Philips M8102A User Manual

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IntelliVue MP2 Patient Monitor

Philips M8102A Technical Data Sheet

The IntelliVue MP2 portable patient monitor is compact in size, ergonomic, and modular in design. It provides an easy-to-use touchscreen user interface, is highly customizable and shares a technological platform with the Philips IntelliVue MP5-MP90 patient monitors.

The IntelliVue series offers a complete monitoring solution that is flexible and modular, designed to suit a broad spectrum of monitoring needs.

Measurement Features

• Compact, rugged, lightweight monitor with built in measurements

• ECG monitoring using any combination of three to 10 electrodes.

• 12-lead ECG monitoring with five electrodes using

the EASI method or with 10 electrodes using the conventional method.

• Multi-lead arrhythmia and ST segment analysis at the bedside on all available leads.

• Mainstream or Sidestream CO

• FAST SpO2 for accurate performance even with low perfusion.

• Invasive Pressure and Temperature measurement

• The monitor can operate using battery power for up to 3 hours with basic monitoring configuration to let you safely and easily monitor patients during in-hospital transfer. AC power is provided by an external power supply.

Usability Features

• Touchscreen and hardkeys as input device.

• Intuitive user interface.

PAD

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• Simple menu hierarchy gives fast access to all basic monitoring tasks.

• Patient data management with tabular and graphic trends.

• Settings “Profiles” for rapid case turnover.

• Patented automatic alarm limits help clinicians provide care more efficiently.

• 3.5" TFT flat panel display with QVGA (320 x 240) resolution, wide viewing angle, large numerics, permanently visible alarm limits, and up to three real-time waves.

• Capable of functioning in a wireless infrastructure (IIT)

Intended Use

The monitor is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of hospitals. The monitor is intended for use by health care professionals.

The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic device.

Rx only: U.S. Federal Law restricts this device to sale by or on the order of a physician.

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11).

EMC Environment:

Main Components

Monitor

The monitor has a color LCD TFT display with a wide viewing angle, providing high resolution waveform and data presentation.

The display, processing unit and measurements are integrated into one device. An external power supply provides power for the monitor.

User Interface

The user interface is designed for fast and intuitive operation. The color graphical user interface ensures that clinicians quickly feel at ease using the monitor.

Configurable SmartKeys with intuitive icons allow monitoring tasks to be performed quickly and easily, directly on the monitor screen.

Waves and numerics are color-coded.

The monitor displays up to three measurement waves simultaneously. For 12-lead ECG monitoring it can display 12 real-time ECG waves, with a rhythm strip and all ST values.

The MP2 monitor is supplied with a resistive touchscreen.

Simulated Keyboard

If alpha or numeric data entry is required, for example to enter patient demographics, an on-screen keyboard will automatically appear on the screen.

The monitor is suitable for use in all establishments incl. those directly connected to the public low-voltage supply network that supplies buildings for domestic purposes. When used with the M2741A Sidestream CO2 sensor, the monitor can only be used in hospital environments.

Upgradability

The MP2 monitor allows new capabilities to be added in the future as your monitoring requirements evolve. This upgradability gives the security of knowing that the monitors can be enhanced and updated as practices and technologies advance, and it protects long-term investments.

Mounting

The mounting options available enable flexible, space saving placement of the monitors for an ergonomic work space. The monitor is shipped with a low cost mounting plate if not specified otherwise.

Application Features

Critical and Cardiac Care Features

• The monitor performs multi-lead arrhythmia detection analysis

on the patient’s ECG waveform at the bedside. It analyzes for ventricular arrhythmias, calculates heart rate, and generates alarms, including asystole, bradycardia, and ventricular fibrillation.

• Up to 12 leads of ST segment analysis can be performed on adult

patients at the bedside, measuring ST segment elevation and depression and generating alarms and events. The user can trend ST changes, set high and low alarm limits, and set both ST and isoelectric measurement points. Using ST Snippets, one-second wave segments can be compared with a baseline segment for each measured ST lead.

• optional ST Map application shows ST changes over time in two

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multi-axis spider diagrams.

• QT/QTc interval monitoring provides the measured QT interval, the calculated heart-rate corrected QTc value and a

'QTc value,

which tracks variation in the QT interval in relation to a baseline value.

• optional 12-lead ECG data can be measured, using either the EASI placement method with five standard electrodes or conventional electrode placement with 10 electrodes.

• 12 realtime ECG waveforms can be displayed simultaneously.

• FAST-SpO2, using Fourier Artifact Suppression Technology, performs accurately even in cases with low perfusion.

• Choice of sidestream or mainstream CO

monitoring for high

quality measurements with intubated and non-intubated patients.

- Vital Signs

- Graphic Trends

- Realtime Wave Reports

Report templates can be defined in advance, enabling print-outs

tailored to each hospital’s specific requirements to be started

quickly. Reports can be printed on centrally-connected printers or

via the IntelliVue PC Printing Solution, and they can be initiated

manually or automatically at user-defined intervals.

• The IntelliVue PC Printing Solution allows printing of reports, waveform captures and trends from the MP2 to a standard off-the shelf printer or to an electronic file.

Alarms

Ease of Use

• Screen layouts are easily adjustable, allowing flexible display of

measurement information.

• Temperature, height, and weight can be configured either in metric

or imperial units. Pressure measurements can be displayed in kPa or mmHg. Gases can be displayed in kPa, mmHg.

Trends

• The trend database stores patient data from up to 30

measurement numerics. The measurement information can be sampled every 12 seconds, one minute, or five minutes, and stored for a period ranging from four to 48 hours.

• Horizon Trends show the deviation from a stored baseline.

Transport Features

• The monitor’s portable design means it can be used for in and out-ofhospital transport: a basic monitor weighs 1.5 kg.

• The monitor can operate using battery power for up to 3 hours, to let you safely and easily monitor patients during procedures or inhospital transfer.

• Specially-designed mounting solutions let you quickly disconnect the monitor for transport and reconnect to the mount after transport.

