OxiMax N-600x Pulse Oximeter Alarm Management System Operators Manual Rev A

Nellcor, Durasensor, Dura-Y, Max-Fast, OxiCliq, Oxiband, OxiMax, Oxinet, Pedi-Check, SatSeconds, OxiMax SPD Alert, and SoftCare are trademarks of Nellcor Puritan Bennett LLC. The OxiMax N-600x™ pulse oximeter is covered by one or more of the following U.S. patents and foreign equivalents: Patent No. 5,485,847; 5,676,141; 5,743,263; 6,035,223; 6,226,539; 6,411,833; 6,463,310; 6,591,123; 6,708,049; 7,016,715; 7,039,538; 7,120,479; 7,120,480; 7,142,142; 7,162,288; 7,190,985; 7,194,293; 7,209,774; 7,212,847. To obtain information about a warranty, if any, contact Nellcor’s Technical Services Department at 1.800.635.5267 or your local representative. Purchase of this instrument confers no express or implied license under any Nellcor Puritan Bennett patent to use the instrument with any sensor that is not manufactured or licensed by Nellcor Puritan Bennett LLC.

Table Of Contents

Chapter 1.

Safety Information ... 7 Overview ...7 Warnings ...7 Cautions...9

Chapter 2.

General Introduction ... 11 Overview ... 11 Oximeter Description and Intended Use... 11 Description ...11 Intended Use...11

List of Components ... 12 Front Panel ... 13 User Interface...13 Oximeter Visual Indicators...14 Monitoring Values...16 Audible Indicators...17

Rear Panel ... 18 Rear Panel Symbols and Descriptions ...18

Oximeter Features ... 19 OxiMax SPD™ Alert Feature ...19 SatSeconds™ Alarm Management Feature...19 Pulse Rate Delay Alarm Management Feature...23

Oximeter Display View Options... 23 General Care Format (GCF) Display ...23 Plethysmographic (Pleth) Display...24 Blip Display ...24 Real-Time Trend Display...24

Chapter 3.

Setting Up the Oximeter... 27 Safety Reminders ... 27 Connecting to an AC Power Source ... 28 Using Battery Power ... 29 Connecting an OxiMax™ Pulse Oximetry Sensor... 30 Reducing EMI (Electromagnetic Interference) ... 31

Chapter 4.

Operating the Oximeter... 33 Overview ... 33 Monitoring Oximeter Power ... 33 Battery Fuel Gauge ...33 Low Battery Indicator ...34

Powering the Oximeter ... 35 Power Prerequisites...35 Power-on Self -Test (POST) ...35 Operator’s Manual

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Automatic Shutdown and Power Off...36

Using OxiMax™ Pulse Oximetry Sensors... 37 Sensor Detection...37 Sensor Detection Failure ...38

Managing the Oximeter Backlight... 38 Managing the View Display... 39 Using the General Care Format (GCF) Display...39 Using the Pleth Display...40 Using the Blip Display...41 Using the Real-Time Trend Display...42

Adjusting the Volume of Audible Tones ... 45 Adjusting the Pulse Beep Volume...45 Managing Oximeter Alarms ...45 Managing Audible Alarms ...46

Using Oximeter Softkey Menus ... 47 Navigating Menu Options...47 Adjusting the Factory Default Settings...55 Using the OxiMax SPD™ Alert Feature...60 Using the Pulse Rate Delay Alarm Management Feature...63 Using the SatSeconds™ Alarm Management Feature ...64

Chapter 5.

Managing Oximetry Data ... 67 Managing Oximeter Trend Data... 67 Trend Data Basics ...67 Reading the Trend Data Display ...68 Storing Trend Data ...71 Clearing Trend Information...72

Managing OxiMax™ Pulse Oximetry Sensor Data ... 73 Understanding Sensor Messages ...73 Using Sensor Event Records...76

Data Port Connectivity... 83 Overview ...83 Data Port Communications ...85 Data Output Information ...86

Using the Nurse Call Interface ... 90 Nurse Call Feature...90 Setting Nurse Call RS-232 Polarity...91

Calculating the Analog Voltage Output ... 92

Chapter 6.

