Technical Specifications - IOPI MEDICAL 2.3 Manual Del Usuario

Technical specifications

APPLICATION
Measuring method
Indications for use
APPLIED STANDARDS
EN 60601-1, 2nd Ed.
EN 60601-1-2:2007
EN 60601-1-6:2007
ISO 14971:2009
DIMENSIONS OF IOPI® DEvICE
Height x Width x Depth
Weight
MEASURING RANGE
Pressure
ACCURACY
Pressure
POWER
Power supply
CLASSIFICATIONS
Protection against electric shock
Protection against ingress of water
Mode of operation
Device Classification
OPERATING ENvIRONMENT
Temperature
Humidity
STORAGE/TRANSPORT ENvIRONMENT
Temperature
Humidity
MANUFACTURER
EU AUThORIzED REPRESENTATIvE
AUSTRALIAN SPONSOR
Fax: +1 (425) 558-4596
Pressure in an air-filled bulb (in kPa).
Tongue and lip strength and endurance measurement
in patients with oral motor problems, including
dysphagia and dysarthria.
18 cm x 10 cm x 2.5 cm
258 g
0 to 100 kPa
±2 kPa
9V alkaline battery
According to IEC 60601-1; Type B
None
Continuous duty
hC/Canada EC - MDD TGA/Australia
FDA/US
I II
16°C to 27°C (60°F to 80°F)
10% to 83% relative humidity
-20°C to 49°C (-4°F to 120°F)
10% to 83% relative humidity
IOPI® Medical LLC
11920 198th Ave NE Redmond, WA 98053 U.S.A.
Tel: +1 (425) 549-0139 FAX: +1 (425) 558-4596
EMERGO EUROPE
Molenstraat 15, 2513 BH, The Hague, The Netherlands
EMERGO AUSTRALIA
Level 20 Tower II, Darling Park, 201 Sussex Street
Sydney, NSW 2000 Australia
I I
800-2301-02 LS3 2014.05
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