Resmed Vpap, H5I User Manual

VPAP™ Adapt

POSITIVE AIRWAY PRESSURE DEVICE

™

H5i

HEATED HUMIDIFIER

Clinical Guide

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

EPAP and Pressure Support ................................................................. 4

VPAP Adapt features .................................................................................... 5

Climate Control .................................................................................... 5

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

............................................................... 4

English

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

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 temporar y 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) air way has been bypassed.

English

Module/Adapter port

SD card slot

DC power inlet

Air filter

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

• 3m air tubing

• ClimateLine™ heated air tubing

• ClimateLine

• 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 ClimateLine

• Advise the patient to purchase and travel with the approved power cord for the region where they will

• ResMed confirms that the VPAP Adapt meets the Federal Aviation Administration (FAA) requirements

™

air tubing

MAX ™

heated air tubing

heated air tubing is not designed to connect directly to the VPAP Adapt device.

be using the VPAP Adapt device.

(RTCA/DO-160, section 21, category M) for all phases of air travel.

MAX

Flip lid seal

Air outlet

ClimateLine/

ClimateLine

connection

MAX

port

Flip lid

Release button

Latch

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:

• ClimateLine

• 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.

MAX

heated air tubing

English

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 H treatment session.

O is set. Therapy is delivered at this pressure for the duration of the

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.

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 air way 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

Pressure cm H

Respiratory airﬂow

Increased ventilation in response to apnea

Normal effort resumes

EPAP + Max PS EPAP + Min PS EPAP

VPAP Adapt features

Climate Control

VPAP Adapt devices, when used in conjunction with the H5i and ClimateLine/ClimateLine 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

MAX

heated air

Automatic constant temperature delivery

MAX

The temperature sensor located at the mask end of the ClimateLine/ClimateLine

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

MAX

The H5i and ClimateLine/ClimateLine

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.

English

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.

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.

English

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:

ClimateLine

MAX

Length:

Inner diameter:

SlimLine

Length:

Inner diameter:

Standard

Length:

Inner diameter:

3 m

Length:

Inner diameter:

Note: When using the SlimLine or ClimateLine above 20 cm H 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.

Heated 6’6” (2 m)

0.6” (15 mm)

Heated 6’3” (1.9 m)

0.75” (19 mm)

6’ (1.8 m)

0.6” (15 mm)

6’6” (2 m)

0.75” (19 mm)

9’10” (3 m)

0.75” (19 mm)

Automatically detected

If using the SlimLine, Standard or 3 m tubing, adjust the tube setting in the Patient Setup or Clinical Setup menus.

O, the device optimum performance

+ 28 hidden pages