ResMed H5i User manual

VPAP™Adapt
POSITIVE AIRWAY PRESSURE DEVICE
H5i™
HEATED HUMIDIFIER
Global leaders in sleep and respiratory medicine www.resmed.com
Clinical Guide
English
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i
English
Contents
Welcome ..................................................................................................... 1
VPAP Adapt indications for use ............................................................ 1
VPAP Adapt contraindications .............................................................. 1
VPAP Adapt adverse effects................................................................. 1
H5i indications for use.......................................................................... 1
H5i contraindications............................................................................ 1
VPAP Adapt at a glance................................................................................ 2
Traveling with the VPAP Adapt.............................................................. 2
H5i at a glance ............................................................................................. 3
Traveling with the H5i........................................................................... 3
Operating information .................................................................................. 4
Modes of operation.............................................................................. 4
Leak Management – Vsync ............................................................... 4
EPAP and Pressure Support ................................................................. 4
VPAP Adapt features .................................................................................... 5
Climate Control .................................................................................... 5
Sleep quality......................................................................................... 6
Sleep quality......................................................................................... 6
Setup............................................................................................................ 7
Mask and tubing setup......................................................................... 8
Filling the water tub ..................................................................................... 9
VPAP Adapt basics ..................................................................................... 10
Navigating the menus ................................................................................ 11
About the menus ....................................................................................... 11
Home menu ....................................................................................... 11
Changing settings via the Home menu.................................... 12
S9 Essentials............................................................................ 12
Viewing the treatment screens................................................ 13
Treatment screen parameters.................................................. 14
Setup menu........................................................................................ 15
Patient Setup menu ................................................................. 15
Clinical Setup menu ................................................................. 15
Clinical setup menu parameters............................................... 16
Info menu........................................................................................... 18
Standard Info menu ................................................................. 18
Advanced Info menu ................................................................ 19
Clinical Info menu .................................................................... 19
Info menu parameters.............................................................. 20
Managing Climate Control ......................................................................... 21
Delivering therapy ...................................................................................... 22
Adding supplemental oxygen ............................................................. 22
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Data management ..................................................................................... 23
SD card............................................................................................... 23
Removing the card ............................................................................. 23
Inserting the card ............................................................................... 23
Analyzing the SD card data ................................................................ 24
Data storage....................................................................................... 24
Data transmission adapters and modules .......................................... 24
Cleaning and maintenance......................................................................... 25
Disassembling the water tub ............................................................. 25
Daily cleaning ..................................................................................... 25
Weekly .............................................................................................. 25
Monthly .............................................................................................. 26
Maintenance checklist........................................................................ 26
Reassembling and filling the water tub .............................................. 26
Replacing the air filter......................................................................... 27
Antibacterial filters ............................................................................. 27
Technical specifications.............................................................................. 28
General technical specifications ......................................................... 28
VPAP Adapt technical specifications .................................................. 29
H5i technical specifications ................................................................ 30
Air tubing technical specifications ...................................................... 30
Humidifier performance ..................................................................... 30
Pneumatic flow path .......................................................................... 31
Flow (maximum) at set pressures...................................................... 31
Displayed values................................................................................. 32
Warnings and cautions............................................................................... 33
WARNINGS ........................................................................................ 33
CAUTIONS.......................................................................................... 33
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1
English
Welcome
Thank you for choosing the VPAP Adapt or H5i.
Before operating these devices, please read the entire Clinical and Information Guides.
CAUTION
In the US, Federal law restricts this device to sale by or on the order of a physician.
VPAP Adapt indications for use
The S9 VPAP Adapt is indicated for the treatment of patients weighing more than 66 lb (30 kg) with
obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. The S9 VPAP Adapt is
intended for home and hospital use.
VPAP Adapt contraindications
ASV therapy is contraindicated in patients with chronic, symptomatic heart failure (NYHA 2-4) with
reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep
apnea.
Positive airway pressure therapy may be contraindicated in some patients with the following pre-existing
conditions:
• severe bullous lung disease
• pneumothorax or pneumomediastinum
• pathologically low blood pressure, particularly if associated with intravascular volume depletion
• dehydration
• cerebrospinal fluid leak, recent cranial surgery, or trauma.
VPAP Adapt 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 these devices:
• drying of the nose, mouth, or throat
• nosebleed
• bloating
• ear or sinus discomfort
• eye irritation
• skin rashes.
