Masimo Shuttle 4721 User manual

Instructions for Use
Masimo Shuttle™
Part Number 4721
LA-00395-R06

Masimo Shuttle™ Contents
Contents
Compliance and safety information..................................................................... 7
Disposal................................................................................................................................7
IP rating................................................................................................................................7
Cautions............................................................................................................................... 7
Use the Masimo Shuttle......................................................................................... 9
General handling instructions.......................................................................................... 9
Connect the Masimo Shuttle.......................................................................................... 10
Troubleshoot the Masimo Shuttle...................................................................... 11
Appendix................................................................................................................. 12
Electromagnetic emissions............................................................................................. 12
Immunity standards..........................................................................................................12
Masimo Corporation 2 www.masimo.com

Masimo Shuttle™ Contents
Trademark attributions
These trademarks and all related logos and brandings are trademarks of Masimo Corporation. All other trademarked
product names, brands, images, and other material are the property of their respective owners. Their use in this
document does not imply a relationship between Masimo Corporation and the trademark holder.
•Masimo®
•Shuttle™
•iSirona™
•DCX™
•HBox®
Revision history
Date Revision number Description
August 27, 2019 1.0 Initial release
October 31, 2019 2.0 The operating temperature range was updated to 0 °C –
40 °C.
December 6, 2019 3.0 The serial port speed was updated to 1M baud. The
operating temperature range was updated to 5 °C - 40
°C.
May 7, 2020 4.0 The company name, logo, fonts, and product image
were updated to Masimo branding. The corporate
contact address was removed and the manufacturer
contact address was updated. The title of the manual was
updated from User Manual to Instructions for Use.
June 4, 2020 5.0 The part number was updated to 4721.
September 23, 2020 6.0 Updated the required environmental humidity range to
5%-95%
Masimo Corporation 3 www.masimo.com

Masimo Shuttle™ Preface
Preface
Symbols
Caution
Manufacturer
Authorized representative
The CE mark indicates conformity with health, safety, and environmental protection standards
for products sold within the European Economic Area
Separate collection for waste of electrical and electronic equipment
Temperature
Humidity
Atmospheric pressure
Intended audience
The intended audience for this document is biomedical engineers and nursing staff authorized by Masimo to
install the Masimo® Shuttle™.
Masimo® Shuttle™ cable is used to connect medical devices with RS-232 ports for the purpose of sending medical
device data to either a Masimo iSirona™, Masimo HBox, or a PC node with a USB port that is running DCX™ Client
software.
Masimo Corporation 4 www.masimo.com

Masimo Shuttle™ Notices
Notices
Legal
© 2020 Masimo Corp. and its affiliates. All rights reserved.
This document and the information presented herein are proprietary and confidential information of Masimo
Corporation (“Masimo”) and shall not, directly or indirectly, be reproduced, in whole or in part, adapted, modified,
disclosed, transmitted, displayed, have derivative works prepared based upon them or otherwise be disseminated
without the prior written consent of Masimo.
The information contained in this document is solely for use by the designated in-house representatives of current
Masimo licensees who have agreed in writing to maintain the confidentiality of Masimo confidential information
and not to use any of same other than as and to the extent necessary to use Masimo Corporation software on
authorized hardware located at client’s authorized facilities within the scope of the license granted to them by
Masimo. Any other use by any other person or entity is strictly prohibited. Any violations of these requirements
shall be reported to Masimo. This document must be returned to Masimo when the user is no longer licensed by
Masimo to use Masimo software, and immediately upon Masimo’s written request.
Masimo may make improvements or changes in the product(s) described in this document at any time.
Masimo makes no representations or warranties regarding this document or the information contained herein
and no information provided in this document modifies any warranties, disclaimers, limitations or other
terms of any client’s license agreement with Masimo. ALL IMPLIED WARRANTIES, INCLUDING, WITHOUT
LIMITATION, IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE
AND NONINFRINGEMENT, ARE HEREBY DISCLAIMED. Masimo shall have no liability for any errors or omissions
contained in this document or otherwise relating to this document.
Authorized representative
EMERGO EUROPE
Prinsessegracht 20
2514 AP The Hague
The Netherlands
Masimo Corporation 5 www.masimo.com

Masimo Shuttle™ Contacts
Contacts
Support contact information
Call Masimo Support at 1-833-274-4955, 24 hours a day, seven days a week.
You can also send an email to [email protected]. We monitor emails from 8:00 a.m. to 5:00 p.m. Central
Time, Monday through Friday. Use email for non-emergencies only.
Manufacturer contact
Masimo Corporation
52 Discovery
Irvine, CA 92618, USA
Tel.: [phone]
Fax.: [phone]
www.masimo.com
Masimo Corporation 6 www.masimo.com

