SpO2 Module Model 8220 Series Directions for Use Rev 00

GENERAL CONTACT INFORMATION

Customer Advocacy - North America Clinical and technical feedback. Phone: (800) 854-7128, Ext. 7812 E-Mail: [email protected]

Technical Support - North America Maintenance and service information support; troubleshooting. United States: Phone: (858) 458-6003 (800) 854-7128, Ext. 6003

Canada: Phone: Eastern: (800) 908-9918 Western: (800) 908-9919

Customer Care - North America Instrument return, service assistance, and order placement. United States: Phone: (800) 482-4822

Canada: Phone: (800) 387-8309

TABLE OF CONTENTS INTRODUCTION ABOUT THE SpO2 MODULE... Principle of Operation... FEATURES AND DEFINITIONS... SYMBOLS...

1 1 2 4

GETTING STARTED WARNINGS AND CAUTIONS... General... Sensors and Cables... MEASUREMENTS... OPERATING FEATURES, CONTROLS AND INDICATORS... INSTALLATION... ATTACHING AND DETACHING MODULES... DISPLAYS... Main Display... START-UP... Powering On System... Responding to Maintenance Reminder... Selecting New Patient and Profile Options... Entering Patient ID... Modifying Patient ID... GENERAL SETUP AND USE...

5 5 6 7 9 10 10 10 10 10 10 10 10 10 10 11

PROGRAMMING MONITORING MODE... Navigating Main Display... Setting Alarm Limits... Navigating Trend Data... Navigating PCA / SpO2 Trend Data... Presilencing Alarm... CHANNEL OPTIONS... Changing Limit Mode... Changing Pulse Beep Volume... Changing Saturation Averaging Time... Changing Sensitivity Mode... POWERING OFF... Powering Off System... Powering Off Module... REVIEWING SERIAL NUMBER... REVIEWING SOFTWARE VERSION...

13 13 14 16 18 20 21 21 22 22 23 24 24 24 24 24

ALARMS AND MESSAGES DEFINITIONS... AUDIO CHARACTERISTICS... ALARMS... MESSAGES...

SpO2 Module, 8220 Series Directions for Use

25 25 25 26

TABLE OF CONTENTS i

MAINTENANCE SPECIFICATIONS... CONFIGURABLE SETTINGS... System Settings... SpO2 Module Settings... CLEANING... INSPECTION REQUIREMENTS... SERVICE INFORMATION... WARRANTY...

27 29 29 29 29 30 30 31

APPENDIX ACCESSORIES... Masimo® LNOP® Sensors... Masimo® SET® Patient Cables...

ii TABLE OF CONTENTS

33 33 34

SpO2 Module, 8220 Series Directions for Use

INTRODUCTION INTRODUCTION

About the SpO2 Module The Medley™ SpO2 Module is indicated for continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate measured by an SpO2 sensor. The SpO2 Module and accessories are indicated for use with adult, pediatric and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities. Only 1 SpO2 Module can be connected to a Medley™ Point-ofCare Unit. NOTE: The Medley™ Point-of-Care Unit was formerly known as the Medley™ Programming Module.

The SpO2 Module uses a wide variety of Masimo® PC patient cables and Masimo® LNOP® series sensors. The Masimo® cables and sensors are designed for use with the Model 8220 SpO2 Module. For specific directions for use, refer to the cable and sensor packaging. Contraindications: The SpO2 Module with Masimo® PC patient cables and Masimo® LNOP® series sensors are contraindicated for use as an apnea monitor. This document provides directions for use for the Medley™ SpO2 Module, Model 8220.

WARNING Read all instructions, for both the SpO2 Module and Point-of-Care Unit, before using the Medley™ System.

