ResMed Tx Link 2 Award-Winning Sleep Lab Titration System User Guide

TxLink™2
User guide

Introduction

The TxLink 2 titration network device provides connectivity between the EasyCare Tx 2 software and a compatible ResMed therapy device. It also relays real-time signals measured by the therapy device to a polysomnograph (PSG).

A typical system comprises of:

1. Compatible ResMed therapy device
2. TxLink 2 titration network device
3. EasyCare Tx 2 titration software

This guide provides instructions for the TxLink 2. Refer to the clinical guides of the connected therapy device and the EasyCare Tx 2 Online Help for instructions on their use.

WARNING
Read this entire guide before using the device.

CAUTION

• In the US, Federal law restricts this device to sale by or on the order of a physician.
• Only attach a ResMed therapy device compliant with IEC 60601-1. For a full list of compatible devices, refer to the Data/Device Compatibility List on ResMed.com/downloads/devices.
• EasyCare Tx 2 should be installed on a PC compliant with IEC 62368.

Indications for use

The TxLink 2 is intended to provide connectivity between the ResMed EasyCare Tx 2 software and ResMed continuous positive airway pressure (CPAP), bilevel, or non-invasive ventilator devices that incorporate ResMed’s proprietary communication protocol. The TxLink 2 relays real-time signals between a CPAP, bilevel, or non-invasive ventilator device and polysomnography (PSG). The TxLink 2 is intended to be used in a clinical environment.
Clinical benefits
Refer to the user or clinical guide of the attached ResMed therapy device.

Components

The following items are supplied with the TxLink 2:

• Ethernet cable—connects the TxLink 2 to the PC running the EasyCare Tx 2 titration software

• Cable USB Type A to B (2 m)—connects the TxLink 2 to the PC running EasyCare Tx 2 for TxLink 2 setup

• TxLink 2 PAP device cable (power/communications)—connects the TxLink 2 to the therapy device

• 24V AC/DC 90W Air11™ power supply unit—connects the TxLink 2 to the power outlet
  Optional component include:

• EasyCare Tx 2 CD (Germany only) (22423)
  Note: Ensure that software is up to date. The latest version of EasyCare Tx 2 is available for download at ResMed.com/downloads/titrationsolutions.

Spares and accessories include:

• Ethernet cable (25919)
• Cable USB Type A to B (2 m) (22422)
• TxLink 2 PAP device cable (power/communications) (22421)
• 24V AC/DC 90W Air11™ power supply unit (39212 EUR)

Device connections
Only one therapy device should be connected at a time via the TxLink 2 PAP device cable (power/communications).

1. DC power in/out
2. Ethernet
3. USB Type B

The DC power in/out connectors are identical. Connect the power supply unit to either connector and the ResMed compatible therapy device to the other connector using the TxLink 2 PAP device cable (power/communications).

PSG connections

TxLink 2 provides up to six analog DC outputs (A-F), which can be used to transmit the real-time streams measured by the ResMed therapy device to a PSG system. To support many different types of PSG systems, each DC output is available at three connection points. Each mono jack connector provides one channel only. Each modular connector provides two channels.

1. 3.5 mm mono jack connector (A-B, C-D, E-F)
2. 6P6C modular connector (A+B, C+D, E+F)
3. 4P4C modular connector (A+B, C+D, E+F)

For further information on setting up PSG connections, refer to the PSG manufacturer’s guide.

Indicators

TxLink 2 provides four LEDs to indicate the current operating state:

| | Indicator| Status
---|---|---|---
1| ****| Power
Indicates the operating state of TxLink 2.| The green LED illuminates when TxLink 2 is powered on.
2| PAP device| Positive airway pressure therapy device
Indicates the operating state of the connected therapy device.| The blue LED illuminates when connected to a therapy device and flashes to indicate communication.
The blue LED is off when disconnected from a therapy device.
3| | Ethernet
Indicates TxLink 2 connectivity to the network.| The blue LED illuminates when connected to the network and flashes to
indicate network traffic. The LED is off when disconnected from the network.
4| | Device error
Indicates if TxLink 2 has errors.| The white LED illuminates or flashes to indicate an internal error.