• The Universal Admit, Discharge and Transfer (ADT) feature means that all ADT information is shared between the networked monitor and the Information Center. Information need only be entered once.

Patient Data Documentation

• An extensive range of Patient Reports can be printed:

- 12-lead ECG Reports

- Alarm Limit Reports

The alarm system can be configured to present either the traditional HP/Agilent/Philips alarm sounds or sounds compliant with the draft ISO/IEC 9703-2 Standard.

Alarm limits are permanently visible on the main screen. The Alarm Limits page provides a graphic depiction of alarm limits in relation to the currently monitored measurement values and lets you adjust alarm limits. It also lets you preview wide and narrow automatic alarm limits before you apply them.

When an alarm limit is exceeded, it is signalled by the monitor in the following ways:

• an alarm tone sounds, graded according to severity

• an alarm message is shown on the screen, color-coded according to severity

• the numeric of the alarming measurement flashes on the screen

• alarm lamps flash for red and yellow alarms and are illuminated for technical INOPs

If the monitor is connected via a network to a central monitoring station, alarming is simultaneous at the monitor and at the Information Center.

Alarms are graded and prioritized according to severity:

• Red Alarms*** identify a potentially life threatening situation for a patient .

• Yellow Alarms** indicate conditions violating preset vital signs limits.

• Technical Alarms (INOPS)

are triggered by signal quality

problems, equipment malfunction or equipment disconnect.

The Silence/Pause Alarms function (equivalent to Silence/Suspend

with previous monitor generations) allows the user to switch off

alarm tones with one touch.

1.EASI-derived 12-lead ECGs and their measurements are approximations to conventional 12-lead ECGs. As the 12-lead ECG derived with EASI is not exactly identical to the 12lead conventional ECG obtained from an electrocardiograph, it should not be used for diagnostic purposes.

All alarms can be paused for a period of one, two, three, five, or 10

minutes or turned off indefinitely.

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Alarm strip recordings are available on a centrally-connected

recorder or via the IntelliVue PC Printing Solution.

Patented automatic alarm limits automatically adapt the alarm limits

to the patient’s currently measured vital signs within a safe margin

defined individually for each patient.

Visual and/or audible latching and non-latching alarm handling is

available.

Profiles

Profiles are predefined configuration settings for Screens, measurement settings, and monitor settings. Each Profile can be designed for a specific application area and patient category, for example OR adult, or ICU neonatal. Profiles enable a quick reaction to patient and care location changes: activating a Profile with a particular patient category (Adult, Pediatric or Neonatal) automatically applies suitable alarm and safety limits and saves time usually spent carrying out a complete set-up procedure.

Profiles can be created directly on the monitor or remotely on a personal computer and transferred to the monitor using the IntelliVue Support Tool. A selection of Profiles for common monitoring situations is provided with the monitor. These profiles can be changed, added to, renamed, or deleted.

Network Interface

The network interface provides the system with networking capability via a wired or wireless network connection.

Wireless Network (optional)

The monitor can function within a telemetry infrastructure compatible with the Philips Cellular Telemetry System (CTS) in the WMTS and ISM bands. Additional components are required to complete the system. Please refer to the M3185A IntelliVue Clinical Network Technical Data Sheet for further information.

Monitor Specifications

Safety Specifications

The monitor complies with the Medical Device Directive 93/42/EEC

) and with IEC 60601-1:1988 + A1:1991 + A2:1995; EN60601-

(CE

0366

1:1990 + A1:1993 + A2:1995; UL 60601-1:2003; CAN/CSA C22.2#601.1-M90; JIS T 0601-1:1999; IEC 60601-1-1:2000; EN 606011-1:2001.

All applied parts are Type CF unless otherwise specified. They are protected against damage from defibrillation and electrosurgery.

Optional Networking Capabilities

The monitor can operate as part of a wired or wireless hospital network system, using the Philips IntelliVue Clinical Network interface.

Service Features

• The Support Tool helps technical personnel to

- carry out configuration, upgrades and troubleshooting via the

network, or on an individual monitor

- share configuration settings between monitors

- back up the monitor settings.

• A password-protected Service Mode ensures that only trained staff can access service tests and tasks.

• The Configuration Mode is password-protected and allows trained users to customize the monitor configuration.

Device Connections

The monitor can be connected to:

• an Information Center (for example M3150B)

•a PC

• MMS Extensions (M3012A, M3014A, M3015A, M3016A)

The possibility of hazards arising from software errors was minimized in compliance with and IEC 60601-1-4:1996 + A1:1999.

The monitor complies with the EMC standards IEC 60601-1-2:2001; EN 60601-1-2:2001

This ISM device complies with Canadian ICES-001. Cet appareil ISM est conforme a la norme NMB-001 du Canada.

The MP2 patient monitor can be used in a transport environment such as road ambulance, airplane or helicopter, except when used with the M2741A Sidestream CO2 sensor. For this purpose, the monitor fulfills the following additional mechanical, EMC and environmental requirements:

• Shock Tests according to IEC TR 60721-4-7, Class 7M3. Test procedure according to IEC/EN 60068-2-27 (peak acceleration up to 100g).

• Random Vibration according to IEC TR 60721-4-7, Class 7M3. Test procedure according to IEC/EN 60068-2-64 (RMS acceleration 5g).

• Sinusoidal Vibration according to IEC TR 60721-4-7, Class 7M3. Test procedure according to IEC/EN 60068-2-6 (acceleration up to amplitude 2g).

1.The MMS Extensions will only function when the monitor is connected to the external power.

ISO 14971:2000, EN60601-1-4:1996 + A1:1999

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• Bump Test according to IEC/EN60068-2-29 (peak acceleration 15g, 1000 bumps).

• Free Fall Test according to EN1789 (covers also IEC TR 60721-4-7 and Class 7M3). Test procedure according to EN 60068-2-32 (height

0.75 m).

