 90 |
| Lead fail indication | Individual lead fault indication on screen | Individual lead fault indication on screen | --- | --- | Same as Star 90 |
| Gain selection / Voltage range | 5mV, 2mV, 1.3mV, 1mV, 0,5, 0.2mV & Auto - User selectable | 5mV, 2mV, 1.3mV, 1mV, 0.75mV, 0.5mV, 0.2mV & Auto - User selectable | --- | --- | Same as Star 90 |
| Heart rate range | 20-350 BPM. | 20-350 BPM. | --- | --- | Same as Star 90 |
| Accuracy | 2bpm or 2% whichever is greater | 2bpm or 2% whichever is greater | --- | --- | Same as Star 90 |
| Input impedance | >2.5 M ohms at 10Hz, &100 M ohm DC | >2.5 M ohms at 10Hz, &100 M ohm DC | --- | --- | Same as Star 90 |
| Common mode rejection | <15mm (max.) (Allowable noise for 3 V p-p 20Hz sine wave) | <15mm (max.) (Allowable noise for 3 V p-p 20Hz sine wave) | --- | --- | Same as Star 90 |
| Frequency response / bandwidth | Bandwidth:3 - 40 Hz for Monitoring mode0.05 - 120 Hz for Diagnostic mode3 - 20HZ for OT mode | Bandwidth:0.5 - 40 Hz for Monitoring mode0.05 - 120 Hz for Diagnostic mode0.5 - 20HZ for OT mode | --- | --- | Same as Star 90 |
| HR ALARMS | Adjustable alarm limits Min - 20 to 320BPM. | Adjustable alarm limits Min - 20 to 320BPM. | --- | --- | Same as Star 90 |
| Title | Subject | Primary Predicate | Secondary Predicate | Tertiary Predicate | Comments |
| Max - 50 to 350 BPM4 seconds delay for HR alarms | Max - 50 to 350 BPM4 seconds delay for HR alarms | ||||
| Defibrillationprotection | Yes | Yes | --- | --- | Same as Star 90 |
| Pacemaker detection/ rejection | When pacer is ON the monitorwill display the HR for all singleand double pacemaker pulseseither 150 or 250 msec apart ofamplitudes ±2mV to±700mVfrom 0.5msec to 2.0 msec. | When pacer is ON themonitor will display theHR for all single anddouble pacemaker pulseseither 150 or 250 msecapart of amplitudes±2mV to±700mV from0.5msec to 2.0 msec. | --- | --- | Same as Star 90 |
| ESU protection | Yes | Yes | --- | --- | Same as Star 90 |
| RESPIRATION: | |||||
| Measurementtechnique | Measured either through ECGor CO2If Capnography option is notprovided then input is fromECG: impedancepneumography method. | Measured eitherthrough ECG or CO2If Capnography optionis not provided theninput is from ECG:impedancepneumography method. | --- | --- | Same as Star 90 |
| Respiration raterange | 0-150 breaths\min. | 0-150 breaths\min. | --- | Same as Star 90 | |
| Accuracy | Up to 30, +/- 1bpm,from 30 to 60 +/-2bpm,>60 +/-4bpm. | Up to 30, +/- 1bpm,from 30 to 60 +/- 2bpm,>60 +/-4bpm. | --- | Same as Star 90 | |
| Sensitivity | Sensitivity (max): 0.2 ohm/cmSensitivity (min): 4 ohm/cmExcitation current: < 300 microAmp at 50 kHz. | Sensitivity (max): 0.2ohm/cm Sensitivity(min): 4 ohm/cmExcitation current: <300 micro Amp at 50kHz. | --- | Same as Star 90 | |
| Gain | Options x1, x2, x3, x4, AUTO(user selectable). x4 is defaultgain level | Options x1, x2, x3, x4,AUTO (user selectable).x4 is default gain level | --- | Same as Star 90 | |
| Title | Subject | Primary Predicate | Secondary Predicate | Tertiary Predicate | Comments |
| Alarms | User-selectable upper andlower respiration rate limits. | User-selectable upperand lower respirationrate limits. | --- | --- | Same as Star 90 |
| TEMPERATURE: | |||||
