Nellcor SpO2 Module (for use with IntelliVue Patient Monitor) Operators Manual Rev B

1 Operator’s Manual

1.1

Introduction

1.1.1 Overview

This manual contains information for operating the Nellcor™ SpO2 module. Before operating the module, thoroughly read all related documentation. Reference Related Documents, p. 1-3. 1.1.2 About This Manual

This manual contains relevant information for installation, operation, and maintenance of the Nellcor™ SpO2 module, as well as pertinent safety and integration information. Section 1

Introduction

p. 1-1

Section 2

Product Overview

p. 1-4

Section 3

Installation

p. 1-6

Section 4

Operation

p. 1-7

Section 5

Performance Considerations

p. 1-9

Section 6

Preventive Maintenance

p. 1-12

Section 7

Troubleshooting

p. 1-13

Section 8

Accessories

p. 1-15

Section 9

Product Specifications

p. 1-17

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Operator’s Manual

1.1.3 Safety Information

Table 1-1. Safety Symbol Definitions Symbol

Definition WARNING Warnings alert users to potential serious outcomes (death, injury, or adverse events) to the patient or user. Caution Cautions alert users to exercise appropriate care for safe and effective use of the product. Note Notes provide additional guidelines or information.

     

1-2

WARNING: Explosion hazard - Do not use in the presence of flammable anesthetics. WARNING: Disconnect the oximeter and Nellcor™ pulse oximetry sensor from the patient during magnetic resonance imaging (MRI) scanning. Objects containing metal can become dangerous projectiles when subjected to the strong magnetic fields created by MRI equipment. Also, induced currents could potentially cause burns. WARNING: As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. WARNING: Do not silence or decrease the volume of the audible alarm if patient safety could be compromised. WARNING: Failure to cover the Nellcor™ 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, Nellcor™ pulse oximetry sensor application errors, and certain patient conditions. Refer to the appropriate sections of this manual for specific safety information. WARNING: Do not use accessories, sensors, and cables other than those specified. Using non-specified components may result in inaccurate readings by the module and increased EMI emission, decreased electromagnetic immunity, and decreased defibrillation protection.

Introduction



WARNING: Do not spray, pour, or spill any liquid on the module, its accessories, connectors, switches, or openings in the chassis, since this may cause damage to the module.

1.1.4 Obtaining Technical Assistance

Technical Services For technical information and assistance, if unable to correct a problem while using the module, contact Covidien or a local Covidien representative. If purchased through Philips Healthcare, contact Philips or a local Philips representative. Covidien Technical Services: Patient Monitoring

Philips Medizin Systeme Boeblingen GmbH

15 Hampshire Street, Mansfield, MA 02048 USA

Hewlett-Packard-Strasse 2, 71034 Boeblingen, GERMANY

1.800.635.5267, 1.925.463.4635 (toll) or contact a local Covidien representative www.covidien.com

www.healthcare.philips.com

When calling Covidien or a local Covidien representative, have the module serial number available. Related Documents Before using the module, thoroughly read all related documentation. •

Instructions for Use: IntelliVue Patient Monitor. This manual contains operational information for the Philips IntelliVue MP40/50, MP60/70/90, MP80, and MX800 Patient Monitor and its components.

•

Operator’s Manual: Nellcor™ SpO2 module. This manual contains operational information for using the Nellcor™ SpO2 module with the IntelliVue line of monitoring systems. This knowledge is essential in operating the module and troubleshooting module errors or malfunctions.

•

Directions for Use: Nellcor™ Pulse Oximetry Sensors. This document accompanies all Nellcor™ pulse oximetry sensors and provides guidance in selecting the appropriate sensor for the patient. Read this document before attaching any of the various Covidien-approved Nellcor™ pulse oximetry sensors to the module.

1.1.5 Warranty Information

Purchase of this module confers no express or implied license under any Covidien patent to use that module with any sensor not manufactured or licensed by Covidien llc.

