Respironics Tranquility Bilevel 1700 User manual

The Respironics Tranquility Bilevel is a medical device.
It has been prescribed by a physician to assist breathing.
Compact Bilevel System
Model 1700
Compact Bilevel System
Model 1700
Patient Operating Instructions
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Table of Contents
User/Owner Responsibility 3
Scope of this Manual 3
Introduction 3-4
Warnings and Cautions 4-6
Set-up and Use
Unpacking and Inspection 6
Initial Use 7-9
Routine Use 9-10
Humidifier 10
Using Oxygen with this System 10-11
AC Fuse 11
Traveling with your Bilevel System 11
DC Operation 12
Altitude Compensation 12
Maintenance
Changing the Filter 12
Cleaning the System 13
Routine Maintenance 13
Troubleshooting Guide 13-15
Maintenance Record 16
Patient Checklist 17
Annual Inspection 17
Specifications 18
Classification 18
Storage and Transport 19
Operating 19
Electromagnetic Compatibility 19
Accessories 20
Glossary of Terms 21
Limited Warranty 22-23
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Glossary of Symbols
Symbol Description
Attention, consult accompanying documents (such as, manuals). Read and understand this entire
manual before using this bilevel system.
OPower switch Off (Disconnection from the mains)
|Power switch On (Connection to the mains)
~Alternating current
Ramp
Class II equipment (Double insulated)
IPX1 Protected against vertically falling water
Type BF applied part
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User/Owner Responsibility
This Respironics Bilevel system and accessories are designed to work as described in this manual. You should not use parts that are
damaged, broken, worn out, dirty or otherwise ineffective. Read this entire manual before using this Bilevel system.
The user/owner of this system shall have the sole responsibility and liability for any injury to persons or damage to property (including
this equipment) resulting from:
1. Operation not in accordance with supplied operating instructions;
2. Maintenance not in accordance with authorized maintenance instructions;
3. Maintenance by anyone other than a factory-authorized service representative;
4. Modification of the system or accessories; or
5. Use of damaged or unauthorized components or accessories.
The Scope of this Manual
This manual will show you how to use the Respironics Tranquility Bilevel PAP system. This system provides positive pressure to the
breathing passages to assist breathing. Read and understand this entire manual before trying to use this system.
Introduction
Nasal Bilevel PAP devices produce small amounts of air pressure at different levels. You will use a nasal mask to apply these pressures.
This pressure opens the breathing passages to prevent blockages and to assist breathing. The Bilevel system is different from Continuous
Positive Airway Pressure (CPAP). CPAP provides one level of pressure. Bilevel provides two levels of pressure, one during inspiration
and a second lower pressure during expiration.
.
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The Tranquility Bilevel (Model 1700) system from Respironics, is a medical device that uses a blower. The blower is controlled to pro-
vide two levels of pressure. The controller allows for the adjustment of the way the pressure changes from one level to the other. The
ComfortControlª on the front of the unit will allow you to adjust the way pressure is delivered. You can select the setting that you feel
is the most comfortable. Also, this compact unit features a linear ramp, a useful handle, and a filter. You can easily wash or replace the
filter.
Warnings and Cautions
WARNING-indicates a potentially harmful situation
1. This is a non-continuous ventilatory assist device. It is intended to assist you with your breathing. It must not be used as a ventilator
that supports or sustains life. This device is not intended to provide you with total support of your breathing. In all cases you should
expect to have no more than short term effects if the device fails to provide pressure during long periods of time (for example, over
night).
2. Do not use this Bilevel unit in the presence of flammable anesthetics.
3. Do not use the Bilevel unit around water in any way. You may use Bilevel with a Respironics supplied Humidifier.
4. If this unit should come in contact with water, unplug the unit.
5. This unit should never be turned on and left unattended.
6. Never operate this unit if the power cord or plug is damaged.
7. If this unit has been dropped or damaged, contact your dealer or Respironics at once.
8. Adjusting the pressure without a physicianÕs instruction could be harmful.
9. Use only a nasal mask and patient circuit supplied by Respironics. The Tranquility Bilevel must be on and operating properly before
you attempt to use the nasal mask and patient circuit.
