Solaris Medical Technology, Inc.

NT3B(12.1″)

Product Description:

◆12.1” High Resolution Color TFT LCD
◆1-8 Channel Waveform Display
◆7 Leads ECG Waveform Display; ST Segment Analysis
◆Defibrillation and ESU Protection
◆OsyCRG diagram, Drug Dose Calculation
◆Venous Punch
◆Flexible Parameter Configuration
◆Applicable for adult, pediatric, and neonatal patients
◆Options: Thermal recorder, CO2, IBP

Product Features :

◆ECGECG Cable: 5 Leadwires ECG cable Lead section: lead I, II, III/aVR, aVL, aVF/ VGain(mm/mV): 1/4,1/2,1,2,4 Frequency response: Diagnosis: 0.05 – 100Hz Monitor: 0.5~40 Hz Surgery:1.0~25 Hz Sweep speed(mm/sec):6.25,12.5, 25, 50 Heart rate range: 0-350 BPM Heart rate accuracy : ± 1 % ST segment deviation analysis: -0.8~+0.8mV

ST accuracy : ±0.02mv

◆Non-Invasive Blood Pressure Measurement type : adult, pediatric, neonatal Measurement range: Systolic 4.0 – 270mmHg Diastolic 20 – 200mmHg Mean 30 – 220mmHg Accuracy : ±3mmHg or 2 %(choice max) Resolution:1mmHg

Protection: over pressure

◆Pules Oximetry SPO2 measurement range: 0 – 100 %Accuracy: ±2% at 70~100%(no specification under 70%) Resolution: 1 % pulse measurement range:30- 250BPM Accuracy: ±2 % or 1BPM (choice max)

Resolution: 1 BPM

Respiration Rate Measurement range: 0 – 120 BPMAccuracy: ±1 BPM or 5 %(choice max)

Resolution: 1 BPM

◆CO2Measurement range: 0 % – 10.0 % (in CO2 and et CO2) Accuracy: ± 2 mm Hg(5 % Measurement value)

Response time: 180 ms

◆IBPChannel number: 2chrange: -40 – +330mmHgAccuracy: ±4mmHg or ±4%(choice max)

Resolution: 1mmHg

◆EnvironmentOpreation Storage Temperature: 5~40 ℃ -20~70 ℃

Relative humidity: ≤ 80% ≤ 95%

◆TemperatureChannel number: 2ch Measurement range: 25~45 ℃ Accuracy: ±0.1 ℃ Resolution: 0.1 ℃

response time: ≤ 3 min

◆Power Requirements Input: 98-260 V AC, 50/60Hz

Consumption: ≤ 80VA

Solaris Medical Technology, Inc.

◆Pulse RateMeasurement range: 30 – 250 bpm Accuracy: ±1 bpm or 2%

         take the bigger one

◆Visual Displays and IndicatorsSp02 Display: Red LED, variable brightness Pulse Rate Display: Green LED, Variable brightness Pulse intensity: Red LED 8 Bars Power Indicator Light: GreenLow Power Voltage: Red and Blink

Low Perfusion Indicator: Red  

◆Audio IndicatorsSensor off (Every 30 seconds) Pulse Beep Key-pressing

Low Battery

◆Power Requirements:Four Standard”AA” Size Batteries

Battery Capacity:≥12 hours

◆Environment:Operating Temperature: Opreation 0~50℃ humidity: ≤95%Altitude:-390m-5000mTransport/Storage Temperature:-40℃-70℃

humidity: ≤95%

◆Physical Characteristics: Dimensions:69mm(W)x130mm(H)x22mm(D)Net Weight:195g/100g(with batteries/without batteries)

Gross Weight:495g/395g(with batteries/without batteries)

◆Compliance:1. SpO2: ISO 9919: 2005(E)2. Safety Standards:    EN 60601-1: 1990+A1: 1993+A2: 1995+A13: 19963. Alarm: IEC60601-1-8: 20054. EMC: EN 60601-1-2: 2007, Group 1 Class A5. Environment : WEEE (2002/96/EC)

6. FDA 510(K)

Solaris Medical Technology, Inc.

Solaris Medical Technology, Inc., a U.S. based company, focuses on R & D, manufacturing and sales of high quality patient monitoring systems and accessories. With its manufacturing facilities (ISO 13485 certified) in China, Solaris Medical Technology, Inc. is able to offer its customers American design expertise and Chinese production efficiencies. The company also offers OEM and ODM solutions to its customers by providing complete patient monitoring systems and modules.

Solaris Medical Technology, Inc. is located in South San Francisco, California, the Birthplace of Biotechnology. Our office overlooks the beautiful San Francisco Bay and is only minutes away from the San Francisco International Airport.

