Download Medical electrical equipment

VICTRONIC TECHNOLOGY CORPORATION
IEC 60601-1
Clause
Requirement + Test
Result - Remark
Verdict
4.9
RM RESULTS TABLE: Use of components with high-integrity characteristics
Clause of
ISO 14971
Document Ref. in RMF
(Document No. & paragraph)
Result - Remarks
N/A
Verdict
4.2
4.3
4.4
5
6.2
6.3
6.4
6.5
4.11
TABLE: Power Input
Pass
Voltage
(V)
Frequency
(Hz)
Current
(A)
Power
(W or VA)
Power factor
(cos φ)
Maximum normal load / --
90
50
0.469
23.3
--
Maximum normal load / --
90
60
0.473
23.4
--
Maximum normal load / 1.2A
100
50
0.444
23.2
--
Maximum normal load / 1.2A
100
60
0.450
23.2
--
Maximum normal load / 0.63A
240
50
0.227
23.8
--
Maximum normal load / 0.63A
240
60
0.227
23.8
--
Maximum normal load / --
264
50
0.213
23.9
--
Maximum normal load / --
264
60
0.214
23.9
--
12 Vdc
--
1.79
21.48
--
Operating Conditions / Ratings
Maximum normal load / 4.2A
Supplementary Information:
Adapter: HITRON ELECTRONICS CORP type HEMG50-S120420-7
”MAXIMUM NORMAL LOAD” was defined as follows: LCD with max. brightness and contrast, with two
USB2.0 (two USB2.0 port total load 5W).
5.1
RM RESULTS TABLE: Type Tests
Clause of
ISO 14971
Document Ref. in RMF
(Document No. & paragraph)
4.2
‹
ONYX-BE381DT_RMF_
Version: 1.00 , Section Version Data
The RMF mention the “Intended
use/intended purpose”
Pass
4.3
‹
ONYX-BE381DT_RMF_
Version: 1.00 , Section Risk Analysis
The manufacturer had compiled a list of
known or foreseeable hazards associated
with the risk analysis of unit type.
Pass
Test Report No.: 1403042002
60601-1TRF_A
Pass
Result - Remarks
Page 120 of 197
Verdict
Issued: 25 July, 2014