10. Do not block or obstruct the vent hole located on the front of the nasal mask.
11. Make sure that all breathing connections are properly secured.
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12. For 12VDC operation, do not use any DC to AC inverter other than that supplied or recommended by Respironics.
13. Check and verify fuse rating before replacement.
14. When using oxygen with this system, make sure that this Bilevel is on before you turn the oxygen source. When you wish to stop
using this Bilevel system, turn off the oxygen flow first before turning this Bilevel unit off.
15. Oxygen quickly accelerates fire. If you are using oxygen, keep this Bilevel system as well as the oxygen source away from heat or
open flame. There must be no smoking in the area near the Bilevel.
16. As with any electrical device, do not use this Bilevel unit during an electrical storm.
17. Do not use this Bilevel unit with a portable electrical generator.
18. At low pressures, the flow through the exhalation port may not be enough to clear all of the exhaled gases from the hose. As a
result, you may breathe in some of the air that you have breathed out or exhaled.
19. Be aware that interference with the operation of this device can occur from external sources. While this device contains methods and
techniques that can provide protection from external sources of interference, you should take the steps listed here to avoid interfer-
ence. Keep the device at least three feet away from all electrical appliances such as TV sets, electric blankets, air conditioners, cord-
less phones and cellular phones.
20. The air flow for breathing produced by the Bilevel can be as much as 1.8¡F (1.0¡C) higher than the temperature of the room. Use
caution if the room temperature is warmer than 90¡F (32¡C).
CAUTION: FEDERAL USA LAW RESTRICTS THIS DEVICE TO SALE BY, OR ON THE ORDER OF, A LICENSED
PHYSICIAN. THIS BILEVEL UNIT SHOULD BE USED ONLY UNDER THE SUPERVISION OF A
LICENSED PHYSICIAN.
CAUTION-indicates a condition that may lead to equipment damage, malfunction, or inaccurate operation.
1. Do not use a room humidifier within six feet of this unit. Dampness may affect device parts.
2. Do not use attachments that are not recommended by Respironics.
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3. This Bilevel system is to be used in the manner described in this manual.
4. Never drop or insert any objects into the connecting hose or air outlets or inlets.
5. Operating the unit with a dirty filter may keep the Bilevel from working properly.
6. Do not use extension cords or electrical adapters.
7. Do not sterilize this unit.
Note: At a fixed flow rate of oxygen flow, the inhaled oxygen concentration will vary, depending on the pressure
settings, your breathing pattern, mask selection, and leak rate. This warning applies to most types of CPAP or Bilevel devices.
Set-up and Use
Unpacking and Inspection
When you get your Bilevel system, carefully open the box and unpack the system. Make sure that you have all the parts listed below and
that nothing looks damaged. This basic package does not include accessories. Accessories can be ordered separately.
Included with this system are the following:
1. Tranquility Bilevel (Model 1700) nasal PAP unit
2. AC Power Cord
3. Six-foot Hose and Tubing Adapter
4. Carry Case
5. User Instruction Manual
You will need a Nasal Mask and Headgear in order to use this system.
IF ANY OF THESE COMPONENTS ARE FOUND TO BE
MISSING OR DAMAGED CONTACT RESPIRONICS AT ONCE.
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Initial Use
1. Prior to each use, inspect this unit for any signs of damage, failure or worn parts. Call Respironics or your Home Care Dealer
immediately to replace these parts. Check to see if there is any moisture in the area of this Bilevel unit. Also check the air inlets
and outlets for any blockage or the presence of any dust or dirt. If you notice any moisture, dry the area completely before use.
Remove any blockage and/or dust or dirt from the air inlets or outlets before each use. Do not use a room humidifier within six feet
of this Bilevel unit.
2. Place the Bilevel unit in a clean, dry place. Place the Bilevel near an electrical outlet not controlled by a wall switch. Do not use
extension cords or electrical adapters. Place this unit in an upright position on a night stand or other suitable surface. Make sure
that the front facing you and that nothing is blocking the vents. Never place the Bilevel on a table or night stand that cannot safely
support the Bilevel unit.
3. Connect the power cord to the AC power inlet on the rear of the unit.
Check to be sure that the Power switch is in the OFF position. Plug the
other end of the power cord into the unswitched outlet.
