40

10.5 Compatible accessories 10.5.1 Expiratory kits:

Single patient kit with disposable mouthpieces, 3 uses, in a box of 10 kits, reference: TUB03_EU

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 Wheeled stand (option), reference PIEDROULANT01

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_EU : 230 V AC 50 Hz The SIMEOX _EU 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.

SIMEOX_NA : 120 V AC 60 Hz

The SIMEOX_NA is designed and manufactured to operate within the supply voltage limits of -15%/+10% set by North American standards, that is 102 VAC to 132 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.