Pág. 1 / 4
Number:
Calibration Certificate
Serial Number:
0034/09
Sealing Label:
1901509 – VentMeter Analisador de Fluxo
00038
Date:
000063
02/06/2009
General Data
Magnamed Tecnologia Médica
Addres:
R. São Paulino, 221 – Vila Mariana – São Paulo - SP
Instrument:
VentMeter – Lung Ventilator Analyzer
Model:
1901509-01
PL
Serial Number:
00038
Flow: 0 – 150 L/min
Pressure: -40 –
200 hPa
M
Range
E
Client:
1901509-NE-48-01
Calibration Date
00033
00034
02/06/2009
SA
Calibration Proceedings
Instrument Number
Proceedings
“The instrument was calibrated as to a Standard of the Quality and Calibration Sector –
Magnamed Tecnologia Médica S.A. The standard flow meter was traced together with IPT/CMF –
RBC/INMETRO according to certificate N° 93 213-101, valid until 10/03/2011. The standard pressure
gauge was traced with ABSi/ RBC-INMETRO, according to certificate N° 60768/09, valid until
26/01/2011.”
“The calibration was executed with the instrument in its position use at temperature 18,4 ±
0,5°C, relative humidity of 48,0 ± 1,5% and atmospheric pressure of 1017,7 ± 1,0 hPa, staying for 30
minutes for stability and balance of the environmental parameters.”
The presented results have restricted significance and are only applied to the tested sample. The use of this document for promotional purposes as well as its partial or total
reproduction depends on the approval in writing of the Magnamed Tecnologia Médica S.A.
MAGNAMED Tecnologia Médica S.A.
R. São Paulino, 221 – Vila Mariana – São Paulo – SP – Brazil – CEP: 04019-040
Fone: (11) 5081-4115 – Fax (11) 5081-3591 – email: [email protected]
CNPJ: 01.298.443/0001-73 - Inscrição Estadual: 149.579.528.111
Pág. 2 / 4
Number:
Calibration Certificate
Serial Number:
1901509 – VentMeter Analisador de Fluxo
0034/09
Sealing Label:
00038
Date:
000063
02/06/2009
Results
1. Calibration of Pressure Measurements (1mbar = 1hPa ≅ 1 cmH2O)
Environmental Conditions – Pressure Measurements:
Temperature: 18,4 ± 0,5 °C
Atmospheric Pressure: 1017,7 ± 1,0 hPa
-20,1
-10,2
-5,1
5,0
10,0
25,2
50,4
75,6
95,6
-20,3
-10,2
-5,1
4,9
10,0
24,8
50,3
75,6
95,6
Mean
Pressure
(cmH2O)
sx
Expanded
Uncertainty
Coverage
Factors k
-20,4
-10,2
-5,0
4,8
9,8
24,9
50,2
75,5
95,7
-20,3
-10,2
-5,1
4,9
9,9
25,0
50,3
75,5
95,7
0,07
0,03
0,03
0,06
0,06
0,11
0,05
0,06
0,06
0,15
0,06
0,07
0,11
0,11
0,21
0,09
0,11
0,11
2
2
2
2
2
2
2
2
2
PL
-20,3
-10,1
-5,0
5,0
9,9
25,1
50,3
75,4
95,8
Relative Humidity: 48,0 ± 1,5%
E
Measured Pressure (cmH2O)
Cicle 1
Cicle 2
↓
↑
↓
↑
M
Indicated
Pressure
(cmH2O)
-20
-10
-5
5
10
25
50
75
95
Date: 02 / 06 / 2009
2. Calibration of Flow Measurements
Environmental Conditions – Pressure Measurements:
Atmospheric Pressure: 1017,7 ± 1,0 hPa
SA
Temperature: 18,4 ± 0,5 °C
Date: 02 / 06 / 2009
Relative Humidity: 48,0 ± 1,5%
Neonate flow Sensor:
Indicated Flow (L.min-1)
Mean Flow (L.min-1)
sx
Expanded
Uncertainty
0,5
1
5
10
15
20
0,57
0,02
0,05
1,01
0,03
0,07
4,93
0,03
0,06
10,00
0,03
0,06
14,99
0,04
0,07
19,97
0,03
0,05
Coverage
Factors k
3,31
2,21
2,04
2
2
2
The presented results have restricted significance and are only applied to the tested sample. The use of this document for promotional purposes as well as its partial or total
reproduction depends on the approval in writing of the Magnamed Tecnologia Médica S.A.