Solaris Medical Technology, Inc.

◆High Resolution Color TFT LCD ◆Waveforms for Every Parameter◆Durable, Compact and Lightweight ◆Long-life Internal Rechargeable Battery for Uninterrupted Monitoring◆Audible/Visual Three Level Alarms with Alarm Volume Control◆72-hour Data Memory Allowing On-screen Data Replay◆Suitable for Adult, Pediatric and Neonate

◆Performance Measurement Range:SpO2: 0%-100%

Pulse Rate: 30bpm~250bpm

◆SpO2 Accuracy:Adults, Pediatrics: 70%-100% ±2%                    0%-69% unspecified     Neonates:      70%-100% ±3%                    0%-69% unspecified◆Pulse Rate Accuracy

Adults, Pediatrics, Neonates: ±3%

◆ECGECG cable: 5 Lead ECG Cable Lead selection:Ⅰ,Ⅱ, Ⅲ/ aVR,  aVL,  aVF/ VGain (mm/mV): 1/4, 1/2,1, 2, 4, Manual/AutomaticSweep speed (mm c):  6.25, 12.5, 25, 50Heart rate range: 30-300bpmHeart rate accuracy:±1bpm or ±1 %ST segment analysis (Diagnostic mode):    a. ST range: -2.0mV-+2.0mV    b. ST accuracy:±0.02mVMonitoring mode: Diagnostic    0.05-100Hz                                Monitoring     0.5-40 Hz

                                Operating      1.0-25 Hz

◆Non-Invasive Blood Pressure:Measurement   type:  Adult, Pediatric, NeonatalMeasurement range: Adult:            Systolic    40-270mmHg                     Diastolic   20-200mmHg                     Mean        30-220mmHgPediatric:        Systolic    40-180mmHg                        Diastolic   15-160mmHg                         Mean        20-170mmHgNeonatal:         Systolic    30-140mmHg                          Diastolic   15-100mmHg                          Mean        20-115mmHgAccuracy:  Meets ANSI/AAMI SP10-1992Resolution: 1mmHg

Protection:  over pressure

◆AlarmAudible/visual Alarms

Adjustable Alarm Limits

◆Temperature:Measurement range: 25 ~ 45 ℃

Accuracy:  ± 0.2 ℃

◆Output:RS-232 Serial Port for Digital Output

Nurse Call Function

◆Electrical Instrument:Power Requirements: 100~240VAC, 50/60Hz, 40VA

Fuse Rating:        1.0A

◆Battery:Internal Battery:   12V

Battery Capacity:     2.5 hours

◆Environment:Operating:Temperature: 5OC~40OC (41OF ~104OF)Humidity:    10%~95%             Transport/Storage:Temperature: -20OC~70OC (-4OF ~158OF)

Humidity:    10%~95%

◆Physical Characteristics:Dimensions:    264mm(W) x 95mm(H) x 172mm(D)               10.39in(W) x 3.74in(H) x 6.77in(D)

Net Weight:      2.25kg/5 Ib

◆Compliance:1. SpO2: ISO 9919: 2005(E)2. Safety Standards:    EN 60601-1: 1990+A1: 1993+A2: 1995+A13: 19963. Alarm: IEC60601-1-8: 20054. EMC: EN 60601-1-2: 2007, Group 1 Class A

5. Environment : WEEE (2002/96/EC)

Solaris Medical Technology, Inc.

◆7” High Resolution Color TFT LCD
◆1-8 Channel Waveform Display
◆7 Leads ECG Waveform Display; ST Segment Analysis
◆Defibrillation and ESU Protection
◆OsyCRG diagram, Drug Dose Calculation
◆Venous Punch
◆Flexible Parameter Configuration
◆Applicable for adult, pediatric, and neonatal patients
◆Options: Thermal recorder, IBP

Product Features :

◆ECGECG Cable: 5 Leadwires ECG cable Lead section: lead I, II, III/aVR, aVL, aVF/ V

Gain(mm/mV): 1/4,1/2,1,2,4

Frequency response: Diagnosis: 0.05 – 100Hz Monitor: 0.5~40 Hz Surgery:1.0~25 Hz Sweep speed(mm/sec):6.25,12.5, 25, 50 Heart rate range: 0-350 BPM Heart rate accuracy : ± 1 % ST segment deviation analysis: -0.8~+0.8mV

ST accuracy : ±0.02mv

◆Non-Invasive Blood Pressure Measurement type : adult, pediatric, neonatal Measurement range: Systolic 4.0 – 270mmHg Diastolic 20 – 200mmHg Mean 30 – 220mmHg Accuracy : ±3mmHg or 2 %(choice max) Resolution:1mmHg