H5i indications for use
The H5i is indicated for the humidification of the air delivered from a CPAP or bilevel device. The H5i is
for use only as recommended by a physician. The H5i is intended for single patient re-use in the home
environment and re-use in a hospital/institutional environment.
H5i contraindications
The H5i is contraindicated for use with patients whose upper (supraglottic) airway has been bypassed.
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Air filter
DC power inlet
SD card slot
Module/Adapter port
Air outlet
VPAP Adapt at a glance
The VPAP Adapt system comprises the following elements:
• VPAP Adapt device
• Air tubing
• 90W power supply unit
• S9 travel bag
• SD card
• S9 SD card protective folder.
Optional components include:
• H5i heated humidifier
• Standard air tubing
• Slimline™air tubing
• 3m air tubing
• ClimateLine™heated air tubing
• ClimateLineMAX ™ heated air tubing
• 30W power supply unit (does not support H5i)
• Power Station II battery pack
• DC/DC Converter 24V/90W
• S9 Oximeter Adapter.
Traveling with the VPAP Adapt
When the patient travels with the VPAP Adapt only:
• Advise the patient to pack the SlimLine or Standard air tubing as the ClimateLine or ClimateLineMAX
heated air tubing is not designed to connect directly to the VPAP Adapt device.
• Advise the patient to purchase and travel with the approved power cord for the region where they will
be using the VPAP Adapt device.
• ResMed confirms that the VPAP Adapt meets the Federal Aviation Administration (FAA) requirements
(RTCA/DO-160, section 21, category M) for all phases of air travel.
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English
Latch
Release
button
ClimateLine/
ClimateLineMAX
connection
port
Air outlet Flip lid
Flip lid seal
H5i
water tub
H5i at a glance
The H5i system comprises the following elements:
• H5i heated humidifier
• H5i standard water tub
• ClimateLine heated air tubing (if sold as a Climate Control Kit).
Optional components include:
• ClimateLineMAX heated air tubing
• H5i cleanable water tub.
Traveling with the H5i
When moving or traveling with the H5i:
• Ensure that the water tub is empty.
• Disconnect the H5i from the VPAP Adapt by pressing the release button.
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Operating information
This VPAP Adapt device uses internal pressure and flow sensors in the air path to respond reliably to
patient flow rates even in the presence of most normal leaks in the patient circuit.
Modes of operation
The following table describes the operating modes available on the VPAP Adapt.
Mode VPAP Adapt
CPAP mode
Treats obstructive sleep apnea where a fixed pressure not greater than
20 cm H2O is set. Therapy is delivered at this pressure for the duration of the
treatment session.
ü
ASV mode
Treats central sleep apnea and/or mixed apneas and periodic breathing by
automatically adjusting the pressure support (PS). In ASV mode, the expiratory
positive airway pressure (EPAP) is adjusted by the clinician to maintain upper
airway patency, while Min PS and Max PS restricts the range of automatically
adjusted pressure support.
ü
Leak Management – Vsync
Vsync monitors and compensates for leak by continuously and automatically adjusting the baseline flow.
This enables reliable triggering and cycling while maintaining the set pressures.
EPAP and Pressure Support
(ASV mode) EPAP can be adjusted to maintain upper airway patency.
Pressure Support (PS) is defined as the difference between the peak pressure at the end of inspiration,
and the minimum pressure at the end of expiration (ie, the amplitude of the pressure waveform
delivered).
The pressure support trigger points (Inspiration:Expiration and Expiration:Inspiration) are set automatically
based on measurement of the patient respiratory flow. ASV mode automatically adjusts pressure support
between Max PS and Min PS to keep the patient’s respiratory flow even.
ResMed recommends maximum pressure support to be greater than or equal to 10 cm.
Normal effort Increased ventilation in
response to apnea
Normal effort resumes
Pressure
cm H2O
Respiratory
airflow
EPAP + Max PS
EPAP + Min PS
EPAP
25
6
5
0
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English
VPAP Adapt features
Climate Control
VPAP Adapt devices, when used in conjunction with the H5i and ClimateLine/ClimateLineMAX heated air
tubing, offer a feature called Climate Control.
Climate Control enables the automatic delivery of a constant value of absolute humidity to the patient’s
upper airway while protecting against rainout and allowing patients to select the air temperature that
offers the most comfort for them.
Rainout protection
Rainout refers to the water or condensation that collects in the patient’s tubing or mask. Rainout is a
common side effect of using a humidifier due to the humidified air cooling as it travels down the tubing
and into the mask. Rainout occurs when relative humidity, which is a measure of the air’s capacity to hold
water vapour, exceeds 100%.
