Breas iSleep 20 User manual

1Table of Contents
iSleep 20 clinician’s manual
Doc. 003923 En-Us V-2
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............................................................................................... 11
2.6 Cleaning and Maintenance............................................................................. 11
2.7 Adverse Patient Symptoms.............................................................................12
2.8 Usage of the HA 01 Humidifier ......................................................................13
2.9 Usage of Oxygen ...........................................................................................14
3 Product Description.......................................................................................................15
3.1 Main Components...........................................................................................15
3.2 Accessories ...........................................................................................17
3.3 The iSleep 20's Front Panel ....................................................................19
3.4 The iSleep 20's Side Panels ....................................................................20
3.5 Equipment Designation and Safety Label ....................................................21
4 Functions and Parameters of the iSleep 20..................................................................22
4.1 Settings...........................................................................................................22
4.2 Home and Clinical Mode.................................................................................23
5 Using the iSleep 20.......................................................................................................24
5.1 Checking the iSleep 20 before Use.................................................................24
5.2 Switching the iSleep 20 On and Off................................................................24
5.3 Using the Menu .............................................................................................25
5.4 Transferring Data between the iSleep 20 and a PC .......................................27
5.5 Using the integrated HA 01 Humidifier ........................................................28
5.6 Using an External Battery ...............................................................................29
6 Preparing the iSleep 20 for Use....................................................................................31
6.1 Installing the iSleep 20....................................................................................31
6.2 Placing the iSleep 20 ....................................................................................32
6.3 Connecting the iSleep 20 to the Power Source .............................................32
6.4 Connecting the Patient Circuit ........................................................................33
7 Setting up the iSleep 20 .............................................................................................34
7.1 Settings Applicable for iSleep 20 ..................................................................35
7.2 Setting the Parameters ...................................................................................35
7.3 Viewing Device Information .........................................................................37
8 Internal Function Error..................................................................................................39
9 Cleaning the iSleep 20 and Replacement of Accessories............................................40
9.1 Cleaning the iSleep 20 ...................................................................................40

2 Table of Contents
iSleep 20 clinician’s manual Doc. 003923 En-Us V-2
9.2 Cleaning and Replacing the Patient Air Filter.................................................42
9.3 Change of Patient...........................................................................................43
10 Maintenance .................................................................................................................44
10.1 Regular Maintenance Control .........................................................................44
10.2 Service and Repair..........................................................................................45
10.3 Storage............................................................................................................45
10.4 Disposal ..........................................................................................................45
11 Technical Specifications................................................................................................46
11.1 System Description ..................................................................................46
11.2 Data ....................................................................................................46
11.3 Compliance of Standards ..............................................................................49
11.4 Delivery Settings ........................................................................................50
12 Accessories...................................................................................................................51
12.1 Breas Accessories List....................................................................................51

3Intended Use of the iSleep 20
iSleep 20 clinician’s manual
Doc. 003923 En-Us V-2
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 pres-
sure. This can prevent the user’s upper airways from collapsing and therefore
avoid breathing problems associated with airway collapse and obstruction.
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
specified 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 under-
stand how the iSleep 20 is operated and maintained before tak-
ing 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 prod-
uct without any prior notification.

4 Intended Use of the iSleep 20
iSleep 20 clinician’s manual Doc. 003923 En-Us V-2
The iSleep 20 has a pressure sensor that continuously monitors output pressure
to the patient and reference ambient pressure, so that the device automatically
will compensate for altitude changes.
The internal memory of the iSleep 20 can be downloaded to a PC where you
can view the patient compliance data in the Breas iSleep PC Software.
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
• Unstable angina pectoris
• Decompensated cardiac failure or hypotension, particularly if associated
with intravascular volume depletion
• Recent thoracic surgery
For more information about the Breas iSleep PC Software, please contact your
Breas representative.
The iSleep 20 is not intended for life support or life-sustaining
applications or for transport of critical care patients.

5Intended Use of the iSleep 20
iSleep 20 clinician’s manual
Doc. 003923 En-Us V-2
• Pneumothorax
• Pneumomediastinum
• Massive epistaxis or previous history of massive epistaxis
(risk of recurrence)
• 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 primarily intended for care providers, clinical personnel, physi-
cians and others who require a working knowledge of the Breas iSleep 20 sys-
tem. The manual comprises detailed information on the settings and functions
of the iSleep 20 to be handled by trained health care personnel only.
Icons
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 con-
tents of this manual without any prior notification.
• Patients and other lay users operating the iSleep 20 will find all the informa-
tion they need in the User Manual.
• Service personnel may order the iSleep 20 Service Manual that contains
detailed technical information for maintenance, service and repair.

6 Intended Use of the iSleep 20
iSleep 20 clinician’s manual Doc. 003923 En-Us V-2
In this manual, icons are used to highlight specific information. The meaning of
each icon is explained in the table below.
ICON EXPLANATION
War ning!
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.
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.