Using OxiMax™ Pulse Oximetry Sensors and Accessories93 Overview ... 93 OxiMax™ Pulse Oximetry Sensors ... 93 Selecting an OxiMax™ Pulse Oximetry Sensor...93 OxiMax™ Pulse Oximetry Sensor Features ...96 Biocompatibility Testing...96

Optional Accessories ... 96 Overview ...96 GCX Adapter Plate ...97 GCX Wall Mount Arm and Channel ...98 iv

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GCX Roll Stand ...99 Soft-Sided Carrying Case... 100

Chapter 7.

Performance Considerations ... 101 Overview ...101 Performance Considerations ...101 Primary Considerations... 101 Oximetry Considerations... 102 Patient Conditions ... 102

OxiMax™ Pulse Oximetry Sensor Performance Considerations ...102 Safety Information ... 102 Inaccurate Sensor Measurement Conditions... 103 Signal Loss ... 103 Recommended Usage ... 103

Chapter 8.

Troubleshooting ... 105 Overview ...105 Help and Support...105 Technical Services... 105 On-Screen Help... 105

Error Codes...109 Prompts and Error Messages ...109 Primary Speaker Failure...113 Low and Critical Battery Conditions...115 Obtaining Technical Assistance...118 Returning your Oximeter ...118

Chapter 9.

Oximeter Maintenance ... 119 Overview ...119 Cleaning ...119 Periodic Safety Checks ...119 Service...120

Chapter 10.

Theory of Operations ... 121 Overview ...121 Understanding Pulse Oximetry...121 Theoretical Principles ... 121 Automatic Calibration ... 122 Functional versus Fractional Saturation ... 122 Measured versus Calculated Saturation ... 122

Oximeter Features ...123 SatSeconds™ Alarm Management Feature... 123 Pulse Rate Delay Alarm Management Feature... 123 OxiMax SPD™ Alert Feature ... 124 OxiMax™ Pulse Oximetry Sensor Technology... 124

Functional Testers and Patient Simulators ...125

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Chapter 11.

Product Specifications ... 127 Overview ...127 Physical Characteristics...127 Electrical Requirements ...127 Power... 127 Battery ... 127 Rating of Nurse Call Relay ... 128

Environmental Conditions...128 Operating... 128 Transport and Storage... 128

Performance Specifications...128 Measurement Range... 128 OxiMax™ Pulse Oximetry Sensors ... 129

Product Compliance ...130 Product Standards for Compliance ... 130 Product Safety Standards... 130 Electromagnetic Compatibility (EMC) Standards ... 130

Manufacturer’s Declaration...130 Basics ... 130 Electromagnetic Compatibility (EMC) ... 131 Sensor and Cable Compliance ... 133

Safety Tests...134 Ground Integrity... 134 Leakage Current ... 135

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Operator’s Manual

1 Safety Information Overview This section contains safety information requiring users to exercise appropriate caution while using the OxiMax N-600x™ pulse oximeter.

Warnings are identified by the WARNING symbol shown above. Warnings alert you to potential serious outcomes (death, injury, or adverse events) to the patient or user.

Cautions are identified by the CAUTION symbol shown above. Cautions alert the user to exercise care necessary for the safe and effective use of the OxiMax N-600x pulse oximeter.

Notes are identified by the NOTE symbol shown above. Notes are listed before or after procedural steps or information and provide additional guidelines or information on the subject being described.

