SPO2 Module 8220 Series Masimo Directions for Use Ver 5

GENERAL CONTACT INFORMATION Customer Advocacy For clinical and technical questions, feedback, and troubleshooting assistance. Phone, toll-free, within the United States and Canada: (800) 854-7128, Ext. 7812 E-Mail: [email protected]

Technical Support For technical information related to maintenance procedures and service manual support. Phone: (858) 458-6003 Toll-free, within the United States: (800) 854-7128, Ext. 6003 Toll-free, within Canada: Eastern: (800) 227-7215 Western: (800) 667-2335 For more detailed information, refer to the “Service Information” section of this document.

INTRODUCTION About the System INTRODUCTION

The MEDLEY™ Medication Safety System is a modular infusion and monitoring system designed to provide SpO2 monitoring capabilities and accurate, automated infusion of a broad range of intravascular fluids, medications and blood products. The MEDLEY™ Medication Safety System consists of the Programming Module (Model 8000), and detachable MEDLEY™Modules (or “channels”) which provide infusion or monitoring capabilities. The MEDLEY™ System is intended for use in hospitals and healthcare facilities on adult, pediatric and neonatal patients. This document provides Directions for Use for the Model 8220 SpO2 Module. Please read all instructions for both the SpO2 Module and the Programming Module before using the device. Only one SpO2 Module can be connected to a MEDLEY™ Programming Module. The SpO2 Module is intended 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. The MEDLEY™ System uses a wide variety of Masimo® LNOP® series sensors and Masimo® PC series patient cables. The Masimo® sensors and cables are designed for use with the Model 8220 SpO2 Module. For specific directions for use, refer to the sensor and cable packaging. Contraindications: The MEDLEY™ SpO2 Module, with Masimo® LNOP® series sensors and Masimo® PC series patient cables are contraindicated for use as an apnea monitor.

INTRODUCTION 1

About the System (Continued) 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 the blood is related to hemoglobin oxygen saturation. The SpO2 Module uses the Masimo® proprietary Signal Extraction Technology® (SET®) to decompose the red and infrared pulsatile absorbance signal into an arterial signal plus a noise component and 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.

2 INTRODUCTION

Features To enhance safety and ease of operation, the MEDLEY™ Medication System provides a full range of audio and visual alarms, advisories and prompts.

Fast SAT

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

Guardrails® Safety Software

The Guardrails® Safety System is designed to help reduce programming errors by: • Customizing device configurable settings to meet the need of the selected hospital area/patient type (Profile). • Comparing user programming with hospital-defined best practice guidelines. • Providing a Guardrails® Advisory prompt if an out–of–limits entry is made.

Masimo® Sensors

Disposable and reusable sensors are available for neonatal, pediatric and adult patients.

PI

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

Pre-Silence

Alarms can be pre-silenced for 120 seconds. The pre-silence alarm can be cancelled before 120 seconds are complete.

Profiles Feature

A profiles feature a unique set of device options configured to optimize device function for a specific hospital area or patient type. A profile is comprised of a Configuration, with device settings and defaults customized by the user to best meet the needs of the profile area/patient type.

Sensitivity Mode

The sensitivity mode, normal or maximum, of the current monitoring configuration is displayed in the options mode. The normal setting is used for normal patient monitoring purposes. The maximum setting is used for improved low perfusion performance.

SET®

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

Signal I.Q.™

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

INTRODUCTION 3

INTRODUCTION

Ease of Use Features

Definitions % SpO2 Alarm Limits

The upper and lower saturation alarm limits are displayed.

% SpO2 Display

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

Limit Mode

The limit mode displays either the adult or neonatal monitoring mode.

Pleth Waveform

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

Pre-Silence

Alarms can be pre-silenced for 120 seconds. The pre-silence alarm can be cancelled before 120 seconds are complete.

Pulse Beat Volume

Pulse beat volume can be configured to a volume level of 1, 2, 3 or off.

Pulse Rate Alarm Limits

The upper and lower pulse rate alarm limits are displayed.

Pulse Rate Display

The patient’s pulse rate is displayed in beats per minute (bpm).

Saturation Averaging Time

The averaging time of this device can be set to 2, 4, 8, 10, 12, 14 or 16 seconds.