• Specification for degrees of protection provided by enclosures according to IEC/EN 60529: IP 32

• EN 1789 +A1:2003 Medical vehicles and their equipment - Road ambulances (chapter 6 - Medical Devices).

• Radiated susceptibility 20 V/m according to EN ISO 9919 (SpO2) and EN ISO 21647 (CO2).

• Altitude Range from -500 to 3000 m operating and -500 to 4600 m storage and transportation.

• Extended radiated susceptibility tests

The MP2 patient monitor with its out-of-hospital parameter set provides a general immunity level of 20 V/m with only few restrictions. Details are as listed below:

- GSM 900: Immunity at 900 MHz (uplink mobile phone), 20V/m,

duty cycle 1:8

- GSM 1800: Immunity at 1800 MHz (uplink mobile phone), 20V/m,

duty cycle 1:8.

- DECT: Immunity at 1800 MHz (digital cordless phone), 20V/m,

duty cycle 1:24

- AM: 1 kHz Immunity from 80 MHz to 2.5 GHz (any radio

communication unit, broadcasting and TV transmitter), 20V/m,

modulation factor 80%. (ECG: 20 V/m except 0.8-1.2 GHz where

it is 10V/m)

• Operating ambient temperature testing over the range from 0 to 40 °C (32 to 104 °F).

• Operating ambient humidity testing up to 95% RH at 40 °C (104 °F), non condensing.

Physical Specifications

Environmental Specifications

Item Condition Range

Temperature Range

Temperature Range when charging the battery

Humidity Range Operating 15% to 95% Relative

Altitude Range Operating -500 m to 3000 m

Ingress Protection

Operating

0 to 40oC

(32 to 104 oF)

Storage (incl. Transport)

Operating

-20 to 60oC

(-4 to 140

0 to 35oC

(32 to 95

Humidity (RH) (non condensing)

Storage and Transport

5% to 95% Relative Humidity (RH)

(10000 ft)

Storage and Transport

-500 m to 4600 m

(15000 ft)

Monitor IP32 (protected against

the ingress of solid foreign objects 2.5 mm in diameter or larger, and the ingress of water when the water is dripping vertically and the monitor is tilted up to 15°).

Product Max Weight W x H x D

M8102A IntelliVue MP2 (without

1.5 kg

(3.3 lb)

< 188 x 99 x 86 mm (7.4 x 3.9 x 3.4 in)

handle and options)

External Power Supply (M8023A)

IP31(protected against the ingress of solid foreign objects 2.5 mm in diameter or larger, and the ingress of water when the water is dripping vertically) when rested on its rubber feet on a flat, level surface.

IP32 when mounted with the connectors facing downwards

a. sufficient for flight altitudes up to 12,000 m with pressurized cabins

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Performance Specifications

Monitor Performance Specifications

Alarm Signal System delay less than 3 seconds

Monitor Performance Specifications

Power Specifications

Battery Specifications

Indicators Alarms Off red LED

Power consumption

Line Voltage 100 to 240 V ~

Current 1.3 to 0.7A

Frequency 50/60 Hz

Operating Time (with new, fully charged battery at 25 °C)

Charge Time When MP2 is off: 2 h

Alarms red/yellow/cyan LED

On/Standby/Error green/red LED

< 40W average, <65W peak

Basic monitor configuration: 3 hours

When MP2 is in use and connected to MP20/30/ 40/50/60/70/80/90 without extensions: 12 h approx.

When MP2 is in use and connected to the external power

Pause duration 1,2,3 minutes or infinite,

depending on configuration

Extended alarm pause

Review Alarms

Real Time Clock

Buffered Memory

Restart time: After power interruption, an ECG wave will be shown on the display after 30 seconds maximum.

Information: all alarms / inops, main alarms on/off, alarms acknowledged and time of occurrence

capacity 500 items

Range: from: January 1, 1997, 00:00 to: December 31, 2080, 23:59

Accuracy: < 4 seconds per day (typically)

Hold Time: infinite if powered by host monitor or external power supply; otherwise at least 48 hours

Contents: Active settings, trends, patient data, realtime reports, review alarms

Hold Time: infinite if powered by external power supply; otherwise at least 48 hours

5 or 10 minutes

M8023A External Power Supply Performance Specifications

AC Power green LED

Battery yellow (charging)/red

blinking (empty) LED

External Power green LED

Sounds Audible feedback for user input. Prompt tone.

QRS tones, or SpO

different alarm sounds.

Trends:

12, or 16 numerics @ 12 sec, 1 minute, 5 minute resolution. Multiple choices of number of numerics, resolution and duration depending on trend option and application area.

modulation tone. Four

M8023A External Power Supply Performance

Specifications

Power Specifications

Indicators AC Power green LED

Power Consumption

Line Voltage 100 to 240 V ~

Current 0.7 to 0.4 A

Frequency 50/60 Hz ~

< 12 W average < 30 W peak

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Interface Specifications

MP2 (M8102A) Interface Specifications

Measurement Link (MSL)

Connectors Female ODU (Proprietary)

Power 30 V to 60 V input

Power Sync RS-422 compliant input

78.125 kHz (typical

LAN signals IEEE 802.3 10-Base-T

complaint

Serial signals RS-422 compliant

Local signals Provided for connecting MMS

extensions

ECG Sync Pulse Output

Cable Detection

Yes

Marker In No

Wave

Output

Connector Binder Series 709/719

Output Levels

Output low <0.8V @ I = 4mA

Output high >2.4 V @ I= 4mA

Isolation None

M8023A External Power Supply Interface Specifications

Measurement Link (MSL)

Connectors Male ODU (Proprietary)

Power 48 V output

Power Sync. RS-422 compliant output

78.125 kHz (typical)

LAN signals IEEE 802.3 10-Base-T complaint

Serial signals

RS-422 compliant output

78.125 kHz (typical)

Local signals Not connected

Display Specifications

Integrated QVGA Display

Sweep

6.25, 12.5, 25 and 50 mm/s;

