Vital-Guard 450C with Masimo SpO2 Operation Manual Rev 03 Aug 2005

User Responsibility This product will perform in conformity with the description thereof contained in this Operation Manual and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. This product must be checked periodically. A defective Product should not be used. Parts that are broken, missing, plainly worn, distorted or contaminated should be replaced immediately. Should such repair or replacement become necessary, IVY Biomedical Systems, Inc. recommends that a telephone call or written request for service advice be made to IVY Biomedical Systems, Inc. Service Department. This product or any of its parts should not be repaired other than in accordance with instructions provided by IVY Biomedical Systems, Inc. trained personnel. The product must not be altered without the prior written approval of IVY Biomedical Systems, Inc. Quality Assurance Department. The user of this Product shall have the sole responsibility for any malfunction, which results from improper use, faulty maintenance, improper repair, damage or alteration by anyone other than IVY Biomedical Systems, Inc. CAUTION: US Federal law restricts this device to sale by or on the order of a licensed medical practitioner.

Ivy Biomedical Systems, Inc. has declared that this product conforms with the Eurpean Council Directive 93/42/EEC Medical Device Directive when its used in accordance with the instructions provided in the Operation and Maintenace Manual.

Ivy Biomedical Systems, Inc. 11 Business Park Drive Branford, Connecticut 06405 (203) 481-4183 y (800) 247-4614 y FAX (203) 481-8734 www.ivybiomedical.com e-mail:[email protected]

The following are trademarks of Masimo Corporation: Masimo®, Masimo SET® and LNOP®. Covered by one or more of the following U.S. Patents: 5,482,036; 5,490,505; 5,632,272; 5,685,299; 5,758,644; 5,769,785; 6,002,952; 6,036,642; 6,067,462; 6,206,830; 6,157,850 and international equivalents. U.S.A. and international patents pending. Possession or purchase of this device does not convey any express or implied license to use the device with replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device.

OM450C-30Aug2005 2684-01-16 Rev.03

Declaration of Conformity Ivy Biomedical Systems, Inc. 11 Business Park Drive Branford, CT 06405

Physiological Monitors Models: 101R, 101NR, 405C, 450C and 2000

We, Ivy Biomedical Systems, Inc., hereby declare that the devices mentioned above comply with the Swedish National Board of Health and Welfare Regulation and guidelines on medical devices SOSFS 1994:20 (M) 28 October 1994 – transposing European Medical Devices Directive 93/42/EEC.

Date of Validity:

December 31, 2001

Classification:

IIb

According to rule No.

10

Notified Body No.

0413

Conformity Assessment Procedure: Annex II

Notified Body:

SEMKO AB

Name of Authorized Signatory: Position held in Company:

Signature

Dick Listro Director of Regulatory

_____________________________________________

This page is intentionally left blank.

TABLE OF CONTENTS

TABLE OF CONTENTS

WARRANTY ...iv INTRODUCTION ...1 SAFETY ...2 Electrical ...2 Explosion...2 Patient Connections ...3 MRI ...3 Pacemakers...3 Electrosurgery ...3 Defibrillation Protection...3 EMC ...3 Electromagnetic Compatibility IEC 60601-1-2:2001 ...4 Description of Warning Labels...8 For monitors used in Australia ...8 MONITOR DESCRIPTION ...9 Classification ...9 Specifications ...10 Controls and Indicators...14 Display...20 Alarms...21 Priority Alarms Feature (If Present)...24 Rear Panel...24 Menu Structure ...25 The PATIENT SETUP Key ...26 The SYSTEM SETUP Key...27 MONITOR SETUP ...28 Adult/Neonate Modes ...28 Heart Rate Source...29 Trace Speed ...29 Set Time and Date...29 Display Setup...30 Data and Waveforms Color Setup...30 Audio Setup ...31 Display Limits...31 Trend Displays ...31 Default Settings ...33 BATTERY OPERATION...34 Internal Battery...34 Status of the Battery ...34 Removing the Battery ...34

