RESMED C-Series Tango Positive Airway Pressure Device User Guide

RESMED C-Series Tango Positive Airway Pressure Device User Guide

C-Series Tango™

User Guide

Intended Use

The Tango CPAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (30 kg). It is intended for home and hospital use.

CAUTION

Federal law restricts this device to sale by or on the order of a physician.

Contraindication
Positive airway pressure therapy may be contraindicated in some patients with the
following pre-existing conditions:

• severe bullous lung disease
• pneumothorax
• pathologically low blood pressure
• dehydration
• cerebrospinal fluid leak, recent cranial surgery or trauma.

Adverse Effects

Patients should report unusual chest pain, severe headache or increased breathlessness to their prescribing physician. An acute upper respiratory tract infection may require temporary discontinuation of treatment.
The following side effects may arise during the course of therapy with the Tango: drying of the nose, mouth or throat

• nosebleed
• bloating
• ear or sinus discomfort
• eye irritation
• skin rashes.

Parts of the Tango

Your Tango comprises:

• C-Series Tango flow generator (shown below)
• Power cord
• 6’6” (2 m) air tubing.

Masks

The ResMed mask systems recommended for use with the Tango are:

• Mirage™ Full Face Mask Series II
• Meridian™ Nasal Mask
• Ultra Mirage™ Full Face Mask
• Mirage™ Nasal Mask
• Mirage Swift™ Nasal Pillows System
• Mirage Activa™ Nasal Mask
• Mirage Swift II Nasal Pillows System
• Mirage Vista™ Nasal Mask
• Papillon™ Nasal Mask
• Ultra Mirage™ II Nasal Mask
• Silent Papillon™ Nasal Mask
• Mirage Liberty™ Full Face Mask
• Mirage Quattro™ Full Face Mask

For information on using masks, see your mask manual.

Humidifiers

For information on using the ResMed C-Series Heated Humidifier or the ResMed Passover, see your humidifier manual.

The Tango Interface

Standby mode When the Tango is powered, the power indicator is lit and the run hours are displayed on the LCD. All changes to altitude and ramp settings are made in standby mode.
Ramp Setting a ramp time enables therapy to start at a low pressure and build up to full pressure during the ramp time (see “Set ramp time”).
Altitude Changes in altitude affect the pressure delivered by the Tango. The altitude feature compensates for pressure changes related to changes in altitude (see “Set altitude”).
Run hours Run hours are displayed when the Tango is in standby mode.
Humidifier The humidifier buttons are used when using the C-Series Heated Humidifier and when setting the altitude. The heating indicator lights when the humidifier is on.

Setting up the Tango

CAUTION

• Be careful to place the device where it cannot be bumped, and where no one will trip over the power cord.
• If you put the device on the floor, make sure the area is free from dust and clear of bedding, clothes or other objects that could block the air inlet.
• Make sure the area around the device is dry and clean.

WARNING

• Make sure the power cord and plug are in good condition and the equipment is not damaged.
• Only ResMed air tubing should be used with the device. A different type of air tubing may alter the pressure you actually receive and reduce the effectiveness of your treatment.
• Blocking the hose and/or air inlet of the device while in operation could lead to overheating of the device.

1. Connect the power cord to the rear of the Tango.
2. Plug the other end into a power outlet.
3. Connect the air tubing to the air outlet of the Tango.
4. Connect the assembled mask system to the free end of the air tubing.

Using the Tango

Cleaning and Maintenance

WARNING

Beware of electric shock. Do not immerse the flow generator or power cord in water.
Always unplug the flow generator before cleaning and make sure it is dry before reconnecting.

CAUTION

• Do not hang the air tubing in direct sunlight as it may harden over time and eventually crack.
• Do not use bleach, chlorine, alcohol, or aromatic-based solutions, moisturizing or antibacterial soaps or scented oils to clean the air tubing or the Tango. These solutions may cause hardening and reduce the life of the product.

Daily: Disconnect the air tubing and hang it in a clean, dry place until next use.
Weekly:

1. Remove the air tubing and wash it in warm water and mild detergent. Rinse thoroughly, hang and allow to dry.
2. Before next use, reassemble the mask and headgear.
3. Reconnect the air tubing.

Monthly:

• Clean the exterior of the Tango with a damp cloth.
• Check the air filter for holes and blockage by dirt. Replace it every six months, or more often in a dusty environment.
  For information on cleaning your mask or humidifier, refer to the manual supplied with your mask or humidifier.

Changing the Air Filter

CAUTION

Do not wash the air filter.

1. With the power cord and air tubing disconnected, turn the Tango upside down so the air inlet is facing you. The air filter is inside the air inlet.
2. Pull the old air filter out of the air inlet.
3. Put the new air filter into the air inlet in the direction shown by the arrow, with the blue side facing towards you.