| No. of channels | Two | Two | --- | --- | Same as Star 90 |
| Temperature range | $0°C - 50°C$ | $0°C - 50°C$ | --- | --- | Same as Star 90 |
| Scale value | Displays direct readings oftemperature input. 'ΔT' valuedisplayed in place of T2 | Displays direct readingsof temperature input.'ΔT' value displayed inplace of T2 | --- | --- | Same as Star 90 |
| Accuracy | $±0.2° C or ±0.4°F$ . | $±0.2° C or ±0.4°F$ . | --- | --- | Same as Star 90 |
| Linearity | $±0.1 °C$ | $±0.1 °C$ | --- | --- | Same as Star 90 |
| Alarms | Temperature limits adjustableMin: 12°C to 47°CMax: 15 °C to 50°C | Temperature limitsadjustableMin: 12°C to 47°CMax: 15° C to 50°C | --- | --- | Same as Star 90 |
| Unit | $°C$ or $°F$ user selectable | $°C$ or $°F$ user selectable | --- | --- | Same as Star 90 |
| Probe fault | Display shows 'OFF' if theprobe not connected.Display shows out of rangecondition (-? -) in the event ofshort circuit or open circuitprobes . | Display shows 'OFF' ifthe probe not connected.Display shows out ofrange condition (-? - ) inthe event of short circuitor open circuit probes. | --- | --- | Same as Star 90 |
| Out of range condition alsoindicate the temperature raisesabove $50° C$ falls below $10° C$ .If a fault is present in thetemperature measuring circuit,the message 'FAULT' will bedisplayed. | Out of range conditionalso indicate thetemperature raises above$50° C$ falls below $10°C$ .If a fault is present inthe temperaturemeasuring circuit, themessage 'FAULT' willbe displayed. | --- | --- | Same as Star 90 | |
| NON-INVASIVE BLOOD PRESSURE (NIBP): | |||||
| Measurementtechnique | Oscillometric | Oscillometric | --- | --- | Same as Star 90 |
| Module Used | Suntech Advantage | Suntech Advantage | --- | --- | Same as Star 90 |
| Title | Subject | Primary Predicate | Secondary Predicate | Tertiary Predicate | Comments |
| Displayedparameters | Systolic, diastolic and mean | Systolic, diastolic andmean | --- | --- | Same as Star 90 |
| Measurement | Manual, Auto & Stat mode | Manual, Auto & Statmode | --- | --- | Same as Star 90 |
| modes | In AUTO mode intervals of2,3,4,5,10,15,30,60,90,120,240,360minutes are user selectable.In STAT mode unit will take asmany readings as possible in5minutes. Duration betweenmeasurements is 10-12 sec | In AUTO mode intervalsof2,3,4,5,10,15,30,60,90,120,240, 360minutes areuser selectable.In STAT mode unit willtake as many readings aspossible in 5minutes.Duration betweenmeasurements is 10-12sec | --- | --- | Same as Star 90 |
| Range | 20 - 250 mmHg | 20 - 250 mmHg | --- | --- | Same as Star 90 |
| Accuracy | +/-5mmHg with a standarddeviation greater than 8 mmHg. | +/-5mmHg with astandard deviationgreater than 8 mmHg. | --- | --- | Same as Star 90 |
| Auto zero | Zero pressure reference isautomatically established afterevery reading. | Zero pressure referenceis automaticallyestablished after everyreading. | --- | --- | Same as Star 90 |
| Total cycle time | 20 to 40 seconds typical | 20 to 40 seconds typical | --- | --- | Same as Star 90 |
| Automatic cuffdeflation | Automatic deflation if :a) Cuff pressure exceeds300mmHg in Adult & Pediatricand 150mmHg in NeonateModeb) Measurement time exceeds50 seconds. | Automatic deflation if :a)Cuff pressure exceeds300mmHg in Adult &Pediatric and 150mmHgin Neonate Modeb) Measurement timeexceeds 50 seconds. | --- | --- | Same as Star 90 |
