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The following example illustrates the representation of an ENDS tobacco product's identifiers and descriptors using the TO domain. Note that this example makes use of TOSCAT (Subcategory of Tobacco Prod ID Element, a permissible variable) uses TOSCAT to emphasize and differentiate the two 2 distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors.

Dataset wrap

Name	to

Dataset2

Row	STUDYID	DOMAIN	SPTOBID	TOSEQ	TOPARMCD	TOPARM	TOCAT	TOSCAT	TOVAL	TOVALU
1	TOB09	TO	VAPE-Z27	1	TBPRDCAT	Tobacco Product Category	NEW PRODUCT	PRODUCT IDENTIFIER	Electronic Nicotine Delivery Systems (ENDS) (VAPESVapes)
2	TOB09	TO	VAPE-Z27	2	TBPRSCAT	Tobacco Product Subcategory	NEW PRODUCT	PRODUCT IDENTIFIER	Closed E-Cigarette
3	TOB09	TO	VAPE-Z27	3	MANUF	Manufacturer	NEW PRODUCT	PRODUCT IDENTIFIER	Joes Vapes USA
4	TOB09	TO	VAPE-Z27	4	TRADENAM	Trade Name	NEW PRODUCT	PRODUCT IDENTIFIER	Everyday Rich Tobacco
5	TOB09	TO	VAPE-Z27	5	PACKTYP	Package Type	NEW PRODUCT	PRODUCT DESCRIPTOR	BOX
6	TOB09	TO	VAPE-Z27	6	PRDQUAN	Product Quantity	NEW PRODUCT	PRODUCT DESCRIPTOR	1	E-CIGARETTE
7	TOB09	TO	VAPE-Z27	7	LENGTH	Length	NEW PRODUCT	PRODUCT DESCRIPTOR	107.2	mm
8	TOB09	TO	VAPE-Z27	8	DIAMETER	Diameter	NEW PRODUCT	PRODUCT DESCRIPTOR	9	mm
9	TOB09	TO	VAPE-Z27	9	NICTNCNC	Nicotine Concentration	NEW PRODUCT	PRODUCT DESCRIPTOR	2	mg/L
10	TOB09	TO	VAPE-Z27	10	PRPYLGLY	Propylene Glycol	NEW PRODUCT	PRODUCT DESCRIPTOR	50	%
11	TOB09	TO	VAPE-Z27	11	VEGGLY	Vegetable Glycerin	NEW PRODUCT	PRODUCT DESCRIPTOR	50	%
12	TOB09	TO	VAPE-Z27	12	CHARFLAV	Characterizing Flavor	NEW PRODUCT	PRODUCT DESCRIPTOR	TOBACCOTobacco
13	TOB09	TO	VAPE-Z27	13	VOLUMEEELQDVOL	Volume, E- liquid Liquid Volume	NEW PRODUCT	PRODUCT DESCRIPTOR	1	mL
14	TOB09	TO	VAPE-Z27	14	WATT	Wattage	NEW PRODUCT	PRODUCT DESCRIPTOR	5.2	Watt	BATCAPC	15	TOB09	TO	VAPE-Z27	15	BATTCAPC	Battery Capacity	NEW PRODUCT	PRODUCT DESCRIPTOR	600	mAh
1615	TOB09	TO	VAPE-Z27	1615	DISPCRTGDSCRTIND	Disposable Cartridge Indicator	NEW PRODUCT	PRODUCT DESCRIPTOR	Y

The manufacturing parameter specifications of the ENDS product as intended for used are represented in the Product Design Parameters ( PD ) domain. The following example below shows the target, minimum, and maximum values associated with each of 33 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally.

