ResMed S8 RESLINK Automatic Cpap Device User Manual

S8 RESLINK Automatic Cpap Device
User Manual

S8 RESLINK Automatic Cpap Device

A. REsllNK
Front view

Back view

B. S8 RESLINK
Front view

Back view

C. SmartMedia card

INTRODUCTION

The RESLINK'” is a device designed for use with Res Med flow generators to help your clinician monitor your sleep and ensure that you are receiving optimal treatment.
When connected to the flow generator, the RESLINK records treatment and pulse optometry data during therapy.
The data is stored on a SmartMedia ™ card-a memory card capable of storing up to 30 sessions of detailed data After treatment, the SmartMedia card containing the data can be removed from the RES LINK device and sent to your clinician for review.
RESLINK AND 58™ RESLINK
The RESLINK device is available in two different mechanical forms (RESLINK and S8 RES LINK) to fit different families of flow generators.
The RESLINK and the S8 RESLINK function in the same way, but they attach to and detach from the flow generator in different ways. When the word ‘RESLINK’ is used in a general sense, it applies to both RESLINK and S8 RESLINK. See “Compatible flow generators” on page 18 to see which device is used with each flow generator.
Note: The 58 Reslink may not be available in all regions.
USER/OWNER RESPONSIBILITY
The user or owner of this system shall have sole responsibility and liability for any injury to persons or damage to property resulting from:

• operation which is not in accordance with the operating instructions supplied
• maintenance or modifications carried out unless in accordance with authorised instructions and by authorised persons.

INTENDED USE
The RES LINK is an accessory to ResMed flow generators that are used for the treatment of Obstructive Sleep Apnoea (OSA) in adult patients. RES LINK is for home and hospital use.
WARNINGS AND 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 in the manual.

• Use the RESLINK only for its intended use as described in this manual.
• The RESLINK is compatible for use with certain ResMed flow generators only. See “Compatible flow generators” on page 18 for details. Do not use the RESLINK with any other flow generators.
• Make sure that the flow generator is turned 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
• There is a serial (9-pin) port at the back of some flow generators. Do not connect the NONIN® X pod connector into the serial port as it may damage the oximeter.
• SmartMedia cards should be obtained only from ResMed 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 RES LINK in the presence of flammable or explosive materials.
• From time to time, electronic devices can be affected by irregularities in the electrical power supply. It is important to periodically check that the RESLINK is working correctly by checking the flow generator Liquid Crystal Display (LCD) for any error messages. This includes checking the pulse oximeter probe for correct operation by inspecting that the Light Emitting Diode (LED) on the finger probe is illuminated when the flow generator is turned on.

Contact your equipment supplier if you have any concerns about correct operation of the RESLINK.

THE RESLINK SYSTEM

The RESLINK system (RES LINK and SmartMedia card) is illustrated in sections A.Band C on the illustration sheet.
ACCESSORIES
See section D on the illustration sheet (8000} Adult Flex Sensor only illustrated).
The NONIN® Model 3012 Pulse Oximeter is compatible for use with the RES LINK. It can be used with either the 8000) Adult Flex Sensor or 8000 AA Adult Finger Clip. The same oximeter cable can be used for either sensor. These accessories are available from ResMed.

SETTING UP THE RESLINK

See sections E and F on the illustration sheet
Note: Your clinician may have already set up the Reslink for you.
INSERTING THE CARD
CAUTION
Avoid touching the gold contacts on the SmartMedia card.

1. Open the RESLINK cover.
2. Insert the SmartMedia card into the card slot on the RES LINK (E-1 ). Make sure that the card is aligned as shown in the diagram.
3. Close the cover after inserting the SmartMedia card.

ATTACHING THE RESLINK
Note: The ResLink and SB Reslink use different attachment mechanisms.
WARNING
Before connecting the Reslink or SS Reslink, make sure that the flow generator is powered off.
RES LINK

1. Ensure that the flow generator is powered off before attaching the RESLINK. Use the switch at the back of the flow generator to power off the device.
2. Slide the lever at the back of the RES LINK to the left (E-2).
3. Place the top catch of the RESLINK onto the notch at the back of the flow generator (E-3).
4. Push the bottom of the RES LINK onto the auxiliary port at the back of the flow generator (E-4).
5. Slide the lever at the back of the RES LINK to the right to lock the RESLINK in place (E-5).

58 RESLINK

1. Ensure that the flow generator is powered off before attaching the SS RESLINK. You will need to tum the power off at the wall outlet.