Climate Control protects the patient from rainout by maintaining a target relative humidity of 80% as well
as maintaining the temperature of the air delivered to the patient without compromising the amount of
absolute humidity delivered.
Automatic constant humidity delivery
For each temperature setting, the Climate Control system delivers a constant amount of water vapour, or
absolute humidity, to the patient’s upper airway. The following table shows the target absolute humidity
value that will be delivered to the mask for a selection of temperature settings.
Temperature delivered to the mask Target absolute humidity at the mask,
Body Temperature Pressure Saturated (BTPS)
60ºF (16ºC) 10 mg/L
68ºF (20ºC) 12 mg/L
75ºF (24ºC) 16 mg/L
80ºF (27ºC) 19 mg/L
86ºF (30ºC) 22 mg/L
Automatic constant temperature delivery
The temperature sensor located at the mask end of the ClimateLine/ClimateLineMAX heated air tube
enables the system to automatically control the temperature of the air delivered to the patient. This
ensures the temperature of the air delivered to the patient does not fall below the set minimum
temperature, therefore maximizing breathing comfort for the patient.
Automatic adjustment
The H5i and ClimateLine/ClimateLineMAX heated tubing are controlled by the Climate Control algorithm to
deliver constant humidity and temperature outputs. The system adjusts automatically to changes in:
• ambient room temperature and humidity values
• flow due to pressure changes
• flow due to mask or mouth leak.
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S9 Essentials
S9 Essentials is designed to make device interaction and menu navigation easier for patients. If enabled,
S9 Essentials disables the Info and Setup functionality so that patients can simply start and stop therapy
and adjust ramp, humidification and Climate Control. S9 Essentials can be enabled via Clinical Setup >
Options > Access.
Sleep quality
Designed to promote compliance, the Sleep Quality indicator allows the patient to actively engage in
their own therapy by identifying leak, usage and AHI information. This information can be set to:
• Usage—where only usage hours are displayed
• On—where usage, leak and AHI information are displayed.
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English
Setup
1. Align your H5i with your VPAP Adapt and push them together until they click into place.
2. Connect the DC plug of the power supply unit to the rear of the VPAP Adapt.
3. Connect the power cord to the power supply unit.
4. Plug the other end of the power cord into the power outlet.
5. Connect one end of the air tubing firmly onto the air outlet.
6. Connect the assembled mask system to the free end of air tubing.
Notes:
•Always ensure that your VPAP Adapt and H5i are placed on a stable, level surface for proper
operation.
•Place the power supply unit away from the H5i to allow for adequate ventilation.
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Mask and tubing setup
• For more information on assembling the mask see the mask user guide.
• If your patient is using a full face mask ensure that the “Full Face” setting is selected. If your patient
is using a nasal pillows mask ensure that the “Pillows” setting is selected. If your patient is using a
nasal mask ensure that the “Nasal” setting is selected with the exception of the Ultra Mirage mask
which should use the “Nasal Ultra” setting.
• For a complete list of recommended masks and their settings go to www.resmed.com on the
Products page under Service & Support. If you do not have internet access, please contact your
ResMed representative.
• The VPAP Adapt device is compatible with the following tubing:
Tube Specifications Settings
ClimateLine
Length:
Inner diameter:
Heated
6’6” (2 m)
0.6” (15 mm)
Automatically detected
ClimateLineMAX
Length:
Inner diameter:
Heated
6’3” (1.9 m)
0.75” (19 mm)
Automatically detected
SlimLine
Length:
Inner diameter:
6’ (1.8 m)
0.6” (15 mm)
If using the SlimLine, Standard or 3 m
tubing, adjust the tube setting in the
Patient Setup or Clinical Setup menus.
Standard
Length:
Inner diameter:
6’6” (2 m)
0.75” (19 mm)
3 m
Length:
Inner diameter:
9’10” (3 m)
0.75” (19 mm)
Note: When using the SlimLine or ClimateLine above 20 cm H2O, the device optimum performance
may not be reached if used with an antibacterial filter. The device performance must be checked prior
to prescribing the SlimLine for use with an antibacterial filter.
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English
Filling the water tub
1. Slide the latch and lift open the flip lid.
2. Remove the water tub.
3. Fill the water tub (through the center hole) with distilled or deionized water
up to the maximum water level mark (12.5 fl oz / 380 mL).
4. Return the water tub to the H5i.
5. Close the flip lid ensuring that it clicks into place.
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Info menu button**
Allows you to view
your sleep statistics
or exit from the
menu.