| Cuff inflation | Initial inflation:Adult:160mmHgNeonates:80mHgPediatric:120mmHgSubsequent inflationapproximately 30 mmHg greaterthan previous systolic pressure | Initial inflation:Adult:160mmHgNeonates:80mHgPediatric:120mmHgSubsequent inflationapproximately 30mmHg greater thanprevious systolic | --- | --- | Same as Star 90 |
| Title | Subject | Primary Predicate | Secondary Predicate | Tertiary Predicate | Comments |
| pressure | |||||
| Alarms | Adjustable alarm limits (forboth SYS & DIA)Upper: 30 to 250 mmHgLower: 20 to 240 mmHg | Adjustable alarm limits(for both SYS & DIA)Upper: 30 to 250mmHgLower: 20 to 240mmHg | --- | --- | Same as Star 90 |
| PULSE OXIMETRY: | |||||
| Technology | Electro optical sensor (2 LEDs& a photo diode) | Electro optical sensor (2LEDs& a photo diode) | Electro optical sensor(2 LEDs & a photodiode) | Electro opticalsensor (2 LEDs& a photo diode) | Same as Star 90 |
| Module Used | Nellcor-Nell 1 | Nellcor-Nell 1 | --- | --- | Same as Star 90 |
| SpO2 range | 1- 100% | 0 - 100% | 0 - 100% | 0 - 100% | Same as Star 90 |
| Accuracy: | Adults/Pediatric:(+/- 1 Std. Dev)70-100% +/-3 digits1- 69% : unspecifiedNeonates:70-100% +/-4 digits1-69% Unspecified | Adults/Pediatric:(+/- 1 Std. Dev)70-100% +/-3 digits0- 69% : unspecifiedNeonates:70-100% +/-4 digits0-69% Unspecified | --- | --- | Same as Star 90 |
| Alarms | Adjustable alarm limits Min 50to 95%Max 55 to 100% | Adjustable alarm limitsMin 50 to 95%Max 55 to 100% | --- | --- | Same as Star 90 |
| IBP (INVASIVE BLOOD PRESSURE): | |||||
| Input Impedance | >1MOhm | >1MOhm | --- | --- | Same as Star 90 |
| Leakage Current | <10 micro Amp at 240V AC,50Hz. | <10 micro Amp at 240VAC, 50Hz. | --- | --- | Same as Star 90 |
| Processed PressureSignals | Systolic, Diastolic and Mean. | Systolic, Diastolic andMean. | --- | --- | Same as Star 90 |
| Accuracy | 2 mmHg or 2% whichever isgreater. | 2 mmHg or 2%whichever is greater. | --- | --- | Same as Star 90 |
| Bandwidth | DC to 20Hz | DC to 20Hz | --- | --- | Same as Star 90 |
| Sensitivity | 5 Micro V / V /mmHg oftransducers. | 5 Micro V / V /mmHgof transducers. | --- | --- | Same as Star 90 |
| CAPNOGRAP HY: | |||||
| Type | Micro Medico -- MicroStream technology fromMedtronic | Micro Medico --Micro Streamtechnology from | --- | --- | Same as Star 90 |
| Title | Subject | Primary Predicate | Secondary Predicate | Tertiary Predicate | Comments |
| Method | Non-depressive infra-redabsorption technique | MedtronicNon-depressive infra-red absorption technique | --- | --- | Same as Star 90 |
| --- | |||||
| Measurement range: | Et CO2: 0-100mmHgFi CO2: 0 – 20mmHg | Et CO2: 0-100mmHgFi CO2: 0 – 20mmHg | --- | --- | Same as Star 90 |
| CO2 accuracy: | 0-20mins:0-38mmHg: +/-4mmHg,39-99mmHg: +/-12% ofreading, | 0-20mins:0-38mmHg: +/-4mmHg,39-99mmHg: +/-12%of reading, | --- | --- | Same as Star 90 |
| 20mins and up:0-38mmHg: +/-4mmHg,39-99 mmHg:+/- 5% ofreading + 0.08% for every1mmHg (above 38 mmHg) | 20mins and up:0-38mmHg: +/-4mmHg,39-99 mmHg:+/- 5%of reading + 0.08% forevery 1mmHg (above38 mmHg) | --- | --- | ||
| Warm Up Time | 40 Sec (Typical) | 40 Sec (Typical) | --- | --- | Same as Star 90 |
