To obtain an image file, contact Technical Communication. Symbols in this chart are modified and managed using the procedure referenced in DIR 80018381. WELCH ALLYN INTERNAL SYMBOL # SYMBOL DEFINITION SUPPLIED IN DFU ISO 7000 ISO 7010 ISO 15223-1:2016 EN 60417 IEC 60878 EN 980 WELCH ALLYN (not recognized in an international standard) Other References 1 WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death. Warning symbols will appear with a grey background in a black and white document. W001 5 Warning, dangerous voltage W012 10 Warning, Hot surface W017 Safety 06 15 Caution, hot surface 5041 5041 20 Caution The caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property, or loss of data. 0434 5.4.4 0434 5.11 25 Consult Directions for Use 1641 5.4.3 1641 5.18 30 Consult directions for use (DFU). A copy of the DFU is available on this website. A printed copy of the DFU can be ordered from Welch Allyn for delivery within 7 calendar days. 35 Follow instructions/directions for use (DFU) -- mandatory action. A copy of the DFU is available on this website. A printed copy of the DFU can be ordered from Welch Allyn for delivery within 7 calendar days. 40 Mandatory - Consult Directions for Use (Do Not Use) Safety 01 45 Mandatory - Consult Directions for Use M002 50 Mandatory - Action M001 55 Fragile 0621 5.3.1 60 This way up 0623 65 Keep away from sunlight 0624 5.3.2 0624 5.20 70 Keep Dry 0626 5.3.4 5.21 75 Temperature limit 0632 5.3.7 0632 5.17.3 80 Do not re-use, Single use device 1051 5.4.2 1051 5.2 85 Recyclable 1135 1135 80022945_Ver F_Regulatory_Symbol_Matrix.xls Page 1 of 15
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Transcript
To obtain an image file, contact Technical Communication.
Symbols in this chart are modified and managed using the procedure referenced in DIR 80018381.
WELCH A
LLYN INTERNAL S
YMBOL
#
SYMBOL
DEFINIT
ION S
UPPLIED IN
DFU
ISO 70
00
ISO 70
10
ISO 15
223-
1:20
16
EN 6041
7
IEC 60
878
EN 980
WELCH A
LLYN (not r
ecognize
d in an
inte
rnat
ional
stan
dard)
Other
Ref
eren
ces
1
WARNING The warning statements in
this manual identify conditions or
practices that could lead to illness,
injury, or death. Warning symbols will
appear with a grey background in a
black and white document.W001
5 Warning, dangerous voltage
W012
10 Warning, Hot surface
W017 Safety 06
15 Caution, hot surface
5041 5041
20
Caution The caution statements in this
manual identify conditions or practices
that could result in damage to the
equipment or other property, or loss of
data. 0434 5.4.4 0434 5.11
25 Consult Directions for Use
1641 5.4.3 1641 5.18
30
Consult directions for use (DFU). A copy
of the DFU is available on this website.
A printed copy of the DFU can be
ordered from Welch Allyn for delivery
within 7 calendar days.
35
Follow instructions/directions for use
(DFU) -- mandatory action. A copy of the
DFU is available on this website. A
printed copy of the DFU can be ordered
from Welch Allyn for delivery within 7
calendar days.
40Mandatory - Consult Directions for Use
(Do Not Use)
Safety 01
45 Mandatory - Consult Directions for Use
M002
50 Mandatory - Action
M001
55 Fragile
0621 5.3.1
60 This way up
0623
65 Keep away from sunlight
0624 5.3.2 0624 5.20
70 Keep Dry
0626 5.3.4 5.21
75 Temperature limit
0632 5.3.7 0632 5.17.3
80 Do not re-use, Single use device
1051 5.4.2 1051 5.2
85 Recyclable
1135 1135
80022945_Ver F_Regulatory_Symbol_Matrix.xls Page 1 of 15
To obtain an image file, contact Technical Communication.
Symbols in this chart are modified and managed using the procedure referenced in DIR 80018381.