Warnings WARNING The OxiMax pulse oximetry sensor extrapolates from the date and time provided by the Nellcor OxiMax N-600x pulse oximeter when recording the sensor event record to the sensor. The accuracy of the date/time is determined by the date/time setting of the pulse oximetry monitor. Set the pulse oximeter date and time to the correct value before connecting a record-enabled sensor to keep the date and time consistent for as long as the sensor remains connected. Since a sensor with sensor event record data can be transported from one oximeter to another, having discrepancies in the date/time

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Safety Information

between oximeters and the sensor event record data will affect the order in which the sensor event record data appear. To eliminate this potential problem, set all oximeters within an institution to the same time. WARNING Explosion hazard-Do not use the OxiMax N-600x pulse oximeter in the presence of flammable anesthetics. WARNING Do not spray, pour, or spill any liquid on the pulse oximeter, its accessories, connectors, switches, or openings in the chassis, since this may cause damage to the oximeter. WARNING Supplemental oxygen will attenuate patterns of desaturation. A patient’s respiratory compromise can be proportionally more severe before patterns appear in the saturation trend. Remain vigilant when monitoring a patient on supplemental oxygen. WARNING The LCD panel contains toxic chemicals. Do not touch broken LCD panels. Physical contact with a broken LCD panel can result in transmission or ingestion of toxic substances. WARNING Do not silence or decrease the volume of the OxiMax N-600x pulse oximeter’s audible alarm if patient safety could be compromised. WARNING Failure to cover the OxiMax pulse oximetry sensor site with opaque material in high ambient light conditions may result in inaccurate measurements. Pulse oximetry readings and pulse signals can be affected by certain environmental conditions, OxiMax pulse oximetry sensor application errors, and certain patient conditions. See the appropriate sections of this manual for specific safety information. WARNING The use of accessories, sensors, and cables other than those specified may result in inaccurate readings of the OxiMax N-600x pulse oximeter and increased emission and/ or decreased electromagnetic immunity of the oximeter . WARNING When installing the pulse oximeter’s AC power cord, ensure the cord is carefully positioned to prevent tripping and entanglement.

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Cautions

Cautions Caution When connecting the OxiMax N-600x pulse oximeter to any instrument, verify proper operation before clinical use. Both the pulse oximeter and the instrument connected to it must utilize a grounded outlet. Accessory equipment connected to the pulse oximeter’s data interface must be certified according to IEC Standard 60950 -1: 2005 for data-processing equipment or IEC Standard 60601-1:1988 + A1:1991 + A2:1995 for electromedical equipment. All combinations of equipment must be in compliance with IEC Standard 60601-1-1:2000 Requirements for Medical Electrical Systems. Anyone connecting additional equipment to the signal input port or signal output port (data port connector) is configuring a medical system and, therefore, is responsible for ensuring that the system complies with the Requirements for Medical Electrical Systems IEC Standard 60601-1-1:2000 and the electromagnetic compatibility IEC Standard 60601-1-2:2001 + A1:2004. Oximeter accuracy may degrade if it is connected to secondary I/O devices when the equipment is not connected to earth reference. Caution Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. Caution Dispose of battery in accordance with local requirements and regulations.

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2 General Introduction Overview WARNING The OxiMax N-600x pulse oximeter is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms.

This manual contains information for operating the OxiMax N-600x™ pulse oximeter. Before operating the oximeter, thoroughly read the N-600x Operator's Manual. The latest version of this manual is available on the Internet at: http://www.nellcor.com/serv/manuals.aspx

Oximeter Description and Intended Use Description The OxiMax N-600x pulse oximeter provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. With the proper firmware, activation of the pulse oximeter’s OxiMax SPD™ Alert (SPD) feature is possible.

Intended Use The OxiMax N-600x pulse oximeter is intended for prescription use only with neonatal, pediatric, and adult patients who are well or poorly perfused in hospitals, hospital-type facilities, intra-hospital transport, and home environments. The OxiMax SPD™ Alert (SPD) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs. Note: Intended typical usage may be defined to include the following for the OxiMax N-600x pulse oximeter:

•

Hospital use typically covers such areas as general care floors (GCFs), operating rooms, special procedure areas, intensive and critical care areas within the hospital and in hospital-type facilities. Hospital-type facilities include physician office-based facilities, sleep labs, skilled nursing facilities, surgicenters, and sub-acute centers.

• •

Intra-hospital transport includes transport of a patient within the hospital or hospital-type facility. Homecare use involves a lay person (parent or other similar non-critical caregiver) in the home environment.