2. Take off the module currently attached to the flow generator (F-1) and store it in the flow generator bag.

3. Push the SS RESLINK onto the flow generator (F-2), making sure that both the top and bottom latches engage firmly with the flow generator.
   Note: The SB ResLink does not have a locking lever.

4. When attached, the SS RESLINK should fit closely onto the back of the flow generator (F-3).

CONNECTING AN OXIMETER TO THE RESLINK (OPTIONAL)
Your clinician may have supplied an oximeter for use with the RES LINK. Connecting an oximeter to the RESLlNK allows collection and storage of oximetry data (oxygen saturation and pulse rate).

1. Ensure that the sensor cable is properly connected to the X pod connector (see illustration D).
2. Insert the oximeter plug into the RESLINK oximeter port (E-6).

WARNING

• Only the NONIN Model 3012 Pulse Oximeter and Models 8000 J or 8000 AA Sensors are compatible with the Reslink. Connecting other oximeters may cause personal injury or damage to the flow generator or the Reslink.
• Check the oximeter cables and the oximeter sensor before use. If there is any sign of damage or wear contact your equipment supplier.
• There is a serial (9-pin) port at the back of some flow generators. Do not connect the NONIN X pod connector into the serial port as it may damage the oximeter.

ATTACHING AN OXIMETER TO YOUR FINGER
CAUTION
The oximeter sensor will not function properly if there is nail polish on your fingernails.
Note: Do not attach the oximeter until you are ready to start therapy.
ATTACHING THE NONIN 8000 J ADULT FLEX SENSOR
See section G on the illustration sheet
Your clinician wi II have attached the sensor to the adhesive side of the Flexi Wrap.

1. Remove the adhesive backing from the Flexi Wrap.
2. Carefully position any one of your fingers (not the thumb) on diode A on the Flexi Wrap (G-1 ). Wrap the two small lower flaps onto the sides of your finger.
3. Carefully fold the Flexi Wrap over the tip of your finger ( G-2). Diode B must be positioned on your fingernail. Check that the two diodes are aligned, with B directly above A (G-3).
4. Wrap the long flap around your finger to secure the sensor (G-4). The Flexi Wrap should feel firm, but not uncomfortably tight
5. Secure the sensor wire to the base of the finger or wrist using medical tape (G-5).

ATTACHING THE NONIN 8000 M ADULT FINGER CUP
See section H on the illustration sheet

1. Open the Finger Clip (H-1) and place your finger inside the device (H-2).
2. Close the Finger Clip (H-3).
3. Secure the sensor wire to the base of the finger or wrist using medical tape.

Note: For more details, please refer to the user guide supplied with the oximeter.

USING THE RESLINK

1. Tum on the flow generator. A series of messages will be displayed on the flow generator LCD. When the following message is displayed, you know that the RESLINK is correctly connected.
2. If necessary. the software in your flow generator will be automatically upgraded. The upgrade ensures that your flow generator is compatible for use with the RESLINK.

WARNING
The flow generator will not deliver therapy during the upgrade. Do not put the mask on until the upgrade is completed.
During upgrade, the LCD backlight flashes and the following is displayed:
On some flow generators, this screen may be shown in multiple languages prior to upgrade.
The upgrade can take up to 20 minutes. Please wait for completion. When upgrade is successful the WELCOME screen will be displayed on the LCD.
Note: If the upgrade is interrupted for any reason, tum the flow generator off, ensure the Reslink is properly attached and the Smart Media card is inserted, then tum the flow generator back on to re start the upgrade. Note that the LCD message may not be shown following an interruption; the screen may be blank for up to 20 minutes during the upgrade.
STARTING TREATMENT
Start treatment as described in the flow generator User’s Manual. The RESLINK will automatically collect and store treatment data.
STOPPING TREATMENT
Press the Front key on your flow generator to stop therapy at the end of the night. If attached. remove the oximeter sensor from your finger.
After stopping therapy on the last night that you use the RESLINK, wait for 15 minutes then tum off your flow generator at the power switch.
CAUTION
Do not power the flow generator on or off while the Reslink is being used, as this may stop the gathering of data. If there is any interruption to the flow generator’s power supply, wait 15 minutes to commence therapy after powering the flow generator back on.
LCD MESSAGES
You may see the following RESLINK messages briefly displayed on the flow generator LCD to inform you about the operation of the RESLINK. These messages will be interspersed with other flow generator messages.

| Successful Reslink connection (number displayed will be current Reslink software version}
---|---
| SmartMedia Card has been detected
| SmartMedia Card has not been detected
| Oximeter is present
| Oximeter is not present
| Summary data is being copied to the SmartMedia Card
| Reslink ready to record Detailed Data
| SmartMedia Card has been removed
| Oximeter has been disconnected
| The flow generator is being upgraded by the Reslink

When an oximeter is attached, a set of six messages similar to those shown below is displayed in sequence. These messages indicate the current oxygen saturation (SpO2) and heart rate being measured by the oximeter. They are intended to assist you in making sure that the oximeter is correctly attached. The sequence runs for approximately one minute.