Principle of Operation The operation of the Medley™ SpO2 Module is based on the principles of pulse oximetry. Oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light (spectrophotometry). The volume of arterial blood in tissue and the light absorbed by the blood changes during the pulse (plethysmography). Because oxyhemoglobin and deoxyhemoglobin differ in light absorption, the amount of red and infrared light absorbed by blood is related to hemoglobin oxygen saturation.

SpO2 Module, 8220 Series Directions for Use

INTRODUCTION 1

About the SpO2 Module (Continued) Principle of Operation (Continued) The SpO2 Module uses the Masimo® Signal Extraction Technology® (SET®) to decompose the red and infrared pulsatile absorbance signal into an arterial signal plus a noise component. Its value is used to find the SpO2 saturation in an empirically derived equation in the Masimo® SET® software. The values in the look-up table are based on human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia states during motion and nonmotion conditions.

Features and Definitions Reference the “Alarms, Errors, Messages” chapter of the Medley™ Point-of-Care Unit Directions for Use (DFU) for the definitions of various alerts. Reference the Point-of-Care Unit DFU for system features and definitions. % SpO2 Alarm Limits

Upper and lower saturation alarm limits are displayed.

% SpO2 Display

Functional arterial hemoglobin oxygen saturation is displayed in units of percentage SpO2.

Fast SAT

When Fast SAT is enabled and there is 1 data point that is significantly different from a previous data point, averaging is disregarded and most recent data point is displayed. For example, if readings were 97%, 96%, 95% and 85%, displayed saturation level would be 85%.

Limit Mode

Displays either adult or neonatal monitoring mode.

PI

Perfusion Index (PI) is a scaled numeric value derived from magnitude of pulsations displayed on plethysmographic (pleth) waveform. It is calculated as a percentage of pulsatile signal to nonpulsatile signal. PI is used to find best perfused site for sensor placement (larger the PI, stronger the perfusion). Operating range is 0.02 to 20.0. Desired number is >1.00 or as large as possible.

Pleth Waveform

Plethysmographic (pleth) waveform is a graphic representation of changes in extremity blood volume during events of cardiac cycle.

Presilence

Alarms can be presilenced for 120 seconds. Presilence alarm can be cancelled before 120 seconds are complete.

Pulse Beat Volume

Can be configured to be off or to a volume level of 1, 2 or 3.

2 INTRODUCTION

SpO2 Module, 8220 Series Directions for Use

Features and Definitions (Continued) Displayed in beats per minute (bpm).

Pulse Rate Alarm Limits

Upper and lower limits are displayed.

Saturation Averaging Time

Averaging time can be set to 2, 4, 8, 10, 12, 14 or 16 seconds.

Sensitivity Mode

Sensitivity mode, normal or maximum, of current monitoring configuration is displayed in options mode. Normal setting is used for normal patient monitoring purposes. Maximum setting is used for improved low perfusion performance.

SET® Technology

Signal Extraction Technology® (SET®) uses adaptive filters to separate arterial signal from nonarterial noise. SET® provides for accurate readings under extreme conditions; such as, low perfusion and motion.

Signal I.Q.™ Feature

A visual indication of pulsation at sensor site. Vertical bar height indicates quality of measured signal. Signal I.Q.™ feature is related to proper sensor application, adequate arterial signal and intensity of motion. Use Signal I.Q.™ feature to verify optimal sensor placement.

Trend Data

A tabular display of %SpO2 and Pulse Rate. Display shows alarm conditions for time period displayed and average, high and low values. Data is stored for 24 hours.

SpO2 Module, 8220 Series Directions for Use

INTRODUCTION 3

INTRODUCTION

Pulse Rate

Symbols Attention: Refer to accompanying documentation.

+

75

Canadian and U.S. Certification Mark: Products bearing this mark have been tested and certified in accordance with applicable U.S. and Canadian electrical safety and performance standards (CSA C22.2 No. 601.1, UL 60601–1). Consult operating instructions.