Troubleshooting

Troubleshooting|
---|---
Problem| Possible Cause| Solution
Tango won’t start| Power cord not connected properly.| Check power cord.
 | Faulty power outlet.| Try another power outlet.
No/low air flow| The air tubing is not connected properly.| Adjust the air tubing connection.
 | The air tubing is blocked, pinched or punctured.| Unblock or free the air tubing. Check the air tubing for punctures.
Treatment pressure seems either low or too high| Altitude setting incorrect.| Adjust altitude setting.
LCD displays an error message and treatment stops or can’t be started| Problem with motor.| Contact your supplier.

Technical Specifications

Operating pressure range                4 to 20 cm H2O
Dimensions (L x W x D)                 8.5” x 7.4” x 4.5” (215 mm x 189 mm x 114 mm)
Weight                                             2.4 lb (1.1 kg)
Power supply                                  Input range 110V, 60Hz, 20VA/10W (typical power consumption),

36VA/15W (maximum power consumption) Operating temperature       +41°F to +104°F (+5°C to +40°C) Operating humidity   10–95% non-condensing
Storage and transport temperature
Storage and transport humidity     -4°F to +140°F (-20°C to +60°C) 10–95% non- condensing
Atmospheric pressure range          1060 hPa (sea level) to 680 hPa (8500’/ 2591 m) Electromagnetic Compatibility
Product complies with all applicable electromagnetic compatibility requirements (EMC) according to IEC60601-1-2, for residential, commercial and light industry environments
Air Filter                                         Two-layered, powder-bonded, polyester non-woven fiber
Air Tubing                                       Flexible plastic, 6’6” (2 m)
Air Outlet                                       The 0.87” (22 mm) conical air outlet complies with EN 1281-1
IEC 60601-1 Classification             Class II (double insulation), Type CF
The manufacturer reserves the right to change these specifications without notice.

Symbols which appear on the Tango

Attention. Consult accompanying documents; Type CF equipment; Class II
equipment; IPX1 Drip proof; Canadian Standards Association.

General Warnings and Cautions

A warning alerts you to possible injury.

• Read the entire guide before using the
• The advice in this guide should not supersede instructions given by the prescribing
• The Tango should only be used with masks (and connectors*) recommended by ResMed, or by a physician or respiratory A mask should not be used unless the Tango is turned on and operating properly. The vent hole or holes associated with the mask should never be blocked.

Explanation: The Tango is intended for use with special masks (or connectors*) with vent holes allowing a continuous flow of air out of the mask.

• When the device is turned on and functioning properly, new air from the device flushes the exhaled air out through the mask vent If the device is not operating, insufficient fresh air is provided through the mask, and the exhaled air may be rebreathed. Rebreathing exhaled air for longer than several minutes can sometimes lead to suffocation. If there is a power failure or the device machine malfunctions, remove the mask.
• The Tango can be set to deliver pressures up to 20 cm H2 In the unlikely event of certain fault conditions, pressures up to 30 cm H2O are possible.
• If oxygen is used with this device, the oxygen flow must be turned off when the device is not If oxygen has been left on while the device is not operating, disconnect the oxygen and wait 30 minutes before turning on the flow generator again.

Explanation: When the CPAP device is not in operation and the oxygen flow is left on, oxygen delivered into the air delivery tubing may accumulate within the CPAP machine enclosure and create a risk of fire.

• Oxygen supports combustion. Do not use oxygen while you are smoking or in the presence of an open
• Always ensure air is flowing from the device before turning on the oxygen
• Always turn the oxygen supply off before stopping the airflow from the Note: At a fixed rate of supplemental oxygen flow, the inhaled oxygen concentration will vary, depending on where the oxygen is introduced, pressure settings, patient breathing pattern, mask selection and leak rate.
• Explosion hazard—do not use in the vicinity of flammable
• Do not use the Tango if there are obvious external defects or unexplained changes in
• Do not open the Tango There are no user serviceable parts inside. Repairs and internal servicing should only be performed by an authorized service agent.

A caution explains special measures for safe and effective use of the device.

• At low pressures, the flow through the exhalation ports of your mask may not clear all exhaled gas from the Some rebreathing may occur.
• The airflow for breathing produced by this device can be as much as 11°F (6°C) higher than the temperature of the room. Be careful if the room temperature is warmer than 90°F (32°C).
• Ports may be incorporated into the mask or in connectors that are near the mask

Servicing

The Tango should be inspected by an authorized ResMed service center 5 years from the date of manufacture. Before this, the device is intended to provide safe and reliable operation if it is operated and maintained according to the instructions provided by ResMed. Warranty details are provided with the device at the time of original supply.