Note: If you see a message similar to that shown below, with dashes instead of numeric values, check to make sure that the oximeter sensor is correctly attached to your finger.

TYPICAL SCENARIOS
SCENARIO 1: NO OXIMETER ATTACHED
This scenario shows the typical sequence of messages displayed when the RES LINK has been correctly set up, the flow generator is powered on and no oximeter is attached. These messages will be interspersed with other flow generator messages.

| Successful Reslink connection
---|---
| indicates that the SmartMedia Card is present
| indicates that the oximeter is not attached
| This screen is displayed on the LCD for 2-5 minutes depending on the amount of Summary Data being transferred.
| Indicates that the Reslink has finished copying the Summary Data and is now ready to log Detailed Data.
This screen dears after a few seconds.

SCENARIO 2: OXIMETER ATTACHED
This scenario shows the typical sequence of messages displayed when the RES LINK has been correctly set up, the flow generator is powered on and an oximeter is attached. These messages will be interspersed with other flow generator messages.

| Successful Reslink connection
---|---
| First oximetry message.
There are 6 messages. Each message is shown for a 5 second interval and then removed for 5 seconds.
| Last oximetry message.
| Indicates that SmartMedia card is present
| Indicates that the oximeter is present
| This screen is displayed on the LCD for 2-5 minutes depending on the amount of Summary Data being transferred.
| Indicates that the ResLink has finished copying the Summary Data and is now ready to log Detailed Data.
This screen clears after a few seconds.

DISCONNECTING THE RESLINK

See sections I and j on the illustration sheet
WARNING
Before disconnecting the Reslink, make sure that the flow generator is powered off.
If an oximeter is connected, pull the oximeter plug out of the RES LINK oximeter port (1-1).
RES LINK

1. Tum the flow generator power off using the power switch.
2. Slide the lever at the back of the RES LINK to the left (E-2). This unlocks the RESLINK from the flow generator.
3. Carefully pull the RESLINK away from the flow generator (1-2, 1-3).
4. Store the RESLINK in its pouch.

S8 RESLINK

1. Tum the power off at the wall outlet
2. To remove the S8 RES LINK from the flow generator; grip it from the top U-1 ).
3. Pull the S8 RES LINK away from the flow generator U-2).
4. Take the module that you took off the flow generator (F-1) and put it back on in its original place.
5. Store the 58 RES LINK in its pouch.

RETURNING THE RES LINK TO YOUR CLINICIAN
If you are returning the RES LINK to your clinician, leave the SmartMedia card in place. Put the RES LINK in its pouch and contact your clinician or equipment supplier for details regarding return.
RETURNING THE SMART MEDIA CARD TO YOUR CLINICIAN
If you are returning only the SmartMedia card to your clinician:

1. Open the RESLINK cover and remove the SmartMedia card. Close the cover after removing the SmartMedia card.
2. Place the SmartMedia card in its plastic sleeve.
3. Place the SmartMedia card in the mail back card supplied with the RESLINK.

CAUTION
If returning the SmartMedia card through the postal service, always use a padded envelope.

CLEANING AND MAINTENANCE

CAUTION
Avoid exposing the Reslink to moisture and extreme temperatures.
CLEANING THE RESLINK
If necessary, wipe the outside of the RESLINK with a clean cloth.
CLEANING THE OXIMETER

1. If necessary, wipe the surfaces with a soft cloth dampened with isopropyl alcohol or a mild detergent.
2. Dry with a soft cloth or allow to air dry.

Note: The oximeter cable and X pod connector can be wiped with a clean cloth.

CAUTION
Do not autoclave or immerse this device in liquid or use caustic or abrasive cleaning agents or any cleaning products containing ammonium chloride.
CLEANING THE OXIMETER SENSOR
For instructions on cleaning the oximeter sensor, please refer to the user guide supplied with this device.
WARNING

• Do not use liquids to clean any part of the ResLink.
• Do not attempt to dismantle the Reslink. Under no circumstances should you attempt to service or repair the device yourself. There are no user serviceable parts inside. Inspection and repair should only be performed by an authorised agent.

TROUBLESHOOTING

If there is a problem, try the following suggestions. If the problem cannot be solved, contact your equipment supplier. Do not attempt to open the RES LINK.