Electrical Shock Protection Rating: Type BF applied part. IPX1

Protection against fluid ingress: Drip Proof IUI Connector: Inter-Unit Interface connector used to establish power and communications between Point-of-Care Unit and attached modules.

Manufacturing Date: Number adjacent to symbol indicates month and year of manufacture. MM-YYYY

CAUTION: Federal (U.S.A.) law restricts this device to sale by or on order of a physician. Do not use if package is damaged.

4 INTRODUCTION

SpO2 Module, 8220 Series Directions for Use

GETTING STARTED Warnings and Cautions Warnings and Cautions provided throughout this Directions for Use (DFU) provide information needed to safely and effectively use the Medley™ SpO2 Module and accessories. Medley™ System Warnings and Cautions, and definitions, are covered in the Point-of-Care Unit DFU. GETTING STARTED

General WARNINGS • The SpO2 Module is NOT to be used as an apnea monitor. • Pulse oximetry readings and pulse signal can be affected by certain ambient conditions, sensor application errors and certain patient conditions. • The SpO2 Module is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. • The SpO2 Module should be considered an early warning device. As a trend towards patient deoxygenation is indicated, blood samples should be analyzed by a laboratory CO-Oximeter to completely understand the patient’s condition. • Interfering Substances: Carboxyhemoglobin and methemoglobin may erroneously increase readings. The level of increase is approximately equal to the amount of carboxyhemoglobin present. Dyes, or any substance containing dyes, that change usual arterial pigmentation may cause erroneous readings. • Do not use the SpO2 Module or sensors during Magnetic Resonance Imaging (MRI). • The SpO2 Module is not rated for defibrillation use. Disconnect the sensor from the patient or patient cable from the module prior to defibrillation. • If an alarm condition on the SpO2 Module occurs while the audio alarm is silenced, the only alarm indications will be visual displays and symbols related to the alarm condition.

SpO2 Module, 8220 Series Directions for Use

GETTING STARTED 5

Warnings and Cautions (Continued) General (Continued) WARNINGS • Check alarm limits each time the SpO2 Module is used, to ensure they are appropriate for the patient being monitored. • Do not lift the SpO2 Module by the cable or power cord because the cable or cord could disconnect from the instrument, causing it to drop on the patient. Do not place the SpO2 Module in any position that might cause it to fall on the patient. CAUTION To ensure Electromagnetic Compliance Integrity, accessories including external communication systems (hospital data communication equipment and/or Nurse call systems) must be certified to applicable standards: • IEC 60601-1 (Electromedical Equipment) or • IEC 950 (Data Processing Equipment) NOTE: Nurse Call systems must be certified to UL 1069 (Hospital Signaling and Nurse Call Equipment) or comply with requirements specified in IEC 60601-1.

Compliance with the electromagnetic compatibility standard (IEC 60601-1-2) is a function of all interconnected equipment including cabling; as such, it is the responsibility of the user to ensure external equipment complies with the applicable EMC standards. Failure to verify such external equipment meets applicable EMC standards may result in degraded electromagnetic compatibility. Sensors and Cables WARNINGS • Inspect the SpO2 sensor site regularly to ensure correct sensor positioning, application and site integrity. Tissue damage could occur over prolonged time periods, depending on the patient profile (such as, neonates) and method of application. Refer to the sensor instructions for additional information.

6 GETTING STARTED

SpO2 Module, 8220 Series Directions for Use

Warnings and Cautions (Continued) Sensors and Cables (Continued) WARNINGS • Carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.

GETTING STARTED

• Before use, read sensor directions for use, including all warnings, cautions and instructions. • Use only approved Masimo® LNOP® sensors and PC Series patient cables. Use of sensors, transducers, cables and accessories other than those specified may cause improper SpO2 Module performance resulting in inaccurate readings, increased emission and/or decreased immunity, and degraded electromagnetic compatibility performance of the SpO2 Module. • Do not use a sensor, cable, connector or SpO2 Module that appears damaged. Do not use a sensor with exposed optical components. Do not immerse or wet the sensor or cable. Clean per manufacturer’s instructions (refer to LNOP® sensors instructions for use). • The sensor disconnect error message and associated alarm indicate the sensor is either disconnected or the wiring is faulty. Check the sensor connection and, if necessary, replace the sensor and/or pulse oximetry cable.