Protection: over pressure

◆Pules Oximetry SPO2 measurement range: 0 – 100 %Accuracy: ±2% at 70~100%(no specification under 70%) Resolution: 1 % pulse measurement range:30- 250BPM Accuracy: ±2 % or 1BPM (choice max)

Resolution: 1 BPM

◆Respiration Rate Measurement range: 0 – 120 BPMAccuracy:    ±1 BPM or 5 %(choice max) Resolution: 1 BPM ◆CO2Measurement range: 0 % – 10.0 % (in CO2 and et CO2) Accuracy: ± 2 mm Hg(5 % Measurement value) Response time: 180 ms ◆IBPChannel number: 2chrange: -40 – +330mmHgAccuracy: ±4mmHg or ±4%(choice max)Resolution: 1mmHg◆Environment                            Opreation    Storage Temperature:       5~40 ℃      -20~70 ℃ Relative humidity: ≤ 80%        ≤ 95%◆TemperatureChannel number: 2ch Measurement range: 25~45 ℃ Accuracy: ±0.1 ℃ Resolution: 0.1 ℃ response time: ≤ 3 min◆Power Requirements Input: 98-260 V AC, 50/60Hz

Consumption: ≤ 80VA

  

Solaris Medical Technology, Inc.

◆Bright, Easy-to-Read Large LED Display◆Durable, Compact and Lightweight ◆Long-life Internal Rechargeable Battery for Uninterrupted Monitoring◆Bright, Easy-to-Read Large LED Display◆Durable, Compact and Lightweight ◆Long-life Internal Rechargeable Battery for Uninterrupted Monitoring◆Audible/Visual Three Level Alarms with Alarm Volume Control◆72-hour Data Memory Allowing On-screen data replay◆Suitable for Adult, Pediatric and Neonate◆Optional Internal Thermal Recorder

Product Features :

◆Performance Measurement Range:SpO2: 0%-100%

Pulse Rate: 30bpm~250bpm

◆SpO2 Accuracy:Adults, Pediatrics: 70%-100% ±2%                    0%-69% unspecified     Neonates:      70%-100% ±3%                    0%-69% unspecified◆Pulse Rate Accuracy

Adults, Pediatrics, Neonates: ±3%

◆ECGECG cable: 5 Lead ECG Cable Lead selection:Ⅰ,Ⅱ, Ⅲ/ aVR,  aVL,  aVF/ VGain (mm/mV): 1/4, 1/2,1, 2, 4, Manual/AutomaticSweep speed (mm c):  6.25, 12.5, 25, 50Heart rate range: 30-300bpmHeart rate accuracy:±1bpm or ±1 %ST segment analysis (Diagnostic mode):    a. ST range: -2.0mV-+2.0mV    b. ST accuracy:±0.02mVMonitoring mode: Diagnostic    0.05-100Hz                               Monitoring     0.5-40 Hz

                               Operating      1.0-25 Hz

◆Non-Invasive Blood Pressure:Measurement   type:  Adult, Pediatric, NeonatalMeasurement range: Adult:            Systolic    40-270mmHg                  Diastolic   20-200mmHg                  Mean        30-220mmHgPediatric:        Systolic    40-180mmHg                  Diastolic   15-160mmHg                  Mean        20-170mmHgNeonatal:         Systolic    30-140mmHg                  Diastolic   15-100mmHg                  Mean        20-115mmHgAccuracy:  Meets ANSI/AAMI SP10-1992Resolution: 1mmHg

Protection:  over pressure

◆AlarmAudible/visual Alarms

Adjustable Alarm Limits

◆Temperature:Measurement range: 25 ~ 45 ℃

Accuracy:  ± 0.2 ℃

◆Output:RS-232 Serial Port for Digital Output

Nurse Call Function

◆Electrical Instrument:Power Requirements: 100~240VAC, 50/60Hz, 40VA

Fuse Rating:        1.0A

◆Battery:Internal Battery:   12V

Battery Capacity:     24 hours

◆Environment:Operating:Temperature: 5OC~40OC (41OF ~104OF)Humidity:    10%~95%             Transport/Storage:Temperature: -20OC~70OC (-4OF ~158OF)

Humidity:    10%~95%

◆Physical Characteristics:Dimensions:    264mm(W) x 95mm(H) x 172mm(D)               10.39in(W) x 3.74in(H) x 6.77in(D)

Net Weight:      2.25kg/5 Ib

◆Compliance:1. SpO2: ISO 9919: 2005(E)2. Safety Standards:    EN 60601-1: 1990+A1: 1993+A2: 1995+A13: 19963. Alarm: IEC60601-1-8: 20054. EMC: EN 60601-1-2: 2007, Group 1 Class A

5. Environment : WEEE (2002/96/EC)

Solaris Medical Technology, Inc.

