Specifications; Declaration Of Conformity - DeVilbiss Healthcare DV5M-697 Guide D'instructions

speCIfICATIons/deClArATIon of ConforMITy

sPeCIfICaTIons

Oxygen Saturation Range (SpO
2
Pulse Rate Range .................................................................................................................................................................... 18 to 300 Pulses Per Minute
Measurement Wavelengths ...............................................................................................................................Red - 660 Nanometers @ 3 mW nominal
Accuracy
1
SpO (70-100%) (±1 SD
2
No Motion ............................................................................................................................................................................................ ±2 digits
Motion .................................................................................................................................................................................................. ±2 digits
Low Perfusion ....................................................................................................................................................................................... ±2 digits
Pulse Rate:
No Motion (18 - 300 BPM) .................................................................................................................................................................. ±3 digits
Motion (40 - 240 BPM) ........................................................................................................................................................................ ±5 digits
Low Perfusion (40 - 240 BPM) ............................................................................................................................................................. ±3 digits
SpO and Pulse Rate display update rate .....................................................................................................................................................................1 Hz
2
Temperature:
Operating ................................................................................................................................................................... 32°F to +122°F (0°C to +50°C)
Non-Operating ........................................................................................................................................................-4°F to +122°F (-20°C to +50°C)
Humidity:
Operating ............................................................................................................................................................................10 to 90% non-condensing
Non-Operating ...................................................................................................................................................................10 to 95% non-condensing
Power Draw .............................................................................................................................................................................. 60 mW - typical operation
Dimensions ................................................................................................................................................................ 2.1" x 0.8" x 0.6" (53 x 20 x 15mm)
Weight ................................................................................................................................................. 0.165 lbs. (75g) (including 6' cable and connector)
Sensors .......................................................................................................................................................................Designed to use Nonin sensors only
Equipment classification with respect to protection from electric shock................................................................................................................ Class II
Degree of protection from electric shock .........................................................................................................................................Type BF Applied Part
Warranty ................................................................................................................................................................................................... One-year limited

DeClaRaTIon of ConfoRMITy

Manufacturer: DeVilbiss Healthcare
Address: 100 DeVilbiss Drive, Somerset, PA 15501
Product Designation: CPAP Accessory
Type, Model: DV5M SmartLink Module
For DeVilbiss IntelliPAP or SleepCube CPAP
We herewith declare that the above mentioned product complies with the requirements of EC Directive 93/42/EEC and the following:
Class: IIa, Rule 2
Quality System
Standards Applied: ISO 13485:2003
Notified Body: TUV NORD
MDD: Annex II Applied
Safety Standards Applied: IEC 60601-1:1988 + A1 1995
IEC 60601-1-4:2000
ISO 14971:2000
EMC Compliance To: IEC 60601-1-2:2001
European Contact: Sunrise Medical Ltd.
High Street
Wollaston West Midlands DY8 4PS
England
44-138-444-6688
0044
All accuracy specifications are results determined by induced Hypoxia studies on healthy adult volunteers using the 8000AA Finger Clip Sensor.
1
2 Standard Deviation (SD) is a statistical measure: up to 32% of the readings may fall outside these limits.
) ....................................................................................................................................................................... 0 to 100%
):
2
Infrared - 910 Nanometers @ 3 mW nominal
A-M697
EN
5