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4. Attach the Bilevel Hose to the Air Outlet Port on the front of the Bilevel unit.
5. Attach the Nasal Mask to the other end of the Hose.
6. Refer to the Nasal Mask Instructions for information on using the mask and
headgear and on adjusting the fit. Do not block the hole (bias flow port) locat-
ed at the base of the Mask.
7. Turn the Bilevel unit on using the Power switch located on the front of the unit.
The unit will deliver the set pressure once the mask is in place. Air flow will
begin to move through the hose.
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Power Ramp Comfort
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8. Place the Nasal Mask on. Adjust the straps to get rid of any leaks. Do not overtighten the straps.
The mask and headgear should fit comfortably.
9. As you breathe in, you will find that the pressure rises slightly. As you exhale, it will fall. This
will make your therapy more comfortable.
10. The ComfortControlª can be used to make the change in pressure even more comfortable. This
control can be set to 1, 2 or 3 based on your preference. This control will alter the rate of change
between the two pressures. You may change this setting at any time.
11. The Ramp button may be used to decrease the pressure to a lower level. The pressure will then increase to the set pressure over a
set period of time. Your Home Care Dealer has already set the ramp time. The ramp indicator will remain lit during the ramp period.
The ramp makes the Bilevel more comfortable as you fall asleep.
12. In the morning or whenever you wish to stop using the unit, you can switch the unit off. Switch the Power Switch to the OFF posi-
tion and remove the Nasal Mask.
Routine Use
Regular use of the Tranquility Bilevel System involves a simple brief, routine that is detailed here.
1. Switch the Power switch to the ON position. The Power indicator light will come on. You will feel air coming out of the hose. The
pressure will rise to the level set by the Home Care Dealer once the mask is in place.
2. Place the Nasal Mask, with the Headgear and Hose attached, on and adjust the Headgear straps as needed. Check the mask for any
leaks and adjust as needed.
3. Press the ramp button to begin the ramp period. The ramp light will come on and the pressure will be reduced.
4. If the Hose becomes disconnected at either the Nasal Mask or the Bilevel unit, the unit may go into a Flow Limit mode. In this
mode the pressure will be reduced to prevent any damage to the unit. When there is no longer a leak, the pressure will return to the
proper level.
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5. If you need to get up during the night, turn the Power switch to the OFF position and remove the Mask. When you wish to start
using the Bilevel unit again, turn the unit ON and replace the Nasal Mask and Headgear. Make sure to check for leaks.
6. In the morning or when you are through using the unit, turn the Power switch OFF and remove the mask.
7. The Nasal Mask, Headgear, and Hose should be removed from the system for cleaning.
Humidifier Use
An optional Humidifier is available through Respironics for use with the system. The Humidifier is
a reservoir that fits under your unit. When properly filled with distilled water, it adds moisture to
the airflow. This moisture can reduce nasal dryness and irritation. Do not leave water in the
Humidifier when the Bilevel is not in use. If the blower accidentally comes on, small amounts of
water may be blown out of the Humidifier. Follow the instructions included with the Humidifier
regarding cleaning.
CONTACT YOUR DEALER FOR FURTHER INFORMATION.
Using Oxygen With This System
It is important that you read, understand and carefully follow these instructions regarding the use of oxygen with your Tranquility
Bilevel system.
CAUTION: Oxygen is a prescription gas and should be used only under the supervision or direction of a licensed physician. While
using oxygen, keep the Bilevel system and oxygen source away from heat and open flame. Smoking by anyone in the presence of
oxygen must not occur.
1. Set-up
Attach the oxygen tubing to the hose using the loops included with the Oxygen
Administration Kit. Thread the oxygen tubing through the holes in the loops.
Attach the T-adapter between the mask and the hose. Attach one end of the tub-
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ing to the T-adapter and the other end to the oxygen source.
2. Oxygen Use
Turn on the Bilevel unit so that air flow will begin before turning on the flow of oxygen. When turning the Bilevel unit off, always
turn the oxygen flow off first and then the Bilevel unit.
NEVER TURN THE BILEVEL UNIT ON OR OFF WITH OXYGEN FLOWING INTO THE UNIT
AC Fuse
If the Bilevel unit power indicator does not light up when the unit is plugged in and turned on, you
may need to replace the fuse. When replacing the fuse, make sure that the power cord is not
plugged into the electrical outlet. Remove the power cord from the inlet on the rear of the unit.
