Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard multi-parameter patient monitoring system with features like vital sign monitoring, trend display, alarms, and communication capabilities. There is no mention of AI or ML in the intended use, device description, or performance studies. The Arrhythmia and ST detection features are mentioned but not described as utilizing AI/ML.

Therapeutic

No
The device is a multi-parameter patient monitoring system designed to measure and display vital signs and physiological parameters, not to treat or modify a physiological function.

Diagnostic

Yes

The device is a patient monitoring system that measures vital signs and provides analysis for conditions like arrhythmia and ST detection, which are used to aid in the diagnosis of patient conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components such as a 12.1" LED display with touch screen, various physical ports (USB, Ethernet, HDMI, External Port), and mentions accessories supplied with the unit, indicating it is a physical device with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Star 65 multi-parameter Patient Monitoring system is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body.
Star 65 Function: The Star 65 monitors physiological parameters directly from the patient's body (ECG, SpO2, Respiration, Temperature, Blood Pressure, Capnography, Cardiac Output, Anesthesia Gas Monitoring). It does not analyze samples taken from the patient.

The Star 65 is a patient monitoring system that measures vital signs in real-time from the patient themselves. This falls under the category of patient monitoring devices, not IVD devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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, Diastolic and Mean), Non-invasive Blood 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).

Product codes

MWI, DRT, DSJ, DXN, DXG, DSF, DRS, CCK, FLL, NHO, CBO, DQA, NHP, CCL, MNR, CBS, NHQ, CBR, KRB

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.

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

Adult, Pediatric or Neonatal

Intended User / Care Setting

professional health care provider, trained clinicians, at the bedside or during intra-hospital transport

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 Study:

Electrical, mechanical environmental safety and performance testing according to consensus standards.
Performance testing: Accuracy, Environment cycling, Temperature Rise Test, wireless co-existence were performed according to Design Requirement specification and Validation plans.
Key results: All test results were satisfactory with no deviations from the applicable standards or protocols. The data from the test reports substantiates the equivalence to the Predicate device, as the specifications of the predicate device and the subject device are similar.

Software Verification and Validation Testing:

Conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Level of concern for software: "major" level of concern.

Clinical Study: Not Applicable. Clinical performance testing was not performed with the subject device to support substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K150512, K161531, K080173

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

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);

1

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

2

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 rate
alarm)
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:

4

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 | Predicate
Priority | Product | 510(k)
Number | Product
Code | Regulation
Number | Regulation
Description |
|----------------------------------------------|-----------------------|---------|------------------|-----------------|----------------------|-------------------------------------------------------------------------------------------|
| Skanray
Technologies Pvt.
Ltd. | Primary | Star 90 | K150512 | MWI | 21 CFR
870.2300 | Cardiac Monitor
(including
Cardiotachometer
and Rate Alarm) |
| Philips
MedizinSysteme
Boeblingen GmbH | Secondary | MP50 | K161531 | MHX | 21 CFR
870.1025 | Arrhythmia
Detector and
Alarm (Including
ST-Segment
Measurement
and Alarm) |
| L&T Medical &
Systems | Tertiary | Star 55 | K080173 | MWI | 21 CFR
870.2300 | Cardiac Monitor
(including
Cardiotachometer
and 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

5

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.