Vital-Guard 450C Operation Manual

i

TABLE OF CONTENTS RECORDER OPERATION ...35 Changing Paper...35 Recorder Menus ...36 Recorder Modes ...36 Recorder Messages...37 Example Printouts ...37 ECG MONITORING...42 Safety Considerations ...42 Patient Connections ...43 ECG Waveform Amplitude...44 Heart Rate (HR) Alarm Limits...44 Lead Selection...44 ECG Filter (Adult Mode Only)...44 ECG On/Off...45 Pacemakers...45 RESPIRATION MONITORING...46 Respiration Size...46 Apnea Delay...47 Coincidence On/Off ...47 Respiration Rate (RR) Alarm Limits ...47 Respiration On/Off ...47 END TIDAL CO2 MONITORING ...48 General Description ...48 Preparation for Monitoring ...53 Response Setting...54 Compensation Settings ...56 Barometric Pressure ...56 N2O Compensation...56 O2 Compensation...56 Trace Scale Setting...57 CO2 Alarm Limits ...57 Respiration Rate Alarm Limits ...57 Respiration On/Off ...57 Gas Calibration ...58 INVASIVE PRESSURE MONITORING ...59 Pressure Transducer...59 Connecting the Transducer...59 Zeroing the Transducer...60 Blood Pressure Scale...60 Pressure Alarm Type ...61 Pressure Alarm Limits...61 Expanded Pressure Scale...61 Alternate Pressure Site Labeling and Automatic Scale/Limit Adjustment Feature (If Present)...62 MASIMO SET® PULSE OXIMETRY MONITORING...63 Overview ...63 Principles of Operation...63 Pulse Oximetry Sensors ...65 Monitoring Procedure ...65 SpO2 Alarm Limits ...66

ii

Vital-Guard 450C Operation Manual

TABLE OF CONTENTS Response Mode Settings ...66 Default Values ...66 Pulse Oximetry with ECG Off ...67 Pulse Oximetry Considerations ...67 NIBP MONITORING ...68 General Description ...68 NIBP Monitoring Considerations...68 Cuff Placement ...69 Monitoring Procedure ...69 NIBP Graph...70 NIBP Messages ...71 Tabular Scrolling ...71 Clear Tabular Data...72 NIBP Mode Select ...72 NIBP Alarm Settings ...72 NIBP Calibration ...72 TEMPERATURE MONITORING...73 Temperature Alarms Description...73 ALARM MESSAGES ...74 MONITOR TESTING ...75 MAINTENANCE AND CLEANING ...76 The Monitor...76 Patient Cables...76 Reusable Pressure Transducer ...76 Cleaning and reuse of SpO2 sensors ...77 Reusable Temperature Probes...77 ETCO2 Sensor and Airway Adapter ...77 Preventive Maintenance ...77 ACCESSORIES...79 ECG/Respiration...79 EtCO2 ...79 Invasive Pressure ...79 Non-Invasive Pressure (NIBP)...80 Temperature...80 Recorder...80 SpO2 Reusable sensors...81 SpO2 Disposable sensors...81 SpO2 Patient cables ...81 SpO2 Starter kits ...81 Disposal ...81

Vital-Guard 450C Operation Manual

iii

WARRANTY

WARRANTY

All products manufactured by Ivy Biomedical Systems, Inc. are warranted to be free from defects in material and workmanship and to operate within published specifications, under normal use, for a period of one year from date of original shipment. All accessories supplied by Ivy Biomedical Systems, Inc. are warranted to be free from defects in material and workmanship and to operate within published specifications, under normal use, for a period of 90 days from date of original shipment. If an examination by Ivy Biomedical Systems, Inc. discloses such products or component parts to have been defective, then our obligation is limited to repair or replacement (at our option). Fuses and batteries are not covered under this warranty. If products need to be returned to the manufacturer for repair or examination contact customer service personnel at IVY Biomedical Systems, Inc. to obtain the Return Authorization Number (RMA) and proper packing instructions.

iv

Vital-Guard 450C Operation Manual

INTRODUCTION

INTRODUCTION This manual is to provide information on the correct use of the Vital-Guard 450C patient monitor. It is up to the user to ensure that any applicable regulations regarding the installation and operation of the monitor are observed. The Information regarding circuit diagrams, board layouts and replacement parts is contained in the Operation and Maintenance Manual. For instructions on how to obtain the Operation Manual or the Operation and Maintenance Manual please contact customer service personnel at IVY Biomedical Systems, Inc. The model 450C is to be operated by qualified personnel only. Using This Manual We recommend that you read this entire manual before operating the equipment. This manual is written to include all parameters for a fully configured monitor. If the configuration of your monitor does not include all parameters, menu selections and display data for those parameters will not appear on your monitor. Use the Monitor Description section for general descriptions of controls and displays. For details on monitoring each parameter, refer to the section of the manual dealing with the appropriate parameter. NOTE: If the monitor beeps when you press a key, it indicates an invalid selection for the current mode or function. Boldface type is used in text to refer to the labeling on user controls. Special brackets [ selections used with the programmable keys.

