Bedside Respiratory Patient Monitoring System In Service Presentation Oct 2013

10/3/2013

Absorption of Light

Absorption and light output

HbO2 and Hb Absorb Red and Infrared Lights Differently

Red LED

IR LED

Hb

HbO2 600

700

800

900

1000

Wavelength (nm)

Far red Near infrared

Source: A Technology Overview of the Nellcor™ OxiMax™ Pulse Oximetry System; Nellcor Technical Staff

3|

COVIDIEN Respiratory & Monitoring Solutions | October 3, 2013 | Confidential

Calibration Curve to Calculate SpO2 Pulsating blood modulates red and IR light. • High SaO2: Red pulse amplitude is smaller. • Low SaO2: Infrared pulse amplitude is smaller.

Red (660 nm)

IR

Pulse oximeters measure R and then estimate SpO2by applying a calibration curve.

Modulation ratio (R)

(900 nm)

Red IR Calibration curve

Observed R

SpO2 50

60

70

80

90

100

SaO2 (%) Source: A Technology Overview of the Nellcor™ OxiMax™ Pulse Oximetry System; Nellcor Technical Staff

4|

COVIDIEN Respiratory & Monitoring Solutions | October 3, 2013 | Confidential

2

10/3/2013

Nellcor™ Auto-Adjusting Cardiac-Gated Averaging (CGA) Averaging is increased when incoming signal quality is poor.

Avg. PR interval

Oldest data

…

Most recent PR interval Prior composite signal

· (1-ω) +

New composite signal

·ω =

Weighting (ω) ranges between approximately 0 and 1

• Signals from successive pulse intervals are averaged to create a “composite” signal. • Portions synchronous with the heartbeat pass through the signal processing, while random interference is attenuated by the averaging process. • Individual pulse weights are based on the quality of incoming signals.

Source: “Digital Signal Processing Technology in Nellcor™ OxiMax™ Pulse Oximeters,” Paul D. Mannheimer, PhD; Clark R. Baker; and the Nellcor Technical Staff.

5|

COVIDIEN Respiratory & Monitoring Solutions | October 3, 2013 | Confidential

Dealing with Signal Interference: A Comparison Cardiac-Based Algorithm

• Assumes random signal interference will occur, but it won’t occur consistently at the heart rate • Focuses on the true cardiac signal to obtain the true arterial saturation

Saturation-Based Algorithm

• Assumes signal interference comes from moving venous blood & suggests that SpO2 can be calculated without first extracting a physiological pulse • Estimates SpO2 from the peak with the highest value of saturation on the saturation power density graph Peak has highest value of saturation

Output energy

True cardiac signal

70

Saturation

100

Source: Internal Covidien research and documentation

6|

COVIDIEN Respiratory & Monitoring Solutions | October 3, 2013 | Confidential

3

10/3/2013

Covidien’s Nellcor™ Signal Processing: Balancing Signal Fidelity & Signal Interference

Signal Interference

Signal Fidelity

Signal Fidelity:

Signal Interference:

To display true physiological value with high accuracy

Electrical interference Ambient light Optical shunting Low perfusion Venous pulsation

Signal Processing Alarm Management System

7|

COVIDIEN Respiratory & Monitoring Solutions | October 3, 2013 | Confidential

Over-processing a signal to cancel out interference often comes at the cost of signal fidelity and can mask a true event.

Similar methodology in Kästle SW, Konecny E. Determining the artifact sensitivity of recent pulse oximeters during laboratory benchmarking. J Clin Monit Comput. 2000; 16(7): 509-522.

8|

COVIDIEN Respiratory & Monitoring Solutions | October 3, 2013 | Confidential

4

10/3/2013

Clinical Recording of Repeated Desaturation

SpO2 (%)

100 90 80 70

Pulse Rate (BPM)

60

9|

160 140 120 100 0:00

0:30

1:00

1:30

2:00

2:30

3:00 3:30 4:00 Elapsed time (m:ss)

4:30

5:00

5:30

6:00

6:30

7:00

COVIDIEN Respiratory & Monitoring Solutions | October 3, 2013 | Confidential

How Nellcor™ Pulse Oximetry “Deals with Signal Interference”

SpO2(%)

100 90 80 70 60

True value

Pulse rate (BPM)

160 140 120 100 0:00

0:30

1:00

1:30

2:00

2:30

3:00

3:30

4:00

4:30

5:00

5:30

6:00

6:30

7:00

Elapsed time (m:ss)

10 |

COVIDIEN Respiratory & Monitoring Solutions | October 3, 2013 | Confidential

5

10/3/2013

Over processing a signal can lead to the display of something that isn’t even happening.

Similar methodology in S. W. Kästle and E. Konecny, “Determining the Artifact Sensitivity of Recent Pulse Oximeters During Laboratory Benchmarking,” Journal of Clinical Monitoring and Computing, September 2000, Vol. 16, No. 7, pp. 509–522.