| RR | 0– 150 bpm | 0– 150 bpm | --- | --- | Same as Star 90 |
| Alarms | EtCO2:High: 5-80 mmHgLow: 0-75 mm HgFiCO2:High: 2-20 mm HgRR:High: 10-150 bpmLow: 5-145 bpm | EtCO2:High: 5-80 mmHgLow: 0-75 mm HgFiCO2:High: 2-20 mm HgRR:High: 10-150 bpmLow: 5-145 bpm | --- | --- | Same as Star 90 |
| Invasive Cardiac Output: | |||||
| Method | Thermo dilution Method | --- | Thermo dilution Method | --- | Same as MP50 |
| Cardiac OutputRange | 0.1 liter /min to 20 liter /min. | --- | 0.1 to 20.0 l/min | --- | Same as MP50 |
| Accuracy | +5 %. | --- | +5 %. | --- | Same as MP50 |
| Blood Temp. | 17°C - 45 °C | --- | 17°C to 43°C | --- | Similar to MP50 |
| Injectate Temp. | 0°C - 30°C | --- | -1 to 30°C | --- | Same as MP50 |
| (Bt) and (It)Accuracy | ±0.1°C | --- | ±0.1°C | --- | Same as MP50 |
| Title | Subject | Primary Predicate | Secondary Predicate | Tertiary Predicate | Comments |
| (Bt) and (It)Resolution | 0.1°C | --- | 0.1°C | --- | Same as MP50 |
| Anesthesia Gas Monitor(AGM): | |||||
| Module Used | Artema Technology fromMindray | Artema Technologyfrom Mindray | --- | ArtemaTechnology fromMindray | Same as Star 90and Star 55 |
| Identification ofAnesthetic Agent | Auto/Manual | Auto | --- | Auto | Similar to Star 90and Star 55 |
| Oxygen sensor type | Galvanic | Galvanic | --- | Galvanic | Similar to Star 90and Star 55 |
| Measurement Range: | |||||
| EtCO2 | 0-80 mmHg or 0.0-10.0kpa/vol% | 0-80 mmHg or 0.0-10.0kpa/vol% | --- | 0-80 mmHg or0.0-10.0 kpa/vol% | Same as Star 90and Star 55 |
| FiCO2 | 0-20 mmHg or 0.0 - 2.6 kPa /Vol%. | 0-20 mmHg or 0.0 - 2.6kPa / Vol%. | --- | 0-20 mmHg or 0.0- 2.6 kPa / Vol%. | Same as Star 90and Star 55 |
| RR | 2-100 bpm | 2-100 bpm | --- | 2-100 bpm | Same as Star 90and Star 55 |
| MeasurementAccuracy | |||||
| RR | Up to 60 - +/- 1bpm, >60unspecified | Up to 60 - +/-1bpm, >60 unspecified | --- | Up to 60 - +/-1bpm, >60unspecified | Same as Star 90and Star 55 |
| N2O | 0 - 20 ±220 - 100 ±3 | 0 - 20 ±220 - 100 ±3 | --- | 0 - 20 ±220 - 100 ±3 | Same as Star 90and Star 55 |
| Halothene | 0-1 ±0.151 - 5 ±0.2> 5 Unspecified | 0 - 1 ±0.151 - 5 ±0.2> 5 Unspecified | --- | 0-1 ±0.151 - 5 ±0.2> 5 Unspecified | Same as Star 90and Star 55 |
| Isoflurane | 0-1 ±0.151 - 5 ±0.2> 5 Unspecified | 0 - 1 ±0.151 - 5 ±0.2> 5 Unspecified | --- | 0-1 ±0.151 - 5 ±0.2> 5 Unspecified | Same as Star 90and Star 55 |
| Enflurane | 0-1 ±0.151 - 5 ±0.2> 5 Unspecified | 0 - 1 ±0.151 - 5 ±0.2> 5 Unspecified | --- | 0-1 ±0.151 - 5 ±0.2> 5 Unspecified | Same as Star 90and Star 55 |
| Sevofurane | 0-1 ±0.151 - 5 ±0.25 - 8 ±0.4 | 0 - 1 ±0.151 - 5 ±0.25 - 8 ±0.4 | --- | 0-1 ±0.151 - 5 ±0.25 - 8 ±0.4 | Same as Star 90and Star 55 |
| Title | Subject | Primary Predicate | Secondary Predicate | Tertiary Predicate | Comments |
| > 8 Unspecified | > 8 Unspecified | > 8 Unspecified | |||
| Desflurane | 0-1 ±0.151 - 5 ±0.25 - 10 ±0.410 - 15 ±0.615 - 18 ±1> 18 Unspecified | 0-1 ±0.151 - 5 ±0.25 - 10 ±0.410 - 15 ±0.615 - 18 ±1> 18 Unspecified | --- | 0-1 ±0.151 - 5 ±0.25 - 10 ±0.410 - 15 ±0.615 - 18 ±1> 18 Unspecified | Same as Star 90and Star 55 |
| CO2 | 0 - 1 ±0.11 - 5 ±0.25 - 7 ±0.37 - 10 ±0.5> 10 Unspecified | 0 - 1 ±0.11 - 5 ±0.25 - 7 ±0.37 - 10 ±0.5> 10 Unspecified | --- | 0-1 ±0.11-5 ±0.25 - 7 ±0.37 - 10 ±0.5> 10 Unspecified | Same as Star 90and Star 55 |