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General Introduction

Use with any particular patient requires the selection of an appropriate OxiMax™ pulse oximetry sensor. Refer to Using OxiMax™ Pulse Oximetry Sensors and Accessories, page 93. Through the use of the four softkeys, users can access trend information, change alarm limits, adjust the internal time clock, select the communications protocol, and choose the interface language native to the language of the facility, caregiver, or user. See Using Oximeter Softkey Menus, page 47. Figure 1. Front Panel Menu Softkeys

The oximeter can operate on AC power or on an internal battery. The controls and indicators for the oximeter are illustrated and identified in OxiMax N-600x Pulse Oximeter Front Panel, Figure 2 on page 13 and OxiMax N-600x Pulse Oximeter Rear Panel, Figure 3 on page 18.

List of Components The typical OxiMax N-600x pulse oximeter carton ships with the following packing list of contents. Table 1. Typical Packing List Quantity

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Item

1

OxiMax N-600x pulse oximeter

1

Nellcor OxiMax pulse oximetry sensor or assortment pack

1

DOC-10 pulse oximetry cable

1

N-600x Operator’s Manual (applicable to country of sale) and/or compact disc

1

Hospital-grade power cord (applicable to country of sale)

2

Fuses, 0.5 A, 250 volts, slow-blow, IEC (5 x 20 mm)

1

N-600x Quick Guide

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Front Panel

Front Panel Figure 2. OxiMax N-600x Pulse Oximeter Front Panel

Table 2. List of Front Panel Components 1

SpO2 Sensor Port

14

ADJUST UP & DOWN Keys

2

Low Battery Indicator

15

Pulse Rate (BPM) Upper Limit Value

3

AC Power Indicator

16

Pulse Rate (BPM) Lower Limit Value

4

ON/STANDBY Key

17

Neonate Mode Icon

5

Battery Fuel Gauge

18

HELP/CONTRAST Key

6

SatSeconds™ Icon & Limit Value

19

Fast Response Mode Icon

7

SPD Icon & Sensitivity Value

20

Pulse Rate (BPM)

8

Blip Bar

21

Menu Selection Softkeys

9

%SpO2 Real-time Value

22

Menu Bar

10

%SpO2 Upper Limit Value

23

Data In-Sensor Indicator

11

%SpO2 Lower Limit Value

24

Interference Indicator

12

Alarm Silence Indicator

25

Pulse Search Indicator

13

ALARM SILENCE Key

26

Oximeter Speaker

User Interface Note: Pressing a key, except the ON/STANDBY key, should result in either a valid or an invalid tone. If the key pressed fails to emit a tone, contact a qualified service technician.

ON/STANDBY Key-Use to turn the oximeter on and off. ALARM SILENCE Key-Use to silence ANY current alarms for the alarm silence duration period. After silencing an alarm, press the key again to reactivate the alarm. Additionally, use it to view and adjust alarm silence duration and alarm volume. The ALARM SILENCE key clears “SENSOR OFF,” “LOW BATTERY,” and “SENSOR DISCONNECT” Operator’s Manual

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General Introduction

messages from the display. It lights continuously when an audible alarm has been silenced. It flashes when the alarm silence duration has been set to OFF. WARNING Pressing ALARM SILENCE will keep ALL alarms from sounding for the alarm silence duration period. WARNING Should the caregiver silence an SPD alarm, this resets the index that tracks repetitive patterns of desaturation and silences ALL alarms. Caution Should the caregiver fail to clear a primary audible alarm within two (2) minutes, a secondary alarm with a unique pitch sounds.

ADJUST UP Key -Use to increase variable parameters of the oximeter. ADJUST DOWN Key-Use to decrease variable parameters of the oximeter. HELP/CONTRAST Key-Use to access the on-screen help or adjust the screen contrast. • Press and release the HELP/CONTRAST key to launch on-screen help. • Press and hold the HELP/CONTRAST key while simultaneously pressing the ADJUST UP and ADJUST DOWN keys to increase or decrease the contrast of the display screen.