Remove the fuse holder by pressing the two tabs together and pulling out on the tabs. You must
replace the fuse with an identically rated fuse. The correct fuse is a T1A, 250V, (1 Amp, 5mm x
20mm, 250 Volt Slo-Blo). Place the new fuse in the fuse holder. Press the holder back into the
inlet. Replace the power cord.
Traveling With Your Bilevel System
The Tranquility Bilevel will operate on a range of voltages from 100 VAC to 240 VAC and on 50 or 60 cycles. You do not need to
switch from one voltage setting to another. You will need to use a plug adapter in some locations in order to connect the power cord into
the available wall outlet. When traveling by airplane, do not check your Bilevel system as baggage because it may be damaged. Always
carry this manual with your Bilevel system when you travel. The manual will serve as a reference guide. The manual also serves as a
notice that this is a medical device that requires regular use. This notice may be helpful in dealing with Customs agents.
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DC Operation
Using the Tranquility Bilevel system with a DC power source will require the use of a Respironics DC to AC Inverter (Part Number
7304). When connecting the DC to AC Inverter, turn off the Bilevel system. Connect the AC power cord to the AC receptacle of the
Inverter. Then, plug the DC to AC Inverter into cigarette lighter-type outlet as found in cars, trucks, boats, etc. Under normal conditions,
this unit will typically draw less than 3 amperes. The maximum draw for the inverter is listed in the DC to AC Inverter manual. For 10
hours of DC to AC Inverter use this unit will typically consume less than 30 Amp hours.
Altitude Compensation
The Tranquility Bilevel unit features a pressure transducer that measures pressure delivered to you. The Bilevel also has a microproces-
sor that adjusts the unit if you travel to a different elevation. The unit will adjust the blower speed to compensate for the new elevation.
The Bilevel will deliver the prescribed pressures at higher elevations.
MAINTENANCE
Changing the Filter
The Tranquility Bilevel is supplied with a reusable filter. This filter can be removed
from the rear of the unit by pulling it out of the filter receptacle. The filter should be
washed well with a mild soap and water solution. After washing, rinse it thoroughly
with clear water. Allow the filter to dry completely before use. Return the filter to the
unit by pressing it against the filter receptacle. Tuck the edges in to place. An optional
disposable filter is available for removal of smaller particles.
Check the condition of the filter prior to each use.
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Cleaning The System
The Bilevel unit can be cleaned using a cloth moistened with water and a mild soap solution. Caution: Unplug the unit before clean-
ing it. Do not place the unit in water. Do not use alcohol or other organic solvents to clean this unit. Let the unit dry completely
before plugging it in or operating it.
Routine Maintenance
Other than the cleaning detailed above, no other maintenance is required by the user. NOTE: You should not attempt to open the unitÕs
enclosure; there are no user serviceable components inside. Unauthorized tampering with the unitÕs enclosure or unauthorized servicing
will void the warranty and could result in damage and or personal injury.
TROUBLESHOOTING GUIDE
PROBLEM POSSIBLE CAUSES INSTRUCTIONS
1. Unit does not turn on. Unit not plugged in to live power source Check to see if unit is plugged into
a live power source.
Fuse needs to be replaced. Call your dealer for a new fuse.
Wrong fuse was used. Call your dealer for a new fuse.
2. No air comes out of unit Filter may be blocked by debris. Wash or replace filter.
when it is turns on
Unit has failed. Call your dealer
3. Air from unit seems warm. Filter may be blocked by debris. Wash or replace filter.
Inlet vent may be blocked. Move the unit away from
the source of blockage.
Room air temperature has increased. Reduce room air temperature.
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PROBLEM POSSIBLE CAUSES INSTRUCTIONS
4. Feeling that the pressure Leak in the system. Check that the mask is not allowing
is to high or too low air to leak and that there are no leaks
in the hose. (Pressure check at zero flow.)
Filter may be clogged. Wash or replace the filter.
Unit has failed. Call your dealer.
Ramp is active. Turn power OFF and then ON to turn off ramp.