◆SpO2Measurement Range: 0~100% Accuracy:±2% during 70%~100%

0%~69% unspecified

◆Pulse RateMeasurement range: 30 – 250 bpm Accuracy: ±1 bpm or 2%

take the bigger one

◆Visual Displays and IndicatorsSp02 Display: Red LED, variable brightness Pulse Rate Display: Green LED, Variable brightness Pulse intensity: Red LED 8 Bars Power Indicator Light: Green-Normal Low Power Voltage: Red and Blink

Low Perfusion Indicator: Red Bar

◆Audio IndicatorsProbe off audio indicator (Every 30 seconds) Pulse audio indicator Key-pressing indicator

Low power voltage

◆Dimensions
130mm(L)×69mm(W)×22mm(H)

◆Weight(with batteries/without batteries)
195g/100g

◆Environmental SpecificationsTemperature Range: Opreation 0~+50℃ Transport/Storage: -40~+70℃ Relative humidity:Operating: 10~95% (noncondensing) Transport/Storage: 0~95% Vibration: Meets or exceeds ASTM 4728, (Method C) MIL-STD-810E, (Method 514.4, Section 1.3.4.3) IEC 68-2-37 Drop/Shock: Meets or exceeds IEC 68-2-32 (Procedure 1) MIL-STD-810E,

(Method 516.4, Section 1-3.6, Procedure IV)

◆Power Requirements
Four standard “AA” size alkaline batteries

◆Battery Life
Seventeen hours minimum

◆Safety StandardsGB9706.1 EN 60601-1 (IEC-601-1) UL 2601-1 adn CAN/CSA 601.1

EN ISO 9919

◆Warranty
One year for both Oximeter and sensor

◆Keys
Pellicle keys

◆Compliance:1. SpO2: ISO 9919: 2005(E)2. Safety Standards:    EN 60601-1: 1990+A1: 1993+A2: 1995+A13: 19963. Alarm: IEC60601-1-8: 20054. EMC: EN 60601-1-2: 2007, Group 1 Class A

5. Environment : WEEE (2002/96/EC)

Solaris Medical Technology, Inc.

◆8.4” High Resolution Color TFT LCD
◆1-8 Channel Waveform Display
◆7 Leads ECG Waveform Display; ST Segment Analysis
◆Defibrillation and ESU Protection
◆OsyCRG diagram, Drug Dose Calculation
◆Venous Punch
◆Flexible Parameter Configuration
◆Applicable for adult, pediatric, and neonatal patients
◆Options: Thermal recorder, CO2, IBP

Product Features :

◆ECGECG Cable: 5 Leadwires ECG cable Lead section: lead I, II, III/aVR, aVL, aVF/ V

Gain(mm/mV): 1/4,1/2,1,2,4

Frequency response: Diagnosis: 0.05 – 100Hz Monitor: 0.5~40 Hz Surgery:1.0~25 Hz Sweep speed(mm/sec):6.25,12.5, 25, 50 Heart rate range: 0-350 BPM Heart rate accuracy : ± 1 % ST segment deviation analysis: -0.8~+0.8mV

ST accuracy : ±0.02mv

◆Non-Invasive Blood Pressure Measurement type : adult, pediatric, neonatal Measurement range: Systolic 4.0 – 270mmHg Diastolic 20 – 200mmHg Mean 30 – 220mmHg Accuracy : ±3mmHg or 2 %(choice max) Resolution:1mmHg

Protection: over pressure

◆Pules Oximetry SPO2 measurement range: 0 – 100 %Accuracy: ±2% at 70~100%(no specification under 70%) Resolution: 1 % pulse measurement range:30- 250BPM Accuracy: ±2 % or 1BPM (choice max)

Resolution: 1 BPM

◆Respiration Rate Measurement range: 0 – 120 BPMAccuracy:    ±1 BPM or 5 %(choice max) Resolution: 1 BPM ◆CO2Measurement range: 0 % – 10.0 % (in CO2 and et CO2) Accuracy: ± 2 mm Hg(5 % Measurement value) Response time: 180 ms ◆IBPChannel number: 2chrange: -40 – +330mmHgAccuracy: ±4mmHg or ±4%(choice max)Resolution: 1mmHg◆Environment                            Opreation    Storage Temperature:       5~40 ℃      -20~70 ℃ Relative humidity: ≤ 80%        ≤ 95%◆TemperatureChannel number: 2ch Measurement range: 25~45 ℃ Accuracy: ±0.1 ℃ Resolution: 0.1 ℃ response time: ≤ 3 min◆Power Requirements Input: 98-260 V AC, 50/60Hz

Consumption: ≤ 80VA