System Configuration

The System Configuration mode provides the ability for qualified personnel to customize device settings. If the profile feature is enabled, the system settings defined for the selected Profile are automatically activated.

Trend Data

The trend data is a tabular display of the %SpO2 and Pulse Rate. The display shows the alarm conditions for the time period displayed and the average, high and low values . The data is stored for 24 hours.

4 INTRODUCTION

Symbols Attention: Refer to accompanying documentation.

75

Consult operating instructions.

Type BF Applied Part IPX1

Protection against fluid ingress: Drip Proof IUI Connector: Inter-Unit Interface connector used to establish power and communications between the Programming Module and add-on channels.

MM-YYYY

Manufacturing Date: Number adjacent to symbol indicates the month and year of manufacture. CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

INTRODUCTION 5

INTRODUCTION

+

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.

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

6 INTRODUCTION

GETTING STARTED NOTE: Although the MEDLEY™ System is built and tested to exacting specifications, it is not intended to replace the supervision of IV infusions and patient monitoring by medical personnel. The user should become thoroughly familiar with the features and operation of the MEDLEY™ System and exercise vigilance in its utilization.

Definitions

GETTING STARTED

WARNING This heading alerts the user to potential serious outcomes (death, injury or serious adverse events) to the patient or user. CAUTION This heading alerts the user to take special care for the safe and effective use of the device.

Warnings and Cautions For WARNINGS and CAUTIONS for the Programming Module, refer to its Directions for Use. To ensure proper performance of the MEDLEYTM System and to reduce potential injury, observe the following WARNINGS and CAUTIONS: WARNING The SpO2 Module is NOT to be used as an apnea monitor. WARNING SpO2 is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. WARNING Pulse oximetry readings and pulse signal can be affected by certain ambient conditions, sensor application errors and certain patient conditions. WARNING 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.

GETTING STARTED 7

Warnings and Cautions WARNING 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. WARNING 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. WARNING Do not use the SpO2 Module or sensors during Magnetic Resonance Imaging (MRI). WARNING The SpO2 Module is not rated for defibrillation use. Disconnect sensor from patient or patient cable from module prior to defibrillation. WARNING Carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. WARNING 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. WARNING Check alarm limits each time the SpO2 Module is used, to ensure they are appropriate for the patient being monitored. WARNING Use only Masimo® approved LNOP® sensors and PC Series patient cables with the SpO2 Module Model 8220. Use of other 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. .

8 GETTING STARTED

Warnings and Cautions (Continued) WARNING Before use, read sensor Directions for Use, including all warnings, cautions and instructions.

GETTING STARTED

WARNING 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 as per manufactures instructions, refer to LNOP® Sensors Instructions For Use. The sensor disconnect error message and associated alarm indicate that 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. WARNING 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 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. 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)

GETTING STARTED 9

Warnings and Cautions (Continued) User Warnings and Cautions To ensure proper performance of the MEDLEY™SpO2 Module and to reduce potential injury to the operator, observe the following WARNINGS and CAUTIONS: WARNING Do not open the instrument case. There are no user serviceable parts inside. The instrument case should only be opened by qualified service personnel using proper grounding techniques. When the instrument case is opened, an electrical shock hazard exists which can result in serious injury to persons and instrument component damage.

Dropping/Jarring Should an instrument be dropped or severely jarred, it should be immediately taken out of use and inspected by qualified service personnel, to ensure its proper function prior to reuse.

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Sp

O2

Mod

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Sp

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O2

PU

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TIE PA

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CA

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L NE AN CH LECT SE OR NIT

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6

2 8

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7 CL

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9

5

1

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Maintenance Disconnect from the Programming Module when performing maintenance. Operating Environment Not for use in the presence of flammable anesthetics.

10 GETTING STARTED

DANGER Explosion risk if used in the presence of flammable anesthetics.

