Medtronic OS1E100 User Manual
Operator's Manual
Exhibit #8
TM
Vital Sync
Wearable SpO2 Patient Monitoring System
Medtronic, the Medtronic logo, and Further, Together are trademarks of Medtronic. Other brands are
trademarks of a Medtronic company.
This manual © 2015, 2016 Medtronic. All rights reserved.
Table of Contents
1 Introduction
1.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.2 Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.3 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.3.1 Safety Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.3.2 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.3.3 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
1.3.4 Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
1.4 Obtaining Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
1.4.1 Technical Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
1.4.2 Related Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
1.5 Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
1.6 Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
1.7 Licensing Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
1.8 HIPAA Disclaimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
2 Product Overview
2.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.2 Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.3 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2.4 Components and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2.5 Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.5.1 Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.5.2 Module with Connected Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.5.3 Docking Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
2.6 Symbols and Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
2.6.1 Monitoring System Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
2.6.2 Packaging and Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
3 Docking Station Setup and Operation
3.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
3.2 Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
3.3 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
3.4 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
3.4.1 Power On and Power Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
3.4.2 Module Battery Recharge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
3.5 Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
3.6 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Operator’s Manual iii
4 Module and Sensor Setup and Operation
4.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.2 Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.3 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
4.4 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
4.4.1 Power On and Power Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
4.4.2 Monitor a Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
4.4.3 Change Alarm Thresholds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
4.4.4 Battery Recharge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
4.5 Alarm Thresholds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
4.6 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
5 Performance Considerations
5.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.2 Oximetry Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.2.1 Monitoring System Constraints . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.2.2 Sensor Performance Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.3 Patient Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
5.4 Reducing Electromagnetic Interference (EMI) . . . . . . . . . . . . . . . 5-4
6 Product Maintenance
6.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.2 Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.2.1 Cleaning and Disinfecting Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.2.2 Clean the Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
6.2.3 Disinfect the Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
6.2.4 Clean or Disinfect the Docking Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
6.3 Module Battery Recharge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
6.4 Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
7 Troubleshooting
7.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.2 Monitoring System Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.3 Docking Station Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
iv Operator’s Manual
Table of Contents
8 Product Specifications
8.1 Physical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
8.2 Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
8.3 Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
8.3.1 Operating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
8.3.2 Transport and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
8.4 Product Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
8.5 Manufacturer’s Declaration and Guidance . . . . . . . . . . . . . . . . . . 8-3
8.5.1 Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
8.5.2 FCC Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
8.6 Sensor Accuracy and Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
8.7 Essential Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9
A Clinical Studies
A.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-1
A.2 Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
A.3 Study Population . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-1
A.4 Study Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-1
A.5 Adverse Events or Deviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-1
A.6 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-1
Operator’s Manual v
Page Left Intentionally Blank
vi
1 Introduction
1.1 Overview
This manual describes the features, setup, and operation of the patient components
of the Vital Sync™ Wearable SpO2 Patient Monitoring System, along with the docking
station used with the device.
This manual applies to the following products:
OS1E
OS1ACC
1.2 Intended Audience
This manual provides information to health-care professionals acting as caregivers in
low-acuity hospital or hospital-type settings for operation and maintenance of the
monitoring system.
Consult facility requirements and protocols for any additional training or skill requirements beyond those identified here for operation and maintenance of the monitoring
system.
Before using the monitoring system or the docking station, thoroughly read this
manual, as well as the user documentation for the monitoring application used as part
of the monitoring system.
1-1
Introduction
Safety Information
1.3
This section contains important information regarding the safe and correct use of the
Vital Sync Wearable SpO2 Patient Monitoring System.
Other important safety information appears in various locations in this manual.
1.3.1
Safety Symbols
Table1-1.
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.
1.3.2 Warnings
The following warnings apply when using the monitoring system.
||new warnings and draft warnings possibly to be added are in blue text||
Hazard Warnings
Safety Symbol Definitions
1-2 Operator's Manual
WARNING:
Electrical shock hazard — Do not soak the monitoring system module or submerge it into
any liquids.