7Safety Information
iSleep 20 clinician’s manual
Doc. 003923 En-Us V-2
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 the patient is admitted to a hospital or is prescribed any other form of
medical treatment, always inform the medical staff that the patient is on
CPAP treatment.
• The iSleep 20 must only be used:
– for the intended treatment in accordance with this clinician’s 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 Breas representative 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 personnel only.
• Always perform the procedure “Checking the iSleep 20 before Use” on
page 24 before use.
• Inadequate use of device or accessories may cause loss of treatment or
decreased performance.
• U.S. Federal law restricts this device to sale by or on order of a physician.
• 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 clinician’s manual Doc. 003923 En-Us V-2
2.2 Electrical Safety
• Do not operate the iSleep 20 if it has a damaged power cord, power supply
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.
• The operator shall not touch accessible contacts of connectors and the
patient simultaneously.
• 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 clinician’s manual
Doc. 003923 En-Us V-2
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 41°F (5°C) and above 104°F (40°C).
– 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 listed in
“Compliance of Standards” on page 49. Necessary measures should be
taken in order to assure field levels exceeding 10 V/m are avoided, since
this may impair the safety and performance of the iSleep 20. 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 disposal
of used equipment and waste.
• The performance of the iSleep 20 and treatment of the patient may deteri-
orate if the operation conditions in “Technical Specifications” on page 46
are not fulfilled. Do not use the iSleep 20 immediately after storage or
transport outside the recommended operating conditions.

10 Safety Information
iSleep 20 clinician’s manual Doc. 003923 En-Us V-2
2.4 Usage of Patient Circuit
• Only use the iSleep 20 with a mask and a patient tube recommended by
Breas Medical AB and your health care professional.
• 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.
• Always use a new mask and a patient tube recommended by Breas Medical
AB when the iSleep 20 is to be used by a new patient.
• 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 leakage ports are never blocked or obstructed. These
ports are used for ventilating 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 leakage ports may be inad-
equate to clear all exhaled gases from the mask. Some re-breathing may
occur.

11Safety Information
iSleep 20 clinician’s manual
Doc. 003923 En-Us V-2
2.5 Usage of Filters
2.6 Cleaning and Maintenance
• Always use the iSleep 20 with a patient air inlet filter installed. Only use fil-
ters 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.
• If the iSleep 20 is used in a clinic by several patients, a low resistance bacte-
ria filter is recommended between the air outlet and the patient circuit to
prevent patient cross-contamination. Reuse of mask or bacteria filter may
expose patients to contagious agents.
• Do not connect any filter to the HA 01 humidifier.
• The iSleep 20 shall be cleaned and maintained in accordance with this clini-
cian’s
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.

12 Safety Information
iSleep 20 clinician’s manual Doc. 003923 En-Us V-2
2.7 Adverse Patient Symptoms
If the patient experiences any of the following symptoms while using the
iSleep 20, a physician or responsible clinician shall be contacted immediately:
• 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
• Severe headache
•Chestdiscomfort
• Shortness of breath

13Safety Information
iSleep 20 clinician’s manual
Doc. 003923 En-Us V-2
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 lower than 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 lower
than the patient to prevent personal injury from accidental spillage.
• If a room humidifier is used, place it at least 6 feet (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 fre-
quency 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.

14 Safety Information
iSleep 20 clinician’s manual Doc. 003923 En-Us V-2
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 operation,
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
6 feet (2 meters) 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.

15Product Description
iSleep 20 clinician’s manual
Doc. 003923 En-Us V-2
3 Product Description
3.1 Main Components
The iSleep 20 system contains the following components:
1
2
3
7
9
5
6
8
4

16 Product Description
iSleep 20 clinician’s manual Doc. 003923 En-Us V-2
* Not 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 003907
3 Patient tube Tube for mask and iSleep 20 000245
4 iSleep 20 power sup-
ply
003773
5 AC power cord 003725
6 Filter (white, disposa-
ble, optional)
Inlet air filtration 004153
(5 pcs)
7 Filter (grey, washable) Inlet air filtration 004154
(5 pcs)
8 Rear lid Usage without HA 01 Humidi-
fier
003591
9 iSleep 20 main unit

17Product Description
iSleep 20 clinician’s manual
Doc. 003923 En-Us V-2
3.2 Accessories
NO. COMPONENT FUNCTION PART NO.
10 HA 01 Humidifier Patient air humidification 003530
11 iMask 100 003971
12 iMask 200 003972
13 Battery cable 24 V DC 004367
14 DC/DC converter
12-24 V
004139
11
10
15
12 13
17
18 19 20 21
14
16

18 Product Description
iSleep 20 clinician’s manual Doc. 003923 En-Us V-2
15 EB 2 Battery kit Includes:
•Charger
•Trafobox
•Isolation
• Battery pack
• Carry bag
• Power cord 24 V AC
• Power cord 24 V DC
•Powercordmains
•EB2Usermanual
004152
16 iSleep PC software kit Data monitoring software 004276
17 iCom kit Includes:
• Isolated communication
interface: PC and iSleep
• iSleep-iCom data cable
• iCom-PC data cable (D-sub)
• iCom-PC data cable (USB)
• iCom User manual
•iComPCdrivers
004143
18 iSleep-PC data cable Data cable: PC and iSleep 20
(RJ45 to D-sub)
003588
19 iSleep-iCom
data cable
Data cable: iSleep 20 and iCom
(RJ45 to D-sub)
003574
20 iCom-PC data cable
D-sub
Data cable: iCom and PC (D-
sub to D-sub)
003721
21 iCom-PC data cable
USB
Data cable: iCom and PC (USB
to USB)
003722
NO. COMPONENT FUNCTION PART NO.

19Product Description
iSleep 20 clinician’s manual
Doc. 003923 En-Us V-2
3.3 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 Function Menu navigation
4 Decrease Decrease setting
5 Increase Increase setting
6 Ramp start and stop Ramp function start and stop
1
3
2
456

20 Product Description
iSleep 20 clinician’s manual Doc. 003923 En-Us V-2
3.4 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 DC inlet External DC power connection
1
2
3
4
5
6