] surround menu

Manufacturer’s Responsibility The manufacturer of this equipment is responsible for the effects on safety, reliability, and performance of the equipment only if: •

Assembly operations, extensions, re-adjustments, or repairs are carried out by persons authorized by the manufacturer

•

The electrical installation complies with all applicable regulations

•

The equipment is used in accordance with the instructions in this manual

Incorrect operation or failure of the user to maintain the monitor in accordance with proper maintenance procedures relieves the manufacturer or his agent from all responsibility for consequent non-compliance, damage, or injury. For technical and service information, please refer to the Vital-Guard 450C Operation and Maintenance Manual or contact: Ivy Biomedical Systems, Inc. 11 Business Park Drive Branford, Connecticut 06405 (203) 481-4183 or (800) 247-4614 e-mail: [email protected] This manual explains how to set up and use the Model 450C. Important safety information relating to general use of the pulse oximeter appears in this manual. Other important safety information is located throughout the manual where appropriate. READ THE ENTIRE SAFETY INFORMATION SECTION BEFORE YOU OPERATE THE MONITOR. Vital-Guard 450C Operation Manual

1

SAFETY

SAFETY

Electrical This product is intended to be operated from a mains power source of nominally 100 to 230 V ~, 47-63 Hz, or from its internal battery. WARNING: To prevent electrical hazards to all personnel, this monitor must be properly grounded. Connect the monitor only to a three-wire, grounded, hospital grade receptacle. The three-conductor plug must be inserted into a properly wired three-wire receptacle; if a three-wire receptacle is not available, a qualified electrician must install one in accordance with the governing electric code. WARNING: Do not under any circumstances remove grounding conductor from the power plug. WARNING: The power cable supplied with this equipment provides for this protection. Do not attempt to defeat this protection by modifying the cable or by using ungrounded adapters or extension cables. The power cord and plug must be intact and undamaged. To disconnect the equipment from the mains power unplug the power cord. WARNING: Do not connect to an electrical outlet controlled by a wall switch or dimmer. WARNING: If there any doubt about the integrity of the protective earth conductor arrangement, operate the monitor on internal battery power until the AC power source protective conductor is fully functional. WARNING: Do not place the monitor in any position that may cause it to fall on the patient. Do not lift the monitor by the power supply cord or patient cable, use only the handle on the monitor. WARNING: Electric shock hazard! Do not remove covers or panels. Refer service to qualified service personnel. WARNING: To avoid electrical shock, disconnect the monitor from its power source before changing fuses. Replace fuses only with same type and rating (1.6ASB, Metric 5x20mm, 250V). WARNING: Do not clean monitor while it is on and/or plugged into a power source. WARNING: If unit is accidentally wet, discontinue use until dry and then test unit for proper operation before reuse on patient. WARNING: This unit uses a common isolation path for the ECG leads. Do not connect any non-isolated accessories to the ECG input when connected to a patient, as this may compromise the safety of the unit. When attached to other devices, insure that the total chassis leakage currents of all units do not exceed 300 μA.

Explosion DANGER: Explosion hazard! Do not use this equipment in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environment or nitrous oxide.

2

Vital-Guard 450C Operation Manual

SAFETY

Patient Connections Patient connections are electrically isolated. For all connections use isolated probes. Don’t let patient connections contact other conductive parts, including earth. See instructions for patient connections in this manual. Carefully route patient cables to reduce the possibility of patient entanglement or strangulation. Leakage current is limited internally by this monitor to less than 10 μA. However, always consider cumulative leakage current that can be caused by other equipment used on the patient at the same time as this monitor. To ensure that the leakage current protection remains within the specifications, use only the patient cables specified in this manual. This monitor is supplied with protected lead wires. Do not use cables and leads with unprotected lead wires having exposed conductors at the cable end. Unprotected lead wires and cables may pose an unreasonable risk of adverse health consequences or death. If an alarm condition occurs while the alarms are set to off, the only alarm indication will be visual displays and symbols related to the alarm condition.