MAGNAMED Tecnologia Médica S.A.
R. São Paulino, 221 – Vila Mariana – São Paulo – SP – Brazil – CEP: 04019-040
Fone: (11) 5081-4115 – Fax (11) 5081-3591 – email: [email protected]
CNPJ: 01.298.443/0001-73 - Inscrição Estadual: 149.579.528.111
Pág. 3 / 4
Number:
Calibration Certificate
Serial Number:
1901509 – VentMeter Analisador de Fluxo
0034/09
Sealing Label:
00038
Date:
000063
02/06/2009
Infant Flow Sensor:
Mean Flow (L.min-1)
sx
Expanded
Uncertainty
1
5
10
20
30
40
50
1,28
0,12
0,26
5,20
0,12
0,24
10,23
0,08
0,16
19,98
0,08
0,16
30,17
0,10
0,20
39,98
0,14
0,28
50,31
0,15
0,30
5
10
25
50
75
100
125
150
sx
Expanded
Uncertainty
5,26
0,26
0,52
10,11
0,10
0,21
25,16
0,27
0,53
50,16
0,16
0,31
75,20
0,44
0,88
99,30
0,36
0,72
125,10
0,61
1,22
150,77
0,44
0,88
SA
where:
Mean Flow (L.min-1)
M
Indicated Flow (L.min-1)
PL
Adult Flow Sensor:
The experimental standard deviation of the mean ( sx ) was calculated by:
sx
= Standard Deviation
Coverage
Factors k
2,21
2,04
2,01
2
2
2
2
E
Indicated Flow (L.min-1)
sx =
Coverage
Factors k
2,04
2,01
2
2
2
2
2
2
sx
n
n = repeated measurements
The expanded uncertainty was calculated by standard uncertainty multiplied coverage factors k. The
assigned expanded uncertainty corresponds a coverage probability of approximately 95%
Standards
Flow Meter: TSI Flowmeter Calibrador Padrão de Fluxo Magnamed, id n. 00033, serial number
40400842004, calibration certificate n° 93 213-101, de 10.03.2009, traced together with IPT/CMF –
RBC/INMETRO, valid until 10/03/2011.
Pressure Meter:: Digital Pressure Gauge 0 - 1600MMCA, id n. 00034, serial number 59601, calibration
certificate n° 60768/09, de 26.01.2009, traced with ABSi/ RBC-INMETRO, valid until 26/01/2011.
The presented results have restricted significance and are only applied to the tested sample. The use of this document for promotional purposes as well as its partial or total
reproduction depends on the approval in writing of the Magnamed Tecnologia Médica S.A.
MAGNAMED Tecnologia Médica S.A.
R. São Paulino, 221 – Vila Mariana – São Paulo – SP – Brazil – CEP: 04019-040
Fone: (11) 5081-4115 – Fax (11) 5081-3591 – email: [email protected]
CNPJ: 01.298.443/0001-73 - Inscrição Estadual: 149.579.528.111
Pág. 4 / 4
Number:
Calibration Certificate
Serial Number:
1901509 – VentMeter Analisador de Fluxo
0034/09
Sealing Label:
00038
Date:
000063
02/06/2009
Calibration Procedures
The VentMeter was calibrated according internal proceedings 1901509-NE-48-01 – Instruction of
Calibration (review 02). The method is based on comparation of VentMeter indicated value and the Standard
indicated value measurements
SA
M
PL
E
The flow results presented in this certificate represents the mean of three repeated measurements.
São Paulo, June 9, 2009
____________________________________
Toru Miyagi Kinjo
Eletronic Engineer
Technical Responsal
CREA n° 5061555031
The presented results have restricted significance and are only applied to the tested sample. The use of this document for promotional purposes as well as its partial or total
reproduction depends on the approval in writing of the Magnamed Tecnologia Médica S.A.
MAGNAMED Tecnologia Médica S.A.
R. São Paulino, 221 – Vila Mariana – São Paulo – SP – Brazil – CEP: 04019-040
Fone: (11) 5081-4115 – Fax (11) 5081-3591 – email: [email protected]
CNPJ: 01.298.443/0001-73 - Inscrição Estadual: 149.579.528.111