RESMED S8 Reslink Module User Guide

: June 4, 2024
: ResMed

**RESMED S8 Reslink Module User Guide

**

INTENDED USE

The RES LINK™ is an accessory to Res Med flow generators that are used for the treatment of obstructive sleep apnoea (OSA) in adult patients. RESLINK is for home and hospital use.

Note: These instructions can be used for Re Sunk and SB ResUnk. They should be used in conjunction with the ResUnk User’s Manual.

WARNINGS & CAUTIONS

A Warning alerts you to possible injury.
A Caution explains special measures for the safe and effective use of the device.
The following are general warnings and cautions. Specific warnings and cautions appear next to the relevant instructions.

Use the REsLINK only for its intended use as described in the ResUnk User’s Manual.
The REsLINK is designed for use with certain ResMed flow generators only. Do not use the REsLINK with any other flow generators. A list of compatible flow generators is included in the ResUnk User’s Manual.
Make sure that the flow generator is powered off before connecting or disconnecting the RESLINK.
Do not attempt to dismantle the REsliNK. There are no user serviceable parts inside. Repairs and internal servicing should only be performed by an authorised agent.
SmartMedia ™ cards should be obtained from ResMed only; as custom upgrade software may be required for operation of the RES LINK.
Avoid touching the gold contacts on the SmartMedia card.
The SmartMedia card should be kept in its plastic sleeve when not in use. This is because dirt may interfere with the RESLINK operation.
Do not use the REsliNK in the presence of flammable or explosive materials.

THE RESLINK SYSTEM

The RESLINK and the SmartMedia card are supplied as part of the RESLINK system. The RESLINK pouch also contains the ResUnk User’s Manual and the SmartMedia card Mailback card.

RES LINK

RES LINK Overview

58 RESLINK

58 RESLINK Overview

Note: The SB ResUnk does not have a loc0ng lever.

SMARTMEDIA CARD

ACCESSORIES

The NONIN ® Model 3012 Pulse Oximeter and Model 8000) Adult Flex Sensor, or Model 8000AA Adult Finger Oip (not pictured here), available from ResMed, are compatible for use with the REsL1NK.
Note: The same oximeter cable can be used for both sensors.
Accessories

OPERATING INFORMATION

When connected to a flow generator, the RESLINK:

collects and stores Summary and Detailed data, and
facilitates upgrade of the flow generator software.

DATA COLLECTION

There are two types of data:

Summary Data
Detailed Data.

A brief explanation of these data types is described in”Summary and Detailed Data” on page 7. Refer to the AUTOSCAN TM and RESSCAN TM manuals for detailed information about Summary and Detailed Data.

Note: When you use a SmartMedia card in combination with a ff ow generator that it has not been used on before, the ResUnk deletes all information currendy stored on the SmartMedia card.

To save patient data, download all information on the SmartMedia card before sending the card to a new patient.
If you are using the same ffow generator for multiple patients, make sure that you have erased all data before you give the ff ow generator and ResUnk to the next patient

To collect data from the flow generator, insert the SmartMedia card into the RES LINK Collection and storage of data occurs automatically during therapy. After therapy. the patient can return the card to the clinician using the Mail back card provided with the RES LINK If returning the SmartMedia card through the postal service, use a padded envelope. You can download data stored on the SmartMedia card for review and analysis.

ResMed produces a Data Management Guide for all compatible flow generators with specific information on the data obtained from the RESLINK.

SOFTWARE UPGRADE

Software upgrades can be performed via the SmartMedia card for either RESLINK or the flow generator. The upgraded version of the software is shown on the label of the SmartMedia card.

The SmartMedia card that is packed with the RES LINK (not the 58 RES LINK) will contain an upgrade for AuTOSET SPIRIT'” or S7 ELITE™ flow generators. Other flow generator upgrades may be shipped separately.

If the flow generator has not yet been upgraded, the RES LINK will detect this and automatically conduct an upgrade when the Smart Media card is first inserted. The initial software upgrade ensures that the flow generator is compatible for use with the RESLINK. It is recommended that you upgrade the flow generator prior to issuing it to patients. This will take approximately 20 minutes.

WARNING
Do not attempt to use the flow generator for therapy during the upgrade.

Note: If your AutoSet Spirit or S7 Elite has software version SXI 16-0207 or less, you will need to follow these steps to upgrade:

Download any summary data from the pow generator to AutoScan or ResScan via cable.
Insert the SmartMedia card into the ResUnk..
Connect the ResUnk, power on the pow generator, and the upgrade will start automatically.
Erase the summary data from the AutoSet Spirit using the LCD, AutoScan or ResScan.

SUMMARY AND DETAILED DATA

Summary and Detailed data from a patient’s flow generator are stored on a SmartMedia card by the RES LINK. The SmartMedia card can be removed and sent to you at the end of the study period. The SmartMedia card is inserted into a SmartMedia card reader attached to your computer and the data can then be downloaded andviewed via RESSCAN or AUTOSCAN.