WARNING:
Always disconnect and remove the monitoring system module and sensor during
magnetic resonance imaging (MRI) scanning. Attempting to use the monitoring system
during an MRI procedure could cause burns or adversely affect the MRI image or the
monitoring system's accuracy.
Patient and Device Safety Warnings
Safety Information
WARNING:
Do not use the monitoring system if the module or sensor appears or is suspected to be
damaged.
WARNING:
Using different alarm limits for the same or similar equipment within a single area of care
may compromise patient safety.
General Usage Warnings
WARNING:
The monitoring system is intended only as an adjunct in patient assessment. It must be
used in conjunction with clinical signs and symptoms and periodic patient observations.
WARNING:
The monitoring system module does not have an on-device screen or display. Users must
view monitored data and alarms in an appropriate application on an external host system
that is communicating with the module and sensor.
WARNING:
The monitoring system module and sensor communicate with the external host system
via the facility’s data network. This may result in delays in reporting of device data and
alarms, depending on network bandwidth and loading and on networking hardware
used.
WARNING:
The monitoring system module reports data periodically, not continuously. The data
reporting interval, as well as delays due to network bandwidth, loading, or hardware
issues, will create a lag between when a patient event happens and when it is reported in
the external application.
WARNING:
Due to the monitoring system’s periodic data reporting, as well as the potential for
network delays, the monitoring system is not suitable for use as a pulse oximeter for
transient events.
Operator's Manual 1-3
Introduction
System Performance and Accuracy Warnings
WARNING:
Verify that accessories and sensors used are compatible with the monitoring system
module. Only use accessories and sensors specified by Medtronic for use with this
monitoring system.
WARNING:
The use of accessories and sensors other than those specified may result in inaccurate
readings of the monitoring system and increased emission and/or decreased
electromagnetic immunity of the monitoring system module and sensor.
WARNING:
For best product performance and measurement accuracy, use only accessories supplied
or specified by Medtronic. Use accessories according to the manufacturer's directions for
use and institutional standards.
WARNING:
Portable and mobile radio frequency (RF) communications equipment can affect medical
electrical equipment.
WARNING:
Interference from electrosurgical generators can degrade the performance or accuracy of
the module and sensor.
1-4 Operator's Manual
WARNING:
The presence of dysfunctional hemoglobin may result in inaccurate SpO2 measurements.
WARNING:
Excessive motion may cause deterioration of SpO2 and pulse rate accuracy.
WARNING:
While the monitoring system is in use, the patient should avoid gripping with the hand to
which the sensor is attached, or inaccurate measurements may result.
Cautions
1.3.3
||new draft cautions possibly to be added are in blue text||
Safety Information
Caution:
Failure to charge the monitoring system module promptly after a low battery indication
may result in the module shutting down.
Caution:
Do not use any constricting instrument, such as a noninvasive blood pressure (NIBP) cuff,
on the same appendage as the monitoring system sensor, or inaccurate measurements
may result.
Caution:
Follow local government ordinances and recycling instructions regarding disposal or
recycling of the monitoring system and its components, including batteries and
accessories.
1.3.4 Notes
Note:
Failure of any cable or connector, or failure of the wireless connection to the external host system,
will interrupt the transfer of data from the monitoring system module to the external host
system.
Operator's Manual 1-5
Note:
If the module is out of range of the external host system, it will not report monitored data or
alarms to the host system.
Note:
If the module loses connection with the external host system, it will continue to monitor data
from the patient. The module will record alarm conditions that occur while it is disconnected or
out of range, and will report them to the monitoring application once it reestablishes connection
with the host system.
Note:
Failure to cover the 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, pulse oximetry sensor application errors,
Introduction
and certain patient conditions. Refer to the appropriate sections of this manual for specific safety
information.
Note:
Do not lift or carry the module by the pulse oximetry sensor or sensor cable. The cable is not
designed to be weight-bearing. It can be damaged if used to lift or carry the module, or can
disconnect, potentially damaging the module if the module falls on a hard surface.
Note:
A functional tester cannot be used to assess the accuracy of the monitoring system module or
sensor.
