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SleepCube Standard - DeVilbiss Healthcare

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Effective Treatment for<br />

Obstructive Sleep Apnoea


The <strong>SleepCube</strong> Series of Positive Airway Pressure devices from <strong>DeVilbiss</strong> <strong>Healthcare</strong> is designed to meet the varied needs of people<br />

suffering from Obstructive Sleep Apnoea (OSA) and Sleep Disordered Breathing (SDB).<br />

Built to the highest standards the <strong>SleepCube</strong> series is a robust compact range of CPAP devices which can be used both in the home<br />

and hospital environment. The <strong>SleepCube</strong>s’ multi voltage capability allows it to be used virtually anywhere in the world and it can<br />

also be operated from a 12 V power source such as those found in a motor home. For the monitoring of patient compliance <strong>DeVilbiss</strong><br />

<strong>Healthcare</strong> has developed SmartCode and SmartLink which are available for use with all models of <strong>SleepCube</strong>.<br />

<strong>SleepCube</strong> <strong>Standard</strong><br />

The <strong>SleepCube</strong> <strong>Standard</strong> is the first in the range of sleep therapy devices from <strong>DeVilbiss</strong><br />

<strong>Healthcare</strong>. It is a fixed pressure CPAP delivering constant pressure all night from 3 - 20<br />

cm H 2 O.<br />

Now with<br />

SmartFlexTM<br />

Inside<br />

<strong>SleepCube</strong> <strong>Standard</strong> Plus<br />

The <strong>SleepCube</strong> <strong>Standard</strong> Plus has all the features of a <strong>SleepCube</strong> <strong>Standard</strong> device with<br />

the addition of SmartFlex expiratory relief, designed to lower the average pressure<br />

throughout the night and increase comfort for the user.<br />

<strong>SleepCube</strong> Auto Plus<br />

Now with<br />

SmartFlexTM<br />

Inside<br />

The <strong>SleepCube</strong> Auto Plus has a unique auto adjusting algorithm that responds to apnoea’s,<br />

hypopnoea’s and snoring to deliver the most effective therapy whilst sleeping. Now<br />

with the added SmartFlex expiratory relief for increased patient adherence.<br />

<strong>SleepCube</strong> BiLevel S<br />

The <strong>SleepCube</strong> BiLevel S is a variation on traditional CPAP. Instead of providing air at a<br />

constant pressure all night the machine senses if you are breathing in or out and varies<br />

its pressure level accordingly. This is particularly useful for those users who require a<br />

higher pressure setting.<br />

<strong>SleepCube</strong> BiLevel ST<br />

The <strong>SleepCube</strong> BiLevel ST is designed to enhance the breathing of patients with<br />

spontaneous respiration. It does not breathe for the patient but instead supports those<br />

who suffer from chronic respiratory failure, breathing difficulties or OSA. Features include<br />

a customisable trigger, real time display and a pressure range of 3 - 25 cm H 2 O.


Patient ID:<br />

Patient ID:<br />

112233<br />

112233<br />

Patient ID2<br />

Patient ID2<br />

kl12mm<br />

kl12mm<br />

First Name:<br />

First Name:<br />

Irene<br />

Irene<br />

Last Name:<br />

Last Name:<br />

Becker<br />

Becker<br />

Gender:<br />

Gender:<br />

Female<br />

Female<br />

Birth Date:<br />

Birth Date:<br />

23.09.1990<br />

23.09.1990<br />

Height:<br />

Height:<br />

1 m 70 cm<br />

70 cm<br />

Weight:<br />

Weight:<br />

60 kg<br />

60 kg<br />

BMI:<br />

BMI:<br />

20.8<br />

20.8<br />

Address 1:<br />

Address 1:<br />

Ludwigsburger Straße 5<br />

Ludwigsburger Straße Address 2:<br />

Address 2:<br />

City:<br />

City:<br />

Heppenheim<br />

Heppenheim<br />

State/Province:<br />

State/Province:<br />

Hessen<br />

Hessen<br />

Postal Code: 64626<br />

Country: Deutschland<br />

Postal Code: 10.08.2010 646268:07:34 AM - 10.08.2010 4:03:42 PM: Country: 112233 - Irene Deutschland Becker: 15.11.2010<br />