The LEDs may be disabled during normal use to avoid patient disruption. However, in the disabled state, the LEDs will continue to indicate TxLink 2 status during power-up, or any system error state. The Power indicator will also remain on (dimmed) in the disabled state.
For more information on enabling and disabling LEDs, refer to the EasyCare Tx 2 Online Help.

Setup
Using the cables supplied, connect the TxLink 2 as shown.

1. TxLink 2 PAP device cable (power/communications)
2. Power supply unit
3. 4 Ethernet cable

For further assistance, contact your ResMed representative or refer to the Titration Equipment Installation Guide in ResMed.com/downloads/titrationsolutions.
Turning off the TxLink 2
To turn off the TxLink 2, place the connected therapy device in standby and disconnect the power cable from the power outlet or turn off the switch at the power outlet.
Turning off the TxLink 2 will also turn off the therapy device that is connected via the TxLink 2 PAP device cable (power/communications). For running the therapy device without the TxLink 2, plug the appropriate power supply unit directly into the therapy device.

CAUTION
The USB Type B port is only to be connected to a computer during installation and setup of TxLink 2, not while the patient is connected to the therapy device.

Configuration

TxLink 2 is initially configured as follows:

• IP Address: acquired automatically by DHCP
• LEDs: During therapy, PAP device and Ethernet are disabled, and Power is dimmed
• Analog DC output configuration as shown in the table below:

Cleaning and maintenance

Wipe the exterior of the device using an alcohol-based cleaning and disinfection wipe/solution (eg, CaviWipes1™ , Mikrozid™ ). Wipe until visually clean following the manufacturer’s instruction for cleaning.
Validated number of cycles is 260.

WARNING

• Always disconnect the power cable from the power outlet before cleaning.
• Ensure the power cable is dry before reconnecting.
• Do not open or modify the device. There are no user serviceable parts inside. Repairs and servicing should only be performed by an authorised ResMed service agent.
• Do not use bleach, chlorine, or aromatic-based solutions, moisturizing or antibacterial soaps or scented oils to clean the device. These solutions may cause damage and reduce the life of the product.

Servicing
The TxLink 2 is intended to provide safe and reliable operation provided that it is operated and maintained in accordance with the instructions provided by ResMed. There is no servicing necessary during the lifetime of the device.
For more information, refer to the Titration Equipment Installation guide and EasyCare Tx 2 online help.
Software license
License Grant. Subject to the terms and conditions below, ResMed grants you, the owner and/or user of this device, a perpetual, non-exclusive, non- sublicensable, personal, limited license to use the ResMed Software solely in connection with the use of this device. All other rights are reserved by ResMed. You will be deemed to have transferred and assigned this license to any person that acquires the owner’s or the user’s rights in this device.
License Restrictions. Software included on or with this device is owned by or licensed to ResMed (the “ResMed Software”). Neither the ResMed Software nor any intellectual property rights in the ResMed Software are sold or assigned by ResMed. No person or entity is licensed or authorized to a) reproduce, distribute, create derivative works, modify, display, perform, decompile or attempt to discover the source code for the ResMed Software, b) remove or attempt to remove the ResMed Software from the ResMed product, or c) reverse engineer or disassemble the ResMed product or the ResMed Software. For avoidance of doubt, the foregoing restrictions are not intended to limit any licensee’s rights to software code incorporated into or distributed with the ResMed Software and licensed under the terms of any open source, free or community software license (collectively, “Open Source Software”).

Troubleshooting

If you experience any problems, try the following suggestions. If you are not able to fix the problem, contact your supplier or ResMed.