| O2 | 0-40±140 - 60 ±240 - 80 ±380 - 100 ±4 | 0-40±140 - 60 ±240 - 80 ±380 - 100 ±4 | --- | 0-40 ±140 - 60 ±240 - 80 ±380 - 100 ±4 | Same as Star 90and Star 55 |
| Resolution: | |||||
| CO2 | +/-1 mm Hg or 0.1 kPa or 0.1Vol % | +/-1 mm Hg or 0.1kPa or 0.1 Vol % | --- | +/- mm Hg or 0.1kPa or 0.1 Vol % | Same as Star 90and Star 55 |
| AA | 0.1% | 0.1% | --- | 0.1% | Same as Star 90and Star 55 |
| N2O | 1% | 1% | --- | 1% | Same as Star 90and Star 55 |
| O2 | 1% | 1% | --- | 1% | Same as Star 90and Star 55 |
| Units: | |||||
| CO2 | mmHg or kPa or Vol %. | mmHg or kPa orVol %. | --- | mmHg or kPa orVol %. | Same as Star 90and Star 55 |
| AA/O2/N2O | Vol% | Vol% | --- | Vol% | Same as Star 90and Star 55 |
| Warm-up Phase | ISO accuracy within 45 s, fullaccuracy within 10 min | ISO accuracy within 45s, full accuracy within10 min | --- | ISO accuracy within 45s, full accuracy within10 min | Same as Star 90and Star 55 |
| Title | Subject | Primary Predicate | Secondary Predicate | Tertiary Predicate | Comments |
| Pump | Flow controlled dual membrane70-200+/- 10ml/min or +/- 10%whichever is greatest | Flow controlled dualmembrane70-200+/- 10ml/min or+/- 10% whichever isgreatest | --- | Flow controlled dualmembrane70-200+/- 10ml/minor +/- 10% whicheveris greatest | Same as Star 90and Star 55 |
| Primary Agent IDThreshold | 0.15% (0.4% during ISOaccuracy mode) | 0.15% (0.4% duringISO accuracy mode) | --- | 0.15% (0.4% duringISO accuracy mode) | Same as Star 90and Star 55 |
| Secondary Agent IDThreshold | 0.3% (0.5% during ISO accuracymode) or 5%REL (10% forIsoflurane) of primary agent ifprimary agent >10% | 0.3% (0.5% during ISOaccuracy mode) or5%REL (10% forIsoflurane) of primaryagent if primaryagent >10% | --- | 0.3% (0.5% duringISO accuracy mode)or 5%REL (10% forIsoflurane) ofprimary agent ifprimary agent >10% | Same as Star 90and Star 55 |
| Zeroing | Automatically performed by themodule. Indicated to the userthrough a message on the screen.Automatically every 4 hours (inFull accuracy mode) in steadystate with room air. Additionalzeroing performed duringstartup. | Automaticallyperformed by themodule. Indicated to theuser through a messageon the screen.Automatically every 4hours (in Full accuracymode) in steady statewith room air.Additional zeroingperformed duringstartup. | --- | Automaticallyperformed by themodule. Indicated tothe user through amessage on thescreen.Automatically every4 hours (in Fullaccuracy mode) insteady state withroom air. Additionalzeroing performedduring startup. | Same as Star 90and Star 55 |
| Calibration | Initiated through Power onservice menu. | Initiated through Poweron service menu. | --- | Initiated throughPower on servicemenu. | Same as Star 90and Star 55 |
| Alarms | Low and high limits adjustableover the complete measurementrange | Low and high limitsadjustable over thecomplete measurementrange | --- | Low and high limitsadjustable over thecompletemeasurement range | Same as Star 90and Star 55 |
| Title | Subject | Primary Predicate | Secondary Predicate | Tertiary Predicate | Comments |
| Delay Time | < 4Sec | < 4Sec | --- | < 4Sec | Same as Star 90and Star 55 |