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Operator’s Manual

1.2

Product Overview

1.2.1 Overview

This section contains basic information about the Nellcor™ SpO2 module. The Nellcor™ SpO2 module is a single parameter pulse oximetry module intended for plug-in compatibility with the Philips IntelliVue line of monitoring systems, the host system. The module relies on unique oximetry technology and design to provide hospitals, clinicians and caregivers with accurate, timely data. The module provides specific patient data to the Philips host system: •

Arterial blood oxygen saturation (SpO2). Functional measure of oxygenated hemoglobin relative to the sum of oxyhemoglobin and deoxyhemoglobin,

•

Pulse rate (PR). Detected pulsations per minute,

•

Plethysmographic waveform (Pleth). Visual waveform representing detected pulsations, and

•

Operating status. Alarm conditions and operational status.

1.2.2 Product Description

The Nellcor™ SpO2 module is a single parameter module used as an accessory to Philips Intellivue Monitoring Systems (MP40, MP50, MP60, MP70, MP80, MP90, and MX800) for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate as measured by Nellcor™ pulse oximetry sensors. 1.2.3 Intended Use



WARNING: The module is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms.

The Nellcor™ SpO2 module is a single parameter module intended for prescription use only with adult, pediatric, and neonatal patients who are well or poorly perfused in hospitals, hospital-type facilities, and during intra-hospital transport.



1-4

Note: •

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 subacute centers.

•

Intra-hospital transport includes transport of a patient within the hospital or hospital-type facility.

Product Overview

1.2.4 Product Views and Symbology Figure 1-1. Front, Rear, and Bottom Panels

1

SETUP indicator

4

Release latch lever

2

SETUP key

5

Power connector

3

Sensor port connector socket

Table 1-2. Labeling and Device Symbols and Descriptions Symbol

Description

Symbol

Description

Caution, consult accompanying documents

Type CF applied part - Defibrillator proof

Manufacturer

Date of manufacture

Atmospheric pressure limitations

Proper waste disposal for electrical and electronic equipment

Humidity limitations

Protection against fluid ingress

Temperature limitations

Complies with EMC directive requirements

Prescription use only

Authorized for sale in European countries

Keep dry

Must consult instructions for use

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Operator’s Manual

1.3

Installation

1.3.1 Overview

This section contains information for the installation and set up of the Nellcor™ SpO2 module, prior to first-time usage, when installed in a compatible Philips IntelliVue Patient Monitor (host system). Before operating the module, thoroughly read the Philips IntelliVue Patient Monitor Instructions for Use. 1.3.2 Installation



WARNING: Do not use any module, Nellcor™ pulse oximetry sensor, cables, or connectors that appear damaged.

The module plugs directly into a compatible Philips IntelliVue Patient Monitor (host system). The host system provides power to the module. 1.3.3 Connecting a Nellcor™ Pulse Oximetry Sensor

   

WARNING: Use only the Philips extension cable with the module. Use of another extension cable will have an adverse effect on performance. WARNING: Use only Nellcor-approved pulse oximetry sensors and pulse oximetry cables when connecting to the sensor connector. Connecting any other cable or sensor influences the accuracy of sensor data, since this may lead to adverse results. Caution: Since the host system design incorporates many different modules, each extension cable connector has a keyed connector socket with a distinctive color. Ensure the color of the extension cable connector matches the color of the connector socket. Do not force a connector into the connector socket, since this might damage the module or cause inaccurate readings. Note: Physiological conditions, medical procedures, or external agents that may interfere with the pulse oximeter’s ability to detect and display measurements include dysfunctional hemoglobin, arterial dyes, low perfusion, dark pigment, and externally applied coloring agents, such as nail polish, dye, or pigmented cream.

When the host system detects a valid pulse, it enters monitoring mode and displays real-time patient data.

1-6

Operation

To fully connect a Nellcor™ pulse oximetry sensor: 1. Firmly connect a correctly color-coded and keyed extension cable into the sensor port connector socket.