5. Unit not cycling between Unit is set to deliver only one pressure level. Call your Home Care dealer.
between two pressure levels
Leak at mask or in circuit interfering Fix leaks.
with triggering.
Blockage in tubing, filter or air inlet. Clear blockage.
6. Discomfort from the feeling Pressure from the Bilevel unit. A period of adjustment, of up to two-
of too much pressure. three weeks, may be required. Relax and take
slow deep breaths. If discomfort continues
after two to three days, call your physician
for assistance.
7. Air leaks around the nasal Mask is not fitting properly. Try again to fit the mask to your face. If leaks
mask irritating the eyes. continue, call your dealer.
Wrong size nasal mask. Call Your Dealer.
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PROBLEM POSSIBLE CAUSES INSTRUCTIONS
8. Skin becomes red where Headgear too tight. Adjust the headgear.
mask touches skin
Wrong size nasal mask. Call your dealer.
General irritation or reaction Stop use and call your physician.
to the mask material.
9. Runny nose. Reaction to air flow. Stop use and call your physician.
10. Dryness of throat or nose. Inadequate humidity. Increase humidity or call your physician
regarding the use of a humidifier.
11. Nasal, sinus, or ear pain. Sinus infection or middle ear infection. Stop use and call your physician.
12. Return of original symptoms. Physical condition has changed. You may need to be retested. Call your
physician. Have your dealer check to see
that your Bilevel unit is working properly.
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MAINTENANCE RECORD
Dates Notes
Replaced Nasal Interface / / / / / / / / / /
Replaced Headgear / / / / / / / / / /
Replaced Hose / / / / / / / / / /
Replaced Filter / / / / / / / / / /
Checked Bilevel Pressure / / / / / / / / / /
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PATIENT CHECKLIST
As you and your Home Care Dealer discuss the use of your Bilevel system, make sure that you understand the following:
❒Why your physician has prescribed the Bilevel system
❒The importance of using your Bilevel System each and every night
❒How to connect the Hose to the device and to the Nasal Mask
❒How to put on the Nasal Mask and Headgear to achieve a good fit
❒The importance of not blocking the Bias Flow Port on the mask
❒The importance of not blocking the Inlet Vent on the Bilevel unit
❒How to use the ComfortControlª
❒How to operate the Ramp feature
❒How to care for the Nasal Mask, Headgear, and Hose
❒How to clean and/or replace the filter
❒How to check the operation of the Bilevel unit
❒What to do if symptoms of obstructive sleep apnea reappear
❒What to do if you experience any ear, nose or sinus pain
ANNUAL INSPECTION
We recommend that the Home Care Dealer perform a routine inspection of the Bilevel system at least once each year. This service
should include: 1. Visually inspecting for any damage; 2. Replacing the filter; 3. Verifying the pressure setting; 4. Checking the condi-
tion of the Mask and Headgear.
** Contact your authorized dealer for further information **
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SPECIFICATIONS
Bilevel Pressure Approx. 3 to 20 cm H2O
Weight 4.8 lbs., (2.3 kg)
Height 5.0" (12.3 cm)
Length 9.5" (23.6 cm)
Width 7.75" (18.9 cm)
Electrical Requirements 100-120/ 200-240 VAC
50/60 Hz, 75VA
12 Volts DC with Optional DC to AC Inverter
Warranty 1 year limited
CLASSIFICATION
IEC Class II
Type BF applied part
Protected against vertically falling water (drip proof)
Not suitable for use in the presence of a flammable anesthetic mixture with oxygen or nitrous oxide
Continuous mode of operation
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STORAGE AND TRANSPORT
Temperature -25¡ C to 60¡ C
Humidity 10 - to 95% noncondensing
Atmospheric Pressure 790-523mm Hg
OPERATING
Temperature 5¡ C to 40¡ C
Humidity 10 to 95% noncondensing
Atmospheric Pressure 790-523mm Hg
ELECTROMAGNETIC COMPATIBILITY
The Tranquility Bilevel (model 1700) is designed to comply with EN 60601-1-2: 1995, Electromagnetic Compatibility - Requirements
and Tests. Move the Bilevel away from other electronic equipment if you suspect the electronic equipment is interfering with the opera-
tion of the Bilevel or if the Bilevel is interfering with the operation of other electronic equipment.
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