Phone Number: 064355/8383834<br />

Email Address: Irene.becker@smartlink.de<br />

Phone Number: 064355/8383834<br />

Email Address: Irene.becker@smartlink.de<br />

Time Zone:<br />

Time Zone:<br />

(GMT+01:00) Amsterdam,<br />

(GMT+01:00) Amsterdam,<br />

Berlin, Bern, Rom,<br />

Berlin, Bern, Rom,<br />

Stockholm, Wien<br />

Stockholm, Wien<br />

Time Statistics - Non-Delay Mode<br />

Time: 7.5 Hours<br />

Time: 7.5 Hours<br />

Time Statistics - Delay Mode<br />

Time:<br />

Time:<br />

0.0 Hours<br />

0.0 Hours<br />

SmartLink 2 Desktop Software<br />

Leak Statistics - Non-Delay Mode<br />

The SmartLink Therapy Management System from <strong>DeVilbiss</strong> <strong>Healthcare</strong><br />

provides a simple means of monitoring and recording CPAP usage<br />

and evaluates the effectiveness of CPAP therapy.<br />

Mask Leak Time:<br />

Average Leak:<br />

Median Leak:<br />

95th Percentile<br />

Leakage:<br />

1.3% of total<br />

30.0 L/Min<br />

24.0 L/Min<br />

60.0 L/Min<br />

Exhale Puff or EPI:<br />

Maximum Leak:<br />

90th Percentile<br />

Leakage:<br />

0.5 Per hour<br />

104.0 L/Min<br />

54.0 L/Min<br />

Main Features<br />

■■<br />

Easily tracks patients and their equipment.<br />

■■<br />

User defined study durations.<br />

■■<br />

Allows remote setting adjustment.<br />

■■<br />

Efficient workflow for setting up new patients, new devices and<br />

managing patient studies.<br />

■■<br />

Auto-detects new study data on data card and imports into the<br />

software.<br />

■■<br />

Customisable Reports – although the software comes as standard<br />

with six report templates, new report templates can be created to<br />

show and hide information as required.<br />

■■<br />

Reports can be easily exported into various formats.<br />

■■<br />

Security Options – enabling three different permission levels to be<br />

adopted;<br />

1. Read only<br />

2. Read and write<br />

3. Administrator – delete, modify reports, database functions<br />

■■<br />

SmartLink Dashboard can be customised to display features such<br />

as reminders, low adherence % and AHI notification.<br />

■■<br />

Personal Reminders can be stored in calendar view for ease of<br />

patient follow up.<br />

■■<br />

A direct connection to download patient information directly<br />

to the PC has been developed alongside the existing download<br />

facility from the data card.<br />

■■<br />

Databases can be added to local and shared networks.<br />

It is possible to import / export information from other locations<br />

or PC’s. All patient databases from previous versions of the<br />

SmartLink software can be imported and added to a new<br />

database.<br />

■■<br />

Documents can be attached directly to patient notes within the<br />

database.<br />

■■<br />

SmartCode, Remote Control Software and Oximetry Software all<br />