Warnings and Cautions (Continued) User Warnings and Cautions (Continued) Radio Frequency Interference Operating the system near equipment which radiates high energy radio frequencies (electrosurgical/cauterizing equipment, portable radios, cellular telephones, etc.) may cause false alarm conditions. If this happens, reposition the device away from the source of interference or turn off the device and manually monitor the vital parameters using an appropriate clinical alternative. GETTING STARTED

CAUTION When using the SpO2 Module in combination with a Programming Module, which is interconnected to hospital data communications equipment and /or Nurse call systems, the external systems must be certified to applicable standards to insure correct operation and electromagnetic compliance integrity. Interconnected data communications systems must be certified to IEC 950 (data processing equipment) or IEC 60601-1 Electromedical Equipment. 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 electromagnetic compatibility standard (IEC 60601-1-2) is a function of all interconnected equipment and cabling and is the responsibility of the user to insure external equipment complies with applicable EMC standards. Failure to verify such external equipment meets applicable EMC standards may result in degraded Electromagnetic Compatibility (refer to Radio Frequency Interference Warning for additional information).

GETTING STARTED 11

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 MEDLEY™ 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. • 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. • Placement of a sensor 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 the nail polish and/or move the sensor to an unaffected site. • Placement too close to electrosurgery equipment. The loss of a pulse signal can occur in any of the following situations: • The 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. • Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, intravascular line or other causes of insufficient perfusion. • The patient has hypotension, severe vasoconstriction, severe anemia or hypothermia. • There is arterial occlusion proximal to the sensor. • The patient is in cardiac arrest or is in shock. • Placement too close to electrosurgery equipment.

12 GETTING STARTED

Controls and Indicators Status Indicators Alarm (red)

Monitor (green)

Standby (yellow)

IUI Connector, Left

IUI Connector, Right

(not visible)

A LA R M

M ON

ITO R

S TA

Sp O

ND

BY

2 Mod

u le

Pulse Rate Display

Channel Message Display

Pulse Bar Display

%S p

O2

PU L

SE (

BP M )

Channel Identification: A, B, C or D

Channel Select Key: When CHA NN SEL EL ECT

pressed, selects the corresponding channel for patient monitoring and setup.

MON

I TO R

Monitor Key: When pressed,

CHA

NN O FF E L

begins patient monitoring.

Channel Off Key: When pressed and held for one second and then released, stops the operation of that channel, deselects that channel, and if only that channel had been operating, the system powers down. Repeat for other operating channels to power off each channel.

Channel Release Latch Patient Cable Connector

GETTING STARTED 13

GETTING STARTED

%SpO2 Display

Installation Procedure Instruments are tested before they are packaged for shipment. They met the specifications listed in the Directions for Use at that time. To ensure proper operation after shipment, it is recommended that an incoming inspection is performed by your facility before putting the instrument into use. Unpacking the SpO2 Module 1.

Remove the product from its carton.

2.

Check for any loose parts.

If the product is damaged, contact ALARIS Medical Systems for authorization to return the equipment for repair, whether damage or malfunction is the responsibility of the carrier or of ALARIS Medical Systems.

Attaching and Detaching Channels Refer to the MEDLEY™ Programming Module (Model 8000) Directions for Use for detailed instructions on attaching and detaching channels.

Start-Up Sequence Powering On the System 1.

Connect the MEDLEY™ Programming Module to an external AC power source.

2.

Attach the SpO2 Module to the Programming Module.

3.

Press the SYSTEM ON key on the Programming Module.

4.

The system self test begins: • The diagnostics test causes all LED display segments and Status Indicator lights of the attached channel(s) to illuminate briefly. • Power Indicator illuminates. • Appropriate channel identification (A, B, C or D) is displayed on the attached channel(s). • An Audio tone sounds.

5.

At the completion of the system-on test, the NEW PATIENT? screen appears on the Programming Module.

14 GETTING STARTED

Start-Up Sequence (Continued) Powering On the System (Continued) NOTE: If any of the following conditions are observed, Programming Module or the affected channel must be removed from use and inspected by qualified personnel:

GETTING STARTED

• LED segments are not illuminated on the channel displays during the system on test. • Indicator lights do not illuminate. • Appropriate channel identification (A, B, C or D) is not displayed. • Audio tone does not sound. • Main Display does not appear backlit, appears irregular, or has evidence of a row of pixels not functioning properly. If the affected channel operates normally when it is attached via the alternate IUI connector, it may be used until replacement channel can be substituted.

General Setup and Use NOTE: Use only Masimo® LNOP® series sensors and PC series patient cables.