Measurements If the accuracy of any measurement does not seem reasonable, first check the patient’s vital signs by alternate means and then check the SpO2 Module to ensure it is functioning properly. An inaccurate measurement may be caused by: • Incorrect sensor application or use. • Significant levels of dysfunctional hemoglobins; such as, carboxyhemoglobin or methemoglobin. • Intravascular dyes such as, indocyanine green or methylene blue.

SpO2 Module, 8220 Series Directions for Use

GETTING STARTED 7

Measurements (Continued) • Exposure to excessive illumination; such as, a surgical lamp (especially one with a xenon light source), bilirubin lamp, fluorescent light, infrared heating lamp or direct sunlight. NOTE: Exposure to excessive illumination can be corrected by covering the sensor with a dark or opaque material.

• Prolonged and/or excessive patient movement. • Venous pulsations. • Sensor placed on an extremity with a blood pressure cuff, arterial catheter, intravascular line or other causes of insufficient perfusion. • Nail aberrations, nail polish, fungus, etc. Remove nail polish and/or move sensor to an unaffected site. • Placement is too close to electrosurgery equipment. • Defibrillation. The loss of a pulse signal can occur in any of the following situations: • Sensor is too tight. • Exposure to excessive illumination; such as, a surgical lamp (especially one with a xenon light source), bilirubin lamp, fluorescent light, infrared heating lamp or direct sunlight. • Sensor placed on an extremity with a blood pressure cuff, arterial catheter, intravascular line or other causes of insufficient perfusion. • Patient has hypotension, severe vasoconstriction, severe anemia or hypothermia, is in cardiac arrest or is in shock. • There is arterial occlusion proximal to sensor. • Placement is too close to electrosurgery equipment.

8 GETTING STARTED

SpO2 Module, 8220 Series Directions for Use

Operating Features, Controls and Indicators

Status Indicators Alarm

Infusing

Standby

(red)

(green)

(yellow)

IUI Connector, Right

IUI Connector, Left

ALARM

GETTING STARTED

(not visible)

MON

ITOR

%SpO2 Display

STA

ND

BY

Pulse Bar Display Pulse Rate Display

%Sp

O2

PUL

Channel (Module) Message Display

SE (

BPM

)

Channel (Module) Identification

Channel (Module) Select Key: CHA N SEL NEL ECT

When pressed, selects corresponding module for patient monitoring and setup.

MON

ITOR

CHA

NN OFF EL

Monitor Key: When pressed, begins patient monitoring. Channel (Module) Off Key: When pressed and held until a beep is heard, stops operation of that module, deselects that module, and if only that module had been operating, system powers down. Repeat for other operating modules to power off each module.

Module Release Latch: When pressed, allows module to be removed.

Patient Cable Connector

SpO2 Module, 8220 Series Directions for Use

GETTING STARTED 9

Installation Instruments are tested and calibrated before they are packaged for shipment. To ensure proper operation after shipment, it is recommended that an incoming inspection be performed before placing the instrument in use. Prior to placing the Medley™ System in use: Perform check-in procedure per Medley™ Maintenance Software/User Manual (Model 8970C, or later).

Attaching and Detaching Modules Reference the Medley™ Point-of-Care Unit DFU.

Displays The displays illustrated throughout this document are for illustration purposes only. The display content will vary, depending on configuration settings and other variables. Main Display Reference the Medley™ Point-of-Care Unit DFU.