built in.<br />

Leak Statistics - Delay Mode<br />

Pressure Statistics - Non-Delay Mode<br />

Mask Leak Time:<br />

Average Leak:<br />

Average Pressure:<br />

Average<br />

Median<br />

Pressure:<br />

Leak:<br />

95th Percentile<br />

95th Percentile<br />

90th Percentile<br />

Pressure:<br />

Pressure:<br />

Max Pressure: Leakage:<br />

Max Pressure:<br />

0.0% of total<br />

0.0 L/Min<br />

5.0 cmH2O<br />

5.0 cmH2O<br />

0.0 L/Min<br />

5.5 cmH2O<br />

5.5 cmH2O<br />

L/Min<br />

5.9 cmH2O<br />

5.9 cmH2O<br />

Exhale Puff or EPI:<br />

Maximum Leak:<br />

Median<br />

Median 95th Percentile<br />

Pressure:<br />

Pressure:<br />

90th Percentile<br />

90th Percentile<br />

Leakage:<br />

Pressure:<br />

Pressure:<br />

0.0 Per hour<br />

0.0 L/Min<br />

5.0 cmH2O<br />

5.0 cmH2O<br />

L/Min<br />

5.0 cmH2O<br />

5.0 cmH2O<br />

1/4<br />

1/4<br />

Created<br />

Created<br />

by<br />

by<br />

<strong>DeVilbiss</strong><br />

<strong>DeVilbiss</strong><br />

SmartLink®<br />

SmartLink®<br />

Report<br />

Report<br />

Generator<br />

Generator<br />

Version<br />

Version<br />

2.2.1.0<br />

2.2.1.0<br />

10.08.2010 8:07:34 AM - 10.08.2010 4:03:42 PM: 112233 - Irene Becker: 15.11.2010<br />

2/4 Created by <strong>DeVilbiss</strong> SmartLink® Report Generator Version 2.2.1.0<br />

Mask Leak Time:<br />

Average Leak:<br />

Median Leak:<br />

90th Percentile<br />

Leakage:<br />

10.08.2010 8:07:34 AM - 10.08.2010 4:03:42 PM: 112233 - Irene Becker: 15.11.2010<br />

Leak Statistics - Non-Delay Mode<br />

Mask Leak Time:<br />

Average Leak:<br />

Median Leak:<br />

95th Percentile<br />

Leakage:<br />

1.3% of total<br />

30.0 L/Min<br />

24.0 L/Min<br />

60.0 L/Min<br />

Leak Statistics - Delay Mode<br />

0.0% of total<br />

0.0 L/Min<br />

0.0 L/Min<br />

L/Min<br />

Exhale Puff or EPI:<br />

Maximum Leak:<br />

90th Percentile<br />

Leakage:<br />

Exhale Puff or EPI:<br />

Maximum Leak:<br />

95th Percentile<br />

Leakage:<br />

0.5 Per hour<br />

104.0 L/Min<br />

54.0 L/Min<br />

0.0 Per hour<br />

0.0 L/Min<br />

L/Min<br />

AHI Statistics - Non-Delay Mode


SmartCode<br />

SmartCode is a simple and effective way to remotely track compliance<br />

data. SmartCode is an alpha-numeric code that is shown on the<br />

display of the <strong>SleepCube</strong> which provides summary data for the<br />

previous day, 7 days, 30 days, 90 days or cumulative. The SmartCode<br />

reading and an internet connection or SmartLink 2 desktop software<br />

is all that is needed to access the patients’ information. The <strong>SleepCube</strong><br />

device does not need to be directly connected to the computer, nor<br />

does it use memory cards.<br />

SmartCode is available in every model of <strong>SleepCube</strong> without any<br />