MRI The model 450C should not be used within the magnetic field during Magnetic Resonance Imaging.

Pacemakers Rate meters might continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely on rate meter alarms. Keep pacemaker patients under close surveillance.

Electrosurgery To avoid the potential of electrosurgery burns at monitoring sites, ensure proper connection of the electrosurgery return circuit as described by manufacturer’s instructions. If improperly connected, some electrosurgery units might allow energy to return through the ECG electrodes, SpO2 sensors, Pressure Transducers, EtCO2 sensors, and Temperature probes. To further reduce the potential of burns, locate the SpO2 sensors, Pressure Transducers, EtCO2 sensors, and Temperature probes as described in the manufacturer’s instructions.

Defibrillation Protection This equipment is protected against 360 J discharge and electrosurgery potentials. The monitor is internally protected to limit current through the electrodes to prevent injury to the patient and damage to the equipment as long as the defibrillator is used in conformance with the manufacturer’s instructions.

EMC This equipment has been certified to be protected to emissions and immunity according to IEC-60601-1-2.

Vital-Guard 450C Operation Manual

3

SAFETY

Electromagnetic Compatibility IEC 60601-1-2:2001 CAUTION: Medical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the Operation Manual. CAUTION: Portable and mobile RF communications equipment can affect medical electrical equipment. WARNING: The model 450C should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the Model 450C should be observed to verify normal operation in the configuration in which it will used.

Accessories WARNING: The use of accessories other than those specified below may result in increased emissions or decreased immunity of the equipment. Part Number Description 590170 Three lead patient cable 590162 Set of three lead wires 590167 Five lead patient cable 590168 Set of five lead wires 590198 Set of three lead wires for prewired electrodes 590317 Low noise three lead patient cable 590318 Set of three radiotranslucent lead wires 590323 Low noise three lead patient cable with 1kohm resistors. The minimum amplitude or value patient physiological signal is 0.5 mV (AAMI EC-13 3.2.6.1). WARNING: The use of the Model 450C below the following amplitude values may cause inaccurate results:

4

Vital-Guard 450C Operation Manual

SAFETY Guidance and manufacturer’s declaration – Electromagnetic emissions The Model 450C is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 450C should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions Group 1 The Model 450C uses RF energy only for its internal CISPR 11 function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions Class A The Model 450C is suitable for use in all CISPR 11 establishments other than domestic and those directly connected to the public low-voltage power Harmonic emissions Class A supply network that supplies buildings used for IEC 61000-3-2 domestic purposes. Voltage fluctuations/ Complies flicker emissions IEC 61000-3-3

Vital-Guard 450C Operation Manual

5

SAFETY Guidance and manufacturer’s declaration – Electromagnetic immunity The Model 450C is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 450C should assure that it is used in such an environment. Immunity test IEC 60601 test Compliance level Electromagnetic environment – level guidance Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete, discharge (ESD) or ceramic tile. If floors are IEC 61000-4-2 ±8kV air ±8kV air covered with synthetic material, the relative humidity should be at least 30%. Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be Transient/burst supply lines supply lines that of a typical commercial or IEC 61000-4-4 hospital environment. ±1 kV for ±1 kV for input/output lines input/output lines Surge ±1 kV differential ±250V differential Remove equipment that can cause IEC 61000-4-5 mode mode electrical disturbance from the vicinity of the input/output ±2 kV common ±2 kV common cables. mode mode Voltage dips, short <5 % UT Mains power quality should be <5 % UT (>95 % dip in UT) (>95 % dip in UT) that of a typical commercial or interruptions, and for 0.5 cycle for 0.5 cycle voltage variations hospital environment. If the user on power supply of the Model 450C requires 40 % UT 40 % UT input lines continued operation during power (60 % dip in UT) for (60 % dip in UT) IEC61000-4-11 mains interruptions, it is 5 cycles for 5 cycles recommended that the Model 450C be powered from an 70 % UT 70 % UT uninterruptible power supply. (30 % dip in UT) for (30 % dip in UT) 25 cycles for 25 cycles