Softkey Menu Bar-Use to display the current softkey menu functions.

Oximeter Visual Indicators AC Power Indicator-Lights continuously when connected to an AC power source and also shows when the battery is charging. Does not light when the oximeter is running on the internal battery. Low Battery Indicator- Lights continuously when 15 or fewer minutes of battery capacity remain, then flashes when the battery capacity reaches a critically low condition. Pulse Search Indicator-Lights continuously prior to initial acquisition of a pulse signal and during prolonged, challenging monitoring conditions. The pulse search indicator flashes during a loss-of-pulse signal. Interference Indicator-Lights whenever the oximeter algorithm detects the incoming signal quality is degraded. An intermittently lit Interference Indicator is common during patient monitoring, and indicates the oximeter algorithm is dynamically adjusting the amount of data required for measuring SpO2 and Pulse Rate. When lit continuously, the oximeter algorithm has extended the amount of data required for measuring SpO2 and Pulse Rate. In this case, fidelity in tracking rapid changes in these values may be reduced. Note: Degradation can be caused by ambient light, poor sensor placement, electrical noise, electro-surgical interference, patient activity, or other causes.

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Front Panel

Data In-Sensor Indicator-Lights to indicate that the attached OxiMax pulse oximetry sensor contains a patient sensor event record. The sensor event record information may be viewed or printed. Battery Fuel Gauge-Displays the battery charge remaining on the oximeter. The battery fuel gauge consists of four bars, each corresponding to approximately 1.5 hours of operating time. All four bars are lit when the battery is fully charged. No bars are lit when a low battery condition exists. Visible in all display views. See Battery Fuel Gauge, page 33. Plethysmographic (pleth) Waveform-This non-normalized waveform uses realtime sensor signals, reflecting relative pulsatile strength and quality of incoming signals. This indicator is only available in the pleth display view. Pulse Amplitude (blip bar)-Indicates pulse beat and the relative (non-normalized) pulse amplitude. As the detected pulse becomes stronger, more bars light with each pulse. This indicator is only available in the blip and general care format (GCF) display views. %SpO2 Value-Indicates hemoglobin oxygen saturation levels. The display value flashes zeros during loss-of-pulse alarms and flashes the %SpO2 value when the SpO2 is outside the alarm limits. The oximeter continues to update the display during Pulse Search. Current upper and lower alarm limit settings appear as smaller values to the right of the dynamic %SpO2 value. Visible in all display views. Pulse Rate Value-Displays the pulse rate in beats per minute. It flashes during loss-of-pulse alarms and when the pulse rate is outside of the alarm limits. During Pulse Search, the oximeter continues to update the display. Pulse rates outside of the pulse rate range of 20 to 250 bpm are displayed as 0 and 250, respectively. Current upper and lower alarm limit settings appear as smaller values to the right of the dynamic pulse rate value. Visible in all display views. Saturation Pattern Detection (SPD) Icon-The OxiMax SPD™ Alert (SPD) feature detects patterns of desaturation in the SpO2 trend in adults. When the SPD feature is enabled, the oximeter detects patterns of desaturation indicative of repetitive reductions in airflow through a patient’s upper airway into the lungs. When the SPD feature detects patterns of desaturation in the SpO2 trend in adults, caregivers are alerted to these patterns via a visual indicator, and optionally, an audio alarm. The triangle icon for SPD appears on the monitor display when the feature is enabled. The triangle fills from the bottom to the top as patterns become more severe. The triangle empties from top to bottom as the patterns become less severe. If the triangle fills, an alarm sounds. With SPD enabled, the default setting is On with the sensitivity set to 1. The feature can be turned off in the LIMITS menu. Caregivers can select from three alarm sensitivity settings: 1 (most sensitive), 2 (medium sensitivity) or 3 (least sensitive), with 1 resulting in more alarms and 3 resulting in fewer alarms. The rate at which the SPD icon fills depends on the SPD sensitivity setting. To explore activation, contact Nellcor’s Technical Services Department at 1.800.635.5267 or your local Nellcor representative. To use the feature, reference Using the OxiMax SPD™ Alert Feature, page 60.