6

Title	Subject	Primary Predicate	Secondary Predicate	Tertiary Predicate	Comments
Device	Star 65	Star 90	MP50	Star 55	---
Indication 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 /5 lead),
SpO2, and Respiration,
Temperature, Invasive Blood
Pressure (Systolic, Diastolic and
Mean), Non-invasive Blood
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	Star 90 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 along with the
appropriate accessories
mentioned / supplied with
the unit. Vital signs
parameters include ECG
(3 lead / 5 lead / 12 lead).
Spo2, Respiration,
Temperature and
Capnography (CO2), IBP.
It can also display the
numeric values of HR/PR,
SpO2, RR, Non-Invasive
Blood Pressure (Systolic,
Diastolic, and Mean)
Temperature, IBP, EtCO2
and 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 are
indicated for use by
health care
professionals whenever
there is a need for
monitoring the
physiological
parameters of patients.
The monitors are
intended to be used for
monitoring and
recording 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 a
hospital environment. The MP50 monitors are additionally intended for use in
transport situations
within hospital environments. The monitors are only for use on one patient at a time. They are not	Star 55 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 along with
the appropriate
accessories
mentioned /
supplied with the
unit. Vital signs
parameters include
ECG (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 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.	and audible alarm signals.
The monitor is not
intended for home use.	intended for home use.
Not therapeutic
devices. The monitors
are for prescription use
only.	(Systolic, Diastolic
and Mean),
Temperature,
EtCO2, 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.
	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).
DISPLAY:
Type	Colour TFT LCD display	Colour TFT LCD
display	Colour TFT LCD
display	---	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 for
Respiration, AGM &
Microstream Capnography	12.5, 25, 50mm/Sec for
ECG, SpO2 IBP1, IBP2,
IBP3 & IBP4.
6.25, 12.5, 25mm/Sec
for Respiration, AGM
& Microstream	---		Same as Star 90
Title	Subject	Primary Predicate	Secondary Predicate	Tertiary Predicate	Comments
		Capnography
Waveform
display options	a) Standard Formats: 3
b) User Formats: 4
c) Auto Format
d) Quick ECG format	e)Standard Formats: 3
f) User Formats: 4
g) Auto Format
h) Quick ECG format	---	---	Same as Star 90
CONTROLS:
	Front Panel:
1 switch for Unit ON / OFF.
1 switch for Alarm
Acknowledgment
1 switch for NIBP start/stop
1 switch for Freeze
1 switch for Home
1 switch for Recording
1 switch for Pump on
1 switch for to set Monitor
in stand-by Mode
1 switch for GOTO (Short cut
Key)
1 switch for Optical encoder
with switch.
1 switch for IBP zeroing	---	---	Front Panel:
1 switch for Unit
ON / OFF.
1 switch for
Alarm
Acknowledgment
1 switch for NIBP
start/stop
1 switch for Freeze
1 switch for Home
1 switch
for
Recording
1 switch
for Pump
on
1 switch for to
set Monitor in
stand-by
Mode
1 switch for
GOTO (Short
cut Key)
1 switch for
Optical encoder	Same as Star 55
Title	Subject	Primary Predicate	Secondary Predicate	Tertiary Predicate	Comments
ALARMS:				with switch.
1 switch for IBP
zeroing
	Notification	Audible & visual	Audible & visual	Audible & visual	Same as Star 90
	Classification	1. Patient Alarms :
High Priority: Audio & Visual
(flashing RED LED alarm) and
message indication. Respective
parameter values will be
highlighted.

Medium Priority: Audio &
Visual (flashing YELLOW
LED alarm) and message
indication. Respective
parameter values will be
highlighted

Equipment Alarms: Audio &
Visual (flashing BLUE LED
alarm) and message Indication
Re-Alarm: 1 minute re-alarm
provided in case condition
persists after alarm
Acknowledgment. (With User
configurable Alarm Pause
duration). | 1. Patient Alarms :
High Priority: Audio &
Visual
(flashing
RED LED alarm) and
message indication.
Respective parameter
values will be
highlighted.

Medium Priority: Audio
& Visual (flashing
YELLOW LED alarm)
and message indication.
Respective parameter
values will be
highlighted

Equipment Alarms:
Audio & Visual (flashing
BLUE LED alarm) and
message Indication
Re-Alarm: 1 minute re-
alarm provided in case
condition persists after
alarm Acknowledgment.
(With User configurable
Alarm 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 | 60 +/-4bpm. | Up to 30, +/- 1bpm,
from 30 to 60 +/- 2bpm,