| Span CalibrationCheck | Once in a Year | Once in a Year | --- | Once in a Year | Same as Star 90and Star 55 |
| W/f sampling rate | 50 | 50 | --- | --- | Same as Star 90and Star 55 |
| No Breath alarm | Within 10-90 seconds whenrespiration not detected. | Within 10-90 secondswhen respiration notdetected. | --- | --- | Same as Star 90and Star 55 |
| System outputs | ECG Analog Output Port (ForIABP Interface)HDMI : External Slave DisplayWi-Fi : Communicating withCentral Nursing station(SKANRAY'S CNS), Bed ToBed, Network/Wireless PrinterSerial Port (1 no ): ForAGM55 ConnectivityEthernet (1 no) :Communicating with CentralNursing station (SKANRAY'sCNS), Bed To Bed.USB (1 no ) : For uploadingsoftware into Monitor, PatientTransfer & for trend datadownload, Bar Code Scanner | ECG Analog OutputPort (For IABPInterface)HDMI : External SlaveDisplayWi-Fi :Communicating withCentral Nursing station(SKANRAY's CNS),Bed To Bed,Network/WirelessPrinterSerial Port (1 no ): ForAGM55 ConnectivityEthernet (1 no) :Communicating withCentral Nursing station(SKANRAY's CNS),Bed To Bed.USB (1 no ) : Foruploading software intoMonitor, PatientTransfer & for trend datadownload, Bar CodeScanner | --- | Same as Star 90 | |
| Title | Subject | Primary Predicate | Secondary Predicate | Tertiary Predicate | Comments |
| Power supply | VOLTAGE : 100 - 240V AC,[50Hz / 60Hz,+/- 5%]WATTAGE: 100 WATTSFUSE: 3.15A, 250V Fuse inLine & NeutralINDICATOR:• Amber LED ON indicatesmains on• Green LED ON indicatesmonitor on• Amber LED OFF and GreenLED ON indicates unit is inthe battery mode | VOLTAGE : 100 -240V AC, [50Hz /60Hz,+/- 5%]WATTAGE: 100WATTSFUSE: 3.15A, 250VFuse in Line & NeutralINDICATOR:• Amber LED ONindicates mains on• Green LED ONindicates monitor on• Amber LED OFF andGreen LED ONindicates unit is in thebattery mode | Same as Star 90Safety Approvalsattached | ||
| BATTERY:Internal battery: | Yes | Yes | — | — | Same as Star 90 |
| Type | Single Lithium ion Battery Pack,14.8V, 4.0 Ah | Single Smart BatteryPack, 10.8V(Nom),Lithium ion | Different. Thisdifference doesnot affect safetyand efficacy ofthe device.Also the batteryis complies withIEC62133:2012 andIEC 60601-1 | ||
| Battery Indication | Main Unit Internal batteriesStatus will be displayed. | Main Unit Internalbatteries Status will bedisplayed. | — | — | Same as Star 90 |
| External batteryprovision | No | No | — | — | Same as Star 90 |
| Battery Chemistry | Lithium ion | Lithium ion | — | — | Same as Star 90 |
| Cells Count | 8 Cells | 6 Cells | — | — | Difference inVoltage |
| Title | Subject | Primary Predicate | Secondary Predicate | Tertiary Predicate | Comments |
| increased cellscount. Thisdifference doesnot affect safetyand efficacy ofthe device.Also the batteryis complies withIEC62133:2012 andIEC 60601-1 | |||||
| Recorder: | |||||
| Technology | Thermal recording | Thermal recording | --- | Thermal recording | Same as Star 55and Star 90 |
| No.of waveformchannels | 2 | 2 | --- | 2 | Same as Star 55and Star 90 |
| Paper width | 58 mm | 58 mm | --- | 58 mm | Same as Star 55and Star 90 |
| Paper speed | 25mm/sec | 25mm/sec | --- | 25mm/sec | Same as Star 55and Star 90 |
| Other printing options: | |||||