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SatSeconds Icon-The SatSeconds feature provides alarm management for mild or brief SpO2 limit violations. When the SatSeconds feature is enabled, the SatSeconds circle icon fills in the clockwise direction as the SatSeconds alarm management system detects SpO2 readings outside of the limit setting. The SatSeconds icon empties in counterclockwise direction when SpO2 readings are within limits. When the SatSeconds icon reaches full, a medium priority alarm sounds. Visible in all display views. For more information about using the feature, reference Using the SatSeconds™ Alarm Management Feature, page 64. Fast Response Mode Icon-Appears at bottom right of the menu bar when enabled. The oximeter algorithm responds to changes in the SpO2 data at differing rates: two to four seconds in Fast Mode and five to seven seconds in Normal Mode when calculating %SpO2. The response mode setting does not affect the algorithm’s calculation of pulse rate, nor does it influence the recording of trend data, which occurs at one-second intervals. The response mode, however, may impact the SPD alarm behavior. Visible in all display views when enabled. For more information about using the feature, reference To set the response mode, page 54. Neonate Alarm Limits Icon-Appears at the bottom far right of the menu bar when enabled. Visible when the alarm limits are set to neonate limit values, but not when set to adult limit values. For more information about using the feature, reference To set adult or neonatal modes, page 58.

Monitoring Values WARNING Failure to cover the OxiMax pulse oximetry sensor site with opaque material in high ambient light conditions may result in inaccurate measurements.

The OxiMax N-600x pulse oximeter continuously assesses the quality of the pulse oximetry signal while monitoring patient SpO2 and pulse rate. Oximeter front panel values reflect the data derived from monitoring. The N-600x pulse oximeter algorithm automatically extends the amount of data required for measuring SpO2 and pulse rate depending on the measurement conditions. • Normal conditions-During normal measurement conditions the averaging time is six to seven seconds (approximately three seconds in Fast Mode).

• Brief abnormal conditions-During conditions such as those caused by low perfusion, interference (e.g., external interference like ambient light), or a combination of these, the oximeter automatically extends the amount of data required beyond seven seconds. If the resulting dynamic averaging time exceeds 20 seconds, the pulse search indicator is lit solid and %SpO2 and Pulse Rates update every second.

• More severe conditions-As these conditions extend, the required amount of data continues to increase. If the dynamic averaging time reaches 40 seconds, the pulse search indicator flashes to denote a loss-of-pulse condition and %SpO2 and pulse rate flash values of zero. This activates the audible alarm state.

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Front Panel

Audible Indicators Audible indicators include pitched tones and beeps. Caregivers may choose to silence alarms by pressing the ALARM SILENCE key. WARNING Pressing ALARM SILENCE will keep ALL alarms from sounding for the alarm silence duration period. Caution Should the caregiver fail to clear a primary audible alarm within two (2) minutes, a secondary alarm with a unique pitch sounds. Table 3. Audible Indicator Functions Function

Description

Alarm Silence Reminder

Three beeps sound approximately every three minutes with the alarm silence duration set to OFF and the alarm silence reminder function enabled.

Piezo Tone

A high-pitched piezo tone sounds if there is no user response to an audible alarm, or if the oximeter detects a failure of the primary speaker.

Pulse Beep

Single beep sounds for each detected pulse. The pitch of the pulse beep signal changes with a point-by-point rise or fall in the saturation level.

High Priority Alarm

High-pitched, fast-pulsing tone indicates loss-of-pulse. Note: If a High Priority Alarm is not silenced within 30 seconds by pressing the ALARM SILENCE key, the oximeter increases the urgency level of the audible alarm signal by alternating a piezo tone with the primary alarm tone.

Medium Priority Alarm

Medium-pitched, pulsing tone indicates an SpO2 or pulse rate limit violation. Note: If a Medium Priority Alarm is not silenced within two minutes by pressing the ALARM SILENCE key, the oximeter increases the urgency level of the audible alarm signal by alternating a piezo tone with the primary alarm tone.