Speeds

Resolution 320 x 240

Refresh

60 Hz

frequency

Useful

72x54mm (2.8x2.1in)

screen

Pixel size 0.22 x 0.22 mm

Pulse Width 100 +/- 10 ms (high)

Delay from R-wave peak

20 ms maximum per AAMI

EC13 to start of pulse

Minimum

0.5 V required Rwave amplitude

MP2 (M8102A) Compatible Devices

IntelliVue Instrument Telemetry Wireless Network

(USA only)

Internal WMTS Adapter

Technology compatible with Philips

Cellular Telemetry System (CTS), cellular infrastructure

Frequency Band

WMTS, 1395-1400 MHz and 1427-1432 MHz

IntelliVue Instrument Telemetry Wireless Network

(except USA)

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MP2 (M8102A) Compatible Devices

Measurement Specifications

Internal ISM Adapter

M4607A Battery Specifications

Physical Specifications

W x D x H 66 mm (2.36 in) x 80 mm (3.15 in) x

Weight 160 g ±5%

Performance Specifications

Nominal Voltage 10.8 Volt

Rated Capacity at discharge C/5

Environmental Specifications

Temperature Range Discharge 0 to 60qC (32 to 122qF)

Humidity Range Operating: 15 % to 95 % Relative

Battery Type Lithium Ion Mangan, 10.8 V,

Safety complies with UL 1642 (UL

Technology compatible with Philips

Cellular Telemetry System (CTS), cellular infrastructure

Frequency Band

2.4 GHz ISM

20 mm (0.79 in)

1000 mAh (typical)

Charge 0 to 60qC (32 to 122qF) Storage and Transportation: -20 to 65qC (-4 to 140qF)

Humidity (RH) Storage and Transportation: 5 % to 95 % Relative Humidity (RH)

1000 mAh,

Recognized)

ECG/Arrhythmia/ST/QT

Complies with IEC 60601-2-25:1993 + A1:1999 /EN60601-2-25:1995 + A1:1999, IEC 60601-2-27:2005/EN60601-2-27:2006, IEC 60601-251:2003 /EN 60601-2-51:2003 and AAMI EC11/EC13:1991/2002.

ECG/Arrhythmia/ST Performance Specifications

Cardiotach Range Adult/pedi:

15 to 300 bpm Neo range: 15 to 350 bpm

Accuracy ±1% of range

Resolution 1 bpm

Sensitivity t200 μV

PVC Rate Range 0 to 300 bpm

Resolution 1 bpm

ST Numeric Range -20 to +20 mm

Accuracy ±0.5 mm or 15%, whichever is

greater

Resolution 0.1 mm

QT Numeric Range 200 to 800 ms

Accuracy ±30 ms

Resolution 8ms

QTc Numeric Range 200 to 800 ms

Resolution 1ms

'QTc Numeric Range -600 to +600 ms

Resolution 1ms

peak

Electromagnetic Compatibility (EMC)

Communication Standard complies with the SMBus specification

complies with the requirements for FCC Type B computing Device, and EN 61000-4-2 and EN 61000-3-2

v1.1

QT-HR Numeric

Range adult

Range pediatric and neonatal

15 to 300 bpm

15 to 350 bpm

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ECG/Arrhythmia/ST Performance Specifications

Sinus and SV Rhythm Ranges

Brady Adult: 15 to 60 bpm

Pedi: 15 to 80 bpm Neo: 15 to 90 bpm

Normal Adult:60 to 100 bpm

Pedi: 80 to 160 bpm Neo: 90 to 180 bpm

Tachy Adult: > 100 bpm

Pedi: >160 bpm Neo: >180 bpm

Bandwidth Diagnostic

Adult/neo/pedi: 0.05 to 150Hz

Mode

Extended

Neo/pedi: 0.5 to 150Hz Monitoring Mode

Monitoring Mode

Adult: 0.5 to 40Hz

Neo/pedi: 0.5 to 55Hz

Filter Mode Adult/neo/pedi: 0.5 to 20Hz

Differential Input Impedance >2M: RA-LL leads (Resp)

>5M: at all other leads (at 10Hz

including patient cable)

Common Mode Rejection Ratio

Diagnostic mode: >86 dB (with a

51 k:/47 nF imbalance).

Filter mode: >106 dB (with a 51

k:/47 nF imbalance).

Electrode Offset Potential

±500mV

Tolerance

Auxiliary Current (Leads off Detection)

Active electrode: <100 nA

Reference electrode: <900 nA

Input Signal Range ±5 mV

ECG/

Arrhythmia/

ST Alarm

Range Adjustment

Specifications

HR 15 to 300 bpm

maximum delay: 10 seconds according to AAMI EC 13-1992 standard

Adult:1 bpm steps (15 to 40 bpm) 5 bpm steps (40 to 300 bpm) Pedi/Neo:1 bpm steps (15 to 50 bpm) 5 bpm steps (50 to 300 bpm)

Extreme Tachy Difference to high

5 bpm steps

limit 0 to 50 bpm

Clamping at 150 to

5 bpm steps

300 bpm

Extreme Brady Difference to low

5 bpm steps

limit 0 to 50 bpm

Clamping at 15 to

5 bpm steps

100 bpm

Run PVCs 2 PVCs Not adjustable by user

PVCs Rate 1 to 99 PVCs/minute 1 PVC

Vent Tach HR 20 to 300 bpm 5 bpm

Vent Tach Run 3 to 99 PVCs/minute 1 PVC

Vent Rhythm

2 to 99 PVCs/minute 1 PVC

Run

SVT HR 120 to 300 bpm 5 bpm

SVT Run 3 to 99 SV beats 1 SV beat

ST High -19.8 to +20 mm 0.2 mm

ST Low -20 to +19.8 mm 0.2 mm

QTc High 200 ms to 800 ms 10 ms steps

'QTc High 30 ms to 200 ms 10 ms steps

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ECG/Arrhythmia/ST Supplemental Information as

required by AAMI EC11/13

Respiration Excitation

Sinusoidal signal, 260 PA, 39 kHz

Waveform

Noise Suppression RL drive gain 44 dB max., max.

