Medtronic Nellcor Instructions Manual
Instructions for Use
TM
Nellcor
OxiCable, USB
305 cm
©2017, 2018 Medtronic. All rights reserved. Medtronic and Medtronic logo are trademarks of Medtronic. All other brands are
trademarks of a Medtronic company.
Table of Contents
1 Introduction
1.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.2 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.2.1 Safety Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1
1.2.2 Patient and Operator Safety - General Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
1.2.3 System Connection, Compliance, and Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
1.2.4 Sensor Use and Performance Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
1.2.5 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1.3 Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1.3.1 Technical Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
1.3.2 Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
2 Product Overview
2.1 Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.2 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.3 Monitoring Cable Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2.4 Labeling Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
3 Connection
3.1 Connection to a Host Monitoring System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
3.2 Connection to a Nellcor™ Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
4 Performance Considerations
4.1 Nellcor™ Sensor Performance Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.2 Electromagnetic Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
5 Product Maintenance
5.1 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.2 Service and Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
6 Accessories
6.1 Nellcor™ Sensor Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
7 Theory of Operations
7.1 Theoretical Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.2 Automatic Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Instructions for Use i
7.3 Functional Testers and Patient Simulators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
7.4 Functional versus Fractional Saturation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
7.5 Measured versus Calculated Saturation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
7.6 System Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
7.6.1 Nellcor™ Sensor Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-4
7.6.2 Data Update Period, Data Averaging, and Signal Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
7.6.3 Pulse Rate Delay Alarm Management Parameter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
7.6.4 SatSeconds™ Alarm Management Parameter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-6
7.7 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
8 Product Specifications
8.1 Physical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
8.2 Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
8.3 Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
8.4 System Accuracy and Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
8.5 Nellcor™ Sensor Optical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
8.6 Product Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
8.7 Biocompatibility Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
8.8 Manufacturer’s Declaration and Guidance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
8.8.1 Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
8.8.2 Safety Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
8.9 Host Monitoring System Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
8.10 Essential Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
A Clinical Study
A.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
A.2 Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
A.3 Study Population . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
A.4 Study Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
A.4.1 Adverse Events or Deviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-4
A.5 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
ii Instructions for Use
1 Introduction
1.1 Overview
This manual provides information for using the Nellcor™ oxicable, USB (the “monitoring cable”).
This manual applies to the following product:
PMC10UB305N
1.2 Safety Information
This section contains important safety information for use of the monitoring cable. Use this
information in conjunction with the safety information specified in the host monitoring system
documentation.
1.2.1 Safety Symbols
Symbol Definition
WARNING
Warnings alert users to potential serious outcomes (death, injury, or adverse events) to
the patient, user, or environment.
Caution
Cautions alert users to exercise appropriate care for safe and effective use of the product.
Note
Notes provide additional guidelines or information.
Table1-1.Safety Symbol Definitions
1-1
Introduction
1.2.2 Patient and Operator Safety - General Use
WARNING:
Shock hazard — Do not immerse or wet the monitoring cable or sensor.
WARNING:
Choking hazard — The monitoring cable contains small detachable parts.
WARNING:
Disconnect the monitoring cable, sensor, and monitoring system 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:
Do not use the monitoring cable in the presence of flammable anesthetics. This may cause an
explosion or fire.
WARNING:
Do not use a pulse oximetry sensor on the same extremity as a blood pressure cuff or other
constricting instrument. Such usage can cause inaccurate pulse oximetry measurements or a loss
of signal.
WARNING:
Do not use any monitoring cable, monitoring system, sensor, cable, or connector that has a
damaged enclosure or any damaged component. Remove any damaged equipment from service
for inspection by a qualified service technician.
WARNING:
As with all medical equipment, carefully route patient cabling to reduce the possibility of patient
entanglement or strangulation.
WARNING:
Ensure that the monitoring cable is carefully positioned to prevent tripping and entanglement.
Caution:
Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
1-2 Instructions for Use
1.2.3 System Connection, Compliance, and Interference
WARNING:
The monitoring cable may cause radio interference or may disrupt the operation of nearby
equipment. Mitigation for such disruption may require re-orienting or relocating the monitoring
cable or shielding the location.
WARNING:
The use of accessories, sensors, and cables other than those specified may result in inaccurate
readings and increased EMI emissions of the monitoring cable.
WARNING:
EMI disruption can cause erratic readings, cessation of operation, or other incorrect functioning.
Caution:
This device has been tested and found to comply with the limits for medical devices related to IEC
60601-1-2: 2007 for Class B Emissions. These limits are designed to provide reasonable protection
against harmful interference in a typical medical installation.
Safety Information
Caution:
Anyone who connects the monitoring cable to a host monitoring system is configuring a medical
system and, therefore, is responsible for ensuring the system complies with the Requirements for
Medical Electrical Systems IEC/EN 60601-1:2005 and electromagnetic compatibility IEC/EN 606011-2:2007.
Caution:
Do not connect the monitoring cable’s USB connector to anything other than a compatible USB 2.0
host device.