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

6

<5 % UT (>95 % dip in UT) for 5 sec cycle 3 A/m

<5 % UT (>95 % dip in UT) for 5 sec cycle Not applicable

Not applicable

Vital-Guard 450C Operation Manual

SAFETY Guidance and manufacturer’s declaration – Electromagnetic immunity The Model 450C is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 450C should assure that it is used in such an environment. Immunity test IEC 60601 test Compliance Electromagnetic environment – guidance level level Portable and mobile RF communications equipment should be used no closer to any part of the Model 450C, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms

d = 1.2

p

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m

d = 1.2

p

80 MHz to 800 MHz

d = 2.3

p

800 MHz to 2.5 GHz

Where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range b Interference may occur in the vicinity of the equipment marked with the following symbol:

NOTE 1 – At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 – These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radios, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, and electromagnetic site survey should be considered. If the measured field strength in the location in which the Model 450C is used exceeds the applicable RF compliance level above, the Model 450C should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Model 450C. b Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.

Vital-Guard 450C Operation Manual

7

SAFETY

Description of Warning Labels Attention, consult ACCOMPANYING DOCUMENTS before attempting to change power supply selection or carry out interconnections. Equipment connected should comply with IEC-60601-1 or IEC-950 with configuration to IEC-60601-1-1. ⎯⏐ ♥ ⏐⎯

Type CF applied part, Defibrillator proof.

Equipotential earth connector adjacent to this symbol.

Fuse type/rating.

Output signal.

ON

Input signal.

_______

Stand By (STBY)

♥

Type CF applied part.

∼

Alternate Current (AC)

WEEE Compliance

For monitors used in Australia For continued Defibrillation protection and proper Respiration monitoring use only patient cables with 1kΩ series resistors. It is important to use only patient cables with 1kΩ series resistors because the respiration circuit is tuned to operate with series resistors. For 3-lead configuration monitors, use 3-lead patient cable with 1kΩ series resistors. Ivy reorder no. 590197. For 5-lead configuration monitors, use 5-lead patient cable with 1kΩ series resistors. Ivy reorder no. 590207.

8

Vital-Guard 450C Operation Manual

MONITOR DESCRIPTION

MONITOR DESCRIPTION The Model 450C Patient Monitor is a color four-trace adult, pediatric, or neonatal monitor for: ECG Heart Rate Respiration - Impedance EtCO2 Two Invasive Pressures Two Temperatures Non-Invasive Blood Pressure (NIBP) Pulse Oximetry The Model 450C is available in several configurations, therefore, not all parameters are included in all monitors. The use of the Model 450C is restricted to one patient at a time. The monitor is intended for use in emergency room, recovery room, intensive care, and surgical applications and transport with 2.5 hours battery operation. The Model 450C is suitable for use in presence of electrosurgery. The Model 450C is not intended for use with any other physiological monitoring unit. An optional integral recorder is available. Recorder settings are made through the monitor menus. Battery operation consists of two rechargeable lead acid cells. The display has four traces available and alphanumeric displays for data, alarms, and user information, such as menus. The monitor automatically senses which devices are connected and acquires and displays data for the parameters being used. Data for parameters not being used is not displayed. Areas for display of those parameters are left blank.

Classification (in accordance with IEC-60601-1) Protection against electric shock:

Class 1 and internally power equipment

Degree of protection against electric shock:

Type CF applied part. Defibrillator proof: ECG Type CF applied part: SpO2, IBP, Temperature, NIBP, & EtCO2.

Degree of protection against harmful ingress of water:

Ordinary equipment IPX0 per IEC-60529

Methods of Maintenance and Cleaning:

See page 72

Degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide:

Equipment not suitable for use in the presence of a flammable anesthetic mixture

Mode of operation:

Continuous

Vital-Guard 450C Operation Manual

9

MONITOR DESCRIPTION

Specifications ECG Lead Selection:

Standard Three-Lead: Five-Lead Option:

ECG Amplitud range:

1 to 100 mm/mv

Patient Cable:

6-Pin AAMI Standard

Isolation:

Isolated from ground related circuits by ≥4 kV rms, 5.5 kV peak

CMRR:

≥90 dB with patient cable and 51 kΩ/47 nF imbalance

Input Impedance:

≥20 MΩ at 10 Hz with patient cable

Frequency Response Display, at 50 mm/sec:

LI, LII, LIII, LI, LII, LIII, aVR, aVL, aVF, V

Filtered: Diagnostic:

0.5 to 35 Hz 0.05 to 100 Hz

Frequency Response X1000 Output:

Filtered: Diagnostic:

0.5 to 35 Hz 0.05 to 100 Hz

Input Bias Current:

Any lead configuration <200 nA dc maximum

Electrode Offset Potential:

± 0.5 V

Noise:

<20 μV peak-to-peak, referred to the input with all leads connected through 51 kΩ/47 nF to ground

Defibrillator Protection:

Protected against 360 J discharge and electrosurgery potentials.