WELCH A
LLYN INTERNAL S
YMBOL
#
SYMBOL
DEFINIT
ION S
UPPLIED IN
DFU
ISO 70
00
ISO 70
10
ISO 15
223-
1:20
16
EN 6041
7
IEC 60
878
EN 980
WELCH A
LLYN (not r
ecognize
d in an
inte
rnat
ional
stan
dard)
Other
Ref
eren
ces
87 Discard or Recycle
90 Do not stack
2402
95 Stacking limit by number
2403
100 Lot Code
2492 5.1.5 5.4
105 Reorder Number
2493 5.1.6 5.10
110 Product Identifier
6050
115 Global Trade Item Number
120 Date of manufacture
2497 5.1.3 2497 5.6
125 Serial Number
2498 5.1.7 5.5
130 Sterile
2499 5.2.1 5.7
135 Do not use if package is damaged
2606 5.2.8 6.3
140 Use by Date
2607 5.1.4 5.3
145 Non-sterile
2609 5.2.7 5.23
150 Patient number
2610 5.7.1
155 Humidity limitation
2620 5.3.8
160 Atmospheric pressure limitation
2621 5.3.9
165Contains or presence of natural rubber
latex2725 5.4.5 6.2
170 Not made with natural rubber latex
175 Battery (schematic)
5001 5001
180 Positive polarity
5005 5005
185 Negative polarity
5006 5006
190 On
5007 5007
195 Off
5008 5008
200 Stand-By
5009 5009
80022945_Ver F_Regulatory_Symbol_Matrix.xls Page 2 of 15
To obtain an image file, contact Technical Communication.
Symbols in this chart are modified and managed using the procedure referenced in DIR 80018381.
WELCH A
LLYN INTERNAL S
YMBOL
#
SYMBOL
DEFINIT
ION S
UPPLIED IN
DFU
ISO 70
00
ISO 70
10
ISO 15
223-
1:20
16
EN 6041
7
IEC 60
878
EN 980
WELCH A
LLYN (not r
ecognize
d in an
inte
rnat
ional
stan
dard)
Other
Ref
eren
ces
205 On/Off Pushbutton
5010 5010
210 Do Not Use this Symbol
215 Fuse
5016 5016
220 Earth
5017 5017
225 Protective Earth (PE)
5019 5019
230 Chassis Ground
5020 5020
235 Equipotential Ground
5021 5021
240 Direct current (DC)
5031 5031
245 Alternating current (AC)
5032 5032
250 Rated power input, AC
6045
255 Rated power input, DC
6046
260 Input
5034 5034
265 Output
5035 5035
270 For indoor use only
5957
275 Not to be used in residential areas
5109 5109
280 Non-ionizing electromagnetic radiation
5140 5140
285 Radiation of laser apparatus
5152 5152
290 Class II equipment
5172 5172
295 Clock; time switch;timer
5184
300 ON for a part of equipment
5264 5264
305 OFF for a part of equipment
5265 5265
310Stand-by or preparatory state for a part
of equipment5266 5266
315 Alarm, general
5307 5307
320 Urgent alarm
5308 5308
325 Alarm Reset
5309 5309
80022945_Ver F_Regulatory_Symbol_Matrix.xls Page 3 of 15
To obtain an image file, contact Technical Communication.
Symbols in this chart are modified and managed using the procedure referenced in DIR 80018381.
WELCH A
LLYN INTERNAL S
YMBOL
#
SYMBOL
DEFINIT
ION S
UPPLIED IN
DFU
ISO 70
00
ISO 70
10
ISO 15
223-
1:20
16
EN 6041
7
IEC 60
878
EN 980
WELCH A
LLYN (not r
ecognize
d in an
inte
rnat
ional
stan
dard)
Other
Ref
eren
ces
330 Alarm Off
5319 5319
335 Alarm Paused
5319
340 Category AP equipment
5331 5331
345 Category APG equipment
5332 5332
350 Type B applied part
5840 5840
355 Defibrillation-proof type B applied part
5841 5841
360 Type BF applied part
5333 5333
365 Defibrillation-proof type BF applied part
5334 5334
370 Type CF applied part
5335 5335
375 Defibrillation-proof Type CF applied part
5336 5336
380 Sound muting
5436 5436
385 External cord connected
2616
390 Power plug
5534 5534
395Alternating Current power present,
battery is charging
400Alternating Current power present,
battery fully charged
405 Positioning of cell
5002 5002
410 Battery check
5546 5546
415 Rechargeable battery
5639 5639
420 Battery absent or faulty
425 Battery charge level
430 Battery
432 Battery Charging - Non-AC powered
433
Battery Charging - AC powered
435 Bell
5013 5013
440 Audio Off
5576 5576
80022945_Ver F_Regulatory_Symbol_Matrix.xls Page 4 of 15
To obtain an image file, contact Technical Communication.
