Starck Sefam S.Box Bedienungsanleitung

2 Sefam S.Box

Manufacturer:

Manufacturing and technical service location:

SEFAM

144 AV CHARLES DE GAULLE

92200 NEUILLY SUR SEINE

FRANCE

SEFAM

10 ALLEE PELLETIER DOISY

54600 VILLERS-LES-NANCY

FRANCE

TEL: +33 (0) 3 83 44 85 00

www.Sefam-medical.com

Technical assistance:

TEL.: +33 (0) 3 83 44 85 17

E:mail: technicals[email protected]om

3 Features of the device Sefam S.Box

CONTENTS

Features of the device........................................................................................................................... 7

Heated humidification ..................................................................................................................................7

Intelligent Start...............................................................................................................................................7

Mask Fit & Go .................................................................................................................................................7

Mask unplugged ............................................................................................................................................7

Comfort Control Plus ....................................................................................................................................7

Information and settings....................................................................................................................... 9

Using the SD card........................................................................................................................................23

Cleaning and maintenance ................................................................................................................. 24

Daily................................................................................................................................................................24

Weekly ...........................................................................................................................................................24

Monthly..........................................................................................................................................................25

Disinfecting the materials ................................................................................................................... 26

Disinfecting the surface of the device .....................................................................................................26

Disinfecting the humidifier chamber (if humidifier is installed) ..........................................................26

Things never to use.....................................................................................................................................27

Troubleshooting tips............................................................................................................................ 28

Device Messages.........................................................................................................................................28

Error Messages............................................................................................................................................29

Technical characteristics.................................................................................................................... 30

Performance of the device ........................................................................................................................30

Humidifier performance .............................................................................................................................30

Conditions of use.........................................................................................................................................31

Transport and storing conditions.............................................................................................................31

Electrical characteristics ............................................................................................................................31

Physical characteristics .............................................................................................................................32

Definition of symbols..................................................................................................................................32

CE marking ...................................................................................................................................................33

Regulatory Requirements ..........................................................................................................................33

End of life disposal of the device..............................................................................................................33

Electromagnetic Compatibility..................................................................................................................34

Special characteristics according to the standard NF EN ISO 17510-1:2009 .................................35

Functional diagram of the internal pneumatic circuit...........................................................................37

Maintenance......................................................................................................................................... 38

Disassembly instructions...........................................................................................................................39

Assembly instructions ................................................................................................................................45

Pressure Verification...................................................................................................................................54

Spare parts....................................................................................................................................................55

4 Features of the device Sefam S.Box

Before you start

This user guide is intended for Physicians & Home Care Providers. Under no condition should it be

given to patients.

Safety guidelines

WARNING:

It means that there is a possibility of danger risk of injuries or accident

to patient.

Please take note of the safety measures indicated in the SEFAM S.Box®Patient Manual.

See Patient Manual for instructions on how to install, maintain and store the device.

It is imperative that each patient is provided with the Patient Manual as well as the accessory use

instructions.

Use this device only with the authorized accessories listed in this manual.

To ensure proper maintenance, and to avoid all possible damages, only qualified and trained personnel is

authorized to perform maintenance work or authorized modifications on the device. The User takes full

responsibilities for any dysfunction of the device caused by any maintenance done by any unauthorized

person.

Do not begin treatment if you detect an anomaly with the device.

Never use the device before making sure that the Air inlet filter is installed.

WARNING: It is advisable not to use portable RF communicating devices (including peripherals, such as

antenna cables as well as external antennas) closer than 30 cm (12 inches) from all parts of the SEFAM

S.Box®device. This also includes the specified cables by the manufacturer. Should the opposite happen,

the performance of these devices could be altered.

In case the device is equipped with a heated humidifier:

The side cover must be removed and replaced by the humidifier that includes the heater plate and

humidifier chamber.

Precaution must be taken by the patient while using the humidifier chamber in order to prevent any risk of

water entering the machine, which can cause irreversible damage. For this purpose, the device must be

placed on a horizontal and stable surface, and not in a tilted position.

The humidifier chamber should always be emptied before moving it with the device or transporting it.

CAUTION:

It means that there is a possibility of material damage to the device or

others.

As this device is an electrical medical device, during its installation, please follow and respect all

instructions concerning the electromagnetic compatibility, as indicated in this manual.