1.4

2.

Select an appropriate and compatible Nellcor™ pulse oximetry sensor. Reference Selecting a Nellcor™ Pulse Oximetry Sensor, p. 1-15.

3.

Firmly plug the extension cable and the pulse oximetry sensor together.

4.

After carefully reading the Directions for Use accompanying the pulse oximetry sensor, apply it to the patient. When the host system detects a valid pulse, it enters monitoring mode and displays real-time patient data.

Operation

1.4.1 Overview

This section identifies methods for viewing and collecting patient oxygen saturation data using the Nellcor™ SpO2 module when installed in a compatible Philips IntelliVue Patient Monitor (host system). Schedule regular maintenance and safety checks with a qualified service technician every 24 months. In the case of mechanical or functional damage, contact Covidien or a local Covidien representative. Covidien Technical Services: Patient Monitoring 15 Hampshire Street Mansfield, MA 02048 USA 1.800.635.5267, 1.925.463.4635 (toll) or contact a local Covidien representative www.covidien.com

1.4.2 Power

When installed in a compatible Philips IntelliVue Patient Monitor, the module derives power from the host system. 1.4.3 User Interface

When installed in a compatible Philips IntelliVue Patient Monitor, the module sends patient information derived from the sensor to the host system. The module has a single SETUP key for triggering the SETUP menu on the host system. Confirm the SETUP indicator lights after pressing the SETUP key. Reference Troubleshooting, p. 1-13, if it does not. Refer to the Instructions For Use for the Philips IntelliVue Patient Monitor for all pulse oximetry patient and device status data. This also applies to setting alarm limits, audio and visual alarm management, and module customization.

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Operator’s Manual

1.4.4 Data Update Period, Effect of Data Averaging, and Other Signal Processing

The advanced signal processing of the OxiMax algorithm automatically extends the amount of data required for measuring SpO2 and pulse rate depending on the measurement conditions. The OxiMax algorithm automatically extends the dynamic averaging time required beyond seven (7) seconds during degraded or difficult measurement conditions caused by low perfusion, signal artifact, ambient light, electrocautery, other interference, or a combination of these factors, which results in an increase in the dynamic averaging. As such measurement conditions extend, the amount of data required may continue to increase. If the dynamic averaging time reaches 40 seconds, and/or 50 seconds for pulse rate, a low priority alarm state results. 1.4.5 Functional Testers and Patient Simulators

Some models of commercially available bench top functional testers and patient simulators can be used to verify the proper functionality of Nellcor™ pulse oximeters, sensors, and cables. Reference the individual testing device's operator's manual for the procedures specific to the model of tester used. While such devices may be useful for verifying that the pulse oximeter sensor, cabling, and oximeter are functional, they are incapable of providing the data required to properly evaluate the accuracy of a system's SpO2 measurements. Fully evaluating the accuracy of the SpO2 measurements requires, at a minimum, accommodating the wavelength characteristics of the sensor and reproducing the complex optical interaction of the sensor and the patient’s tissue. These capabilities are beyond the scope of known bench top testers. SpO2 measurement accuracy can only be evaluated in vivo by comparing pulse oximeter readings with values traceable to SaO2 measurements obtained from simultaneously sampled arterial blood using a laboratory CO-oximeter. Many functional testers and patient simulators have been designed to interface with the pulse oximeter's expected calibration curves and may be suitable for use with Nellcor™ pulse oximeters and/or sensors. Not all such devices, however, are adapted for use with the OxiMax digital calibration system. While this will not affect use of the simulator for verifying system functionality, displayed SpO2 measurement values may differ from the setting of the test device. For a properly functioning oximeter, this difference will be reproducible over time and from oximeter to oximeter within the performance specifications of the test device. 1.4.6 Nellcor™ Pulse Oximetry Sensors



1-8

WARNING: Do not use any other cables to extend the length of the extension cable. Increasing the length of the extension cable will degrade signal quality and may lead to inaccurate measurements.