additional fees, equipment or software and provides insightful<br />

data that can be used to determine the patients’ compliance.<br />

<strong>SleepCube</strong> with SmartCode display<br />

35<br />

Apnea/Hypopnea Index<br />

35<br />

High Leak Flow Time (>95 L/Min)<br />

30<br />

30<br />

Events/Hour<br />

25<br />

20<br />

15<br />

10<br />

5<br />

5.5<br />

5.5<br />

5 5<br />

% of Time Used<br />

25<br />

20<br />

15<br />

10<br />

5<br />

10<br />

12<br />

9<br />

10<br />

0<br />

Last 90 Days Last 30 Days Last 7 Days Last Day<br />

0<br />

Last 90 Days Last 30 Days Last 7 Days Last Day<br />

35<br />

Non-Responding Event Index<br />

35<br />

Exhale Puff Index<br />

30<br />

30<br />

Events/Hour<br />

25<br />

20<br />

15<br />

10<br />

Events/Hour<br />

25<br />

20<br />

15<br />

10<br />

5<br />

1.75<br />

1.5 1<br />

0.25<br />

0<br />

Last 90 Days Last 30 Days Last 7 Days Last Day<br />

5<br />

0<br />

2 2<br />

3<br />

1<br />

Last 90 Days Last 30 Days Last 7 Days Last Day<br />

Model<br />

<strong>SleepCube</strong><br />

<strong>Standard</strong><br />

<strong>SleepCube</strong><br />

<strong>Standard</strong> Plus<br />

Optional Channels<br />

<strong>SleepCube</strong> Auto Plus<br />

<strong>SleepCube</strong> BiLevel S<br />

<strong>SleepCube</strong> BiLevel ST<br />

Parameters<br />

% of days at least 4 or 5 hours (min threshold)<br />

Day Count<br />

Days at least 4 or 5 hours<br />

Average hours per day<br />

While breathing hours<br />

As above including the following parameters:<br />

Apnoea / Hypopnoea Index – number of apnoea / hypopnoea events detected/hr<br />

Non-Responding Event Index – number of non-responding events detected/hr<br />

High Leak Flow Time – % of therapy time that the system leak was above 95 l/min<br />

EPI – Exhale Puff Index (mouth breathing)<br />

As above including the following parameters:<br />

Time at Pressure – 90th / 95th percentile pressure<br />

Pressure Plateau – percentage of time at upper pressure limit<br />

As above including the following parameters:<br />

% Machine Inspiration – the % breaths in which the Timed Backup feature has been initiated on Inspiration<br />

% Machine Expiration – the % breaths in which the Timed Backup feature has been initiated on Expiration


Features & Accessories<br />

SmartFlex – Expiratory Relief<br />

SmartFlex increases the comfort and adherence to the CPAP<br />

therapy by reducing the pressure when the patient is exhaling.<br />

SmartFlex has three settings, each of which reduces the CPAP<br />

pressure by 1 cm H 2 O during exhalation. SmartFlex can either<br />

be used for the whole night or simply during the ramp period<br />

to enable patients to fall asleep more easily. If an apnoea,<br />

hypopnoea or a snore is detected SmartFlex will turn off and<br />

will only resume once events are no longer detected. SmartFlex<br />

is available in the <strong>SleepCube</strong> <strong>Standard</strong> Plus and Auto Plus.<br />

Flow Rounding<br />

Flow Rounding is a patented technology from <strong>DeVilbiss</strong> <strong>Healthcare</strong><br />

which enables a smooth transition from inspiratory (IPAP) to<br />

expiratory pressure (EPAP). There are 6 levels of flow rounding<br />

with level 0 having the steepest slope and quickest transition<br />

and level 5 having the gentlest slope and slowest transition.<br />

By tailoring the pressure waveform (see diagram) according to<br />

the users requirements, the chances of waking the patient are<br />

reduced and comfort is increased. Flow Rounding is available in<br />

<strong>SleepCube</strong> <strong>Standard</strong> Plus, Auto Plus, BiLevel S and BiLevel ST.<br />

CPAP Pressure<br />

Flex 1<br />

Exhale<br />

Rounding<br />

1-5<br />

SmartFlex and Flow Rounding settings<br />

Inhale<br />

Rounding<br />

1-5<br />

Flex 2 Flex 3<br />

Heated Humidifier<br />

The optional heated humidifier integrates seamlessly into the<br />

<strong>SleepCube</strong> CPAP devices and offers the patient 10 heat settings<br />

to ensure maximum comfort during therapy.<br />

SmartLink Module<br />

(For Sleep Labs and Physicians only)<br />

The SmartLink module can be added to any <strong>SleepCube</strong> device<br />

increasing its capability from being a CPAP to a complete therapy<br />

management system. When attached to a <strong>SleepCube</strong> Auto Plus,<br />