Start-Up Reference the Medley™ Point-of-Care Unit DFU for the following procedures: Powering On System Responding to Maintenance Reminder Selecting New Patient and Profile Options Entering Patient ID Modifying Patient ID

10 GETTING STARTED

SpO2 Module, 8220 Series Directions for Use

General Setup and Use 1.

Attach Masimo® patient cable to SpO2 Module. Ensure secure connection and patient cable is not twisted, sliced or frayed. Attach Masimo® LNOP® sensors to Masimo® patient cable. Refer to sensor’s directions for use for detailed instructions.

3.

Ensure sensor’s red LED is on.

4.

Attach sensor to patient. Refer to sensor’s directions for use for detailed instructions.

5.

Verify high and low alarm rates for SpO2 and pulse rate are correct for patient by selecting CHANNEL SELECT key.

Use only approved Masimo® LNOP® sensors and PC Series patient cables. Use of sensors, transducers, cables and accessories other than those specified may cause improper SpO2 Module performance resulting in inaccurate readings, increased emission and/or decreased immunity, and degraded electromagnetic compatibility performance of the SpO2 Module.

NOTES:

• SEARCHING may appear in Channel Message Display until SpO2 and pulse readings have stabilized (approximately 15 seconds).

• If sensor is not attached to a site after powering up, module will display SENSOR OFF. If sensor is not attached during message display, module will go into sleep mode. To begin monitoring once module is in this mode, press MONITOR key.

6.

Monitor patient.

7.

After patient monitoring is complete, remove sensor from patient according to hospital protocol.

8.

Turn off SpO2 Module by pressing and holding CHANNEL

OFF key for 1 second.

NOTE: Module will initiate power down when CHANNEL OFF key is released.

SpO2 Module, 8220 Series Directions for Use

GETTING STARTED 11

GETTING STARTED

2.

WARNING

T H I S PA G E I N T E N T I O N A L LY LEFT BLANK

12 GETTING STARTED

SpO2 Module, 8220 Series Directions for Use

PROGRAMMING Monitoring Mode Navigating Main Display 1.

Attach SpO2 Module to Point-of-Care Unit.

2.

Power on system by pressing SYSTEM ON key on Pointof-Care Unit. • NEW PATIENT? screen appears.

Midtown Hospital

NEW PATIENT ?

Yes

“Yes” Clears Previous Patient Data

No

>Select Yes or No DISPLAY CONTRST

To clear previous SpO2 trend data, press Yes soft key.

PROGRAMMING

3.

OR

To retain previous SpO2 trend data, press No soft key. • Main Display appears. OR

Midtown Hospital Adult ICU

A SPO2

AUDIO ADJUST

If Guardrails® Safety Software is enabled, profiles screen appears.

Midtown Hospital Profiles

1 of 2

Adult ICU

View

Adult General Care

View

Neonatal

View

If Yes is selected, a prompt to confirm last profile selected appears.

Peds ICU

View

Neonatal ICU

View

If No is selected, a prompt to choose a profile appears.

>Select a Profile Confirm

NOTE: When Guardrails® Safety Software is enabled: • •

4.

CONFIRM

PAGE DOWN

Attach patient cable and sensor as described in “Getting Started” chapter, “General Setup and Use” section.

SpO2 Module, 8220 Series Directions for Use

PROGRAMMING 13

Monitoring Mode (Continued) Navigating Main Display (Continued) 5.

To view SPO2 Main display, press CHANNEL SELECT key. NOTE: To prevent the screen from reverting to the Main Display, press the ENTER key within 30 seconds after the SPO2 Main screen is initially displayed.

A SPO2 Main

Adult Mode

% SPO2

97

Off 90

PULSE RATE

82

150 50

- pleth waveform - Signal I.Q.™ PI = 10.56 - PI >Press ENTER to Retain Current View TREND

6.

To return to Main Display, press MAIN SCREEN soft key.

LIMITS

MAIN SCREEN

Midtown Hospital Adult ICU

A SPO2

AUDIO ADJUST

Setting Alarm Limits 1.