voltage 1.8 Vrms

ECG/Arrhythmia/ST Supplemental Information as

required by AAMI EC11/13

Heart Rate Meter Accuracy and Response to Irregular Rhythm

Ventricular bigeminy: 80 bpm Slow alternating ventricular bigeminy: 60 bpm Rapid alternating ventricular bigeminy: 120 bpm Bidirectional systoles: 90 bpm

Time to Alarm for Tachycardia

Vent Tachycardia 1mVpp,206

bpm

Gain 0.5, Range 6.5 to 8.4 seconds, Average 7.2 seconds

Gain 1.0 Range 6.1 to 6.9 seconds, Average 6.5 seconds

Gain 2.0, Range 5.9 to 6.7 seconds, Average 6.3 seconds

Vent Tachycardia

,195b

2mV

Gain 0.5, Range 5.4 to 6.2 seconds, Average 5.8 seconds

Gain 1.0, Range 5.7 to 6.5 seconds, Average 6.1 seconds

Gain 2.0, Range 5.3 to 6.1 seconds, Average 5.7 seconds

Tall T-Wave Rejection Capability

Exceeds ANSI/AAMI EC 13 Sect.

3.1.2.1(c) minimum recommended 1.2 mV T-Wave amplitude

Heart Rate Averaging Method Three different methods are

used: Normally, heart rate is computed by averaging the 12 most recent RR intervals. For runs of PVCs, up to 8 RR intervals are averaged to compute the HR. If each of 3 consecutive RR intervals is greater than 1200 ms (that is, rate less than 50 bpm), then the 4 most recent RR intervals are averaged to compute the HR.

Response Time of Heart Rate Meter to Change in Heart Rate

HR change from 80 to 120 bpm: Range: [6.4 to 7.2 seconds] Average: 6.8 seconds

HR change from 80 to 40 bpm: Range: [5.6 to 6.4 sec] Average:

6.0 seconds

Accuracy of Input Signal Reproduction

Methods A and D were used to establish overall system error and frequency response.

Respiration

Respiration Performance Specifications

Respiration Rate

Bandwidth 0.3 to 2.5Hz (–6dB)

Noise Less than 25m:(rms) referred to

Respiration

Alarm Speci-

fications

High Adult/pedi:

Low Adult/pedi: 0

Range Adult/pedi: 0 to 120 rpm

Neo: 0 to 170 rpm

Accuracy at 0 to 120 rpm ±1 rpm

at 120 to 170 rpm ±2 rpm

Resolution 1 rpm

the input

Range Adjustment Delay

under 20 rpm: 1 10 to 100 rpm Neo: 30 to

rpm steps

over 20 rpm: 5

rpm steps 150 rpm

under 20 rpm: 1 to 95 rpm Neo: 0 to 145 rpm

rpm steps

over 20 rpm: 5

rpm steps

max. 14 seconds

for limits from 0 to 20 rpm: max. 4 seconds for limits above 20 rpm: max. 14 seconds

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Respiration

Alarm Speci-

Range Adjustment Delay

fications

Apnea Alarm 10 to 40

5 second steps

seconds

SpO

Complies with EN ISO 9919:2005 (except alarm system; alarm system complies with IEC 60601-2-49:2001).

Measurement Validation: The SpO

accuracy has been validated in

human studies against arterial blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are statistically distributed, only about two-thirds of the measurements can be expected to fall within the specified accuracy compared to COoximeter measurements. Display Update Period: Typical: 2 seconds, Maximum: 30 seconds. Max. with NBP INOP suppression on60 seconds.

SpO2 Performance Specifications

SpO2* Range 0 to 100%

Accuracy Philips Reusable Sensors:

M1191A, M1191AL, M1191ANL, M1191B, M1191BL, M1192A, M1192AN: 2% (70% to 100%)

M1193A, M1193AN, M1194A, M1194AN, M1195A, M1195AN, M1196A: 3% (70% to 100%)

Philips Reusable Sensors with M1943A(L):

M1191T, M1192T, M1193T (Adult), M1196T: 3% (70% to 100%)

M1193T (Neonate): 4% (70% to 100%)

Philips Disposable Sensors with M1943A(L):

M1132A, M1133A (adult/ infant): 2%

M1131A, M1133A (neonate), M1901B, M1902B, M1903B, M1904B: 3% (70% to 100%)

SpO2 Performance Specifications

SpO2* Accuracy

NellcorPB® Sensors with M1943A(L):

MAX-A, MAX-AL, MAX-P, MAX-I, MAX-N, D-25, D-20, I20, N-25, OxiCliq A, P, I, N: 3% (70% to 100%)

Masimo Reusable Sensors

with LNOP MP12 or LNC MP10:

LNOP DC-I, LNOP DC-IP, LNOP YI, LNCS DC-I, LNCS DC-IP, LNCS TF-I: 2% (70% to 100%)

LNOP TC-I, LNCS TC-I:

3.5% (70% to 100%)

Masimo Disposable

Sensors

with LNOP MP12

or LNC MP10:

LNOP Adt, LNOP Adtx, LNOP Pdt, LNOP Pdtx, LNOP Inf-L, LNCS Adtx, LNCS Pdtx, LNCS Inf-L: 2% (70% to 100%)

LNOP Neo-L, LNOP NeoPt-L, LNCS Neo-L, LNCS NeoPt-L: 3% (70% to 100%)

Resolution 1%

Pulse Range 30 to 300 bpm

Accuracy ±2% or 1 bpm, whichever is

greater

Resolution 1 bpm

Sensors Wavelength range: 500 to 1000

nm Emitted Light Energy: d 15mW

Information about the wavelength range can be especially useful to clinicians (for instance, when photodynamic therapy is performed)

Pulse Oximeter Calibration

70 - 100%

Range

*The specified accuracy is the root-mean-square (RMS) difference between the measured values and the reference values

