Sakura M01-021E-01, Руководство по эксплуатации

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1. Introduction
15
1.4.2 Specifications
General name Paraffin-embedded block preparation system
Brand name Tissue-Tek ® TEC ™ 6 Cryo Module
Model TEC 6-CM-J0 TEC 6-CM-A1 TEC 6-CM-E2 TEC 6-CM-JC2
Product code 5105 5109 5113 5117
Manufacturing license number 20B2X00014000036 - - -
Dimensions
330 (W) × 617 (D) × 377 (H) mm
(Cold plate size:300 (W) × 370 (D))
Weight Approximately 22 kg
Rated power supply 100 VAC 50/60 Hz 3.0 A 115 VAC 60 Hz 2.0 A 230 VAC 50 Hz 1.0 A 230 VAC 50 Hz 1.0 A
Temperature
control
Heated area &
Program-mable range
-10 to 0 °C
Lowest temperature
achievable
-5°C ± 3.5°C or below
(Room temperature of 25°C, with no wind, measured at a center of the cold plate under no loaded environment)
Time to reach at a
setting -5°C
Within 30min after started to operate
(Room temperature of 25°C, with no wind, measured at a center of the cold plate under no loaded environment)
Safety device
Overcurrent protection (circuit protector)
Overload protection for compressor (overload protection relay)
Detection of fan rotation (built-in fan sensor)
Location of the Instrument Indoor use
Required
facilities
Voltage 100 VAC ±10% 115 VAC ±10% 230 VAC ±10% 230 VAC ±10%
Frequency 50/60 Hz 60 Hz 50 Hz 50 Hz
Capacity 15 A or higher 15 A or higher 10 A or higher 10 A or higher
Operating
environment
Ambient temperature 10 to 35°C
Relative humidity
30 to 85% (non-condensing)
Altitude 2,000 m or lower
Storage
environment
Ambient temperature -10 °C to 60 °C
Relative humidity
30 to 85% (non-condensing)
Overvoltage category II (2)
Transient overvoltage up to the level 1500V
Electromagnetic environment Normal electromagnetic environment
Pollution degree * 2 (*per IEC61010)
Noise* 60 dB or less (A-weighted level) (*per JIS Z8737-2:2000)
Vibration/Drop Vibration test per JIS Z 0200, JIS Z 0232
Refrigerant
Coolant Type Hydrofluorocarbon (HFC)
Coolant No. HFC-134a
GWP value 1430
Amount 110 g 105 g 105 g 105 g
Regulatory
and
applicable
standards
Law
Pharmaceutical Affairs Law FDA Class1 IVD CE Marking
EMC/LVD/RoHS Directive
CFDA
Electrical safety
evaluation
JIS C 1010-1:2014
JIS C 1010-2-101:2013
UL61010-1; 3rd ed: 2012
CSA-C22.2 No.61010-1-
2012
IEC61010-2-010:2014
IEC61010-2-101:2015
EN 61010-1-2010 GB 4793.1-2007 (IEC61010-
1:2001)
GB 4793.6-2006
(IEC61010-2-010:2005)
YY 0648-2008 (IEC61010-
2-101:2002)
Risk management
JIS T 14971:2012
IEC 62366:2007
- - -
Medical equipment
software
JIS T 2304:2017 - - -
Quality management ISO13485:2003 - - -
Electro-magnetic
compatibility
JIS C 1806-2-6:2012 - EN 61326-1:2013 GB/T 18268.1-2010
(IEC61326-1:2005)
GB/T 18268.26-2010
(IEC61326-2-6:2005)
Others - - EN 50581:2012(RoHS) -
(TEC 6-CM-A1) (TEC 6-CM-E2)