ResMed flow generators only. See “Compatible flow generators” on page 18.
The RESLINK may be attached incorrectly.| See “Attaching the Reslink” on pages.
Flow generator and RESLINK not working (no display on LCD).| Power cord is not plugged into the flow generator or power outlet properly.| Check that the power cord is plugged firmly at the back of the flow generator and into a working power outlet.
Flow generator not powered on.| Check that the flow generator is turned on.
Faulty power outlet.| Try another power outlet.
Flow generator LCD continuously displays black boxes or blank screen on power up.| Previous failed software upgrade.| Power off the flow generator. Attach RESLINK with a SmartMedia card inserted. Power on the flow generator. Allow 20 minutes for the software upgrade.
Note: During the upgrade the ‘UPGRADING, WAIT’ screen may not be displayed.
The following messages are displayed on the LCD of an Auto Set CS2 flow generator that has had a RESLINK connected: | Upgrade failed due to loss of power to the Auto Set CS2.| Power off the flow generator. Attach RESLINK with a SmartMedia card inserted. Power on the flow generator. Allow 20 minutes for the software upgrade.
Note: During the upgrade the ‘UPGRADING, WAIT’ screen may not be displayed.
The ‘Successful Reslink
connection’ message (see page 8) is not displayed after power up.| The RESLINK is not securely attached to the flow generator.| Power the flow generator off. Ensure that the RESLINK is securely connected to the flow generator. Also ensure that the lever at the back of the RESLINK is in the lock position. Power the flow generator back on.
For the S8 RESLINK make sure that the top and bottom latches are secured properly.
Incompatible flow generator.| The RESLINK and S8 RESLINK are compatible for use with certain ResMed flow generators only. See “Compatible flow generators” on page 18.
Faulty RESLINK.| Contact your equipment supplier.
Difficulty inserting the Smart Media card into the RESLINK.| Incompatible memory card used.| Ensure that a SmartMedia card, obtained from ResMed only, is used.
The SmartMedia card is inserted incorrectly.| See “‘Inserting the Card” on page 5.
A SmartMedia card is inserted but is not displayed.| Software upgrade not required.| This is OK. Continue with setup.
The follow ing Is displayed
on the LCD when a Smart Media card is Inserted and the flow generator is powered on:| SmartMedia card cannot be accessed it may be
partially inserted.
Alternatively, the gold contacts could be dirty.| Power the flow generator off.
Remove and then re-insert the SmartMedia card.
The SmartMedia Card may be damaged.| Contact your equipment supplier.
During software upgrade, a blank screen is displayed on the LCD.| loss of power supply to the flow generator.| Power the flow generator off. Reinsert the SmartMedia card. Check the power supply to the flow generator. Power the flow generator back on. See ”Using the Reslink” on page 7.
A SmartMedia card containing upgrade software is inserted and
the following is displayed on the LCD:| Incompatible flow generator, or alternatively
the flow generator cannot be upgraded.| Power the flow generator off.
Remove the RESLINK with SmartMedia card inserted.
Contact your equipment supplier.
Flow generator was delivering therapy.| Stop therapy. Power the flow generator off. Check the power supply to the flow generator.
Power the flow generator back on. See “Using the Reslink” on page 7.
Difficulty inserting the oximeter into the RESLINK.| Incompatible oximeter used.| Ensure that a NONIN (Model 3012) Pulse Oximeter is used. See “Connecting an Oximeter To the ResLink (optional)” on page 6.
Oximeter plug not oriented correctly.| See “Connecting an Oximeter To the Reslink (optional)” on page 6.
The following message is
displayed on the LCD: | Incompatible oximeter.| Ensure that a NONIN (Model 3012) Pulse Oximeter is used.
The oximeter sensor cable and X pod connector are not properly connected.| Ensure that the oximeter sensor cable and X pod connector are properly connected.
Faulty oximeter.| Contact your equipment supplier.
The following message is displayed on the LCD: | The SmartMedia card has not been inserted or
correctly positioned in the RESLINK.| Power off the flow generator, re insert the SmartMedia card and power the flow generator back on.
The following message is displayed on the LCD for more than 20 minutes and never leaves th is state.| Software upgrade not yet completed.| Wait another 10 minutes.
The SmartMedia card has been removed during
software upgrade.| Power the flow generator off. Reinsert the SmartMedia card. Power the flow generator back on. See “Using the Reslink” on page 7
Faulty SmartMedia card.| Power the flow generator off. Contact your equipment supplier.
Damaged flow generator.| Power the flow generator off. Contact your equipment supplier.
The message on the LCD
alternates between the RESLINK connected message, and the message to indicate that RESLINK has been removed.| SmartMedia card may be damaged.| If the message does not clear, disconnect the RESLINK and contact your equipment supplier to get a new SmartMedia Card.
RESLINK may be faulty.| Contact your equipment supplier.
The following message is
displayed on the LCD:| Oximeter is not present during the copying of
Summary Data to the Smart Media Ca rd.| If you are not intending to use an oximeter, this message is OK. If you are intending to use an oximeter, make sure that the oximeter is plugged in correctly.
The following message is
displayed on the LCD: | The SmartMedia Card is full and cannot store any more data.| Contact your equipment supplier to get a new SmartMedia Card.
The following message is
displayed on the LCD: | SmartMedia Card is write protected.| Contact your equipment supplier to get a new SmartMedia Card.
The following message is
displayed on the LCD: | The software on the RESLINK itself is being upgraded, using data on the SmartMedia Card.| This is OK. Wait for approximately three minutes. RESLINK should then start normal operation.
The following message is
displayed on the LCD: | RESLINK has been removed from the flow generator or not attached correctly.| Attach the RESLINK or S8 RESLINK to the flow generator. Make sure that it is properly attached.
Difficulty disconnecting the RESLINK from the flow
generator.| The RESLINK is locked in place.| Unlock the RESLINK. See “Disconnecting the ResLink” on page 11.
Difficulty disconnecting the S8 RESLINK from the flow generator.| There is no locking device on the S8 RESLINK.| See “58 ResLink” on page 11.