Like all electrical medical devices, the device could experience interferences and disturbances from mobile

or wireless radiofrequency communication equipment (Wi-Fi, cell phones or mobile phones…).

Recommended use

The SEFAM S.Box®is designed for the treatment of Obstructive Sleep Apnea–Hypopnoea Syndrome

(OSAHS) in patients over 30 kg, breathing spontaneously. This device is not intended to provide

assistance to vital functions. It can be used at home or in healthcare centers (hospital or clinics). It is

also designed for hassle free travelling and can be used on airplanes.

The S.Box heated humidifier is an accessory designed to warm and add moisture to the air flow

delivered to the patient by the SEFAM S.Box device, for the treatment of Obstructive Sleep Apnea–

Hypopnoea Syndrome (OSAHS). It is intended for use by adult patients in either the homecare or the

hospital environment.

Sefam S.Box Features of the device 5

NOTE: The EMISSION characteristics of this device allows the machine to be used in industrial zones

and in healthcare centres (class A defined in the CISPR 11). When it is used in a residential area

(class B defined in the CISPR 11 is normally required), this device may not provide enough protection

for communication services with radio frequencies. Users may have to take certain measures, such

as the repositioning or the reorientation of the device in order to correct for this.

Contra-indications

Studies have shown that using positive pressure can be contraindicated in certain patients with one

of these pre-existing medical conditions:

Severe bullous emphysema

Pneumothorax

Pneumocephalus, trauma or recent surgery with sequela of cranio-nasopharyngeal fistula.

Decompensated cardiac insufficiency or hypotension, particularly in case of decreased blood

volume or cardiac arrhythmia

Dehydratation

Tracheotomy.

Furthermore, due to the fact that positive pressure affects the cardiac output in certain heart failure

patients, it is recommended that patient blood pressure and heart rate are carefully monitored when

starting treatment at an effective pressure. The risks and benefits of treatment by Continuous

Positive Airway Pressure must be individually evaluated in such subjects. This evaluation must take

into account the fact that the device can be adjusted to deliver pressures up to 20 cm H2O, and under

certain defect conditions, static pressures up to 40 cm H2O are possible. The device must not be

used then, if such pressure level presents a risk to the patient.

Essential performance of the device

The essential performance of the SEFAM S.Box®is to deliver a pressure equivalent to that of the

adjusted pressure ± 0.5 cm H2O.

The device was designed to maintain basic safety and essential performance without maintenance

regarding electromagnetic disturbance during the lifetime of the machine. However, in case of failure

the device has to be repaired by authorized persons who will use original parts only.

6 Features of the device Sefam S.Box

List of authorized accessories

The SEFAM S.Box®product can be used with the following optional accessories:

Description

Reference

SEFAM S.Box

M-116412

S.Box®heated humidifier

M-216430-06

S.Box®humidifier chamber

M-216430-15

Oximeter 3150

3150-0201

Connectivity:

S.Box®modem

M-116500

S.Box®WIFI module

M-116900

Tubings:

S.Box®heated tube

M-216430-07

S.Box®Ø 15 mm standard tube

M-261000-05

S.Box®Ø 22 mm standard tube

M-261000-06

Travel accessories:

S.Box®carrying bag

M-816405-00

SEFAM S.Box®by Starck carrying case

M-816405-01

S.Box®cigarette cable (24 VDC-5 m)

M-216430-08

Machine data analysis:

SEFAM Analyze Software

M-215630-04

S.Box®SD card

M-216430-05

S.Box®USB cable

M-216430-09

Divers:

Inlet air filters (50 pcs)

M-315940-01

S.Box®Power supply

M-416410-00

WARNINGS:

Use only the authorized accessories given in the list above or compliant with the standard

EN ISO 17510-2:2007.

Only connect the USB authorized cable to the USB connector. The SEFAM S.Box®should not be used if

connected via USB to an unauthorized device.

Use only those accessories which can guarantee the patient’s treatment pressure and reduce the re-

breathing of CO2. When a full face mask is necessary, always use a mask which is equipped with an anti-

asphyxia valve to maintain spontaneous breathing.

WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because

it could result in improper operation. If such use is necessary, this equipment and the other equipment

should be observed to verify that they are operating normally.