Performance Considerations



WARNING: Use only Nellcor-approved pulse oximetry sensors and pulse oximetry cables when connecting to the sensor connector. Connecting any other cable or sensor influences the accuracy of sensor data, since this may lead to adverse results.

The module sends patient data obtained from the pulse oximetry sensor to the host system. Reference Selecting a Nellcor™ Pulse Oximetry Sensor, p. 1-15, for more information on selecting the right pulse oximetry sensor for the specific patient and situation. Consider all possible variables. If still in doubt, contact Covidien or a local Covidien representative.

 1.5

Note: When first applying a Nellcor™ pulse oximetry sensor to a patient, users may experience a slight delay as the host system acquires a pulse signal.

Performance Considerations

1.5.1 Overview

This section contains information for optimizing the performance of the Nellcor™ SpO2 module. Verify the performance of the module by following the procedures outlined in the SRC-MAX Pulse Oximetry Functional Tester Technical Manual. Have a qualified service technician perform these procedures prior to initial installation in a clinical setting and every 24 months as part of preventive maintenance. Reference Service, p. 1-13. 1.5.2 Patient Conditions

Application issues and certain patient conditions can affect the measurements of the module and cause the loss of the pulse signal. •

Anemia - Anemia causes decreased arterial oxygen content. Although SpO2 readings may appear normal, an anemic patient may be hypoxic. Correcting anemia can improve arterial oxygen content. The pulse oximeter may fail to provide an SpO2 reading if hemoglobin levels fall below 5 gm/dl.

•

Dysfunctional hemoglobins - Dysfunctional hemoglobins such as carboxyhemoglobin, methemoglobin, and sulphemoglobin are unable to carry oxygen. SpO2 readings may appear normal; however, a patient may be hypoxic because less hemoglobin is available to carry oxygen. Further assessment beyond pulse oximetry is recommended.

•

Poor peripheral perfusion

•

Excessive patient activity

•

Venous pulsations

•

Intravascular dyes, such as indocyanine green or methylene blue

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Operator’s Manual

•

Dark skin pigment

•

Externally applied coloring agents (nail polish, dye, pigmented cream)

•

Defibrillation

1.5.3 Sensor Performance Considerations

   

WARNING: Pulse oximetry readings and pulse signal can be affected by certain ambient conditions, sensor application errors, and certain patient conditions. WARNING: Tissue damage can be caused by incorrect application or inappropriate duration of use of a Nellcor™ pulse oximetry sensor. Inspect the sensor site as directed in the Directions for Use DFU. WARNING: Use only Nellcor-approved pulse oximetry sensors and pulse oximetry cables when connecting to the sensor connector. Connecting any other cable or sensor influences the accuracy of sensor data, since this may lead to adverse results. WARNING: Failure to cover the Nellcor™ pulse oximetry sensor site with opaque material in high ambient light conditions may result in inaccurate measurements.

Inaccurate Sensor Measurement Conditions A variety of conditions can cause inaccurate sensor measurements.

1-10

•

Incorrect application of the Nellcor™ pulse oximetry sensor

•

Placement of the Nellcor™ pulse oximetry sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line

•

Ambient light

•

Failure to cover the Nellcor™ pulse oximetry sensor site with opaque material in high ambient light conditions

•

Excessive patient activity

•

Dark skin pigment

•

Intravascular dyes or externally applied coloring, such as nail polish or pigmented cream

Performance Considerations

Signal Loss Loss-of-pulse signal can occur for several reasons. •

Pulse oximetry sensor applied too tightly

•

Inflation of a blood pressure cuff on the same extremity as the attached Nellcor™ pulse oximetry sensor

•

Arterial occlusion proximal to the Nellcor™ pulse oximetry sensor

•

Poor peripheral perfusion

Recommended Usage Select an appropriate Nellcor™ pulse oximetry sensor, apply it as directed, and observe all warnings and cautions presented in the Directions for Use accompanying the sensor. Clean and remove any substances such as nail polish from the application site. Periodically check to ensure that the sensor remains properly positioned on the patient. High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the performance of a Nellcor™ pulse oximetry sensor. To prevent interference from ambient light, ensure that the sensor is properly applied, and cover the sensor site with opaque material. If patient activity presents a problem, try one or more of the following remedies to correct the problem. •

Verify the Nellcor™ pulse oximetry sensor is properly and securely applied.