LCD screen*
Displays the menus,
treatment screens and
reminders.
Setup menu button**
Allows you to make
changes to settings or
exit from the menu.
Push dial
Turning the dial
allows you to
scroll through the
menu and change settings.
Pushing the
dial allows you to
enter into a menu and confirm
your choice.
Start/Stop button
Starts or stops
treatment.
VPAP Adapt basics
Key:
Home
Humidity level
Ramp
Heated tube
Climate Control
Start/Stop
Power Save mode (hold for 3 sec)
Push Dial
Setup menu
Info menu
Advanced Info menu (hold for 3 sec)
Clinical Setup menu (hold for 3 sec)
* Backlight—When treatment is being delivered, the
backlight (including the Start/Stop button) automatically
turns off after 30 seconds, otherwise it turns off after 3
minutes.
** The Info and Setup menus are disabled if S9Essentials
is enabled.
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English
Navigating the menus
In general, to navigate the menus:
1. Turn until the
parameter you
require is displayed
in blue.
2. Press .
The selection is
highlighted in
orange.
3. Turn until you
see the setting that
you require.
4. Press to confirm
your choice. The
screen returns to
blue.
About the menus
There are three menus that are designed to help you choose your options. They are:
1. Home menu—for day to day adjustments.
2. Info menu—provides sleep quality information.
3. Setup menu—where settings can be adjusted.
Home menu
The Home menu shows you and your patient what features are currently activated, and the accessories
that are connected to the device.
Ramp—displayed when the Max Ramp function is activated in the
Clinical Setup menu.
Humidity Level—displayed when the H5i is connected.
Climate Control—displayed when both the H5i and the
ClimateLine/ClimateLineMAX heated air tube are connected and
when Climate Control is activated in the Clinical Setup menu.
Humidity Level and Heated Tube—displayed when both the H5i
and the ClimateLine/ClimateLineMAX heated air tube are connected
and when Climate Control is set to Manual in the Clinical Setup
menu.
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Changing settings via the Home menu
From the home menu, you can adjust or check the following features:
Ramp
Designed to make the beginning of treatment more comfortable for the
patient, ramp time is the period during which the pressure increases from an
initial pressure to the prescribed treatment pressure or minimum treatment
pressure.
Humidity level
The patient can adjust their humidity level at any time to find the setting that
is most comfortable for them.
Climate Control
When the ClimateLine/ClimateLineMAX heated air tubing is connected and
Climate Control is enabled, the patient can adjust the air temperature to find
the setting that is most comfortable for them.
When set to Auto, Climate Control prevents rainout by maintaining 80%
relative humidity in the delivered air. If Climate Control is set to Manual,
Humidity Level and Heated Tube temperature can be set independently.
Mask-fit
Mask-fit is designed to help patients fit the mask properly.
The mask-fit feature delivers treatment pressure for a three-minute period,
prior to starting treatment. During this time, the mask can be adjusted to
minimize leaks.
To use mask-fit:
1. Fit the mask as described in the mask user guide.
2. Press for at least three seconds.
One of the MASK FIT screens is displayed (as shown on the left).
3. If necessary, adjust the mask, mask cushion and headgear until there is
a secure and comfortable fit. After three minutes, the pressure reverts
to the set pressure and treatment will begin. You can end mask-fit at any
time by pressing .
S9 Essentials
When S9 Essentials is enabled, the patient can simply start and stop therapy, access mask fit and adjust
ramp, humidification and Climate Control.
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English
Viewing the treatment screens
Depending on how the system has been configured, you will see one of the following screens when the
device is running:
üH5i humidifier üH5i humidifier
üClimateLine/ClimateLineMAX
heated air tube
üClimate Control – Auto
üH5i humidifier
üClimateLine/ClimateLineMAX
heated air tube
üClimate Control – Manual
üStandard VPAP Adapt
without optional accessories
üOximetry data via the
oximeter adapter
In ASV mode, the fixed lines on the pressure bar indicate the minimum and maximum pressures. In
CPAP mode, only the set pressure is shown.
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Treatment screen parameters
Parameter Modes Description
CPAP ASV
Treatment screen
CPAP üShows the fixed treatment pressure.
ASV üShows the treatment pressures.
Ramp üOrange icon shows that device is ramping up.
Oxygen saturation
(SpO2)*
ü ü Measure of the saturation of blood hemoglobin with oxygen,
expressed as a percentage (sampled every second).