up to 72 hours of detailed therapy data can be collected, giving<br />

all the parameters needed for overnight assessment or titration<br />

purposes.<br />

Optional <strong>SleepCube</strong> Heated Humidifier<br />

SmartLink Module and Software package<br />

Pulse Oximeter<br />

By adding the oximeter accessory to the <strong>SleepCube</strong>, it becomes<br />

the ideal device for conducting CPAP titrations and split night<br />

studies. A selection of different probes are available including<br />

finer probes and an ear probe. The oximetry reports are combined<br />

within the SmartLink 2 desktop software for greater ease of<br />

patient analysis.<br />

<strong>SleepCube</strong> with SmartLink Module and pulse oximeter attached


Specifications<br />

<strong>SleepCube</strong><br />

<strong>Standard</strong><br />

<strong>SleepCube</strong><br />

<strong>Standard</strong> Plus<br />

<strong>SleepCube</strong><br />

Auto Plus<br />

10.7 x 16.5 x 17.5 cm<br />

<strong>SleepCube</strong><br />

BiLevel S<br />

<strong>SleepCube</strong><br />

BiLevel ST<br />

Dimensions (H x W x L)<br />

Weight 1.2 kg 1.2 kg 1.2 kg 1.2 kg 1.2 kg<br />

Pressure Range (cm H 2 O) 3 - 20 CPAP 3 - 20 CPAP 3 - 20 CPAP 3 - 25 BiLevel 3 - 25 BiLevel<br />

Operation Modes CPAP CPAP CPAP,<br />

AutoAdjust<br />

CPAP,<br />

Spontaneous<br />

CPAP,<br />

Spontaneous,<br />

Spontaneous<br />

Timed,<br />

Timed only<br />

Operating<br />

5° C to 40° C; 0 % to 95 % R.H. non-condensing<br />

Atmospheric Conditions<br />

Sea level to 2,600 m<br />

Storage & Transportation<br />

- 40° C to + 70° C; 0 % to 95 % R.H. non-condensing<br />

Sound Level 26 dBA (tested per ISO 17510)<br />

Power Consumption<br />

Maximum 65 W from AC power source (PAP device only)<br />

Electrical Requirements<br />

100 - 240 VAC, 50/60 Hz<br />

Equipment classification with<br />

respect to protection from electric<br />

Class II<br />

shock<br />

Degree of protection from<br />

electric shock<br />

Type BF Applied Part<br />

Degree of protection<br />

against ingress of liquids<br />

IPX1<br />

Auto Altitude Adjustment 3 3 3 3 3<br />

Max. Operating Altitude ca. 2750 m 2750 m 2750 m 2600 m 2600 m<br />

Ramp Time<br />

Linear Ramp 0 - 45 in 5 min. increments<br />

Auto ON/OFF 3 3 3 3 3<br />

SmartFlex – 3 3 – –<br />

Quick.-View option – 3 3 – –<br />

Real-time Display – – – 3 3<br />

Pressure Rounding – 3 3 3 3<br />

Event Detection (AP, HYP, SN,) – 3 3 3 3<br />

Visual Mask Off Alert 3 3 3 3 3<br />

<strong>DeVilbiss</strong> <strong>Healthcare</strong> Ltd.<br />

High Street Wollaston/Stourbridge<br />

West Midlands DY8 4PS<br />

United Kingdom<br />

Phone + 44 (0) 13 84 44 68 58<br />

Fax + 44 (0) 13 84 44 66 28<br />

www.devilbisshc.com<br />

enquiries@devilbisshc.com<br />

Distributor:<br />

<strong>DeVilbiss</strong> <strong>Healthcare</strong> has a policy of continuing improvement, we therefore reserve the right to vary details<br />

at any time without notice. Porti is a registered trademark of Dr. Fenyves und Gut Deutschland GmbH.<br />

0211/2000/SO-serv/000690191.UK

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