•

Move the sensor to a less active site.

•

Use an adhesive sensor that improves patient skin contact.

•

Use a new sensor with fresh adhesive backing.

•

Keep the patient still, if possible.

If poor perfusion affects performance, consider using the Nellcor™ forehead SpO2 sensor (Max-Fast), which provides superior detection in the presence of vasoconstriction. Nellcor™ forehead SpO2 sensors work particularly well on supine patients and mechanically ventilated patients. During low perfusion conditions, Nellcor™ forehead SpO2 sensors reflect changes to SpO2 values up to 60 seconds earlier than digit sensors. 1.5.4 Reducing EMI (Electromagnetic Interference)



Caution: This device has been tested and found to comply with the limits for medical devices related to IEC 60601-1-2: 2007. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation.

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Operator’s Manual

Because of the proliferation of radio frequency transmitting equipment and other sources of electrical noise in health care environments (for example, electrosurgical units, cellular phones, mobile two-way radios, electrical appliances, and high-definition television), it is possible that high levels of such interference due to close proximity or strength of a source might result in disruption of module performance. The module is designed for use in environments in which electromagnetic interference might obscure the client’s pulse. During such interference, measurements may seem inappropriate or the module may not seem to operate correctly. EMI disruption can cause erratic readings, cessation of operation, or other incorrect functioning. If this occurs, survey the site of use to determine the source of this disruption, and take the listed actions to eliminate the source. •

Turn equipment in the vicinity off and on to isolate the offending equipment.

•

Reorient or relocate the interfering equipment.

•

Increase the separation between the interfering equipment and the Philips IntelliVue Patient Monitor.

The module generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with these instructions, may itself cause harmful interference with other susceptible devices in the vicinity. 1.6

Preventive Maintenance

1.6.1 Overview

This section describes the steps required to maintain, service, and properly clean the Nellcor™ SpO2 module. 1.6.2 Cleaning

 

WARNING: Do not spray, pour, or spill any liquid on the module, its accessories, connectors, switches, or openings in the chassis. Caution: Before cleaning the module, always remove it from the monitoring system.

For surface cleaning and disinfection of the module, follow your institution's procedures or the recommended actions below.

1-12

•

Surface cleaning. Use a soft cloth dampened with either a commercial, nonabrasive cleaner or a solution of 70% alcohol in water, lightly wiping the surfaces of the module.

•

Disinfection. Use a soft cloth saturated with a solution of 10% chlorine bleach in tap water, lightly wiping the surfaces of the module.

Troubleshooting

Before attempting to clean a Nellcor™ pulse oximetry sensor, read the Directions for Use enclosed with the sensor. Each sensor model has cleaning instructions specific to that sensor. Follow the pulse oximetry sensor cleaning and disinfecting procedures in the particular sensor's Directions for Use. 1.6.3 Periodic Safety Checks

Perform the following checks every 24 months. •

Inspect the equipment for mechanical and functional damage or deterioration.

•

Inspect safety-relevant labels for legibility. Contact Covidien or a local Covidien representative, if labels are damaged or illegible.

•

Ensure all user interface keys, cables, and accessories function normally.

1.6.4 Service

 

WARNING: Only qualified service personnel should remove the module cover. There are no user-serviceable parts inside. Caution: Dispose of module in accordance with local requirements and regulations.

The module requires no calibration.