Symbols in this chart are modified and managed using the procedure referenced in DIR 80018381.
WELCH A
LLYN INTERNAL S
YMBOL
#
SYMBOL
DEFINIT
ION S
UPPLIED IN
DFU
ISO 70
00
ISO 70
10
ISO 15
223-
1:20
16
EN 6041
7
IEC 60
878
EN 980
WELCH A
LLYN (not r
ecognize
d in an
inte
rnat
ional
stan
dard)
Other
Ref
eren
ces
445 Audio Paused
5576 5576
450 Caution, risk of electric shock
6042
455Caution, non-ionizing electromagnetic
radiation6166
460 Manufacturer
3082 5.1.1 5.12
465Authorized Representative in the
European Community5.1.2 5.13
470
Meets essential requirements of the
European Medical Device Directive
93/42/EC
475
Meets essential requirements of the
European Medical Device Directive
93/42/EC
480 CE Mark for Telecommunication?
485
China RoHs
Green "e" - The product does not
contain any hazardous substances.
Orange "10 or #" - The product contains
certain hazardous substances.
490
Separate collection of Electrical and
Electronic Equipment. Do not dispose
as unsorted municipal waste.
495Separate collection of batteries. Do not
dispose as unsorted municipal waste.
Battery -
component
level
497
Separate collection of batteries. Do not
dispose as unsorted municipal waste.
Contains Li-ion batteries.
500 Call for maintenance
0717
505 Do Not Use this symbol
510 Ethernet
5988
515 USB
520 Wireless signal strength
525 Nurse call N/A N/A N/A N/A N/A N/A
80022945_Ver F_Regulatory_Symbol_Matrix.xls Page 5 of 15
To obtain an image file, contact Technical Communication.
Symbols in this chart are modified and managed using the procedure referenced in DIR 80018381.
WELCH A
LLYN INTERNAL S
YMBOL
#
SYMBOL
DEFINIT
ION S
UPPLIED IN
DFU
ISO 70
00
ISO 70
10
ISO 15
223-
1:20
16
EN 6041
7
IEC 60
878
EN 980
WELCH A
LLYN (not r
ecognize
d in an
inte
rnat
ional
stan
dard)
Other
Ref
eren
ces
530Australia "C-Tick" (OLD DO NOT USE
FOR UPDATES or NEW RELEASES)
535
Australian Communications and Media
Authority (ACMA) Radio Compliance
Mark (RCM).
540Intertek Testing Laboratories Approved
(ETL)
545
Prescription only or "For Use by or on
the order of a licensed medical
professional"
550 X
555 X
560 Task Light N/A N/A N/A N/A N/A N/A X
562 Lamp; Lighting; Illumination
565 Brazilian INMETRO symbol
570 One-Tube BP Cuff
575 Two-Tube BP Cuff
580 Printer
585 Brazilian INMETRO Metrology Symbol
590Technical Regulations Conformity Certification of
Specified Radio Equipment
600 Mass in kilograms (kg)
605 Polarity of d.c. power connector 5926
610 InMetro - NCC
615 KC mark
620 FCC Logo
625 TUV Rheinland certification mark
630 Radio approval symbol for South Africa
635 Japan's PSE approval symbol for Category A
640 Japan's PSE approval symbol for Category B
645Electrical Appliance and Material Safety Law –
Japan Electrical Safety & Environment Technology
Laboratories
80022945_Ver F_Regulatory_Symbol_Matrix.xls Page 6 of 15
To obtain an image file, contact Technical Communication.
Symbols in this chart are modified and managed using the procedure referenced in DIR 80018381.
