10.5 Compatible accessories

10.5.1 Expiratory kits:

Single patient kit with disposable mouthpieces, 10

uses, in a box of 10 kits, reference: TUB10_EU

Single patient kit with reusable mouthpieces, 25

uses, in a box of 10 kits, reference: TUB25_EU

10.5.2 Accessories:

Carrying bag (supplied), reference SAC01

Wrist strap (supplied), reference DRAG01

10.6 Communications

Warning! Because of its Bluetooth, Bluetooth Low

Energy and RFID components, SIMEOX can be subject

to interference from other products, even if they

comply with CISPR emission requirements.

SIMEOX uses wireless communications in the following

bands:

To communicate via Bluetooth with a tablet,

SIMEOX uses GFSK modulation for an effective

radiated power of 3mW on the band [2.400 GHz-

2.4835 GHz].

To communicate via RFID with the consumable,

SIMEOX uses ASK modulation for an effective

radiated power of 0.2512μA/m in the frequency

13.56MHz.

To communicate with its remote control, SIMEOX

uses a Bluetooth BLE interface: [2.400 GHz-

2.4835 GHz] with a bandwidth of 2MHz per

communication channel.

10.7 Stipulated environmental

conditions

SIMEOX is intended to be used: in healthcare facilities,

in medical or paramedical practices, at home.

The conditions of use are the following (SIMEOX could

not operate in accordance with its specifications if

these are not present):

Temperature limits at the place of use: +5 to +40°C

Humidity limits at the place of use: 15% to 93%

Atmospheric pressure at the place of use: 700hPa

to 1060hPa

When SIMEOX is subjected to extreme temperatures

(low or high), make sure to wait at least 4 hours

before using, to allow its components to return to a

temperature that allows for its optimal use.

10.8 Electrical characteristics

10.8.1 Supply voltages:

SIMEOX_H_EU : 230 V AC 50 Hz

The SIMEOX is designed and manufactured

to operate within the supply voltage limits of

-15%/+10% set by European standards, that is 195

VAC to 253 VAC.

10.8.2 Applied parts (according to

standard EN 60601-1):

In compliance with standard EN 60601-1.

When used at home, the patient being the user, all

accessible parts of SIMEOX are considered applied

parts.

These are Type BF applied parts.

42