Press CHANNEL SELECT key.

A SPO2 Main % SPO2

97

Off 90

PULSE RATE

82

150 50

Adult Mode

PI = 10.56

>Press ENTER to Retain Current View TREND

2.

Press LIMITS soft key.

LIMITS

MAIN SCREEN

A Adult Alarm Limits %SPO2 HIGH

%SPO2 LOW PULSE HIGH PULSE LOW

Off 90 150 50

>Select Parameter Limit Confirm

14 PROGRAMMING

SpO2 Module, 8220 Series Directions for Use

Monitoring Mode (Continued) Setting Alarm Limits (Continued) 3.

To change a limit setting, press soft key next to applicable parameter. • Selected parameter is highlighted. • Display prompts for a value to be entered.

A Adult Alarm Limits %SPO2 HIGH %SPO2 LOW PULSE HIGH PULSE LOW

Off 90 150 50

>Enter High %SPO2 Limit Confirm

4.

Enter a numeric value for selected alarm limit.

A Adult Alarm Limits

NOTES:

• The %SPO2 HIGH limit can be Off or a numeric value.

%SPO2 LOW PULSE HIGH PULSE LOW

_98 90 150 50

Off

PROGRAMMING

Numeric values can be entered using the keypad or the and keys. After the field containing a valid value has been highlighted for 3 seconds, the display prompt changes to >Press CONFIRM to Apply Changes.

%SPO2 HIGH

>Press CONFIRM to Apply Changes

• Pressing Confirm soft key will confirm the alarm limits

Confirm

and return to the SPO2 Main display.

5.

To move to next limit, press ENTER key on Point-of-Care Unit.

A Adult Alarm Limits %SPO2 HIGH %SPO2 LOW PULSE HIGH PULSE LOW

98 _90 150 50

>Enter Low %SPO2 Limit Confirm

6.

To confirm alarm settings and return to SPO2 Main display, press Confirm soft key.

A SPO2 Main % SPO2

97

Off 90

PULSE RATE

82

150 50

Adult Mode

PI = 10.56

>Press ENTER to Retain Current View TREND

SpO2 Module, 8220 Series Directions for Use

LIMITS

MAIN SCREEN

PROGRAMMING 15

Monitoring Mode (Continued) Setting Alarm Limits (Continued) 7.

To return to Main Display, press MAIN SCREEN soft key.

Midtown Hospital Adult ICU

A SPO2

AUDIO ADJUST

Navigating Trend Data 1.

To view SPO2 Main display, press CHANNEL SELECT key.

A SPO2 Main % SPO2 PULSE RATE

Adult Mode

97

Off 90

82

150 50

PI = 10.56

>Press ENTER to Retain Current View TREND

2.

To view Trend Data, press TREND soft key.

Data A Trend Adult Mode

09:00 PULSE

2001-07-06 SPO2 MAX AVG

TIME

NOTES: •

Tabular information will not be updated while the Trend Data view is displayed. The tabular data will be updated, using the new trend data stored in the SpO2 Module, after leaving the Trend Data view. To view the latest data, return to the Trend Data view.

•

will only be displayed if a limit violation occurred for the indicated limit in the time window.

•

If there are no SPO2 or PULSE rate values for the time period displayed, dashes (---) will be displayed.

•

Six data collection periods are displayed on a screen page.

16 PROGRAMMING

MAIN SCREEN

LIMITS

07:01

97 97

05:01

97

03:01

97

MIN 100 90 100 90 100 90 100 88

01:01

--97

100 90

60

30

09:01

23:01 ZOOM:

120

82

MAX MIN 152 50 150 50 150 50 150 50

--82

150 50

AVG

82 82 82

5

1

minutes

>Press UP/DOWN Keys to Move Cursor. ZOOM

SPO2 MAIN

PAGE DOWN

SpO2 Module, 8220 Series Directions for Use