Leak ü ü Estimate of the total rate of air escaping due to mouth and
unintentional mask leaks, expressed in L/min (5-breath moving
average).
Minute Ventilation (MV) ü ü Volume of air breathed in, or out within any 60-second period,
expressed in L/min (5-breath moving average).
Target minute
ventilation (TgMV)
üMinute ventilation the device is attempting to achieve. Pressure
support increases if the minute ventilation falls below the target,
and decreases if it goes above the target.
Pulse* ü ü Number of heart beats in a 60-second time frame (sampled
every second).
Respiratory rate (RR) ü ü Frequency of breathing, expressed as the number of breaths
per minute (5-breath moving average).
Tidal volume (Vt) ü ü Volume of air inspired or expired in one respiratory cycle
(breath), expressed in mL (5-breath moving average).
Pressure support (PS) üDifference between the peak pressure at the end of inspiration
and the minimum pressure at the end of expiration.
* Only available via the oximeter adapter. .
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English
Setup menu
The Setup menu consists of:
• Patient Setup menu—allows the patient to optimize comfort settings as well as make changes to
the mask or tube type.
• Clinical Setup menu—allows the clinician to set all parameters pertaining to the patient’s therapy.
Patient Setup menu
Only settings relevant to the patient are displayed in the Patient Setup menu. Depending on how the
device has been customized via the Clinical Setup menu, the following screens can be viewed:
Tube—only displayed if ClimateLine/ClimateLineMAX is not connected. If
ClimateLine/ClimateLineMAX is attached, no setting is required.
Climate Ctrl—only displayed if ClimateLine/ClimateLineMAX is connected and
also set to PATIENT in the Clinical Setup menu.
Mask—always available.
Mask Fit—always available.
Leak Alert—only displayed if set to PATIENT in the Clinical Setup menu.
SmartStart—only displayed if set to PATIENT in the Clinical Setup menu.
+ Clinical Setup menu
To access the Clinical Setup menu, press and hold the Setup button and push dial for three seconds.
There are four screens available from the Clinical Setup menu as shown in ASV mode below:
Settings
Displays parameters directly affecting the patient’s therapy.
Note: Clinical menus are identified by the yellow open lock shown in the
top right corner. Where further options exist on a screen, the blue scroll bar
down the right of the screen indicates your position within these options.
Options
Displays parameters affecting the patient’s comfort, therapy feedback and
compliance reporting.
Reminders
Displays parameters for accessories requiring replacement.
Configuration
Displays general device setting and resetting options.
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Clinical setup menu parameters
Parameter Modes Default Range Description
CPAP ASV
Settings
Mode ü ü ASV CPAP / ASV Sets the therapy mode available
on the device.
EPAP ü5 cm H2O 4–15 cm H2O,
0.2 cm H2O
increments
Sets the pressure which will be
delivered to the patient when the
device is cycled into expiration.
Max PS ü15 cm H2O 8–16 cm H2O Sets the maximum pressure
support delivered by the device.
Min PS ü3 cm H2O 3–6 cm H2O Sets the minimum pressure
support delivered by the device.
Max Ramp ü45 minutes Off–45 minutes,
5-minute
increments
Limits the ramp time the patient
may select.
Start Pressure ü4 cm H2O 4–Set pressure,
0.2 cm H2O
increments
Sets the pressure at the start
of ramp, up to fixed treatment
pressure.
Set pressure ü8 cm H2O 4–20 cm H2O,
0.2 cm H2O
increments
Sets the fixed treatment
pressure.
Circuit
Mask type ü ü Full Face Full Face /
Nasal / Pillows /
Nasal Ultra
Sets the type of mask used by
the patient.
Tube type ü ü SlimLine
[Standard]*
SlimLine /
Standard / 3m
Sets the type of air tubing used
by the patient.
AB filter ü ü No No / Yes Enables or disables antibacterial
filter.
Options
Climate Control ü ü Auto Auto / Manual /
Patient
Sets the type of Climate Control.
Sleep quality ü ü Usage
[On]*
On / Usage Sets Sleep Quality to Usage or
On.
SmartStart ü ü Off
[On]*
On / Off /
Patient
Enables or disables the
SmartStart feature.
Leak Alert ü ü Off Off / On Enables or disables the Leak
Alert feature; when enabled,
leaks >40L/min (0.7 L/s) for >20
sec result in an audible alert and
a high leak message on the LCD.
Also functions as a mask-off
alert.
*[Asia Pacific]
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