11 |

COVIDIEN Respiratory & Monitoring Solutions | October 3, 2013 | Confidential

How Competing Pulse Oximetry “Deals with Signal Interference”

SpO2

100 90 80 70 60

True value

Pulse rate

160 140 120 100 0:00

0:30

1:00

1:30

2:00

2:30

3:00

3:30

4:00

4:30

5:00

5:30

6:00

6:30

7:00

Elapsed time (m:ss)

12 |

COVIDIEN Respiratory & Monitoring Solutions | October 3, 2013 | Confidential

6

10/3/2013

New Bedside Respiratory Lamp Monitor

15 | October 3, 2013

Features • Nellcor Oximax Low Saturation Cardiac Based technology • Field Upgradable via USB port • Colour touch screen • 48 hours trend data storage • Sat Seconds and Saturation Pattern Detection software • Connectivity to Philips Vuelink • Easy to change battery, with 6 hour battery life • Easy access for Biomed Service and Log mode

16 | October 3, 2013

8

10/3/2013

Monitor Front Panel Monitoring Screen Power on/off Key

AC Indicator Speaker

Sensor Port

Parameter Module

Monitor Side Panel

Data port (DB-15)

Ethernet Port (RJ-45) Universal Serial Bus Port (USB)

9

10/3/2013

Monitor Rear Panel

Equipotential Terminal (Ground) AC Power Connecter Fuse Drawer

Monitor Rear Panel (cont.)

Carrying Handle

Screw hole for adapter plate Internal battery access

Parameter Module

10

10/3/2013

Monitor User Interface Default Screen

Dynamic % SpO2 value w upper and lower limits

Pulse Rate Real time value w upper and lower limits

Silence Alarm

Menu Selection

Help Information

Lock key

Monitor User Interface Default Screen (cont.) Monitoring Status Field

Battery Fuel Gauge Date & Time Field

Alarm Status Field

11

10/3/2013

Monitor User Interface Default Screen (cont.) Trend Data Type Button

Trend Data Time Scale Button Pleth Waveform

Trend Data Graph

Monitor User Interface Default Screen (cont.) SatSeconds Icon & Limit Value SPD Icon & Sensitivity Value Response Mode

Pulse Beat Icon

12

10/3/2013

Alarm Display Monitor Status Field displays alarms and notifications

Alarm is displayed with yellow background

Alarm Silence Button

(Silenced Icon)

SatSeconds Alarm Management If the oxygen saturation is outside the limits… SatSeconds = [SAT POINTS BELOW THRESHOLD] • 100 98 96 94

× [SECONDS]

Navigate from the default screen to the monitoring history screen •Adjust the time scale to review the last hour of trend data for your patient •Determine what your patient’s SpO2 reading was 30 minutes ago

92

Alarm Threshold

90

6%

1%

88

10%

15 sec 15 SatSeconds™

86 84

2 sec

82

12 SatSeconds™

Alarm 2.5 sec

80

25 SatSeconds™

78

Time Seconds

76 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 54 56 58 60 TIME

26 | Covidien Respiratory and Monitoring Solutions

| October 3, 2013 | Confidential

13

10/3/2013

OxiMax SPD Alert The OxiMax SPD alert detects patterns of desaturation that are indicative of repetitive reductions in airflow in adults, which may be the result of a lower level of consciousness and an abnormal airway. SPD alert occurs 20 minutes before serious desat

(SpO2)

100 90 80 70 0

0

10

20

30

Time (min)

27 | Covidien Respiratory and Monitoring Solutions

| March 1, 2012 | Confidential

What Can Patterns Tell Us? Decreased level of consciousness

+

Potential respiratory issues: Central apnea

Upper airway edema

Obstructive sleep apnea

Airway anatomic abnormality

Expanding airway hematoma

Others…

Repetitive reductions in airflow

Patterns of desaturation

COVIDIEN Respiratory & Monitoring Solutions

The OxiMax SPD™ feature detects the patterns that are indicative of repetitive reductions in airflow. Note: OxiMax SPD™ alert is intended for adult in-hospital use only. Do not use OxiMax SPD™ alert with pediatric or neonatal patients.

| Confidential

14

10/3/2013

Introduction to Menu Options

Press the Menu Button to access Menu Options

Alarm Limits Sub-menu Provides access to adjust alarm settings

15

10/3/2013

Adjusting Alarm Limits Slide the bar or Use the arrows

Shortcut to Adjust Alarm Limits (SpO2 and Pulse) SpO2 Limit Shortcut Touch Here

Pulse Rate Limit Shortcut Touch Here

16

10/3/2013

SatSeconds Settings Press the desired SatSeconds setting

Monitoring History Time Scale

Visible Trend Field

Clear Historical Trend Data

Scroll Bar

17

10/3/2013

Sound Settings Menu Press to Adjust Volume Level Lower

Press to Adjust Volume Level Higher

Display Settings Menu

Pleth and Trend

Pleth Only

Trend Only

Numbers Only

18

10/3/2013

Other Settings

Saving the Institutional Settings During Power On: 1.

Enter the Service Menu

2.

Enter the Service Code

3. 4.

Make the necessary alarm limits changes Save the settings - Monitor will restart

62907

19

10/3/2013

Installing the Battery 1.

Remove the battery door

2.

Insert the battery in the battery compartment

3.

Replace the battery door

39

Key Take – Away’s •

Motion artifact is very complex (it’s not just pulsing venous blood).

•

Real-world motion is random and chaotic in clinical settings (not rhythmic and persistent).

•

All vendors, except for one, use a cardiac based approach to filter artifacts (Nellcor™ OxiMax™ looks for a pulse).

•

Nellcor Oximax is the latest in a Digital based Low Saturation SpO2 platform which utilises the Cardiac Based technology.

•

OxiMax™ outperforms during clinically relevant motion.

•

Fundamentals of the new Respiratory Bedside Monitor

40 |

COVIDIEN Respiratory & Monitoring Solutions | October 3, 2013 | Confidential

20

10/3/2013

41 |

COVIDIEN Respiratory & Monitoring Solutions | October 3, 2013 | Confidential

21