WARNING: Use of accessories, transducers and cables other than those specified or provided by the

manufacturer of this equipment could result in increased electromagnetic emissions or decreased

electromagnetic immunity of this equipment and result in improper operation.

Sefam S.Box Features of the device 7

Features of the device

The SEFAM S.Box®can operate either in constant mode (CPAP), it then delivers a constant pressure

level, or automatic mode (Auto-CPAP) where the pressure changes between a minimum pressure

and a maximum pressure depending on the detected respiratory events. When selected, the AUTO-

CPAP mode will be activated 5 minutes after starting treatment.

Heated humidification

This function allows to control the power supplied to the heater plate depending on the air flow, and

to regulate the heating power to maintain the difference in temperature between the water and the air

constant. The device is delivered with an installed side cover and depending on the selected

configuration, it may be delivered with a heated humidifier which needs installing. In this case, the

side cover must be removed from the device and replaced by the humidifier including the heater plate

and the humidifier chamber (refer to the patient manual for the setup). The presence of the

humidification system is automatically detected by the machine and the heated humidification

function starts and stops simultaneously with the device.

Intelligent Start

This feature permits the patient to start the treatment automatically at the first breathings in the

mask, without using the start / standby button . It can be activated or deactivated by following

the instructions of paragraph ”1. Setting menu” page 19.

Mask Fit & Go

Before starting the treatment and when the device is in standby mode, the patient can check the air

tightness of his/her mask by using the touch button . The level of unintentional leak is displayed

and in case of undesired leak, the patient can adjust his/her mask.

Mask unplugged

When the patient removes his mask, the device automatically switches to low power. The machine

will restore normal power when the mask is reconnected (pressure delivered above 3 cm H2O) or if

the start / standby button or the ramp button is pressed. If the mask is unplugged for more

than 5 minutes, the compliance session is stopped and recorded, and the device will automatically

turn off after 30 minutes.

Note:

If the patient uses a resistive interface (nasal pillows mask), a specific calibration of the pneumatic

configuration may be performed so that the device can detect that the mask is unplugged (Ciruit Select

function).

Comfort Control Plus

The Comfort Control Plus CC+ is intended to increase the treatment pressure while inhaling and to

decrease it while exhaling to make the patient's breathing more comfortable during the treatment. It

can be activated during the ramp or the treatment. In both cases, three levels are available in order to

get an optimal comfort.

8 Features of the device Sefam S.Box

Ramp function

The ramp function makes it possible to gradually increase the pressure to help the patient fall asleep.

If it is activated, it starts automatically when the device is switched on (if the ramp time is different

than zero). Pressing the ramp button deactivates (and by pressing again reactivates) this

function. There are two types of ramp:

T RAMP Time ramp: you can determine the ramp time

I RAMP Intelligent ramp: the ramp time is automatically determined by the device.

Time ramp

In CPAP mode, the treatment begins at a reduced pressure called Ramp pressure (ramp start

pressure), and then the pressure rises up to the prescribed pressure (during the ramp time). If the

T Ramp function is deactivated, the pressure increases immediately to the prescribed pressure.

In AUTO-CPAP mode, this function is used to delay the activation of automatic operation (during the

latency or ramp time). In the case where the Ramp pressure (ramp start pressure) is less than the

minimum pressure, a progressive increase in pressure will be done from the Ramp pressure to the

minimum pressure. If the function is deactivated, the pressure remains at the Ramp pressure within

the first 5 minutes of treatment and then switches to automatic operation.

T Ramp function in CPAP mode

T Ramp function in Auto-CPAP mode

The symbol is displayed in the status bar and you can adjust the Ramp pressure, the ramp time

or latency time and the maximum ramp time (if the Ramp pressure is below the prescribed pressure).

Intelligent ramp

The I Ramp function permits the beginning of the treatment at an adjustable Ramp pressure (ramp

start pressure), then a faster increase pressure in the CPAP mode or the activation of the automatic

operation in the Auto-CPAP mode as soon as the device starts to detect respiratory events indicating

that the patient has fallen asleep.

The symbol is displayed in the status bar. The I Ramp stops automatically when the maximum

ramp time bas been reached (45 minutes).

Sefam S.Box Information and settings 9

Information and settings

The adjustment of the therapeutic pressure must be determined by the prescribing physician for

each patient individually, with the configuration of the equipment to be used, including the

accessories. The correct installation and positioning of the patient interface are critical to the proper

operation of the device.