Masimo Shuttle™ Compliance and safety information
Compliance and safety information
Masimo Shuttle is currently designed to meet regulations for use in the United States, Canada, and Europe.
Federal Communications Commission (FCC)
The Masimo Shuttle cable complies with the FCC rules and regulations delineated in Title 47 CFR, Part 15, Subpart
B, Class B for unintentional radiators.
Canadian ISED Compliance
Masimo Shuttle complies with Canada's Interference-Causing Equipment Standards, ICES-003 Class B for
unintentional radiators.
Conformité Européenne (CE)
The Masimo Shuttle complies with the following CE directives:
•Electromagnetic Compatibility Directive 2014/30/EU
•Restriction of Hazardous Substances Directive 2011/65/EU
•Waste Electrical and Electronic Equipment Directive 2012/19/EU
Disposal
This symbol on the Masimo Shuttle indicates that this product must not be disposed of with your other unsorted
waste. Instead, it is your responsibility to dispose of your waste equipment by handing it over to a designated
collection point for the recycling of waste electrical and electronic equipment. The separate collection and
recycling of your waste equipment at the time of disposal will help conserve natural resources and ensure that it is
recycled in a manner that protects human health and the environment. For more information about where you can
drop off your waste for recycling, please contact your local authority, or the manufacturer contact.
IP rating
Masimo Shuttle has an IP rating of IP-54.
•Protected from limited dust ingress.
•Protected from water spray from any direction.
Note Ingress of dust or liquid is not entirely preventable.
Cautions
Any and all configurations that use this device must be tested for electrical isolation before
being used for patient care.
Do not modify device without authorization. Any modifications must be inspected and
approved by Masimo.
Use of this equipment adjacent to or stacked with other equipment should be avoided because
it could result in improper operation or degraded performance.
Masimo Corporation 7 www.masimo.com

Masimo Shuttle™ Compliance and safety information
Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
The use of ITE grade USB extenders or USB hubs is not recommended. Only the RS232
interface can be extended but not more than 15m.
Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the Masimo
Shuttle cable assembly or any attached RS-232 extension cables. Otherwise, a degradation in
the performance of this equipment could result.
The Masimo Shuttle should only be connected to IEC 60601-1 compliant devices.
Masimo Corporation 8 www.masimo.com

Masimo Shuttle™ Use the Masimo Shuttle
Use the Masimo Shuttle
The Masimo Shuttle is a medical-grade USB-to-RS232 converter specially designed to connect various medical
devices to the Masimo iSirona, Masimo HBox, or a PC node running Masimo’s DCX™ Client software.
•It connects medical devices with RS-232 ports to a USB port on either an iSirona, HBox, or a Windows® PC
running DCX Client for the purpose of reporting vitals data.
•It provides a unique identifier used by DCX that enables proprietary medical device data to be streamed to a
DCX Client and DCX Server for processing before being sent to the EMR.
The Masimo Shuttle includes a 9-pin RS-232-type male connector for connection to a medical device. Opposite
the RS-232 connector is a USB-A connector for connection to the iSirona, HBox, or node.
Light Emitting Diodes (LEDs) at the base of the USB connector indicate when the Masimo Shuttle is transmitting or
receiving data to and from the medical device.
When flashing, the green LED indicates that the Masimo Shuttle is transmitting data from DCX to the medical
device. The blue LED, when flashing, indicates that the Masimo Shuttle is receiving data from the medical device.
Features
The Masimo Shuttle is compliant with IEC 60601-1. Other features include the following:
•Adds one RS-232 serial port by connecting to USB
•Easy plug-and-play installation and RS-232 device connection
•USB 2.0 compatible device
•First-in first-out (FIFO) transmission: featuring a 128-byte transmit buffer and 256-byte receive buffer
•RS-232 data signals: TxD, RxD, RTS, CTS, DSR, DTR, GND
•Powered by the USB port. No external power adapter is required.
•Serial port speed is up to 1M baud
•Serial Communication Parameters
•Parity: None, Even, Odd
•Data bits: 7, 8
•Flow control: RTS/CTS, DSR/DTR, X-ON/X-OFF, None
•One DE-9P male connector
•LEDs indicate transmit and receive activity for monitoring port status and easy diagnostics
General handling instructions
General cleaning
The Masimo Shuttle cable is water resistant and may be wiped down or sterilized with alcohol or liquid cleaners
without degrading. Clean per hospital protocol.
Note Medical disinfectant wipes are recommended.
Masimo Corporation 9 www.masimo.com