1.7

•

Have a qualified service technician perform periodic testing using the SRC-MAX Pulse Oximetry Functional Tester.

•

If service is necessary, contact Covidien or a local Covidien representative. Reference Obtaining Technical Assistance, p. 1-3.

Troubleshooting

1.7.1 Overview

This section describes how to troubleshoot common problems while using the Nellcor™ SpO2 module. This information only pertains to the module and not the entire Philips IntelliVue Patient Monitor host system. Reference the Patient Alarms and INOPs section of the Philips IntelliVue Patient Monitor Instructions for Use for patient and technical alarm messages. Reference the Maintenance and Troubleshooting section of the Philips IntelliVue Patient Monitor Instructions for Use for service and troubleshooting information.

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Operator’s Manual

1.7.2 Issue Categories

Table 1-3. Error Conditions Issue No power to the module, Power failure to the host system

SETUP key does not work

SETUP indicator does not light

No SpO2 or pulse rate appear on the host system display

“No Sensor” message

1-14

Potential Cause •

Improperly installed module

•

Hardware failure, in either module or host system

•

Facility power issue

•

Improperly installed module

•

Hardware failure, in either module or host system

•

Incompatible system

•

Improperly installed module

•

Hardware failure, in either module or host system

•

Incompatible system

Potential Action •

Remove and completely re-seat module. If the user unplugs the module during normal operation, the host system emits an audible tone and displays a message indicating the module was unplugged.

•

Move module to another slot or host system

•

Replace the module.

•

Move the host system to an alternate power source.

•

Remove and completely re-seat module. If the user unplugs the module during normal operation, the host system emits an audible tone and displays a message indicating the module was unplugged.

•

Move module to another slot or host system.

•

Replace the module.

•

Move the host system to an alternate power source.

•

Remove and completely re-seat module. If the user unplugs the module during normal operation, the host system emits an audible tone and displays a message indicating the module was unplugged.

•

Move module to another slot or host system.

•

Replace the module.

•

Move the host system to an alternate power source.

•

Improperly installed module

•

Press the SETUP key.

•

Hardware failure, in either module or host system

•

Check the host system menu options.

•

Remove and completely re-seat the module.

•

Incompatible system •

Move module to another slot or host system.

•

Replace the module.

•

Replace and reconnect a new sensor.

•

Replace and reconnect a new extension cable.

•

Remove and completely re-seat the module.

•

Replace the module.

•

Hardware failure, in either module or host system

•

Incompatible system

Accessories

Table 1-3. Error Conditions (Continued) Issue Error messages related to the module No audible alarms

Potential Cause

Potential Action

•

Requires corrective action

•

Follow corrective action(s) listed on host system

•

Hardware failure

•

Replace module

•

Alarm Silence enabled

•

Correct on host system.

•

Inappropriate alarm thresholds

•

Have technician inspect host system hardware.

•

Alarm permanently disabled

•

Hardware failure

1.7.3 Return

Contact Covidien or a local Covidien representative for shipping instructions, including a Returned Goods Authorization (RGA) number. Unless otherwise instructed by Covidien, it is not necessary to return the sensor or other accessory items with the module. Pack the module in its original shipping carton. If the original carton is not available, use a suitable carton with appropriate packing material to protect it during shipping. Return the module by any shipping method that provides proof of delivery.

 1.8

Note: For those modules purchased through Philips, please contact Philips Customer Service at 1.800.722.9377.

Accessories

1.8.1 Overview

This section contains information for selecting the appropriate Nellcor™ pulse oximetry sensor for use with the Nellcor™ SpO2 module. 1.8.2 Selecting a Nellcor™ Pulse Oximetry Sensor

 

WARNING: Before use, carefully read the pulse oximetry sensor Directions for Use, including all warnings, cautions, and instructions. WARNING: Do not use a damaged pulse oximetry sensor or pulse oximetry cable. Do not use a sensor with exposed optical components.

