Instrumentarium Dental PaloDEx Group Oy SM Manual De Usuario
6 Technical specifications
200150 rev 3
Instrumentarium Dental
35
6.6
I
MAGE
ACQUISITION
SYSTEM
REQUIREMENTS
The Sigma M acquisition system consists of Sigma M sensor and PC
hardware. Sigma M sensor is a medical device.
hardware. Sigma M sensor is a medical device.
WARNING!
If a IEC 60950-compliant (non-medical) PC is used, it must not be
brought in to the patient environment (see Sigma M installation
manual for details).
brought in to the patient environment (see Sigma M installation
manual for details).
WARNING!
Do not bring open (unconnected) USB cable to the patient area. If the
sensor is used with USB cable in the patient area, the user must make
sure that system leakage current does not exceed IEC/ISO 60601-1-1
limits (see Sigma M installation manual for details).
sensor is used with USB cable in the patient area, the user must make
sure that system leakage current does not exceed IEC/ISO 60601-1-1
limits (see Sigma M installation manual for details).
6.5
A
MBIENT
CONDITIONS
The Sigma M unit
Transportation and storage
temperature:
Transportation and storage
temperature:
-40°...+60°C (-40F...+158F),
note battery discharge
during long storage and high
temperature
note battery discharge
during long storage and high
temperature
Operating temperature:
+10°...+40°C (+50F...+104F)
Relative humidity (storage):
10-93%
Water tightness:
IP67 (sensor)
IP21 (sensor unit)
IP21 (sensor unit)
The battery
Charge Temperature
Charge Temperature
Charge:
0°...+45°C (+32F...+113F)
0°...+45°C (+32F...+113F)
Storage Temperature and time to
prevent self discharge
prevent self discharge
1 Year at
-20°...+20°C (-4F...+68F)
3 Month at
-20°...+45°C (-4F...+113F)
1 Month at
-20°...+60°C (-4F...+140F)
-20°...+20°C (-4F...+68F)
3 Month at
-20°...+45°C (-4F...+113F)
1 Month at
-20°...+60°C (-4F...+140F)
Materials
Sensor cover
Sensor cover
PA
Sensor cable
PUR
Hygienic cover
Ethylene Methyl Acrylate
Copolymer
Copolymer
6 Technical specifications
200150 rev 3
Instrumentarium Dental
35
6.6
I
MAGE
ACQUISITION
SYSTEM
REQUIREMENTS
The Sigma M acquisition system consists of Sigma M sensor and PC
hardware. Sigma M sensor is a medical device.
hardware. Sigma M sensor is a medical device.
WARNING!
If a IEC 60950-compliant (non-medical) PC is used, it must not be
brought in to the patient environment (see Sigma M installation
manual for details).
brought in to the patient environment (see Sigma M installation
manual for details).
WARNING!
Do not bring open (unconnected) USB cable to the patient area. If the
sensor is used with USB cable in the patient area, the user must make
sure that system leakage current does not exceed IEC/ISO 60601-1-1
limits (see Sigma M installation manual for details).
sensor is used with USB cable in the patient area, the user must make
sure that system leakage current does not exceed IEC/ISO 60601-1-1
limits (see Sigma M installation manual for details).
6.5
A
MBIENT
CONDITIONS
The Sigma M unit
Transportation and storage
temperature:
Transportation and storage
temperature:
-40°...+60°C (-40F...+158F),
note battery discharge
during long storage and high
temperature
note battery discharge
during long storage and high
temperature
Operating temperature:
+10°...+40°C (+50F...+104F)
Relative humidity (storage):
10-93%
Water tightness:
IP67 (sensor)
IP21 (sensor unit)
IP21 (sensor unit)
The battery
Charge Temperature
Charge Temperature
Charge:
0°...+45°C (+32F...+113F)
0°...+45°C (+32F...+113F)
Storage Temperature and time to
prevent self discharge
prevent self discharge
1 Year at
-20°...+20°C (-4F...+68F)
3 Month at
-20°...+45°C (-4F...+113F)
1 Month at
-20°...+60°C (-4F...+140F)
-20°...+20°C (-4F...+68F)
3 Month at
-20°...+45°C (-4F...+113F)
1 Month at
-20°...+60°C (-4F...+140F)
Materials
Sensor cover
Sensor cover
PA
Sensor cable
PUR
Hygienic cover
Ethylene Methyl Acrylate
Copolymer
Copolymer
Approved
Reviewed: Anttila Mika Johannes 02.05.07 09:54:49
Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32
See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31
Approved: Levälampi Juhani Eemeli 02.05.07 12:02:32
See the PaloDEx Group Oy PDM system to determine the status of this document. Printed out: 04.05.07 12:38:31