Dataset wrap

Name	pd

Dataset2

Row	STUDYID	DOMAIN	SPTOBID	PDSEQ	PDPARMCD	PDPARM	PDVALTRG	PDVALMIN	PDVALMAX	PDVALU
1	TOB09	PD	VAPE-Z27	1	DRWRST	Draw Resistance	90.0	80.0	120.0	mm H2O
2	TOB09	PD	VAPE-Z27	2	PUFCNT	Puff Count	300	290	310
3	TOB09	PD	VAPE-Z27	3	CRTVOL	Cartridge Volume	3	1	5	mL
4	TOB09	PD	VAPE-Z27	4	HTELNUM	Number of Heating Elements	1	1	1
5	TOB09	PD	VAPE-Z27	5	HTELGTH	Heating Element Length	3	2.7	3.3	mm
6	TOB09	PD	VAPE-Z27	6	HTEDIAM	Heating Element Diameter	3	2.9	3.2	mm
7	TOB09	PD	VAPE-Z27	7	HTELRST	Heating Element Resistance	0.75	0.25	1.5	ohm
8	TOB09	PD	VAPE-Z27	8	HTELRNG	Heating Element Range	175	100	250	C
9	TOB09	PD	VAPE-Z27	9	HTELCFG	Heating Element Configuration	SPIRAL	SPIRAL	SPIRAL
10	TOB09	PD	VAPE-Z27	10	BTVLTORG	Battery Voltage Operating Range	4.5	3	6	V
11	TOB09	PD	VAPE-Z27	11	BTCRTORG	Battery Current Operating Range	1000	650	1600	mAh
12	TOB09	PD	VAPE-Z27	12	BATCAPC	Battery Capacity	1100	800	3000	mAh
13	TOB09	PD	VAPE-Z27	13	BATNOMV	Battery Nominal Voltage	4.2	4.0	4.5	V
14	TOB09	PD	VAPE-Z27	14	BTCRTRT	Battery Current Rating	2500	2000	2800	mA
15	TOB09	PD	VAPE-Z27	15	BTCHTPL	Battery Charging Temperature Limits	200	100	315	C
16	TOB09	PD	VAPE-Z27	16	BTDCTMPL	Battery Discharge Temperature Limits	20	-20	60	C
17	TOB09	PD	VAPE-Z27	17	BTENDCV	Battery End of Discharge Voltage	3.0	2.0	3.5	V
18	TOB09	PD	VAPE-Z27	18	BTMXCHC	Battery Maximum Charging Current	24	20	30	mA
19	TOB09	PD	VAPE-Z27	19	BTMXDCC	Battery Maximum Discharging Current	2700	2400	3000	mA
20	TOB09	PD	VAPE-Z27	20	BTULCHV	Battery Upper Limits Charging Voltage	4.2	4.1	4.3	V
21	TOB09	PD	VAPE-Z27	21	PDUVOR	PDU Voltage Operating Range	3.7	3.2	4.2	V
22	TOB09	PD	VAPE-Z27	22	PDUCOR	PDU Current Operating Range	1200	850	1800	mA
23	TOB09	PD	VAPE-Z27	23	PDUWTOR	PDU Wattage Operating Range	75	70	80	W	24	TOB09	PD	VAPE-Z27	24	PDUTCTOF	PDU Temperature Cut-off	70	55	65	C
2524	TOB09	PD	VAPE-Z27	2524	AIRFLRT	Airflow Rate	720	700	740	L/min
2625	TOB09	PD	VAPE-Z27	2625	PDUCRCOF	PDU Current Cut-off	35	20	50	mA
2726	TOB09	PD	VAPE-Z27	2726	INHAERT	Inhaled Aerosol Temperature	37	35	40	C
2827	TOB09	PD	VAPE-Z27	2827	VENTLTNVENTLTOT	Total Ventilation	50	40	60	%
2928	TOB09	PD	VAPE-Z27	2928	ELQDVISC	E-Liquid Viscosity	500	75	1130	mPa/s
3029	TOB09	PD	VAPE-Z27	3029	ELQDVOL	E-liquid Volume	60	10	120	mL
3130	TOB09	PD	VAPE-Z27	3130	PNUMCNC	Particle Number Concentration	500	108	1010	/cm3
3231	TOB09	PD	VAPE-Z27	3231	CTMDDIAM	Count Median Diameter	200	150	250	nm
3332	TOB09	PD	VAPE-Z27	3332	PM2.5	Particulate Matter 2.5	25	12	35	ug/m3