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Operator’s Manual

     

WARNING: Tissue damage can be caused by incorrect application or duration of use of a pulse oximetry sensor. Inspect the sensor site periodically as directed in the sensor Directions for Use. WARNING: Use only Nellcor-approved pulse oximetry sensors and pulse oximetry cables when connecting to the sensor connector. Connecting any other cable or sensor influences the accuracy of sensor data, since this may lead to adverse results. WARNING: Pulse oximetry readings and pulse signal can be affected by certain ambient environmental conditions, sensor application errors, and certain patient conditions. WARNING: Do not immerse or wet the pulse oximetry sensor. Caution: The module will only operate with Nellcor™ pulse oximetry sensors. Caution: Adhesive pulse oximetry sensors are intended for single-patient use only. Do not reuse such sensors or transfer a sensor from one patient to a second patient.

When selecting a Nellcor™ pulse oximetry sensor, consider the patient’s weight and activity level, the adequacy of perfusion, the available sensor sites, the need for sterility, and the anticipated duration of monitoring. Use the following table to guide your selection or contact Covidien or a local Covidien representative. Reference Sensor Performance Considerations, p. 1-10. Table 1-4. Pulse Oximetry Sensor Models and Patient Sizes Pulse Oximetry Sensor

SKU

Patient Size

1-16

Nellcor™ Preemie SpO2 Sensor, non-adhesive (Single-patient use)

SC-PR

<1.5 kg

Nellcor™ Neonatal SpO2 Sensor, non-adhesive (Single-patient use)

SC-NEO

1.5 to 5 kg

Nellcor™ Adult SpO2 Sensor, non-adhesive (Single-patient use)

SC-A

>40 kg

Nellcor™ Adult-Neonatal SpO2 Sensor with Wraps (Reusable with adhesive)

OXI-A/N

<3 or >40 kg

Nellcor™ Pediatric-Infant SpO2 Sensor with Wraps (Reusable with adhesive)

OXI-P/I

3 to 40 kg

Nellcor™ Pediatric SpO2 Sensor, Two Piece (Sterile, single-use only)

P

10 to 50 kg

Nellcor™ Neonatal-Adult SpO2 Sensor, Two Piece (Sterile, single-use only)

N

<3 or >40 kg

Nellcor™ Adult SpO2 Sensor, Two Piece (Sterile, single-use only)

A

> 30 kg

Nellcor™ Neonatal-Adult SpO2 Sensor (Sterile, single-use only)1

MAX-N

<3 or >40 kg

Product Specifications

Table 1-4. Pulse Oximetry Sensor Models and Patient Sizes (Continued) Pulse Oximetry Sensor

SKU

Patient Size

1. 2. 3. 4.

Nellcor™ Infant SpO2 Sensor (Sterile, single-use only)2

MAX-I

3 to 20 kg

Nellcor™ Pediatric SpO2 Sensor (Sterile, single-use only)3

MAX-P

10 to 50 kg

Nellcor™ Adult SpO2 Sensor (Sterile, single-use only)4

MAX-A

>30 kg

Nellcor™ Adult XL SpO2 Sensor (Sterile, single-use only)

MAX-AL

>30 kg

Nellcor™ Adult SpO2 Nasal Sensor (Sterile, single-use only)

MAX-R

>50 kg

Nellcor™ Forehead SpO2 Sensor

MAX-FAST

>10 kg

Nellcor™ Adult SpO2 Sensor, Reusable (Nonsterile)

DS-100A

>40 kg

Nellcor™ SpO2 Sensor, Multisite Reusable (Nonsterile)

D-YS

>1 kg

Nellcor™ SpO2 Ear Clip, Reusable (Nonsterile)

D-YSE

>30 kg

Nellcor™ Pediatric SpO2 Clip, Reusable (Nonsterile)

D-YSPD

3 to 40 kg

Philips-distributed sensor equivalent: M1901B Philips-distributed sensor equivalent: M1902B Philips-distributed sensor equivalent: M1903B Philips-distributed sensor equivalent: M1904B

The extension cable connects the module with the patient pulse oximetry sensor.