Note: If you see a message not shown here, contact your equipment supplier.

TECHNICAL SPECIFICATIONS

RES LINK
Dimensions (H X W X D):
126 mm x 65 mm x 60 mm
Weight: I I 0 g
Power Supply:
Maximum power consumption derived from the flow generator. 200 mA at 24-30 V

58 RESLINK
Dimensions (H X W X D):
120 mm x 65 mm x 65 mm
Weight: I 14 g
Power Supply:
Maximum power consumption derived fr om the flow generator. 400mA at 12 V
RESLINK AND 58 RESLINK
Housing Construction:
Flame retardant engineering thermoplastic.
IEC 60601-1 Classification: Class II (double insulation). Type CF
Electromagnetic Compatibility
Product complies with all applicable electromagnetic compatibility requirements (EMC) according to IEC60601-1-2, for residential, commercial and light industry environments.
Environmental Conditions
Operating Temperature: 5 °C to 40°C
Operating Humidity: 10% – 95% non-condensing
Storage and Transport Temperature: -20°C to 60°C
Storage and Transport Humidity: 10% – 95% non-condensing
NONIN MODEL 3012 PULSE OXIMETER, 8000 J ADULT FLEX SENSOR AND 8000 M ADULT FINGER CUP
Sp0 2
70-100% ± 3 digits
Pulse rate
18 to 300 pulses per minute ± 3% ± I digit
Environmental Conditions
Operating Temperature: 0°C to 50°C
Operating Humidity: 10% – 90% non-condensing
Storage and Transport Temperature: -20°C to 50°C
Storage and Transport Humidity: 10% – 95% non-condensing

COMPATIBLE FLOW GENERATORS

GLOSSARY OF SYMBOLS

| Attention, consult accompanying documents
---|---
| Type CF applied part
| Class II equipment
| Drip proof
| Manufacturer
| European Authorised Representative
| Environmental information
WEEE 2002/96/EC 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 www.resmed.com/environment.

Not all flow generators are available in all regions
Manufacturer: ResMed Pty Lid 1 Elizabeth MacArthur Drive Bella Vista NSW 2153 Australia.
Distributed By: ResMed Corp 9001 Spectrum Center Boulevard San Diego CA 921 23 USA.
****ResMed (UM Ltd 96 Milton Park Abingdon Oxford shire OX14 4RY UK. Seewww.resmed.com for other ResMed locations worldwide.
For patent information, see www.resmed.com/ip.
Auto Set Spirit Auto Set CS2, ResLink, S7 Elite, S8, S8 Auto Score, S8 Auto Set, S8 Auto Set Spirit, S8 Auto Set Vantage, S8 Elite, VPAP, VPAP Adapt SV, VPAP Auto, VPAP Malibu and VPAP Ill are trademarks of ResMed.
‘Non-in and X Pod’ are trademarks of Win Medical Inc,
SmartMedia is a trademark of Toshiba.
® 2012 ResMed

Global leaders in sleep and respiratory medicine
www.resmed.com

References

• Environmental policy - ResMed
• Legal disclaimers and intellectual property - ResMed

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