Note:
Use and store the monitoring system module in environmental conditions that are within
specifications. Refer to
Note:
Before using this device, carefully review this manual, the associated accessory
, and all precautionary information and specifications.
Use
Note:
The module contains WEEE materials. Do not discard the module as unsorted municipal waste.
Environmental Conditions
on page
8-2
.
Instructions for
1.4 Obtaining Technical Assistance
1.4.1 Technical Services
For technical information and assistance, if unable to correct a problem while using
the device, contact Medtronic or a local Medtronic representative.
Medtronic Technical Services (Patient Monitoring & Recovery)
15 Hampshire Street
Mansfield, MA 02048 USA
1.800.635.5267, or 1.925.463.4635,
or contact a local Medtronic representative
www.medtronic.com
When calling Medtronic or a local Medtronic representative, provide the serial
number from the label on the bottom of the monitoring system module.
1-6 Operator's Manual
Related Documents
1.4.2
Before using the device, review both this manual and the user documentation for the
monitoring application on the external host system. This information is essential for
understanding the data posted to the external host system and appearing in the
monitoring application, as well as the device’s own visual indicators. In addition,
review the instructions for use for the wrist strap and cradle and the sensor.
Also read all precautionary information and specifications both for the device and its
associated accessories, and for the monitoring application in which the device data is
being viewed.
Revision History
Document Description
Vital Sync™ Wearable SpO2 Patient Monitoring
System Operator’s Manual
Vital Sync™ Wearable SpO2 Patient Monitoring
System Wrist Strap Instructions for Use
Nellcor™ Adult SpO
(MAXNW)
1.5
Revision History
Sensor Instructions for Use
2
Table1-2.
Related Documents
Provides information on device operation and on troubleshooting errors or malfunctions.
Provides information on use of the wrist strap and cradle with
the module.
Provides information on positioning and use of the connected
sensor.
The part number, revision level and date on the documentation indicate its version.
The revision level and date change when a new edition is printed in accordance with
the revision history of the documentation. Minor corrections and updates incorporated at reprint do not cause the revision number to change. The document part number
may change when extensive technical changes are incorporated into the document.
1.6
Warranty Information
The information contained in this document is subject to change without notice.
Medtronic makes no warranty of any kind with regard to this material, including, but
not limited to, the implied warranties or merchantability and fitness for a particular
purpose. Medtronic shall not be liable for errors contained herein or for incidental or
consequential damages in connection with the furnishing, performance, or use of this
material.
Operator's Manual 1-7
Introduction
1.7
Licensing Information
Users of the external host system and associated software applications to which the
Vital Sync Wearable Patient Monitoring System is connected must obtain licenses for
the host system and associated applications separately.
1.8 HIPAA Disclaimer
The Vital Sync Wearable SpO2 Patient Monitoring System interfaces with an external
host system and software applications used in conjunction with electronic medical
devices within the customer’s secure health information system.
Healthcare providers using such systems and software are expected to take appropriate security measures to protect the confidentiality of all data created, stored or transmitted on their systems, including data received from the Vital Sync Wearable SpO2
Patient Monitoring System.
Although the external host system and software applications used in conjunction
with the monitoring system (such as the Vital Sync Virtual Patient Monitoring Platform
and Informatics Manager) contain certain features to assist users in the users’ steps to
protect their data, Medtronic cannot provide any assurance that the user’s use of said
applications in conjunction with the Vital Sync Wearable SpO2 Patient Monitoring
System will comply with HIPAA regulations or be otherwise in compliance with the
customer’s obligations as a covered entity.
1-8 Operator's Manual
2 Product Overview
2.1 Overview
This chapter provides general descriptive information for the Vital Sync™ Wearable
SpO2 Patient Monitoring System.
2.2 Product Description
The Vital Sync™ Wearable
wireless automated spot check device that measures functional oxygen saturation of
arterial hemoglobin (SpO2).
The monitoring system consists of a module and a pulse oximetry sensor. The sensor
collects signals usable for determining SpO2 and pulse rate values and sends them to
the module. The module then wirelessly transmits the measured parameter data to an
external host system.