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NBP

SpO2 Alarm

Specifica-

Range Adjustment Delay

tions

SpO

Adult: 50 to 100%

1% steps (0, 1, 2, Pedi/Neo: 30 to 100%

Desat Adult: 50 to Low

1% steps alarm limit Pedi/Neo: 30 to Low alarm limit

Pulse 30 to 300 bpm Adult:

1 bpm steps

(30 to 40 bpm)

5 bpm steps

(40 to 300

bpm)

Pedi/Neo:

1 bpm steps

(30 to 50 bpm)

5 bpm steps

(50 to 300

bpm)

Tachycardia Difference to high

5 bpm steps max. 14 limit 0 to 50 bpm

Clamping at 150 to

5 bpm steps 300 bpm

Bradycardia Difference to low

5 bpm steps max. 14 limit 0 to 50 bpm

Clamping at 30 to

5 bpm steps 100 bpm

3,... 30) + 4 seconds

max. 14 seconds

seconds

Complies with IEC 60601-2-30:1999/EN60601-2-30:2000.

NBP Performance Specifications

Measurement Ranges

Systolic Adult: 30 to 270 mmHg (4 to 36

kPa) Pedi: 30 to 180 mmHg (4 to 24 kPa) Neo: 30 to 130 mmHg (4 to 17 kPa)

Diastolic Adult: 10 to 245 mmHg (1.5 to 32

kPa) Pedi: 10 to 150 mmHg (1.5 to 20 kPa) Neo: 10 to 100 mmHg (1.5 to 13 kPa)

Mean Adult: 20 to 255 mmHg (2.5 to 34

kPa) Pedi: 20 to 160 mmHg (2.5 to 21 kPa) Neo: 20 to 120 mmHg (2.5 to 16 kPa)

Pulse Rate Adult:40 to 300

Pedi: 40 to 300 Neo: 40 to 300

Accuracy Max. Std. Deviation: 8 mmHg (1.1

kPa) Max. Mean Error: ±5 mmHg (±0.7 kPa)

Pulse Rate Measurement Accuracy

40 to 100 bpm: ± 5 bpm

101 to 200 bpm: ± 5% of reading

201 to 300 bpm: ± 10% of reading

(average over NBP measurement cycle)

Heart Rate Range 40 to 300 bpm

Measurement Time Typical at HR > 60bpm

Auto/manual: 30 seconds (adult) 25 seconds (neonatal) Stat: 20 seconds

Maximum time: 180 seconds (adult/ pediatric) 90 seconds (neonates)

Page 13

NBP Performance Specifications

Cuff Inflation Time Typical for normal adult cuff: Less

than 10 seconds Typical for neonatal cuff: Less than 2 seconds

Initial Cuff Inflation Pressure

Adult: 165 ±15 mmHg Pedi: 130 ±15 mmHg Neo: 100 ±15 mmHg

Auto Mode Repetition Times

1, 2, 2.5, 3, 5, 10, 15, 20, 30, 45, 60 or 120 minutes

STAT Mode Cycle Time 5 minutes

Venipuncture Mode Inflation

Inflation Pressure

Adult 20 to 120 mmHg (3 to 16 kPa)

Pediatric 20 to 80 mmHg (3 to 11 kPa)

Neonatal 20 to 50 mmHg (3 to 7 kPa)

Automatic deflation after

Adult/

170 seconds

pediatric

Neonatal 85 seconds

Measurement Validation: In adult and pediatric mode, the blood pressure measurements determined with this device comply with the American National Standard for Electronic or Automated Sphygmomanometers (ANSI/AAMI SP10 - 1992) in relation to mean error and standard deviation, when compared to intra-arterial or auscultatory measurements (depending on the configuration) in a representative patient population. For the auscultatory reference the 5th Korotkoff sound was used to determine the diastolic pressure.

In neonatal mode, the blood pressure measurements determined with this device comply with the American National Standard for Electronic or Automated Sphygmomanometers (ANSI/AAMI SP10 - 1992 and AAMI/ANSI SP10A -1996) in relation to mean error and standard deviation, when compared to intra-arterial measurements in a representative patient population.

NBP Alarm

Specifications

Range Adjustment

Systolic Adult: 30 to 270 mmHg

(4 to 36 kPa)

Pedi: 30 to 180 mmHg (4 to 24 kPa)

Neo: 30 to 130 mmHg (4 to 17 kPa)

Diastolic Adult: 10 to 245 mmHg

(1.5 to 32 kPa)

Pedi: 10 to 150 mmHg (1.5 to 20 kPa)

Neo: 10 to 100 mmHg (1.5 to 13 kPa)

Mean Adult: 20 to 255 mmHg

(2.5 to 34 kPa)

Pedi: 20 to 160 mmHg (2.5 to 21 kPa)

Neo: 20 to 120 mmHg (2.5 to 16 kPa)

NBP Overpressure Settings

Adult > 300 mmHg (40 kPa)

> 2 sec

Pedi > 300 mmHg (40 kPa)

> 2 sec

Neo > 150 mmHg (20 kPa)

> 2 sec

10 to 30 mmHg: 2 mmHg (0.5 kPa) > 30 mmHg: 5 mmHg (1kPa)

not user adjustable

Page 14

Invasive Pressure and Pulse

Complies with IEC 60601-2-34:2000/EN60601-2-34:2000.

