Descrizione Tecnica; General Information; Intended Use - Apex XT Manual De Instrucciones

Italiano

8 Descrizione tecnica

Elemento
N. modello: 9S-006500
Requisiti di
AC100-240V, 50/60Hz, 0.6-1.2A
alimentazione:
Potenza fusibile: T2 A, 250 V CA
Riscaldatore: 25,5 x 17,5 x 5 cm (10" x 6,9" x 1,97")
Dimensioni:
Serbatoio dell'acqua: 13,6 x 15 x 10,5 cm (5,36" x 5,91" x 4,14")
Riscaldatore: sotto i 600 g (1,32 libbre)
Peso (a secco):
Serbatoio dell'acqua: sotto i 250 g (0,55 libbre)
Capacità acqua: 450 ml
Temperatura massima
della piastra del Circa 70°C (158°F)
riscaldatore:
Caduta di pressione: 0,2 cmH O @ 60 LPM
2
≥10 mgH2O/L (temperatura ambiente di 23 °C ± 2 °C, umidità relativa
Umidità in uscita:
ambiente 60% ± 15%)
Temperatura: 5℃-35℃
Ambiente operativo Umidità: 15%-95%RH
Pressione atmosferica: 609-768 mmHg
Temperatura: -15℃-50℃
Ambiente di stoccaggio Umidità: 10%-90%RH
Pressione atmosferica: 609-768 mmHg
Classe II
Tipo BF, maschera nasale delle parti applicate
Non adatto per l'utilizzo in presenza di miscele di anestetici
Classificazione
infiammabili
IPX0: Apparecchio incluso senza protezione dall'ingresso di acqua
Funzionamento continuo.
NOTA:
1. La specifica è adatta anche per altre aree operative con la stessa alimentazione elettrica.
2. Consultare il distributore o il rappresentante UE per altri documenti tecnici.
Specifiche
98
English
1. Introduction
This manual is provided to explain initial set up and operating instructions.

1.1 General Information

This system has been tested and successfully approved by the following standards.
EN60601-1
EN60601-1-2
0197
EN 61000-3-2 Class A
EN 61000-3-3
EMC Warning Statement
This equipment has been tested and found to comply with the limits for medical devices for
EN 60601-1-2: 2007. These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation. This unit generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance with the instructions, may cause
harmful interference to other devices in the vicinity. However, there is no guarantee that interference
will not occur in a particular installation. If this equipment does cause harmful interference to other
devices, which can be determined by turning the equipment off and on, the user is encouraged to try
to correct the interference by one or more of the following measures:
- Reorient or relocate the unit.
- Increase the distance between the conflicting equipment.
- Connect the unit into an outlet that is on a different circuit than the other device(s).
- Consult the manufacturer or field service technician for help.
This system has been tested and is in compliance with the following volunteer standards.
FDA

1.2 Intended use

XT Heated Humidifier is intended for use with the XT series CPAP unit. It has been designed to
increase the moisture of the air delivered from the CPAP, relieving symptoms of a dry nose and throat
that some people may experience.
NOTE: This equipment is not suitable for use in the presence of a flammable anesthetic mixture with
oxygen and/or nitrous oxide.
3