| Network PrinterType | PCL 3 / 5e Laser or InkjetPrinter | PCL 3 / 5e Laser orInkjet Printer | --- | --- | Same as Star 90 |
| No.of waveformchannels | 4 (max) | 4 (max) | --- | --- | Same as Star 90 |
| Paper width | Paper Mode (A4) , PaperlessMode (PDF) | Paper Mode (A4) ,Paperless Mode (PDF) | --- | --- | Same as Star 90 |
| Paper speed | NA | NA | --- | --- | Same as Star 90 |
| OTHER FEATURES / SPECIFICATIONS: | |||||
| Operating ambienttemperature | 0 °C to 35 °C | 0 °C to 40 °C | --- | --- | Similar as Star90 |
| Operating Relativehumidity | 10 - 90%RH (non-condensing) | 10 - 90%RH (non-condensing) | --- | --- | Same as Star 90 |
| Operating Pressure | 0 ft - 10,000ft | 0 ft - 10,000ft | --- | --- | Same as Star 90 |
| Title | Subject | Primary Predicate | Secondary Predicate | Tertiary Predicate | Comments |
| Storage conditions | -10° C to 50° С0 – 90%RH (non-condensing)Storage pressure: -1,250ft –15,000ft | -10° C to 50° С0 – 90%RH (non-condensing)Storage pressure: -1,250ft – 15,000ft | --- | --- | Same as Star 90 |
| CONNECTORS: | Power: Standard 3-pin IECpower connector with Line,Neutral & Earth with fuseSide panel:Green colour NICOLAY roundconnector for ECGYellow colour NICOLAYround connector for SpO2Metallic Female coupling forNIBPIBP - Red colour NICOLAYround connectorCO2 - Filter lineTemp – 2 pin connector | Power: Standard 3-pinIEC power connectorwith Line, Neutral &Earth with fuseSide panel:Green colourNICOLAY roundconnector for ECGYellow colourNICOLAY roundconnector for SpO2Metallic Femalecoupling for NIBPIBP - Red colourNICOLAY roundconnectorCO2 - Filter line | --- | --- | Same as Star 90 |
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Table 2 Substantial Equivalent Comparison
Substantial Equivalence Discussion – with Star 90 (K150512), Star 55 (K080173) and MP50 (K120366) Similarities between Star 65 & Star 90:
Star 65 is designed and developed with reference to our previous 510K cleared product star 90. These 2 products are similar in terms of.
- ECG, Respiration, Temperature, IBP, NIBP,SpO2, CO2 and AGM .
- Display type
- Alarm systems
- . Thermal recorder / printer
- Equipment classification and Applicable standards .
Similarities between Star 65 & MP50:
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Star 65 is compared with MP50 for:
- · Invasive Cardiac Output
Similarities between Star 65 & Star 55:
Star 65 is compared with Star 55 for:
- · Keyboard Controls
- . Display size
Differences between Star 65 & predicate Devices:
Star 65 is different from Star 90 in terms of:
- · Battery
Star 65 is a Single Lithium ion Battery Pack, 14.8V, 4.0 Ah. For the same intended purpose as compared to Predicate device, Star 65 performs equivalent and there is no safety issue differences between these differences between the subject and predicate(s) do not impact safety and effectiveness.
Method of Acceptance - Battery complies with IEC 62133:2012 and IEC 60601-1 standards requirements.
Refer Annexure 12 A IEC 61233:2012 Report, Annexure 17 B Electrical Safety Report 1 and Annexure 12 B IEC 62133 CB Certificate Battery Cells
We have performed a thorough verification and testing of the differences in checking the performance and the safety and efficacy. So this difference does not affect safety and efficacy of the device.