ResMed service centre for investigation.
TxLink 2 power LED is not illuminated| Check the power supply and make sure the plug is fully inserted. If the problem persists, disconnect the TxLink 2 and return to a ResMed service centre for investigation.

For more details, refer to the Titration Equipment Installation Guide in ResMed.com/downloads/titrationsolutions.

Technical specifications

90W AC adaptor
Dimensions (H x W x L)
Weight
AC input range
DC output
Class of equipment| 32 mm x 65 mm x 132 mm
250 g
100–240 V, 50–60 Hz
115 V, 400 Hz
24 V
Class II
---|---
TxLink 2
Dimensions (H x W x L)
Weight| 45 mm x 125 mm x 147 mm
350 ± 50 g
Typical power consumption
Peak power consumption| TxLink 2
3 W
5 W| 90 W AC adaptor (with ResMed therapy device attached)
77 W
101.5 W
Housing construction
Operating temperature
Operating humidity
Storage and transport temperature
Storage and transport humidity
Operating altitude| Flame retardant engineering thermoplastic +5ºC to +35oC
10%–95% non-condensing
-25ºC to 70 ºC
5% to 95% non-condensing
Sea level to 3,010 m
Analog outputs
All channels isolated from mains
All channels isolated from
communications signals
No isolation between channels
Voltage range
Accuracy
Bandwidth
Output impedance| 6 channels
3 kV
1.5 kV
–
–1 VDC to +1 VDC
± 5%
25 Hz
50 Ohm
Electromagnetic compatibility:| Product complies with all applicable electromagnetic compatibility requirements (EMC) according to IEC60601-1-2 (class B). Information regarding the electromagnetic emissions and immunity of these ResMed devices can be found on ResMed.com/downloads/devices.
IEC60601-1 classification| Class II
Design life| 5 years
Intended operator| Sleep technician or clinician

Notes:

• The manufacturer reserves the right to change these specifications without notice.
• The performance of the analog outputs is determined by the attached ResMed therapy device.

Symbols

The following symbols may appear on the device or packaging:

Follow instructions before use. Indicates a warning or caution is necessary when operating the device or control. Manufacturer. Prescription only (In the US, Federal law restricts these devices to sale by or on the order of a physician). European Authorised Representative. Batch code. Catalogue number. Serial number. Keep away from rain. Fragile, handle with care. USB. DC 24V 24V Direct Current. **Power. PAP deice** ResMed therapy device. Ethernet. Device error. MR unsafe (do not use in the vicinity of an MRI device). Humidity limitation. Temperature limitation. Altitude limitation. Medical device. Importer. Swiss authorised representative. Power and CAN bus connection.

See symbols glossary at ResMed.com/symbols.
Environmental information WEEE 2012/19/EU is a European Directive that requires the proper disposal of electrical and electronic equipment. This device should be disposed of separately, not as unsorted municipal waste. To dispose of your device, you should use appropriate collection, reuse and recycling systems available in your region. The use of these collection, reuse and recycling systems is designed to reduce pressure on natural resources and prevent hazardous substances from damaging the environment.
If you need information on these disposal systems, please contact your local waste administration. The crossed-bin symbol invites you to use these disposal systems. If you require information on collection and disposal of your ResMed device please contact your ResMed office, local distributor or go to ResMed.com/environment.

General warnings and cautions

The following are general warnings and cautions. Specific warnings, cautions and notes appear with the relevant instructions in the guide.

WARNING

• Maintain patient isolation: The TxLink 2 should be placed outside the patient environment (outside a 1.5 m radius of the patient’s bed).
• Maintain separation from liquids: The TxLink 2 should be placed at least 0.5 m away from and above the humidifier and liquids.
• Only use the supplied ResMed power cable.
• Discontinue use and contact the supplier or ResMed service center if any of the following occurs on the device or power supply:
• does not perform as usual
• damaged or have signs of wear
• making unusual sounds
• Beware of electrocution:
• Do not immerse the device or any of its components in water.
• Do not connect to power while the device is wet. Make sure that all parts are dry before plugging them in.
• If liquids are spilled into or onto the device, unplug the device and let the parts dry.
• The device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 10 cm to any part of the device. Otherwise, degradation of the performance of this equipment could result.