Leakage Current:

<10 μA at 120 V ~, 60 Hz

Electrosurgical Interference Protection:

Standard

Lead Fault Detection:

Lead fault detection in any lead configuration with any of the leads open

NOTE: The Phase Delay from patient electrode to rear panel outputs is < 3ms Cardiotach

10

Range:

15 to 300 bpm

Accuracy:

±1%

Resolution:

1 bpm

Sensitivity:

Adult: Neonate:

Pacer Rejection Width:

0.1 to 2 ms at ±2 to ±700 mV

Tall T Wave Rejection:

Rejects T waves ≤R wave

300 μV peak 100 μV peak

Vital-Guard 450C Operation Manual

MONITOR DESCRIPTION Temperature (Two Channels) Thermistor:

YSI Series 400 or equivalent

Range:

19°C to 45°C

Accuracy:

±0.1°C from 25°C to 40°C

Resolution:

0.1°C

Isolation:

Isolated from ground related circuits by ≥4 kV rms, 5.5 kV peak

Leakage:

<10 μA at 120 V ~, 60 Hz

Respiration Excitation Current:

<400 μA rms

Excitation Frequency:

57 kHz

Maximum Electrode Impedance:

4 kΩ

Size Adjustment:

Manual

Respirotach Range:

Neonate: Adult:

4 to 150 br/min 4 to 60 br/min

Sensitivity Range:

Neonate: Adult:

0.1 to 10 Ω, 4 to 150 br/min 0.3 to 10 Ω, 4 to 60 br/min

Pace Pulse Rejection Width:

0.1 to 2 ms at ±2 to ±700 mV

End Tidal CO2 Measurement Range:

0.0 to 100.0 Torr

Reporting Range:

–5.0 to 120.0 Torr

Resolution:

0.1 Torr (0.01%)

Bias:

0.0 to 40.0 Torr: 40.1 to 100.0 Torr:

±2.0 Torr Abs ±5.0% Relative

Precision:

0.0 to 40.0 Torr 40.1 to 100 Torr

<0.5 Torr (RMS) <1.0 Torr (RMS)

CO2 Compensation:

Local Barometric Pressure: 500 to 850 Torr (in whole units) 0 to 100% (in whole units) N2O 0 to 100% (in whole units) O2

Vital-Guard 450C Operation Manual

11

MONITOR DESCRIPTION MASIMO SET® Pulse Oximetry Range: Saturation (%SpO2) Pulse Rate (bpm)

1% - 100% 25 - 240

Accuracy: Saturation (%SpO2) – During no motion conditions Adults 70% - 100% ± 2 digits 0% - 69% unspecified Neonates 70% - 100% ± 3 digits Saturation (%SpO2) – During motion conditions Adults 70% - 100% ± 3 digits 0% - 69% unspecified Pulse (bpm) – During no motion conditions 25 to 240 ± 3 digits Pulse (bpm) – During motion conditions 25 to 240 ± 5 digits Resolution: Saturation(%SpO2) Pulse Rate (bpm)

1% 1

Non-Invasive Blood Pressure Measurement Technique:

Oscillometric method determines mean arterial pressure (MAP), systolic, and diastolic pressure.

Resolution:

1 mmHg

Measuring Range:

Systolic Mean Diastolic Pulse Rate

12

Adult (mmHg) 60–250 45–235 40–220 30 –180

Neonatal (mmHg) 40–130 35–105 20– 90 30 –240

Accuracy:

Over the blood pressure measurement range stated above, for systolic and diastolic pressures treated separately, the mean difference of the paired measurement of the test system and the comparison system shall be ±5mmHg or less, with a standard deviation of 8mmHg or less.

Inflation speed:

At sea level <10 seconds.

Maximum leak rate:

5 mmHg/3 min.

Over pressure protector: (Maximum cuff pressure)

Adult/Child Neonate

300mmHg 150mmHg

Vital-Guard 450C Operation Manual