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VII.NON-CLINICAL STUDY
- 1.1 Electrical, mechanical environmental safety and performance testing according to the following consensus standards
| Consensus Standardnumber | Standard Description | FDA ID |
|---|---|---|
| AAMI / ANSI ES60601-1:2005/(R)2012 | Medical Electrical Equipment - Part 1: General Requirements ForBasic Safety And Essential Performance (IEC 60601-1:2005, MOD) | 19-4 |
| IEC 60601-1-2 Ed 3: 2007 | Medical electrical equipment -Part 1-2: General requirements forsafety - Collateral standard: Electromagnetic compatibility -Following Requirements and tests | 19-1 |
| IEC 60601-1-6 Ed 3.1:2013 | Medical Electrical Equipment - Part 1-6: General Requirements ForBasic Safety And Essential Performance - Collateral Standard:Usability | 5-89 |
| IEC 60601-1-8 Ed 2.1: 2012 | Medical Electrical Equipment - Part 1-8: General Requirements ForBasic Safety And Essential Performance - Collateral Standard:General Requirements, Tests And Guidance For Alarm Systems InMedical Electrical Equipment And Medical Electrical Systems | 5-76 |
| IEC 60601-2-27 Ed 3.0:2011 | Medical Electrical Equipment - Part 2-27: Particular RequirementsFor The Basic Safety And Essential Performance OfElectrocardiographic Monitoring Equipment | 3-126 |
| IEC 80601-2-30 Ed 1.1:2013 | Medical Electrical Equipment - Part 2-30: Particular RequirementsFor The Basic Safety And Essential Performance Of AutomatedNon-Invasive Sphygmomanometers | 3-123 |
| IEC 60601-2-34 Ed 3.0:2011 | Medical Electrical Equipment - Part 2-34: Particular RequirementsFor The Basic Safety, Including Essential Performance, Of InvasiveBlood Pressure Monitoring Equipment | 3-115 |
| IEC 60601-2-49 Ed 2.0:2011 | Medical electrical equipment - Part 2-49: Particular requirements forthe basic safety and essential performance of multifunction patientmonitoring equipment | None |
| ISO 80601-2-55 FirstEdition 2011-12-15 | Medical Electrical Equipment - Part 2-55: Particular RequirementsFor The Basic Safety And Essential Performance Of RespiratoryGas Monitors | 1-96 |
| ISO 80601-2-56 FirstEdition 2009-10-01 | Medical Electrical Equipment - Part 2-56: Particular RequirementsFor Basic Safety And Essential Performance Of ClinicalThermometers For Body Temperature Measurement | 6-232 |
| ISO 80601-2-61 FirstEdition 2011-04-01 | Medical Electrical Equipment - Part 2-61: Particular RequirementsFor Basic Safety And Essential Performance Of Pulse OximeterEquipment | I-85 |
| IEC 62304 Edition 1.12015-06 | Medical Device Software - Software Life Cycle Processes | 13-79 |
| ISO 14971 Ed 2.0 : 2012 | Application of risk management to medical devices | 5-40 |
All test results were satisfactory. Refer EMC Test Summary & Safety Test Report Summary in section 017 "Electromagnetic Compatibility and Electrical Safety" of this submission document.
- 1.2 Performance testing- Accuracy, Environment cycling, Temperature Rise Test, wireless co-existence were performed according to Design Requirement specification and Validation plans.
"All test results were satisfactory with no deviations from the applicable standards or protocols. Refer summary of performance in section 018 "Performance Testing-Bench" of this submission document for more details".
The data from the test reports (Annexure 18) A to Annexure 18 I) substantiates the equivalence to the Predicate device, as the specifications of the predicate device and the subject device are similar.
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VIII.SOFTWARE VERIFICATION AND VALIDATION TESTING:
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.
IX.CLINICAL STUDY:
Not Applicable, Clinical performance testing was not performed with the subject device to support substantial equivalence.
X. CONCLUSION
Star 65 is substantially equivalent to the predicate device in Indications for Use, Materials and Design. Safety and performance testing was performed and Skanray Technologies has concluded that the device does not introduce any significant questions of safety and efficacy and is substantially equivalent to the predicate devices.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).