1.

Attach a Masimo® patient cable to the SpO2 Module. Ensure a secure connection and patient cable is not twisted, sliced or frayed.

2.

Attach a Masimo® LNOP® sensor to the Masimo® patient cable. Refer to the sensor’s directions for use for detailed instructions.

3.

Ensure the sensor’s red LED is on.

4.

Attach sensor to patient. Refer to the 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 pressing the CHANNEL SELECT key. NOTE: SEARCHING may appear in the Channel Message Display until the SpO2 and pulse readings have stabilized (approximately 15 seconds). NOTE: If the sensor is not attached to a site after powering up, the Module will display SENSOR OFF. If a sensor is not attached while this message is displayed, the Module will go into a sleep mode. To begin monitoring once the Module is in this mode, press the MONITOR key.

6.

Monitor the patient.

GETTING STARTED 15

General Setup and Use (Continued) 7.

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

8.

Turn off the SpO2 Module by pressing and holding the CHANNEL OFF key for one second. NOTE: Channel will initiate power down when CHANNEL OFF key is released.

16 GETTING STARTED

Displays Main Display Refer to the MEDLEY™ Programming Module (Model 8000) Directions for Use for general information in the Main Display. Title Bar

Soft Keys

A SPO2 B

M ALAR

MONITOR

STAND B

Y

®

SpO2 Module

PATIENT CARE SYSTEM

% SpO2

PULSE (BPM)

CHANNEL SELECT

SILENCE

SYSTEM ON

OPTIONS

MONITOR

CHANNEL OFF

1 4

2

3

5

6

7

8

9

ENTER

CLEAR

0

.

CANCEL

>Select Channel AUDIO ADJUST

NOTE: Throughout the following sections of this chapter, display screens are aligned with the corresponding steps.

Monitoring Mode Navigating Main Display 1.

Attach the SpO2 Module to the Programming Module.

2.

Power on the system by pressing the SYSTEM ON key on the Programming Module. The NEW PATIENT? screen will appear.

Midtown Hospital

NEW PATIENT ?

Yes

“Yes” Clears Previous Patient Data

No

• A Yes selection clears the previous SpO2 trend data. • A No selection retains the previous SpO2 trend data. >Select Yes or No DISPLAY CONTRST

• Once a selection is made either the Main Display will appear or, if the Guardrails® Safety Software is enabled, the profiles screen (as shown on the right) will be displayed. NOTE: When Guardrails® Safety Software is enabled:

• If Yes is selected, you will be prompted to confirm the last Profile selected.

• If No is selected, you will be prompted to choose a Profile.

Midtown Hospital Profiles

1 of 2

Adult ICU

View

Adult General Care

View

Neonatal

View

Peds ICU

View

Neonatal ICU

View

>Select a Profile CONFIRM

PAGE DOWN

GETTING STARTED 17

GETTING STARTED

Channel Status • A solid Channel Letter display indicates channel is operating. • An outlined Channel Letter display indicates that the channel is attached and ready for use.

Monitoring Mode (Continued) Navigating Main Display (Continued) 3. Attach the patient cable and sensor as described in the “General Setup and Use” section of this document.

Midtown Hospital Adult ICU

A SPO2

>Select Channel AUDIO ADJUST

4.

Press the CHANNEL SELECT key on the SpO2 Module to view the SPO2 Main display. The following information can be viewed in this display: • limit mode (Adult or Neonatal) • %SPO2, with high and low alarm limits • PULSE RATE, with high and low alarm limits • pleth waveform • Signal I.Q.™ • PI

5.

Press the MAIN SCREEN soft key to return to the Main Display.

A SPO2 Main % SPO2

97

Off 90

PULSE RATE

82

150 50

Adult Mode

- pleth waveform - Signal I.Q.™ PI = 10.56 - PI TREND

LIMITS

MAIN SCREEN

A SPO2

>Select Channel AUDIO ADJUST

Setting Alarm Limits 1.

Press the CHANNEL SELECT key on the SpO2 Module.

A SPO2 Main % SPO2

97

Off 90

PULSE RATE

82

150 50

Adult Mode

PI = 10.56

TREND

18 GETTING STARTED

LIMITS

MAIN SCREEN