Idiomas disponibles
Idiomas disponibles
Safety Standards
This product is classified as medical equipment and has been tested to
comply for the following standards:
Compliances
General Basic Safety:
Computer readable form
•
IEC 60601-1:2012, (3.1 Edition). Canada and USA national deviations:
Datamatrix barcode sample (scale 2:1)
•
CAN/CSA C22.2 No. 60601-1:2014, 3.1
•
ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/
(R)2012 and A2:2010/(R)2012 (also referred to as ANSI/AAMI
ES60601-1:2005/(R)2012)
•
21 CFR 1040 - Performance Standards for Light-Emitting Products
EMC:
•
IEC 60601-1-2:2014 - (4th Edition)
•
EN 60601-1-2:2015 - (4th Edition)
LED Safety:
•
IEC 60601- 2-57: 2011 (1st Edition)
Human readable form
$$+7A12345/16D20160812C
or
•
IEC 62471:2006 (1st Edition) including European deviations
ing pre x
itech's Labeler Identi cation Code (LIC) code provided by HIBCC
el of the device. Can only contain alphanumeric data
of measure – always zero (0)
delimiter (separating di erent data)
l number pre x
l number (6 alphanumeric characters)
delimiter (separating di erent data)
ufacture date pre x
ufacture date (YYYYMMDD)
k character (character that changes each time)
5
4
34
MN 421.012 Rev 3
REV.
0
Initial Release
Re-drawn, changed to Data Matrix code, updated/clarify MFG
1
code, changed serial number to 5 digits
2
FDA UDI requirements ECN68
Computer readable form
Datamatrix barcode sample (scale 3:1)
DESIGNED
CHECKED
ENG APPR.
MFG APPR.
Q.A.
MATERIAL
FINISH
Human readable form
THE INFORMATION CONTAINED IN THIS DRAWING IS THE SOLE PROPERTY OF MEDITECH INTERNATIONAL INC. ANY REPRODUCTION
IN PART OR AS A WHOLE WITHOUT THE WRITTEN PERMISSION OF MEDITECH INTERNATIONAL INC IS PROHIBITED.
+B271CUP0
3
/$$+7A12345/16D20160812C
Where:
+
Starting pre x
B271
Meditech's Labeler Identi cation Code (LIC) code provided by HIBCC
CUP
Model of the device. Can only contain alphanumeric data
REVISIONS
Warning Symbols and Labels
DESCRIPTION
Controller Unit
NOTES:
1. Label Stock Part Number: Zebra 10011705
(Size: 3.5" x 1.0")
(UL recgonized and ROHS compliant)
2. Text Font - Arial Narrow 6pt
3. DataMatrix - size = 0.44" x 0.44"
Model: SLD+180
*+B271SLD1800
/$$+7A12345/16D20160812C*
Meditech International Inc.
NAME
SIGN.
DATE
E. Pike
Dec.20/16
411 Horner Ave., Unit 1, Etobicoke, ON, Canada M8W4W3
DESCRIPTION:
180 Serial Number Label
DWG. NO.
SIZE
A
DW400.014
FIRST ANGLE PROJECTION
SCALE: 1:1
FILE:
180 Serial Number label.pdf
PROPRIETARY AND CONFIDENTIAL
2
DATE
APPROVED
Nov. 27, 2015
Feb. 1, 2016
Dec. 20, 2016
Consult User Manual
Refer to the User Manual for instructions.
TYPE BF APPLIED PART
This product is classified as a Type BF Applied
Part, according to the degree of protection
REVISIONS
against electric shock.
REV.
DESCRIPTION
0
Initial Release
Waste Electrical and Electronic
1
FDA UDI update
Equipment Directive
This symbol indicates that the waste of electrical
and electronic equipment must not be disposed
as unsorted municipal waste and must be
collected separately.
Model and Serial Number Label
This label shows the models and serial numbers
(S/N) of your system's components.
2
2
NOTES:
Human readable form
1. Label Stock Part Number: THT-147-422-10
*+B271CUP0
+B271CUP0
/$$+7A12345/16D20160812C*
/$$+7A12345/16D20160812C
(Size: 1.5" x 0.375")
Where:
(UL recgonized and ROHS compliant)
+
Starting pre x
B271
Meditech's Labeler Identi cation Code (LIC) code provided by HIBCC
2. Text Font - Arial Narrow 5pt
CUP
Model of the device. Can only contain alphanumeric data
Tel: (416) 251-1055 Fax: (416) 251-2446
0
Unit of measure – always zero (0)
3. DataMatrix - minimum density = 0.012
/
Data delimiter (separating di erent data)
$$+7
Serial number pre x
maximum size = 0.32" x 0.32"
A12345
Serial number
/
Data delimiter (separating di erent data)
REV
16D
Manufacture date pre x
2
20160812 Manufacture date (YYYYMMDD)
C
Check character (character that changes each time)
WEIGHT:
SHEET 1 OF 1
1
NAME
SIGN.
DATE
DESIGNED
Earon Pike
Sept. 27, 2016
CHECKED
DATE
APPROVE
Nov. 27 2015
Sept. 27 2016
Meditech International In
35
MN 421.012 Rev 3
411 Horner Ave., Unit 1, Etobicoke, ON, Canada M8W4
Tel: (416) 251-1055 Fax: (416) 251-2446