1.2.4 Sensor Use and Performance Considerations
WARNING:
Certain physical conditions may affect calculation of SpO
include, but are not limited to: dysfunctional hemoglobin, intravascular dyes, low perfusion, and
darkly pigmented skin. Refer to Nellcor™ Sensor Performance Considerations, page 4-1.
Caution:
Use only Medtronic-approved sensors when connecting to the sensor port. Connecting any other
sensor influences the accuracy of sensor data, which may lead to adverse results.
and pulse rate. These conditions
2
Instructions for Use 1-3
Introduction
1.2.5 Disposal
Caution:
Dispose of the monitoring cable in accordance with local requirements and regulations.
1.3 Technical Assistance
1.3.1 Technical Services
For technical information and assistance, if unable to correct a problem while using the monitoring cable, or to order parts, contact Medtronic or a local Medtronic representative.
Medtronic Technical Services: Patient Monitoring
15 Hampshire Street
Mansfield, MA 02048 USA
1.800.635.5267, 1.925.463.4635 (toll)
or contact a local Medtronic representative
www.medtronic.com
When calling Medtronic or a local Medtronic representative, have the monitoring cable serial
number available.
1.3.2 Warranty Information
To obtain information, contact Medtronic or a local Medtronic representative. See Technical Ser-
vices, page 1-4.
Purchase of this instrument confers no express or implied license under any Medtronic patent to
use that instrument with any sensor not manufactured or licensed by Medtronic.
1-4 Instructions for Use
2 Product Overview
2.1 Product Description
When used with a host monitoring system, the Nellcor™ oxicable, USB (the “monitoring cable”)
provides continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO
cable relies on unique oximetry technology and design to provide hospitals, clinicians, and caregivers with accurate, timely data.
The monitoring cable provides the following patient data to the host monitoring system:
• Arterial blood oxygen saturation (SpO
tive to the sum of oxyhemoglobin and deoxyhemoglobin.
• Pulse rate (PR) - Detected pulsations per minute.
• Plethysmographic waveform (Pleth) - Visual waveform representing detected pulsations. (Non-
normalized)
) and pulse rate, as measured by Nellcor™ pulse oximetry sensors. The monitoring
2
) - Functional measure of oxygenated hemoglobin rela-
2
• Operating status - Alarm conditions and operational status.
2.2 Indications for Use
The Nellcor™ OxiCable, USB is indicated for prescription use only for spot check or continuous
non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO
pulse rate. It is intended for use with neonatal, pediatric, and adult patients during both no
motion and motion conditions and for patients who are either well or poorly perfused, in hospitals and hospital-type facilities.
Note:
• Hospital use typically includes such areas as the intensive care unit (ICU), neonatal intensive care unit
(NICU), operating room (OR), post-anesthesia care unit (PACU), emergency department, and
medical/surgical general care floor (GCF).
• Hospital-type facilities include step-down units and long-term care facilities.
Use with any particular patient requires the selection of an appropriate Nellcor™ sensor. See Nellcor™
Sensor Selection, page 6-1.
) and
2
2-1
Product Overview
Monitoring Cable Components
2.3
Figure2-1.Monitoring Cable Components
1 Sensor Port
(to Nellcor™ Sensor)
2 Sensor Latch 4 USB Connector
3 Isolation Module
(to Host Monitoring System)
2-2 Instructions for Use
Labeling Symbols
2.4
Symbol Description Symbol Description
Must consult instructions for use Date of manufacture
Universal Serial Bus (USB) connector Proper waste disposal for electrical and
Labeling Symbols
Table2-1.Labeling Symbols
electronic equipment
Protection against particulate and fluid
ingress:
Protected against solid objects greater than
1mm.
Protected against the effects of submersion
in water up to 1 meter deep for up to 30
minutes.
Atmospheric pressure limitations (see Envi-
ronmental Conditions, page 8-1)
Temperature limitations (see Environmental
Conditions, page 8-1)
Humidity limitations (see Environmental
Conditions, page 8-1)
Serial number Prescription only
Consult instructions for use
Type BF applied part: Nellcor™ sensor and
sensor cable
Defibrillator proof
Keep dry
Catalog number
CSA – Canadian Standards Association certification mark
Instructions for Use 2-3
Product Overview
Page Left Intentionally Blank
2-4 Instructions for Use
3 Connection
3.1 Connection to a Host Monitoring System
To connect the Nellcor™ oxicable, USB (the “monitoring cable”) to a host monitoring system,
insert the monitoring cable’s USB connector into a compatible USB port on the host system.
Figure3-1.USB Connector on Monitoring Cable
Note:
The monitoring cable derives power from the host monitoring system. The monitoring cable has no
power switch. To ensure that power is removed from the monitoring cable, disconnect it from the host
monitoring system.
3.2 Connection to a Nellcor™ Sensor
Prior to using a Nellcor™ sensor with the monitoring cable:
• See Nellcor™ Sensor Selection, page 6-1 for information about selecting the appropriate sensor for the
patient.
• Read the Instructions for Use accompanying the sensor.
• See Nellcor™ Sensor Performance Considerations, page 4-1 for information about optimizing the per-
formance of the sensor and monitoring cable during patient use.
3-1
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