Note: Physiological conditions, medical procedures, or external agents that may interfere with the ability to detect and display measurements include dysfunctional hemoglobin, arterial dyes, low perfusion, dark pigment, and externally applied coloring agents such as nail polish, dye, or pigmented cream.

1.8.3 Biocompatibility Testing

Biocompatibility testing has been conducted on Nellcor™ pulse oximetry sensors in compliance with ISO 10993-1, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing. Nellcor™ pulse oximetry sensors have passed the recommended biocompatibility testing and are therefore in compliance with ISO 10993-1. 1.9

Product Specifications

1.9.1 Overview

This section contains physical and operational specifications for the Nellcor™ SpO2 module. Ensure all product requirements are met prior to installation of the module.

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Operator’s Manual

1.9.2 Physical Characteristics

Weight

7.2 oz. (.21 kg)

Dimensions

3.80 in. x 3.67 in. x 1.39 in. (9.65 cm x 9.32 cm x 3.53 cm)

1.9.3 Environmental Conditions

Transport and Storage

Operating Conditions

-40 ºC to 70 ºC (-40 ºF to 158 ºF)

0 ºC to 45 ºC (32 ºF to 113 ºF)

Altitude

-500 m to 15,300 m (-1,640 ft. to 50,197 ft.)

0 m to 4600 m (0 ft. to 15,092 ft.)

Atmospheric Pressure

107 kPa to 11 kPa (31.6 in. Hg to 3.2 in. Hg)

101 kPa to 57 kPa (29.9 in. Hg to 16.8 in. Hg)

Temperature

Relative Humidity

15% to 95% non-condensing

1.9.4 Performance Specifications

Table 1-5. Nellcor™ Pulse Oximetry Sensor Ranges Range Type

Range Values Measurement Ranges

SpO2 Saturation Range

0% to 100%

Pulse Rate Range

25 to 300 beats per minute (bpm) Operating Range and Dissipation



1-18

Red Light Wavelength

Approximately 660 nm

Infrared Light Wavelength

Approximately 900 nm

Optical Output Power

Less than 15 mW

Power Dissipation

52.5 mW

Note: For a complete listing of SpO2 accuracy across the full line of available Nellcor™ pulse oximetry sensors, contact Covidien, a local Covidien representative, or online at www.covidien.com.

Product Specifications

1.9.5 Product Compliance

Standards Compliance

ISO 9919:2005 IEC 60601-1-2:2007 IEC 60601-1:1998 + A1:1991 + A2:1995 EN 60601-1:1990 + A11:1993 + A12:1993 + A13:1996 CAN/CSA C22.2 No. 601.1 M90 UL 60601-1: 1st edition

Equipment Classifications Type of Protection against electric shock

Determined by the host system

Degree of Protection against electric shock

Type CF - Defibrillation Protected - Applied part

Mode of Operation

Continuous

Electromagnetic Compatibility

IEC 60601-1-2:2007

Liquid Ingress

IPX1

Degree of Safety

Not suitable for use in the presence of flammable anesthetics

1.9.6 Manufacturer’s Declaration



WARNING: The use of accessories, Nellcor™ pulse oximetry sensors, and cables other than those specified may result in inaccurate readings of the pulse oximeter and increased emission of the pulse oximeter.

The module is suitable for prescription use only in the specified electromagnetic environments when installed in a compatible Philips IntelliVue Patient Monitor (host system). Use the module in accordance with the electromagnetic environments described in the Philips Instructions for Use: IntelliVue Patient Monitor. Safety Tests

Table 1-6. Patient Applied and Patient Isolation Risk Current Condition

Normal Single Fault

IEC 60601-1, ANSI/AAMI 60601-1 Patient Applied Risk Current

Patient Isolation Risk Current

10 μA

N/A 50 μA

1-19