WARNING:

Before setting the device, confirm that the product delivers an air flow when it is in operation mode. Otherwise,

stop the machine immediately and contact the technical support.

Settings are accessible directly on the interface of the device, via a Bluetooth connection (tablets/cell

phones apps), via a configured SD card or remotely through S.Box®Wi-Fi module or S.Box®modem.

You can also adjust the device with the SEFAM Analyze software, by connecting the machine to a

computer with a USB cable or a wireless connection.

CAUTION:

The USB connection inhibits automatically any Bluetooth communication.

The most recent compliance data are recorded by sessions in the device memory and on the SD card

up to one year for 8 hours of operation per day. They can also be retrieved by wired or wireless

connection with the PC software, on the SD card or by modem. Using SEFAM Analyze, you can

analyze the compliance data, the use of the device by the patient and the treatment efficiency.

Definitions

Bluetooth, BLE

(Bluetooth Low Energy):

low-power, short-range wireless communications technology for

connecting devices.

Device hour counter:

device operating time.

Usage hour counter:

total time during which the patient has effectively breathed in the mask

(treatment time minus the time when the mask was removed and the

time with no respiration).

Ramp pressure (ramp

start pressure):

level of pressure produced by the device at the beginning of the ramp

function to help the patient fall asleep comfortably. In Auto-CPAP

mode, the pressure is reset to the Ramp pressure or the minimum

pressure (if the Ramp pressure is lower than the minimum pressure)

when no breathing cycle is detected for more than 2 minutes.

Maximum pressure:

maximum pressure that the device can deliver in Auto-CPAP mode.

Minimum pressure:

minimum pressure that the device can deliver in Auto-CPAP mode.

Prescribed pressure:

level of pressure prescribed for the patient.

Humidifier chamber:

chamber containing the water necessary for humidification.

Session:

period during which data is recorded to memory between the time the

device starts operation and the time the device goes into standby.

Heating time:

time needed for the device to reach the operating level required by the

heated humidification feature.

Ramp time:

time taken by the device to reach the prescribed pressure from the

Ramp pressure in CPAP mode or to activate the Auto-CPAP feature

when the time ramp is enabled.

Maximum ramp time:

parameter accessible only by the home care provider which restricts

10 Information and settings Sefam S.Box

the maximum value of the ramp time adjustable by the patient when

the ramp is activated.

3G:

wireless mobile telecommunication technology for connecting

electronic devices.

Wi-Fi:

high-speed wireless transmission technology for connecting electronic

devices to one another.

Settings ranges

The following tables indicate the operating mode of the device, the default value, the minimum and

maximum values that can be set for each parameter, and the available functions.

Operating mode:

Parameter

Display

By default

Operating mode

CPAP

APAP

(Auto-CPAP)

APAP

(Auto-CPAP)

Adjustable parameters:

Parameter

Minimum

value

Maximum

value

Value by

default

Increment

Humidification level (if the

humidifier is installed)

OFF

Heating power of the heated

tube (if installed)

OFF

AUTO (with humid.)

01 (without humid.)

Mask select: theoretical leak

in the mask at 12.0 cm H2O

20 l/min

(Type:A)

60 l/min

30 l/min

(Type:B)

2 l/min

Ramp time

(if T Ramp is selected)

OFF

Maximum

ramp time

15 min

5 min

Maximum ramp time

(if T Ramp is selected)

OFF

45 min

5 min

Brightness of the display

In CPAP mode:

Set pressure

4 cm H2O

20 cm H2O

8 cm H2O

0.5 cm H2O

Ramp pressure (ramp start

pressure)

4 cm H2O

Prescribed pressure

4 cm H2O

0.5 cm H2O

In Auto-CPAP mode:

Ramp pressure (ramp start

pressure)

4 cm H2O

Maximum

set pressure

4 cm H2O

0.5 cm H2O

Maximum pressure

4 cm H2O or

minimum pressure

20 cm H2O

0.5 cm H2O

Minimum pressure

4 cm H2O

20 cm H2O or

maximum pressure

4 cm H2O

0.5 cm H2O

The device is switched on by holding down the start / standby button . If the heated humidifier is

installed, it switches on automatically if the humidification level is set between 01 to 10.

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