Masimo Shuttle™ Use the Masimo Shuttle
Environmental requirements
Ensure the following environmental requirements are met:
•Keep the Masimo Shuttle away from sunlight.
•Keep the Masimo Shuttle dry.
The following table details the normal environmental limits within which the Masimo Shuttle will operate.
Environmental requirements
Parameter Range low Range high
Operating Temperature 5° C 40° C
Storage Temperature -25° C +70° C
Humidity 5% 95%
Atmospheric Pressure 700 hPa 1060 hPa
Transportation and storage
Do not store or transport Masimo Shuttle in an uncontrolled environment where the storage temperature is
below -25°C or above 70°C. Do not store or transport it in an uncontrolled environment where the atmospheric
pressure is below 700 hPa or higher than 1060 hPa. Do not store or transport Masimo Shuttle in an uncontrolled
environment where it exceeds the IP rating. Doing so may damage it.
Connect the Masimo Shuttle
To connect the Masimo Shuttle to a medical device and a Masimo iSirona, Masimo HBox, or PC node, follow these
steps:
Note If you don't need an extension cable, you can connect the Masimo Shuttle directly to the medical device.
1. Connect an extension cable, with a vendor-specified pinout, to the serial port on the medical device.
If you don't know what extension cable to use, contact Masimo Support.
2. Insert the Masimo Shuttle RS-232 9-pin male connector into the extension cable's 9-pin female adapter.
3. Insert the USB-A connector of the Shuttle into a USB port on the iSirona, HBox, or PC node.
Masimo Corporation 10 www.masimo.com

Masimo Shuttle™ Troubleshoot the Masimo Shuttle
Troubleshoot the Masimo Shuttle
When flashing, the green LED indicates that the Masimo Shuttle is transmitting data from DCX to the medical
device. The blue LED, when flashing, indicates that the Masimo Shuttle is receiving data from the medical device.
While the LEDs are not required for intended operation, if neither are flashing within the cycle period defined
within DCX for the medical device, there may be an issue with connectivity and data flow.
To troubleshoot the problem, take the following steps:
1. Ensure the extension cable that you use to connect the medical device to the Masimo Shuttle is the correct
cable and that it works.
2. Ensure the extension cable plugged into the medical device is connected to the correct port.
3. Make sure the RS-232 connection between Masimo Shuttle and the medical device is a solid connection.
4. Make sure the USB connection between Masimo Shuttle and the Masimo iSirona, Masimo HBox, or node is a
solid connection.
5. Ensure that both the medical device and the iSirona, HBox, or node are plugged into their respective power
outlets and are powered on.
6. If none of the above resolves the issue, the Masimo Shuttle itself may have a problem. Do the following:
a) Check the DCX-CS log or DCX-Server log to see whether the device is transmitting data despite no
indication from the LEDs.
b) Contact Masimo Support.
Masimo Corporation 11 www.masimo.com

Masimo Shuttle™ Appendix
Appendix
Electromagnetic emissions
Emission Standards
TVU SUD Reports: TP72151747.100 | Issue: 01, TP72151747.200 | Issue: 01
Standard Test Description Test Levl/Limits Results
EN 55032 Radiated Emissions EN 55011 Class B Pass
CISPR 11 2009/A1: 2010
EN 55016-23: 2004 + A1:
2005
Electromagnetic Radiation
Disturbances
EN 55011 Class B Pass
Immunity standards
Immunity Standards
TVU SUD Reports: TP72151747.200 | Issue: 01, TP72151747.300 | Issue: 01
Standard Test Description Test Level/Limits Results
EN 55024:2010 / A1:2015 Enclosure Port -
Radio-frequency
electromagnetic field
Amplitude modulated
80 to 1000MHz, 3 V/m Pass
EN 55024:2010 / A1:2015 Enclosure Port -
Electrostatic discharge
Air: +/-2, 4, & 8kV Direct
Contact: +/-8kV Indirect
Contact: 8kV
Pass
IEC 61000-4-2 2008 Immunity to Electrostatic
Discharge (Enclosure Port)
Air: +/-2, 4, 8 & 15kV
Direct Contact: +/-8kV
Indirect Contact: 8kV
Pass
IEC 61000-4-3 2006
A2:2010
Immunity to Radiated RF
Electromagnetic Fields
(Enclosure Port)
80 to 2700MHz, 3 V/m Pass
IEC 61000-4-3 2006
A2:2010
Immunity to Proximity
Fields from RF Wireless
Communication
Equipment
385MHz - 27 V/m;
450MHz - 28 V/m; 710,
745, 780MHz - 9 V/m;
810, 870, 930MHz - 20 V/
m; 1.720, 1.845, 1.970,
2.450GHz - 28 V/m; 5.240,
5.500, 5.785GHz - 9 V/m
Pass
IEC 61000-4-6 2013 Immunity to Conducted
Disturbances Induced by
RF Fields (Signal Input/
Output Ports)
0.15 - 80MHz - 3V, ISM
bands in this range 6V
Pass
Masimo Corporation 12 www.masimo.com