Invasive Pressure Performance Specifications

Measurement Range –40 to 360 mmHg

Pulse Rate Range 25 to 350 bpm

Accuracy ±1% Full Range

Resolution 1 bpm

Input Sensitivity Sensitivity:5μV/V/mmHg (37.5μV/V/

kPa) Adjustment range:±10%

Transducer Load Impedance:200 to 2000 :

(resistive) Output Impedance:d3000 : (resistive)

Frequency Response dc to 12.5 Hz or 40 Hz

Zero Adjustment

Range ±200 mmHg (±26 kPa)

Accuracy ±1 mmHg (±0.1 kPa)

Drift Less than 0.1mmHg/°C (0.013 kPa/

°C)

Gain Accuracy

Accuracy ±1%

Drift Less than 0.05%/°C

Non linearity

Error of d0.4% FS (@CAL

200 mmHg) and Hysteresis

Overall Accuracy

Volume displacement

(including transducer)

± 4% of reading or ± 4 mmHg (± 0.5

kPa), whichever is greater

0.1 mm3 /100 mmHg

of CPJ840J6

Invasive

Pressure

Alarm

Range Adjustment Delay

Specifications

Pressure –40 to 360

mmHg (–5.0 to 48 kPa)

-40 to 30 mmHg 2 mmHg (0.5 kPa)

> 30 mmHg 5 mmHg (1 kPa)

Extreme High Difference to

high limit 0 to

5 mmHg steps (0.5 kPa)

25 mmHg

Clamping at 40 to 360

5 mmHg steps (1.0 kPa)

mmHg

Extreme Low Difference to

low limit 0 to

5 mmHg steps (0.5 kPa)

25 mmHg

Clamping at 40 to 360

5 mmHg steps (1.0 kPa)

mmHg

Pulse 25 to 300 bpm Adult:

1 bpm steps (25 to 40 bpm) 5 bpm steps (40 to 300 bpm) Pedi/Neo: 1 bpm steps (25 to 50 bpm) 5 bpm steps (50 to 300 bpm)

max. 12 seconds

Tachycardia Difference to

high limit 0 to

5 bpm steps max. 14

seconds

50 bpm

Clamping at

5 bpm steps 150 to 300 bpm

Page 15

Invasive

Pressure

Alarm

Specifications

Range Adjustment Delay

The CO2 measurement in the monitor, M3014A and M3015A complies with EN ISO 21647:2004 + Cor.1:2005 (except alarm system; alarm system complies with IEC 60601-2-49:2001).

Bradycardia Difference to

5 bpm steps max. 14 low limit 0 to 50 bpm

Clamping at 25

5 bpm steps to 100 bpm

Temp

Complies with EN 12470-4:2000

Temp Performance Specifications

Temp Range –1 to 45 qC

(30 to 113 qF)

Resolution 0.1 qC (0.2 qF)

Accuracy ±0.1 qC (±0.2 qF)

Average Time Constant Less than 10 seconds

Alarms Range –1 to 45 qC (30 to 113 qF)

Adjustment -1 to 35 qC (30 to 95 qF): 0.5 qC

(1.0 qF) steps

35 to 45 qC (95 to 113 qF): 0.1 qC (0.2 qF) steps

seconds

M3015A Microstream CO2 Performance Specifications

Range 0 to 98 mmHg (0 to 13 kPa), or

13 % CO

, whichever is lower

Accuracy Up to 5 minutes during warmup:

±4 mmHg or 12 %, whichever is greater After 5 minutes warmup: 0 to 40 mmHg (0 to 5.3 kPa): ±2.2 mmHg (±0.3 kPa) Above 40 mmHg (5.3 kPa):±(5.5 % + (0.08 %/mmHg above 40 mmHg)) of reading These specifications are valid for 21 % O

and N2 balance, up to 35qC

ambient temperature, up to 60 rpm in adult mode and 100 rpm in neonatal mode.

Outside of these

conditions the accuracy reaches at a minimum ±4 mmHg or ±12 % of the reading, whichever is greater.

Resolution Numeric: 1.0 mmHg (0.1 kPa)

Wave: 0.1 mmHg (0.01 kPa)

Stability Included in Accuracy specifications

Temp Alarm

Specifications

Temp High/ Low Alarms

Range Adjustment

–1 to 45 ºC (30 to 113 ºF)

-1 to 35 qC (30 to 95 qF), 0.5 qC (1.0 qF) steps 35 to 45 qC (95 to 113 qF),

0.1 qC (0.2 qF) steps

awRR Range 0 to 150 rpm

Accuracy 0 to 40 rpm: ±1 rpm

41 to 70 rpm: ±2 rpm 71 to 100 rpm: ±3 rpm >100 rpm: ±5 % of reading

Warm-up Time 5 minutes for full accuracy

specification

Rise Time 190 ms for neonatal mode

(measured with FilterLine H for neonatal)

240 ms for adult mode (measured with FilterLine H for adult)

Sample Flow Rate 50 + 15/-7.5 ml/minute

Page 16

M3015A Microstream CO2 Performance Specifications

Gas Sampling Delay Time Typical:2.3 seconds

Maximum:3 seconds

Sound Pressure Acoustic noise: <45 dBA

Total System Response Time

The total system response time is the sum of the delay time and the rise time.

M3014A Mainstream CO2 Performance Specifications

Range 0 to 150 mmHg (0 to 20.0 kPa)

Accuracy after 2 minutes warmup:

For values between 0 and 40 mmHg: ±2.0 mmHg (±0.29 kPa) For values from 41 to 70 mmHg: ±5 % of reading For values from 71 to 100 mmHg: ±8 % of reading The specifications are valid for standard gas mixtures, balance air, fully hydrated at 35°C, P

= 760 mmHg,

abs

flow rate = 2 l/min.

Resolution Numeric: 1.0 mmHg (0.1 kPa)

Wave: 0.1 mmHg (0.01 kPa)

Stability: Short term drift Long term

±0.8 mmHg over four hours Accuracy specification will be maintained over a 120 hour period

drift

awRR Range 2 to 150 rpm

Accuracy ±1 rpm

M3014A Sidestream CO2 Performance Specifications

Range 0 to 150 mmHg (0 to 20.0 kPa)

Accuracy after 2 minutes warmup:

For values between 0 and 40 mmHg: ±2.0 mmHg (±0.29 kPa) For values from 41 to 70 mmHg: ±5 % of reading For values from 71 to 100 mmHg: ±8 % of reading For values from 101 to 150 mmHg: ±10 % of reading At respiration rates above 80 rpm, all ranges are ±12 % of actual. The specifications are valid for gas mixtures

, balance N2, dry gas at

of CO

760 mmHg within specified operating temperature range.