CAUTION

• Use only approved ResMed equipment, parts, and components.
• The TxLink 2 should not be placed close to life support equipment.
• The TxLink 2 is a network device. Ensure that an appropriate cyber-security policy is established and maintained at your premises to ensure reliable operation of your network, security of information, and protection of attached equipment.
• Ensure wiring is placed away from other equipment and personnel.
• The TxLink 2 contains no user-serviceable parts.
• The 24V DC power cable and TxLink 2 contain no user-serviceable parts.
• Do not place the device where it can be bumped, stepped on, or where someone is likely to trip over the device.
  Note: For any serious incidents that occur in relation to this device, these should be reported to ResMed and the competent authority in your country.

Limited warranty

ResMed Pty Ltd (hereafter ‘ResMed’) warrants that your ResMed product shall be free from defects in material and workmanship from the date of purchase for the period specified below.

• Mask systems (including mask frame, cushion, headgear and tubing)—excluding singleuse
devices
• Accessories—excluding single-use devices
• Flex-type finger pulse sensors
• Humidifier standard water tubs| 90 days
• Batteries for use in ResMed internal and external battery systems| 6 months
• Clip-type finger pulse sensors
• CPAP and bilevel device data modules
• Oximeters and CPAP and bilevel device oximeter adapters
• Humidifiers and humidifier cleanable water tubs
• Titration control devices| 1 year
• CPAP, bilevel and ventilation devices (including external power supply units)
• Battery accessories
• Portable diagnostic/screening devices| 2 years

This warranty is only available to the initial consumer. It is not transferable.
During the warranty period, if the product fails under conditions of normal use, ResMed will repair or replace, at its option, the defective product or any of its components.
This limited warranty does not cover: a) any damage caused as a result of improper use, abuse, modification or alteration of the product; b) repairs carried out by any service organization that has not been expressly authorized by ResMed to perform such repairs; c) any damage or contamination due to cigarette, pipe, cigar or other smoke; d) any damage caused by exposure to ozone, activated oxygen or other gases; and e) any damage caused by water being spilled on or into an electronic device.
Warranty is void on product sold, or resold, outside the region of original purchase. For product purchased in a country in the European Union (“EU”) or European Free Trade Association (“EFTA”), “region” means the EU and EFTA.
Warranty claims on defective product must be made by the initial consumer at the point of purchase.
This warranty replaces all other expressed or implied warranties, including any implied warranty of merchantability or fitness for a particular purpose. Some regions or states do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you.
ResMed shall not be responsible for any incidental or consequential damages claimed to have resulted from the sale, installation or use of any ResMed product. Some regions or states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation may not apply to you.
This warranty gives you specific legal rights, and you may also have other rights which vary from region to region. For further information on your warranty rights, contact your local ResMed dealer or ResMed office.
Visit ResMed.com for the latest information on ResMed’s Limited Warranty.

ResMed Pty Ltd
1 Elizabeth Macarthur Drive, Bella Vista NSW 2153 Australia
See ResMed.com for other ResMed locations worldwide. Air11 and TxLink are trademarks and/or registered trademarks of the ResMed family of companies. CaviWipes1 is a trademark of Metrex Research, LLC. Mikrozid is a trademark of Schülke & Mayr GmbH. For patent and other intellectual property information, see ResMed.com/ip
© 2022 ResMed. 2281867/3 2022-10

ResMed.com

References

• ResMed.com/downloads/devices
• Mask Sizer Terms of Use - ResMed
• ResMed.com/downloads/titrationsolutions
• Environmental policy - ResMed
• ResMed.com/symbols
• Environmental policy - ResMed

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