60 +/-4bpm. | | --- | Same as Star 90 |
| Sensitivity | Sensitivity (max): 0.2 ohm/cm
Sensitivity (min): 4 ohm/cm
Excitation current: 1MOhm | >1MOhm | --- | --- | Same as Star 90 |
| Leakage Current | 60
unspecified | Up to 60 - +/-
1bpm, >60 unspecified | --- | Up to 60 - +/-
1bpm, >60
unspecified | Same as Star 90
and Star 55 |
| N2O | 0 - 20 ±2
20 - 100 ±3 | 0 - 20 ±2
20 - 100 ±3 | --- | 0 - 20 ±2
20 - 100 ±3 | Same as Star 90
and Star 55 |
| Halothene | 0-1 ±0.15
1 - 5 ±0.2
5 Unspecified | 0 - 1 ±0.15
1 - 5 ±0.2
5 Unspecified | --- | 0-1 ±0.15
1 - 5 ±0.2
5 Unspecified | Same as Star 90
and Star 55 |
| Isoflurane | 0-1 ±0.15
1 - 5 ±0.2
5 Unspecified | 0 - 1 ±0.15
1 - 5 ±0.2
5 Unspecified | --- | 0-1 ±0.15
1 - 5 ±0.2
5 Unspecified | Same as Star 90
and Star 55 |
| Enflurane | 0-1 ±0.15
1 - 5 ±0.2
5 Unspecified | 0 - 1 ±0.15
1 - 5 ±0.2
5 Unspecified | --- | 0-1 ±0.15
1 - 5 ±0.2
5 Unspecified | Same as Star 90
and Star 55 |
| Sevofurane | 0-1 ±0.15
1 - 5 ±0.2
5 - 8 ±0.4 | 0 - 1 ±0.15
1 - 5 ±0.2
5 - 8 ±0.4 | --- | 0-1 ±0.15
1 - 5 ±0.2
5 - 8 ±0.4 | Same as Star 90
and Star 55 |
| Title | Subject | Primary Predicate | Secondary Predicate | Tertiary Predicate | Comments |
| | > 8 Unspecified | > 8 Unspecified | | > 8 Unspecified | |
| Desflurane | 0-1 ±0.15
1 - 5 ±0.2
5 - 10 ±0.4
10 - 15 ±0.6
15 - 18 ±1
18 Unspecified | 0-1 ±0.15
1 - 5 ±0.2
5 - 10 ±0.4
10 - 15 ±0.6
15 - 18 ±1
18 Unspecified | --- | 0-1 ±0.15
1 - 5 ±0.2
5 - 10 ±0.4
10 - 15 ±0.6
15 - 18 ±1
18 Unspecified | Same as Star 90
and Star 55 |
| CO2 | 0 - 1 ±0.1
1 - 5 ±0.2
5 - 7 ±0.3
7 - 10 ±0.5
10 Unspecified | 0 - 1 ±0.1
1 - 5 ±0.2
5 - 7 ±0.3
7 - 10 ±0.5
10 Unspecified | --- | 0-1 ±0.1
1-5 ±0.2
5 - 7 ±0.3
7 - 10 ±0.5
10 Unspecified | Same as Star 90
and Star 55 |
| O2 | 0-40±1
40 - 60 ±2
40 - 80 ±3
80 - 100 ±4 | 0-40±1
40 - 60 ±2
40 - 80 ±3
80 - 100 ±4 | --- | 0-40 ±1
40 - 60 ±2
40 - 80 ±3
80 - 100 ±4 | Same as Star 90
and Star 55 |
| Resolution: | | | | | |
| CO2 | +/-1 mm Hg or 0.1 kPa or 0.1
Vol % | +/-1 mm Hg or 0.1
kPa or 0.1 Vol % | --- | +/- mm Hg or 0.1
kPa or 0.1 Vol % | Same as Star 90
and Star 55 |
| AA | 0.1% | 0.1% | --- | 0.1% | Same as Star 90
and Star 55 |
| N2O | 1% | 1% | --- | 1% | Same as Star 90
and Star 55 |
| O2 | 1% | 1% | --- | 1% | Same as Star 90
and Star 55 |
| Units: | | | | | |
| CO2 | mmHg or kPa or Vol %. | mmHg or kPa or
Vol %. | --- | mmHg or kPa or
Vol %. | Same as Star 90
and Star 55 |
| AA/O2/N2O | Vol% | Vol% | --- | Vol% | Same as Star 90
and Star 55 |
| Warm-up Phase | ISO accuracy within 45 s, full
accuracy within 10 min | ISO accuracy within 45
s, full accuracy within
10 min | --- | ISO accuracy within 45
s, full accuracy within
10 min | Same as Star 90
and Star 55 |
| Title | Subject | Primary Predicate | Secondary Predicate | Tertiary Predicate | Comments |
| Pump | Flow controlled dual membrane
70-200+/- 10ml/min or +/- 10%
whichever is greatest | Flow controlled dual
membrane
70-200+/- 10ml/min or
+/- 10% whichever is
greatest | --- | Flow controlled dual
membrane
70-200+/- 10ml/min
or +/- 10% whichever
is greatest | Same as Star 90
and Star 55 |
| Primary Agent ID
Threshold | 0.15% (0.4% during ISO
accuracy mode) | 0.15% (0.4% during
ISO accuracy mode) | --- | 0.15% (0.4% during
ISO accuracy mode) | Same as Star 90
and Star 55 |
| Secondary Agent ID
Threshold | 0.3% (0.5% during ISO accuracy
mode) or 5%REL (10% for
Isoflurane) of primary agent if
primary agent >10% | 0.3% (0.5% during ISO
accuracy mode) or
5%REL (10% for
Isoflurane) of primary
agent if primary
agent >10% | --- | 0.3% (0.5% during
ISO accuracy mode)
or 5%REL (10% for
Isoflurane) of
primary agent if
primary agent >10% | Same as Star 90
and Star 55 |
| Zeroing | Automatically performed by the
module. Indicated to the user
through a message on the screen.
Automatically every 4 hours (in
Full accuracy mode) in steady
state with room air. Additional
zeroing performed during
startup. | Automatically
performed by the
module. Indicated to the
user through a message
on the screen.
Automatically every 4
hours (in Full accuracy
mode) in steady state
with room air.
Additional zeroing
performed during
startup. | --- | Automatically
performed by the
module. Indicated to
the user through a
message on the
screen.
Automatically every
4 hours (in Full
accuracy mode) in
steady state with
room air. Additional
zeroing performed
during startup. | Same as Star 90
and Star 55 |
| Calibration | Initiated through Power on
service menu. | Initiated through Power
on service menu. | --- | Initiated through
Power on service
menu. | Same as Star 90
and Star 55 |
| Alarms | Low and high limits adjustable
over the complete measurement
range | Low and high limits
adjustable over the
complete measurement
range | --- | Low and high limits
adjustable over the
complete
measurement range | Same as Star 90
and Star 55 |
| Title | Subject | Primary Predicate | Secondary Predicate | Tertiary Predicate | Comments |
| Delay Time |