Low Priority Alarm

Low-pitched, slow-pulsing tone at 3.5 second intervals indicates an OxiMax pulse oximetry sensor disconnect, low battery, or oximeter failure. Note: If a Low Priority Alarm is not silenced within two minutes by pressing the ALARM SILENCE key, the oximeter increases the urgency level of the audible alarm signal by alternating a piezo tone with the primary alarm tone.

SPD Alarm

A trio of quick high-, medium-, high-pitched tones at 2.5 second intervals.

High SpO2Alarm

A pair of quick medium-pitched tones followed by a high-pitched pulsing tone at 2.5 second intervals.

Power-On Self-Test Pass

One-second tone indicates the oximeter has been turned on and has successfully completed the power-on self-test.

Confirmation Tone

Three beeps sound to confirm default settings are either saved or reset to factory defaults, or the trend data has been deleted.

Invalid Softkey Press

Quick, low-pitched tone indicates a softkey has been pressed that is inappropriate for the current state of the oximeter.

Valid Softkey Press

Quick, medium-pitched tone indicates appropriate softkey has been pressed.

Volume Setting Tone

Continuous tone indicates alarm volume adjustment.

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General Introduction

Rear Panel Figure 3. OxiMax N-600x Pulse Oximeter Rear Panel

Table 4. Rear Panel Components 1

Equipotential Terminal (Ground)

2

AC Power Connector

3

Data Port Connector

4

Fuse Holder

5

Supply Voltage Selector Switch

Rear Panel Symbols and Descriptions Warning! See Instructions for Use Fuse replacement Equipotential terminal (ground) Date of manufacture Data interface Proper WEEE Waste Disposal Type BF applied part - Not defibrillator proof

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Oximeter Features

Oximeter Features OxiMax SPD™ Alert Feature The OxiMax SPD™ Alert (SPD) feature detects patterns of desaturation in adults that are indicative of repetitive reductions in airflow through a patient's upper airway into the lungs. Relative reductions in a patient's minute ventilation over a period of time may cause a progressive drop in alveolar partial pressure of oxygen, leading to arterial desaturation. If these decreases in ventilation are repetitive, they generate distinct patterns in the saturation trend. Patterns of repetitive desaturation often develop gradually over time, increasing in severity. Detection of patterns indicates that a patient might be suffering progressively severe decrements in airflow that may increase in acuity if left untreated. Patterns of desaturation are multiple, sequential occurrences of a desaturation followed by a resaturation. The SPD feature qualifies patterns of desaturation resulting from such repetitive reductions in airflow based on specific characteristics. • The severity of the desaturation event (the depth of the desaturation during the event) and the extent of the following resaturation

• The regularity of the desaturation events (how often the pattern repeats) • The slope of the desaturation/resaturation trends that form the events The SPD feature qualifies these patterns of desaturation over a period of six (6) minutes. Depending on the sensitivity setting for SPD, patterns that persist may result in an SPD alarm, alerting the caregiver to the condition. Figure 4. Clinically Significant Desaturation Patterns

Reference Oximeter Display View Options, page 23, Managing the View Display, page 39, Using the OxiMax SPD™ Alert Feature, page 60, and OxiMax SPD™ Alert Feature, page 124 for details.

SatSeconds™ Alarm Management Feature The oximeter monitors the percentage of hemoglobin binding sites saturated with oxygen in the blood. With traditional alarm management, upper and lower alarm Operator’s Manual

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General Introduction

limits are set to alarm at specific SpO2 levels. When the SpO2 level fluctuates near an alarm limit, the alarm sounds each time it violates the alarm threshold. SatSeconds monitors both degree and duration of desaturation as an index of desaturation severity. Thus, the SatSeconds feature helps distinguish clinically significant events from minor and brief desaturations that may result in nuisance alarms. Figure 5. First SpO2 Event: No SatSeconds Alarm

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