As with all electrical devices, if any irregularity becomes apparent, you should have the device inspected by an authorized ResMed service center.

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.

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

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. This Limited Warranty does not cover:

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

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 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 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.

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions and

Immunity

The C-Series Tango system is intended for use in the electromagnetic environment specified below. The customer or the user of the C-Series Tango system should assure that the device is used in such an environment

Emissions test| Compliance| Electromagnetic environment—guidance
---|---|---
RF emissions CISPR11| Group 1| The C-Series Tango system uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11| Class B| The C-Series Tango system is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage network that supplies buildings used for domestic purposes.
Harmonic Emissions IEC 61000-3-2| Class A
Voltage Fluctuations/Flicker Emissions IEC 61000-3-3| Complies

Warnings: The C-Series Tango system should not be used adjacent to or stacked with other equipment.
Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to EMC information provided in this document.If adjacent or stacked use is necessary, t
he C-Series Tango system should be observed to verify normal operation in the configuration in which it will be used.
The use of accessories (eg, humidifiers) other than those specified in this manual is not recommended. They may result in increased emissions or decreased immunity of the C-Series Tango system.

Guidance and manufacturer’s declaration—electromagnetic immunity

The C-Series Tango system is intended for use in the electromagnetic environment specified below. The customer or the user of the C-Series Tango system should assure that the device is used in such an environment.

Immunity test| IEC60601-1-2 test level| Compliance level| Electromagnetic environment— guidance
---|---|---|---
Electrostatic discharge (ESD)

IEC 61000-4-2

| ±6 kV contact

±8 kV air

| ±6 kV contact

±8 kV air

| Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burst IEC 61000-4-4| ±2 kV for power supply lines| ±2 kV| Mains power quality should be that of a typical commercial or hospital environment.
±1 kV for input/output lines| Not Applicable
Surge

IEC 61000-4-5

| ±1 kV differential mode| ±1 kV differential mode| Mains power quality should be that of a typical commercial or hospital environment.
±2 kV common mode| ±2 kV common mode
Voltage dips, short interruptions and voltage variations on power supply input lines.

IEC 61000-4-11

| <5% Ut

(>95% dip in Ut) for 0.5 cycle

| <12V

(>95% dip in 240V) for 0.5 cycle

| Mains power quality should be that of a typical commercial or hospital environment.

If the user of the C- Series Tango system requires continued operation during power mains interruptions, it is recommended that the

C-Series Tango system be powered from an uninterruptible power source.

40% Ut

(60% dip in Ut) for 5 cycles

| 96V

(60% dip in 240V) for 5 cycles

70% Ut

(30% dip in Ut) for 25 cycles

| 168V

(30% dip in 240V) for 25 cycles

<5% Ut

(>95%dip in Ut) for 5 sec

| <12V

(>95%dip in 240V) for 5 sec

Power frequency (50/60 Hz)

magnetic field IEC 61000-4-8

| 3 A/m| 3 A/m| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note: Ut is the AC mains voltage prior to application of the test level.

Immunity test| IEC60601-1-2

test level

| Compliance level| Electromagnetic environment—guidance
---|---|---|---
 |  |  | Portable and mobile RF communications equipment should be used no closer to any part of the C-Series Tango system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
 |  |  | Recommended separation distance
Conducted RF IEC 61000-4-6| 3 Vrms

150 kHz to 80 MHz

| 3 Vrms| d = 1.17 √P
Radiated RF IEC 61000-4-3| 10 V/m

80 MHz to 2.5 GHz

| 10 V/m| d = 0.35 √P 80 MHz to 800 MHz
 |  |  | d = 0.70 √P 800 MHz to 2.5 GHz
 |  |  | where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
 |  |  | Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b
 |  |  | Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the C-Series Tango system is used exceeds the applicable RF compliance level above, the C-Series Tango system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the C-Series Tango system.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the C-Series Tango system

The C-Series Tango system is intended for use in an environment in which radiated RF disturbances are controlled. The customer or the user of the C-Series Tango system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the C-Series Tango system as recommended below, according to the maximum output power of the communications equipment.

d = 1.17 √P

| 80 MHz to 800 MHz

d = 0.35 √P

| 800 MHz to 2.5 GHz

d = 0.7 √P

0.01| 0.17| 0.04| 0.07
0.1| 0.37| 0.11| 0.22
1| 1.17| 0.35| 0.7
10| 3.69| 1.11| 2.21
100| 11.70| 3.50| 7.0

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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References

• Sleep apnea and COPD - learn about symptoms and treatment | ResMed

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