The monitoring system module has four colored LEDs to indicate system status. The
monitoring system module does not include a dedicated on-unit data display. Users
view monitored data and see associated alarm indications in an appropriate application (e.g., the Vital Sync™ Virtual Patient Monitoring Platform and Informatics Manager)
residing on the host system.
The monitoring system is powered by an internal battery, and is able to operate for a
minimum of 12 hours before requiring recharging.
Note:
For purposes of using the monitoring system, “hospital use” refers to low-acuity areas within a
hospital and in hospital-type facilities.
“Hospital-type facilities” are medical care facilities external to a hospital; examples include skilled
nursing facilities, long term acute care centers, and step-down units. “Low-acuity areas” are
patient care locations where patients are not at risk of rapid desaturation. Patients using the
monitoring system are spot-checked periodically, and may be ambulatory and under minimal
supervision.
SpO2
Patient Monitoring System is a noninvasive wearable,
2-1
Product Overview
2.3
Indications for Use
WARNING:
The monitoring system is intended only as an adjunct in patient assessment. It must be
used in conjunction with clinical signs and symptoms and periodic patient observations.
The Vital Sync™ Wearable SpO2 Patient Monitoring System is a wireless pulse oximeter
indicated for prescription use only as an automated spot check of functional oxygen
saturation of arterial hemoglobin (SpO2) and pulse rate of adult patients in motion
and no motion conditions who are well or poorly perfused. It is intended for use in
hospitals and hospital-type facilities with a transceiver.
The Nellcor™ Adult SpO2 Sensor, model MAXNW, is indicated for single patient use
when spot-check, non-invasive arterial oxygen saturation and pulse rate monitoring
are required for adults weighing more than 40 kg.
2.4 Components and Accessories
The patient components of the monitoring system include the following:
•
The module, which interprets signal data from the connected sensor and transmits measured parameter data to an external host system.
•
The OxiMax™ MAXNW sensor for collecting the patient’s SpO2 level and pulse rate signal
information. This connects to the module.
In addition, the following accessories are available:
•
The hook and loop wrist strap and attached cradle, used to secure the module to the
patient.
•
An additional hook and loop strap (if included with the sensor), usable as needed to
further secure the sensor cable.
•
The docking station, which recharges up to five modules simultaneously.
Table2-1.
Item Number Description
GR107997 Module, Vital Sync Wearable Patient SpO2 Monitoring System
MAXNW Adult SpO
OS1ACWS Wearable SpO
OS1ACC Docking Station, Vital Sync Wearable SpO
2-2 Operator's Manual
Monitoring System Patient Components and Accessories
Sensor
2
Strap and Cradle
2
Patient Monitoring System
2
Views
2.5
2.5.1 Module
Views
Figure2-1.
1 Sensor Connector Socket 4 Nominal Condition LED (green)
2 Low Battery LED (orange) 5 Patient Data Error LED (orange)
Monitoring System Module (top view)
3 Wireless Connection LED (blue) 6 Power Button
Operator's Manual 2-3
Note:
The visible indicators on the module do not relate to the patient’s physiological condition; they
only show the status of the module and connected sensor.
2.5.2 Module with Connected Sensor
ImageObject
Figure2-2.
||Module with Connected Sensor – graphic pending||
Product Overview
2.5.3
Docking Station
Figure2-3.
2.6 Symbols and Descriptions
Docking Station
This section lists and defines the symbols on the monitoring system module and the
packaging labeling.
2.6.1 Monitoring System Module
Table 2-1 defines the symbols that appear on the monitoring system module.
Table2-2.
Symbol Description Symbol Description
Connection error (monitoring
system not connected to external
host).
Module battery charge low (if
module is not docked), or module
battery recharging (if docked).
Sensor error or sensor disconnect. Not safe in any magnetic resonance
Nominal condition (monitoring
system is operating normally).
Power on / power off. Protection against fluid ingress.
Part number. Serial number.
Symbols on Module
US federal law restricts this device to
sale by or on the order of a physician.
Follow instructions for use (appears
in blue on the device).
(MR) environment.
Defibrillator-proof type BF applied
part.
2-4 Operator's Manual
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