SUMMARY DATA

Some examples of Summary Data that can be viewed are:

Patient usage data
Summary of the median, 95th centile, and maximum pressure and leak values as well as an Apnoea Hypopnoea Index (AHi), Apnoea Index (Al) and Hypopnoea Index (HI).

DETAILED DATA

Some examples of Detailed Data that can be viewed are;

Events (s)
Minute ventilation (Umin)
Leak (Usec)
AHi (Events/hr)
Pressure (cm H20)
Snore (Quiet to Loud)
Flattening (Round to Flat)
Flow (Umin)
Pressure contribution
Respiratory rate (BPM).

If the oximeter is used, you can also view:

Pulse rate (bpm)
Sp02 (%).

Note: Refer to the individual Power generator manual and Data Management Guide for detailed information about the types of data that will be stored.

PREPARING FOR PATIENT USE

PREPARING THE RESLINK

In order to make the REsLINK system simple and easy to use, it is advisable that all components are set up before issuing it to the patient. Set-up includes the following steps:

Ensure that the SmartMedia Card is inserted correctly in the RESLINK.
Ensure that the RESLINK is attached to the flow generator:
Ensure that the flow generator has been upgraded (if required-this can take up to 20 minutes to complete).

Note: If you need to use an oximeter. it is also advisable to make sure that the oximeter cable is correctly plugged into the ResUnk.

PREPARING THE OXIMETER (FLEXIWRAP 8000J ONLY)

We recommend that you attach the oximeter sensor to the adhesive backing before giving the device to patients. This simplifies the process because it removes possible errors that can occur when aligning the sensor diodes with the adhesive backing.

PATIENT MANAGEMENT

Before issuing the RESLINK, you should make sure that the User’s Manual and Mail back card are in the pouch. Check that the patient knows:

To use the Front key. not the power switch, to start and stop therapy each day.
That on the final night of therapy with the RES LINK, always wait 15 minutes after stopping therapy before powering off the flow generator at the power switch.
To remove the SmartMedia card only when the flow generator is powered off.
Whether to return the RES LINK or SmartMedia card.
When to return the RESLINK and SmartMedia card.
How to return the SmartMedia card using the Mailback card and a padded envelope (if mailed).
If using the oximeter; how to attach it to their finger and how to use the six oximeter readings to ensure a secure connection.
That there is a diode on the oximeter sensor that will emit a red light
How to return the RES LINK.

SMARTMEDIA CARD MANAGEMENT

Do not discard SmartMedia cards: each SmartMedia card is reusable. When issuing a SmartMedia card to a new patient, immediately replace the existing card label with a new label on which you have written:

the new patient’s name and address
the version number of any software upgrade on the card.

Extra labels can be obtained from your equipment supplier.
The serial numbers of upgraded flow generators are automatically stored on the SmartMedia card. Contact ResMed if you wish to access this information.

PROTECTING DATA

Use the silver dot stickers (provided with the SmartMedia cards) if you wish to prevent data stored on the SmartMedia cards from being overwritten.
The message ‘Read-Only Card’ will be displayed on the flow generator if a SmartMedia card with a silver dot is inserted into a RESLINK. This indicates that the SmartMedia card is write-protected and as a result the RES LINK cannot store any additional data.
Protecting Data

LIMITED WARRANTY

ResMed warrants that your ResMed product shall be free from defects in material and workmanship for the period specified below from the date of purchase by the initial consumer. This warranty is not transferable.

Product	Warranty Period
ResMed humidifiers, ResControl”‘, ReslinkTM, ResTraxxT	1 Year
ResMed flow generators	2 Year

Accessories, mask systems (including mask frame, cushion, headgear and tubing). Excludes single-use devices.| 90 Year

Note: Some models are not available in all regions.
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. T his Limited Warranty does not cover.

any damage caused as a result of improper use, abuse, modification or alteration of the product;
repairs carried out by any service organization that has not been expressly authorized by ResMed to perform such repairs;
any damage or contamination due to cigarette, pipe, cigar or other smoke;
any damage caused by water being spilled on or into a flow generator.

Warranty is void on product sold, or resold, outside the region of original purchase.
Warranty claims on defective product must be made by the initial consumer at the point of purchase.

This warranty is in lieu of all other express or implied warranties, including any implied warranty of merchant ability 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 occurred as a result of 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.

Support

Manufacturer: ResMed Pty Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia. Distributed by: ResMed Corp 9001 Spectrum Center Boulevard San Diego CA 92123 USA,

ResMed (UK) Ltd 96 Milton Park Abingdon Oxfordshire 0X14 4RY UK. See wwwresmed.com for other ResMed locations worldwide.

For patent information, seewww.resmeithcom/ip.

Auto Set Spirit, AutoSet CS2, Re Slink, S7 Elite, S8, S8 Auto Score, Se Auto Set, S8 Auto Set Spirit, S8 Auto Set Vantage, S8 Elite, VPAP, VPAP Adapt S , VPAP Auto, VPAP Malibu and VPAP III are trademarks of Res Med Pty Ltd. ‘Nonin’ and ‘XPod’ are trademarks of Nonin Medical Inc,

SmartMedia is a trademark of loshiba. C E ,Et;

2012 ResMed.