Appendix A: Specifications; Easyone-Cs Model 2001 Spirometer; Easyone-Cs Model 2010 Screen-Connector - Medizintechnik EasyOne-CS 2001 Manual Del Usuario

2030434-002 Rev. B

17 Appendix A: Specifications

17.1 EasyOne-CS Model 2001 Spirometer

Size:
Weight:
Measuring accuracy:
Measuring range:
Resistance:
Display:
Data input:
Data memory capacity:
Test types:
Parameters:
Breathing tube:
Measuring principle:
Adult normals:
Pediatric normals:
Power supply:
Power consumption:
Report format:
Storage:
Operating conditions:
Approvals:
Device classification:

17.2 EasyOne-CS Model 2010 Screen-Connector

Size:
Weight:
Power supply:
Power consumption:
Function:
Connections:
Storage:
Operating conditions:
PC:
83 x 158 x 43 mm
242 g
Volume: ±2 % or 0.050 l
Flow: ±2 % or 0.020 l/s, (apart from PEF)
PEF: ±5 % or 0.200 l/s
MVV: ±5 % or 5 l/min
Volume: ±12 l
Flow: ±16 l/s
Less than 0.3 cm H O/l/s
2
64 x 160 graphic display
14-key keypad
Up to 700 tests (in the internal memory of the EasyOne-CS)
FVC, FVL, slow VC, MVV, Pre/Post
FVC, MVV, FEV6, FEV1, FEV1/FVC, FEV1/VC, FEV1/FEV6, MEF25 (FEF75), MEF50
(FEF50), MEF75 (FEF25), MEF25%-75% (FEF25%-75%), PEF, FET, FIVC, PIF, IVC, ERV,
IRV, Pre-Post % variation, lung age
Disposable spirette™ breathing tube
Ultrasonic transit time measurement
NHANES-III, Knudson_83, Knudson_76, Crapo, Morris, ERS (ECCS/ECGS), Forche (Aus-
tria), Sapaldia (Switzerland), Roca (Spain), Berglund, Gulsvik, Hedenström, Gore,
Cherniak (for MVV only)
Dockery (Harvard), Hsu, Zapletal, Polgar, Hibbert
2 alkaline batteries, Type AA, 1.5 V
Typically 0.6 W
A4
Temperature: -20 to 50 °C, relative humidity: 5 % to 95 %,
Ambient pressure: 500 to 1060 hPa
Temperature: 0 to 40 °C, relative humidity: 5 % to 95 %,
Ambient pressure: 500 to 1060 hPa
CE Declaration of Conformity
C CSA US approval, CAN/CSA-C22.2 No. 601.1-M90, S1-94, CSA 601.1 Amendment
2:1998, UL Standard No. 2601.1.
FDA 510(k) approval, K993921.
EasyOne-CS complies with or excels the published targets of the European Respiratory
Society (ERS), the American Thoracic Society (ATS) and the National Lung Health Edu-
cation Program (NLHEP).
Application section of Type BF
In the case of operation with PC, safety class 2 in accordance with IEC/EN 60601-1
Device not suitable for use in flammable anesthetic gases in mixtures with O
64 x 44 x 25 mm
82 g
Via USB port
Typically 0.15 W
Connects the EasyOne-CS spirometer to a PC
Standard USB 1.1, Type A, connector for connection to PC
Temperature: -20 to 50 °C, relative humidity: 5 % to 95 %,
Ambient pressure: 500 to 1060 hPa
Temperature: 0 to 40 °C, relative humidity: 5 % to 95 %,
Ambient pressure: 500 to 1060 hPa
The PC must comply with the corresponding IEC Standard
(e.g. IEC 60950-1).
The user/operator must ensure that the requirements of IEC 60601-1-1 regarding
safety of medical electrical systems are complied with.
Pins: 1 = VBus, 2 = D–, 3 = D+, 4 = GND
Page 40
or NO.
2