WELCH A
LLYN INTERNAL S
YMBOL
#
SYMBOL
DEFINIT
ION S
UPPLIED IN
DFU
ISO 70
00
ISO 70
10
ISO 15
223-
1:20
16
EN 6041
7
IEC 60
878
EN 980
WELCH A
LLYN (not r
ecognize
d in an
inte
rnat
ional
stan
dard)
Other
Ref
eren
ces
650Maximum safe working load limits (specific value
presented with symbol)
655Degree of protection provided by enclosure (IP
code)
660 SGS safety mark
665 Hand tighten only
670 Radio approval symbol for Serbia
675 Radio approval symbol for Ukraine
680 Radio approval symbol for Moldova
685 Radio approval symbol for Pakistan
690Warning – Intense Light – Avoid extended eye
exposure.
695 UL Certification Mark
700 UL Certification Mark
705 TISI mark
710 ETL Brazil symbol
715Verbiage may vary. Background may be yellow if
print is not black and white
720Electrical Appliance and Material Safety Law –
Intertek Testing Services
725MR Unsafe items should not enter the MRI
scanner room. Patients with MR Unsafe devices
should not be scanned.
730 Medical Device
735
Unique Device Identifier
740 Single patient multiple use 3706
80022945_Ver F_Regulatory_Symbol_Matrix.xls Page 7 of 15
To obtain an image file, contact Technical Communication.
Symbols in this chart are modified and managed using the procedure referenced in DIR 80018381.
80022945_Ver F_Regulatory_Symbol_Matrix.xls Page 8 of 15
To obtain an image file, contact Technical Communication.
Symbols in this chart are modified and managed using the procedure referenced in DIR 80018381.
80022945_Ver F_Regulatory_Symbol_Matrix.xls Page 9 of 15
To obtain an image file, contact Technical Communication.
Symbols in this chart are modified and managed using the procedure referenced in DIR 80018381.
80022945_Ver F_Regulatory_Symbol_Matrix.xls Page 10 of 15
To obtain an image file, contact Technical Communication.
Symbols in this chart are modified and managed using the procedure referenced in DIR 80018381.
80022945_Ver F_Regulatory_Symbol_Matrix.xls Page 11 of 15
To obtain an image file, contact Technical Communication.
Symbols in this chart are modified and managed using the procedure referenced in DIR 80018381.
80022945_Ver F_Regulatory_Symbol_Matrix.xls Page 12 of 15
To obtain an image file, contact Technical Communication.
Symbols in this chart are modified and managed using the procedure referenced in DIR 80018381.
80022945_Ver F_Regulatory_Symbol_Matrix.xls Page 13 of 15
To obtain an image file, contact Technical Communication.
Symbols in this chart are modified and managed using the procedure referenced in DIR 80018381.
80022945_Ver F_Regulatory_Symbol_Matrix.xls Page 14 of 15
The use of PMS Black is used as the preferred color for text, symbols, and marks. The use of
WA Cool Gray (PMS Cool Gray 5C) on background color WA Cool Light Gray, WA Medium
Gray (PMS Cool Gray 8C) on background color WA Cool Medium Gray, and Welch Allyn
Dark Blue (PMS 5405C) on background color WA Cool Blue, may be substituted for the
preferred PMS Black color, if approved by the Regulatory staff for the individual business.
This color substitution is only for symbols that do not have specific color requirements as
indicated by this Guidance and must conform to the Welch Allyn Design Language System.
The exception to any color substitution is Symbols 35 and 45, which must print in Safety Blue
(closest match is Pantone 2945C) and yellow Warning symbols 1, 5, and 10 must print in
Safety Yellow (closest match is Pantone 109C)
This is a controlled document that requires an Engineering Change Order (ECO) to make any
changes. If you need to add or edit this document, you must contact your Regulatory Affairs
Department.
All Symbols and Marks should be obtained from Technical Communication to ensure
consistency in usage across all Welch Allyn businesses.
For many of the symbols containing text, the fonts “Arial” Regular, Bold, or Narrow, "Univers"
Regular, Narrow, or Bold, or “Gotham” may be used. The exception is the CE mark, which