Resolution Numeric: 1.0 mmHg (0.1 kPa)

Wave: 0.1 mmHg (0.01 kPa)

Stability: Short term drift Long term

±0.8 mmHg over four hours Accuracy specification will be maintained over a 120 hour period

drift

awRR Range 2 to 150 rpm

Accuracy ±1 rpm

Warm-up Time 2 minutes with CO2 sensor attached

for full accuracy specification

Sample Flow Rate 50 ±10 ml/minute

Total System Response

3seconds

Time

Warm-up Time 2 minutes with CO2 transducer

attached for full accuracy specification

Response Time Less than 60 ms (with adult or infant

reusable or disposable adapter)

Operating Temperature 0 to 40°C (32 to 104°F)

M3014A Mainstream and Sidestream CO2 Humidity Correction Factor

Either BTPS or STPD can be selected as the humidity correction factor for the CO

Where p = partial pressure, P

readings. The formula for the correction calculation is:

abs

---------------------------

STPDPBTPS



–

absPH2 O

= absolute pressure, and P

abs

H2O

= 42

mmHg @35°C and 100 % RH.

Page 17

M3016A Mainstream CO2 Performance Specifications

Range –4 to 150 mmHg (-0.5 to 20.0 kPa)

Accuracy after 20 minutes warmup and

calibration: For values between 0 and 40 mmHg: ±2.2 mmHg (±0.29 kPa) For values between 40 and 76 mmHg: ±5.5 % of reading The specifications are valid for 45 %

and N2 or N2O balance. Outside

these conditions the accuracy reaches at a minimum the requirements of EN864/ISO9918.

Resolution Numeric: 1.0 mmHg (0.1 kPa)

Wave: 0.1 mmHg (0.01 kPa)

Stability ±1.0 mmHg over a 7 day period

awRR Range 0 to 150 rpm

Accuracy ±2 rpm

Warm-up Time 20 minutes with CO2 transducer

attached for full accuracy specification

Response Time Less than 125 ms (for step from 10 %

to 90 %)

Mainstream CO2 Humidity Correction Factor

Either BTPS or STPD can be selected as the humidity correction factor for the Mainstream CO

readings. The formula for the correction

calculation is:

abs

STPDPBTPS

Where p = partial pressure, P

---------------------------



–

absPH2 O

= absolute pressure, and P

abs

H2O

47 mmHg @37qC and 100 % RH.

CO2 Alarm

Specifications

Range

etCO2 High 20 to

95 mmHg (2 to 13 kPa)

etCO2 Low 10 to

90 mmHg (1 to 12 kPa)

imCO2 High 2 to

20 mmHg (0.3 to

3.0 kPa)

awRR High Adult/pedi:

10 to 100 rpm Neo: 30 to 150 rpm

awRR Low Adult/pedi:

0 to 95 rpm Neo: 0 to 145 rpm

Apnea delay 10 to

40 seconds

Adjust-

ment

1mmHg (0.1 kPa)

steps of 1mmHg (0.1 kPa)

under 20 rpm: 1 rpm steps over 20 rpm:5 rpm steps

5 second steps

Delay

M3014A/ M3016A: less than 14 seconds M3015A: less than18 seconds.

M3015A: settings <20 rpm: less than 8 seconds >20 rpm: less than 18 seconds

M3014A/ M3016A settings <20 rpm: less than 4 seconds >20 rpm: less than 14 seconds

set apnea delay time + 4 seconds (M3014A/ M3016A) or 8seconds (M3015A)

Page 18

Ordering Information

Ordering information for the M81052A patient monitor is given here.

Sensors and Disposables

Parameters M8102A

Order one Bxx option

ECG, Resp, NBP, SpO

ECG, Resp, NBP, SpO2, Press/Temp

ECG, Resp, NBP, SpO2, CO

B20

B22

B23

Application Options

Application Options M8102A

Full Arrhythmia Capability C01

12-Lead ECG Application (conventional) C12

ST Map C13

Full Networking C15

Hardware Options

Accessory M8102A

3-lead Accessories Bundle ICU-AAMI Tyco low cost cable

3-lead Accessories Bundle ICU-IEC Tyco low cost cable

5-lead Accessories Bundle ICU-AAMI Tyco low cost cable

5-lead Accessories Bundle ICU-IEC Tyco low cost cable

5-lead Accessories Bundle ICU-AAMI H06

5-lead Accessories Bundle ICU-IEC H07

5-lead Accessories Bundle OR-AAMI H08

5-lead Accessories Bundle OR-IEC H09

Accessories Bundle Neonatal-AAMI H14

Accessories Bundle Neonatal-IEC H15

3-lead Accessories Bundle ICU-AAMI H16

3-lead Accessories Bundle ICU-IEC H17

G06

G07

G08

G09

Hardware Add-Ons M8102A

Anti-slip pad E18

MMS Mount E20

Add 1X Lithium-Ion battery E24

Add 2X Lithium-Ion battery E26

SN3 ECG Sync Cable SN3

Interface Options

Interfaces M8102A

Instrument Telemetry 1.4 GHz J45

Instrument Telemetry 2.4 GHz J47

3-lead Accessories Bundle OR-AAMI H18

3-lead Accessories Bundle OR-IEC H19

CO2 Mainstream Sensor N01

Reusable Adult Airway Adapter (msCO2) N02

Reusable Infant Airway Adapter (msCO2) N03

Single Use Adult Airway Adapter (msCO2) N04

Single USe Infant Airway Adapter (msCO2) N05

CO2 Sidestream Sensor N11

Non-intubated Adult Airway Adapter (ssCO2) N12

Non-intubated pediatric Airway Adapter (ssCO2) N13

Intubated Adult Airway Adapter (ssCO2) N14

Intubated Pediatric Airway Adapter (ssCO2) N15

Page 19

Philips M8102A User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual