Breas iSleep 20+ User manual

1Table of Contents
iSleep 20+ users manual
Doc. 004270 En-Eu T-3b
Table of Contents
1 Intended Use of the iSleep 20+ ......................................................................................3
1.1 What is the iSleep 20+?....................................................................................3
1.2 Indications for Use ............................................................................................4
1.3 Contraindications ..............................................................................................4
1.4 About this Manual ..........................................................................................5
2 Safety Information...........................................................................................................7
2.1 General User Precautions ...............................................................................7
2.2 Electrical Safety ............................................................................................8
2.3 Environmental Conditions ...............................................................................9
2.4 Usage of Patient Circuit ...............................................................................10
2.5 Usage of Filters...............................................................................................10
2.6 Cleaning and Maintenance............................................................................. 11
2.7 Adverse Patient Symptoms............................................................................. 11
2.8 Usage of the HA 01 Humidifier ......................................................................12
2.9 Usage of Oxygen ...........................................................................................13
3 Product Description.......................................................................................................14
3.1 Main Components...........................................................................................14
3.2 The iSleep 20+'s Front Panel ..................................................................16
3.3 The iSleep 20+'s Side Panels ...................................................................17
3.4 Equipment Designation and Safety Label ....................................................18
4 Functions and Parameters of the iSleep 20+................................................................19
4.1 Settings...........................................................................................................19
5 Using the iSleep 20+.....................................................................................................21
5.1 Checking the iSleep 20+ before Use ..............................................................21
5.2 Switching the iSleep 20+ On and Off..............................................................21
5.3 Using the Menu .............................................................................................22
5.4 Using the integrated Humidifier.......................................................................23
5.5 Using an External Battery ...............................................................................26
6 Preparing the iSleep 20+ for Use..................................................................................28
6.1 Installing the iSleep 20+..................................................................................28
6.2 Placing the iSleep 20+ ..................................................................................29
6.3 Connecting the iSleep 20+ to the Mains Supply.............................................29
6.4 Connecting the Patient Circuit ........................................................................30
7 Setting up the iSleep 20+ ...........................................................................................31
7.1 Settings Applicable for iSleep 20+ ................................................................31
7.2 Setting the Parameters ...................................................................................31
7.3 Viewing Device Information .........................................................................32
8 Indications.....................................................................................................................33
9 Cleaning the iSleep 20+ and Replacing the Filters.......................................................36
9.1 Cleaning the iSleep 20+ .................................................................................36
9.2 Cleaning and Replacing the Patient Air Filter.................................................38
10 Maintenance .................................................................................................................39
10.1 Regular Maintenance Control .........................................................................39

2 Table of Contents
iSleep 20+ users manual Doc. 004270 En-Eu T-3b
10.2 Service and Repair..........................................................................................40
10.3 Storage............................................................................................................40
10.4 Disposal ..........................................................................................................40
11 Technical Specifications................................................................................................41
11.1 Data ....................................................................................................41
12 Accessories...................................................................................................................43
12.1 Breas Accessories List....................................................................................43
13 Patient Settings.............................................................................................................44

3Intended Use of the iSleep 20+
iSleep 20+ users manual
Doc. 004270 En-Eu T-3b
1 Intended Use of the iSleep 20+
1.1 What is the iSleep 20+?
The iSleep 20+ is a CPAP system that provides a continuous positive airway
pressure. This can prevent the user’s upper airways from collapsing and there-
fore avoid breathing problems associated with airway collapse and obstruction.
The iSleep 20+ has a pressure sensor that continuously monitors output pres-
sure to the patient and reference ambient pressure, so that the device automati-
cally will compensate for altitude changes.
WARNING!
iSleep 20+ must only be used:
• For the intended treatment in accordance with this manual and
with the instructions given by the responsible clinical personnel.
• In accordance with the operating conditions specified in this
manual.
• In original and unmodified shape and only with accessories spec-
ified or approved by Breas Medical AB.
Every other use may lead to risk of personal injury!
CAUTION!
Read this manual thoroughly so that you completely understand how
the iSleep 20+ is operated and maintained before taking it into use, to
ensure correct usage, maximum performance and serviceability.
WARNING!
Do not use the iSleep 20+ for any kind of life support treatment.
Breas Medical AB reserves the right to make changes to this product
without any prior notification.

4 Intended Use of the iSleep 20+
iSleep 20+ users manual Doc. 004270 En-Eu T-3b
The iSleep 20+ has a memory that stores the usage, and can be downloaded by
your care provider to a PC.
1.2 Indications for Use
The iSleep 20+ is intended for non-invasive use.
The iSleep 20+ shall only be used by patients with spontaneous breathing.
The CPAP function is intended to deliver continuous positive airway pressure
therapy for the treatment of obstructive sleep apnea in adults (who weigh more
than 30 kg).
The iSleep 20+ can be used in clinical settings (e.g., hospitals, sleep laboratories,
sub-acute care institutions) and home environments. It must always be pre-
scribed by a licensed physician.
The iSleep 20+ is intended to be operated by trained users and qualified person-
nel.
1.3 Contraindications
Therapy with the iSleep 20+ should not be prescribed when the following spe-
cific diseases or conditions are present:
• Bullous lung disease
• Pathologically low blood pressure
• Severe cardiac arrhythmias
• Coronary artery disease
• Unstable angina pectoris
• Decompensated cardiac failure or hypotension, particularly if associated
with intravascular volume depletion
• Recent thoracic surgery
• Pneumothorax
• Pneumomediastinum
• Massive epistaxis or previous history of massive epistaxis
(risk of recurrence)
The iSleep 20+ is not intended for life support or life-sustaining applica-
tions or for transport of critical care patients.

5Intended Use of the iSleep 20+
iSleep 20+ users manual
Doc. 004270 En-Eu T-3b
• Pneumoencephalus, recent trauma or surgery that may have produced
cranio-nasopharyngeal fistula
• Cerebral spinal fluid (CSF) leaks
• Acute or unstable respiratory failure or insufficiency
Caution should be used when prescribing CPAP therapy for susceptible
patients, such as patients with abnormalities of the cribriform plate, or prior his-
tory of head trauma.
The use of CPAP therapy may be temporarily contraindicated if the patient
exhibits signs of a sinus or middle ear infection.
1.4 About this Manual
Audience
This manual is intended for patients and other lay users operating the
iSleep 20+.
Icons
In this manual, icons are used to highlight specific information. The meaning of
each icon is explained in the table below.
Always read this manual before setting up and using the iSleep 20+ or
performing maintenance on the iSleep 20+, to ensure correct usage,
maximum performance and serviceability.
Breas Medical AB reserves the right to make changes to the contents of
this manual without any prior notification.
Care providers, clinical personnel, physicians and others who require a working
knowledge of the iSleep 20+ will find additional information on settings and func-
tions in the Clinician’s Manual.
ICON EXPLANATION
Warning!
Risk of death and serious personal injury.
Caution!
Risk of minor or moderate injury. Risk of equipment damage,
loss of data, extra work, or unexpected results.

6 Intended Use of the iSleep 20+
iSleep 20+ users manual Doc. 004270 En-Eu T-3b
Note
Information that may be valuable but is not of critical impor-
tance, tips.
Reference
Reference to other manuals with additional information on a
specific topic.
ICON EXPLANATION

7Safety Information
iSleep 20+ users manual
Doc. 004270 En-Eu T-3b
2 Safety Information
2.1 General User Precautions
• The iSleep 20+ should not be used for any kind of life support treatment.
• The iSleep 20+ shall only be used by patients with spontaneous breathing.
• If you are admitted to a hospital or are prescribed any other form of medi-
cal treatment, always inform the medical staff that you are on CPAP treat-
ment.
• The iSleep 20+ must only be used:
– for the intended treatment in accordance with this user manual and with
the instructions given by the responsible clinical personnel;
– in accordance with the operating conditions specified in this manual;
– in original and unmodified shape and only with accessories specified or
approved by Breas Medical AB.
• Do not use the iSleep 20+ and contact your responsible care provider for
an inspection in the event of suspected damage to the device, unexplainable
or sudden pressure, performance or sound changes during operation, or if
the delivered air from the iSleep 20+ is abnormally hot or emits an odour.
• The iSleep 20+ therapy settings must always be based on medical advice
and must be carried out by authorized clinical personnel only.
• Always perform the procedure “Checking the iSleep 20+ before Use” on
page 21 before use.
• Inadequate use of device or accessories may cause loss of treatment or
decreased performance.
• Clinical personnel and the patient must read the manual thoroughly and
understand the usage of the iSleep 20+ before setting up and using the
iSleep 20+.
• Handle the iSleep 20+ with care.
• Do not use the iSleep 20+ while in bag.

8 Safety Information
iSleep 20+ users manual Doc. 004270 En-Eu T-3b
2.2 Electrical Safety
• Do not operate the iSleep 20+ if it has a damaged power cord, power sup-
ply or casing.
• The iSleep 20+ may not work properly if any part has been dropped, dam-
aged or submerged in water.
• To avoid electrical shock, disconnect the electrical supply to the iSleep 20+
before cleaning. Do not immerse the iSleep 20+ into any fluids.
• When handling the HA 01 humidifier, disconnect the iSleep 20+ from any
power source.
• If an external battery is used it must be disconnected when the iSleep 20+
is switched off. Otherwise the battery will discharge.
• The performance of the iSleep 20+ may deteriorate at:
– AC supply voltage below -15% and above +10% of declared nominal
value.
– DC supply voltage below -15% and above +25% of declared nominal
value.

9Safety Information
iSleep 20+ users manual
Doc. 004270 En-Eu T-3b
2.3 Environmental Conditions
• Do not use the iSleep 20+ in any toxic environment.
• Do not use the iSleep 20+ in environments where there are explosive gases
or other flammable anesthetic agents present.
• The performance of the iSleep 20+ may deteriorate at:
– ambient temperatures below 5°C (41°F) and above 40°C (104°F).
– ambient relative humidity below 10% RH (relative humidity) and above
95% RH.
– atmosphere pressure below 700 mbar and above 1060 mbar.
• Do not use the iSleep 20+ while positioned in a warm place, such as direct
sunlight.
• The device complies with the EMC requirements of standards. Measures
should include but not be limited to:
– normal precautions with regard to relative humidity and conductive char-
acteristics of clothing in order to minimize the build-up of electrostatic
charges.
– avoiding use of radio emitting devices closer than 1 m to the iSleep 20+.
Radio emitting devices are for example cellular or cordless telephones,
microwave ovens and high-frequency surgery apparatus.
• The iSleep 20+, any accessories and all replaced parts must be disposed of
in accordance with the local environmental regulations regarding the dis-
posal of used equipment and waste.
• The performance of the iSleep 20+ and treatment of the patient may dete-
riorate if the operation conditions in “Technical Specifications” on page 41
are not fulfilled. Do not use the iSleep 20+ immediately after storage or
transport outside the recommended operating conditions.

10 Safety Information
iSleep 20+ users manual Doc. 004270 En-Eu T-3b
2.4 Usage of Patient Circuit
2.5 Usage of Filters
• Only use the iSleep 20+ with a mask, patient tube and ventilation valve (if
applicable) recommended by Breas Medical AB and your health care pro-
fessional.
• Do not breathe in the connected patient circuit unless the iSleep 20+ is
turned on and operating properly.
• Do not use patient hoses or tubes made of electrically conductive or static
material.
• Patient connected parts and filter must be replaced regularly to ensure cor-
rect function of the iSleep 20+. All replaced parts must be disposed of
according to local environmental regulations regarding the disposal of used
equipment and parts.
• If the patient is using a full face mask (covering mouth and nose), the mask
must be equipped with a safety entrainment valve.
• Make sure that the ventilation holes in the mask or the adjoining ventilation
valve are never blocked or obstructed. These devices are used for ventilat-
ing the mask in order to prevent re-breathing of exhaled air. Re-breathing
of exhaled gases for longer than a few minutes can, in some circumstances,
lead to suffocation.
• At low CPAP pressures, the air flow through the ventilation holes in the
mask or the adjoining ventilation valve may be inadequate to clear all
exhaled gases from the mask. Some re-breathing may occur.
• Always use the iSleep 20+ with a patient air inlet filter installed. Only use
filters that are specified in this manual.
• Replace or clean the filters regularly to ensure correct function of the
iSleep 20+, especially when changing patient. Failure to replace or clean a
dirty filter may cause the iSleep 20+ to operate at higher temperatures than
intended.
• When operating the iSleep 20+, make sure that the air inlet and the filter is
not obstructed or occluded.

11Safety Information
iSleep 20+ users manual
Doc. 004270 En-Eu T-3b
2.6 Cleaning and Maintenance
2.7 Adverse Patient Symptoms
• The iSleep 20+ shall be cleaned and maintained in accordance with this
user manual.
• Do not attempt to autoclave or sterilise the iSleep 20+.
• The iSleep 20+ shall be subjected to maintenance, service and control and
any applicable upgrades, in accordance with Breas service instructions.
• The iSleep 20+ should only be repaired or modified in accordance with
Breas service manuals, technical bulletins, and any special service instruc-
tions, by service technicians authorized by Breas Medical AB.
• Do not under any circumstances attempt to service or repair the iSleep 20+
yourself. If you do so, the manufacturer will no longer be responsible for
the performance and safety of the iSleep 20+.
If the patient experiences any of the following symptoms while using the
iSleep 20+, a physician or responsible clinician shall be contacted immedi-
ately:
• Bloated feeling from excessive swallowing of air while awake
• Air continually leaking from the mouth while sleeping
• Dryness of air passages or nose
• Ear pain, runny nose or sinus discomfort
• Day time sleepiness
• Disorientation or memory lapse
• Mood change or irritability
• Skin sensitivity
• Morning headache

12 Safety Information
iSleep 20+ users manual Doc. 004270 En-Eu T-3b
2.8 Usage of the HA 01 Humidifier
• The HA 01 humidifier and the iSleep 20+ are intended for non-invasive
use.
• When using an external humidifier, it should be located below the
iSleep 20+ and the patient to prevent personal injury from accidental spill-
age.
• When using the HA 01 humidifier, the iSleep 20+ should be located below
the patient to prevent personal injury from accidental spillage.
• If a room humidifier is used, place it at least 2 meters away from the
iSleep 20+.
• Periodically check for moisture in the patient circuit. When present,
remove the moisture. Before attempting to dry the circuit, disconnect it
from the iSleep 20+ to ensure no water back-flow into the iSleep 20+. The
frequency at which these checks must be performed will depend on the
patient’s own condition and the device used. This should be assessed on an
individual basis in accordance with the patient’s needs.
• If the condensation in the patient circuit is excessive, the use of a heated
humidifier may require the installation of a water trap in the circuit. The
water trap prevents any condensated water in the patient circuit from run-
ning into the patient airways and causing personal injury.
• The HA 01 humidifier shall be disconnected from the iSleep 20+ during
transportation.
• The iSleep 20+ shall not be placed in the bag with the HA 01 humidifier
attached.

13Safety Information
iSleep 20+ users manual
Doc. 004270 En-Eu T-3b
2.9 Usage of Oxygen
• The presence of oxygen can speed up combustion of inflammable materi-
als.
• If oxygen has been prescribed, connect the oxygen supply tube to the
appropriate oxygen port of the nasal mask or breathing system connector.
• At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen con-
centration will vary, depending on the pressure delivered, patient’s breath-
ing pattern, mask selection, and leak rate.
• When oxygen is used with the iSleep 20+, the oxygen flow must be turned
off when the iSleep 20+ is not operating. If the iSleep 20+ is not in opera-
tion, and the oxygen flow is left on, oxygen delivered into the patient tubing
may accumulate within the iSleep 20+ enclosure. Oxygen accumulated in
the iSleep 20+ enclosure will create a risk of fire.
• Ventilate the room adequately.
• Do not smoke in a room where oxygen is being used.
• Naked light bulbs and other sources of ignition must be kept a minimum of
2 metres away from the oxygen cylinder or any part of the patient circuit.
• Do not use aerosols or solvents close to the oxygen supply, even when the
oxygen supply is shut off.

14 Product Description
iSleep 20+ users manual Doc. 004270 En-Eu T-3b
3 Product Description
3.1 Main Components
The iSleep 20+ system contains the following components:
1
2
3
7
8
10
5
6
9
4

15Product Description
iSleep 20+ users manual
Doc. 004270 En-Eu T-3b
* Included in the iSleep 20+ basic package.
NO. COMPONENT FUNCTION PART NO.
1 Carrying bag Storage for transportation 003793
2* Users manual Product and usage information 004270
3* Patient tube Tube for mask and iSleep 20+ 000245
4* iSleep power supply 003773
5* Mains power cord 003723
6 HA 01 Humidifier Patient air humidification 003530
7* Rear lid Usage without HA 01 Humidi-
fier
003591
8* Filter (white, disposa-
ble, optional)
Inlet air filtration 003762
9* Filter (grey, washable) Inlet air filtration 003693
10* iSleep 20+ main unit

16 Product Description
iSleep 20+ users manual Doc. 004270 En-Eu T-3b
3.2 The iSleep 20+'s Front Panel
NO. USER BUTTONS AND DISPLAYS FUNCTION
1 Start/Stop Main unit: On/Off
2 Display window Mode and settings display
3 Navigation Navigation in menu system
1
3
2

17Product Description
iSleep 20+ users manual
Doc. 004270 En-Eu T-3b
3.3 The iSleep 20+'s Side Panels
NO. ITEM FUNCTION
1 Air outlet Air path out to the patient
2 Locking mechanism Release and lock HA 01 humidifier or rear
lid
3 HA 01 Humidifier
(optional)
Patient air humidification
4 Air inlet Air path in, replaceable filters
5 Data connection Data cable connection
6 Memory card slot Read and write memory card
7 DC inlet External DC power connection
1
2
3
4
5
7
6

18 Product Description
iSleep 20+ users manual Doc. 004270 En-Eu T-3b
3.4 Equipment Designation and Safety Label
NO. SYMBOL EXPLANATION
1Modeldesignation
2 Serial number (the last seven alphanumeric char-
acters)
3 Class II electrical equipment; dual isolation
4 Body floating (IEC 60601-1 Type BF, Isolated
Applied Part)
5 Read the User Manual thoroughly before con-
necting the iSleep 20+ to the patient.
6 CE marking applies in accordance with the direc-
tive MDD 93/42/EEC.
7 Read “Disposal” on page 40 for information
about recycling and disposal.
1, 2 3, 4, 5, 6, 7

19Functions and Parameters of the iSleep 20+
iSleep 20+ users manual
Doc. 004270 En-Eu T-3b
4 Functions and Parameters of the iSleep 20+
4.1 Settings
All the parameters that are used for controlling the breathing by the iSleep 20+
are listed below.
The Ramp function
The ramp function provides a pressure increase from the ramp start pressure to
the set CPAP pressure during a set time.
The ramp function will not be available if your care provider has chosen to deac-
tivate it.
Mask-Off Detection
If the patient removes the mask, the iSleep 20+ will minimise the pressure to
approximately 1 cmH
2
O (the pressure level depends on the mask type). When
the patient has put on the mask again and taken a few breaths, the iSleep 20+
will go back to the pressure delivered before the patient removed the mask.
The iSleep 20+ automatically detects
if the mask is taken off during opera-
tion and reduces the air flow.
CPAP
Ramp start pressure
Set ramp time
Pressure
Time
Ramp start

20 Functions and Parameters of the iSleep 20+
iSleep 20+ users manual Doc. 004270 En-Eu T-3b
The iSleep 20+ will exclude any mask-off time and ramp time when registering
the patient operating time.
Snooze
In order to start the treatment again, start to breath in the mask or press the
Start/Stop button shortly. The iSleep 20+ will then increase the pressure to the
set level during up to 10 seconds.
The iSleep 20+ will turn off automatically after 10 minutes of inactivity once
the snooze function has been activated.
Once the snooze is activated, and the mask has not been taken off within
10 seconds, the pressure will rise to the pressure set before the snooze function
was activated.
Humidifier (optional)
The humidifier function is adjustable to provide additional humidity to the
patient air.
Automatic Restart After Power Fail
The iSleep 20+ will restart after a power failure with a duration shorter than 5
seconds.
Wake Up (optional)
The wake up function will initiate an alarm at a set time when activated. Press
the Start/Stop button to turn off the alarm.
If the mask is not fitted properly to the patient, the iSleep 20+ may incor-
rectly detect that the mask is taken off and may change the delivered
pressure to the reduced mask-off level. In this case, check the mask fit-
ting and adjust it if necessary.
The snooze function allows the
patient to pause the treatment. This is
done by shortly pressing the Start/
Stop button. When the snooze is
started, the display will lighten up and
the iSleep 20+ delivers a low flow.