Finally, the Tobacco Product Testing ( PT ) domain is used to represent the actual results of testing the manufactured ENDS product for conformance to the tobacco product design parameters shown in PD above. PTCAT is a required Required variable and is set to "DESIGN PARAMETER TESTING" for all records here. Typically, applicants would submit data on each parameter in multiple replicates. For simplicity of review, only one 1 replicate per parameter is shown. Note that PTREPNUM (repetition number) = 1 for all rows.

Dataset wrap

Name	pt

showSummary

Dataset2

Row	STUDYID	DOMAIN	SPTOBID	PTSEQ	PTREFID	PTTESTCD	PTTEST	PTTSTCND	PTCAT	PTSCAT	PTORRES	PTORRESU	PTSTRESC	PTSTRESN	PTSTRESU	PTREPNUM

Jira

false

server

Issue Tracker (JIRA)

serverId

85506ce4-3cb3-3d91-85ee-f633aaaf4a45

key

TOBA-105

PTTPT

PTTPTNUM

1

TOB09

PT

VAPE-Z27

1

DRWRST

Draw Resistance

DESIGN PARAMETER TESTING

91

mm H2O

91

mm H2O

1

Week 01

2

TOB09

PT

VAPE-Z27

2

PUFCNT

Puff Count

DESIGN PARAMETER TESTING

309

1Week 0

		1
3	TOB09	PT	VAPE-Z27	3		CRTVOL	Cartridge Volume		DESIGN PARAMETER TESTING		3.09	mL	3.09	3.09	mL	1

Week 0

1

4

TOB09

PT

VAPE-Z27

4

HTELNUM

Number of Heating Elements

DESIGN PARAMETER TESTING

1

Week 01

5

TOB09

PT

VAPE-Z27

5

HTELGTH

Heating Element Length

DESIGN PARAMETER TESTING

2.97

mm

2.97

mm

1Week 0

	1
6	TOB09	PT	VAPE-Z27	6	HTEDIAM	Heating Element Diameter	DESIGN PARAMETER TESTING	3.05	mm	3.05	3.05	mm	1
7	TOB09	PT	VAPE-Z27	7	HTELRST	Heating Element Resistance	DESIGN PARAMETER TESTING	0.77	ohm	0.77	0.77	ohm

1Week 0

	1
8	TOB09	PT	VAPE-Z27	8		HTELRNG	Heating Element Range		DESIGN PARAMETER TESTING		174	C	174	174	C	1

Week 01

9

TOB09

PT

VAPE-Z27

9

HTELCFG

Heating Element Configuration

DESIGN PARAMETER TESTING

SPIRAL

1

Week 0

1

10

TOB09

PT

VAPE-Z27

10

BTVLTORG

Battery Voltage Operating Range

DESIGN PARAMETER TESTING

4.6

V

4.6

V

1

Week 01

11

TOB09

PT

VAPE-Z27

11

BTCRTORG

Battery Current Operating Range

DESIGN PARAMETER TESTING

997

mAh

997

mAh

1Week 0

	1
12	TOB09	PT	VAPE-Z27	12		BATCAPC	Battery Capacity		DESIGN PARAMETER TESTING		1112	mAh	1112	1112	mAh

1Week 0

	1
13	TOB09	PT	VAPE-Z27	13		BATNOMV	Battery Nominal Voltage		DESIGN PARAMETER TESTING		4.18	V	4.18	4.18	V	1

Week 0

1

14

TOB09

PT

VAPE-Z27

14

BTCRTRT

Battery Current Rating

DESIGN PARAMETER TESTING

2488

mA

2488

mA

1

Week 01

15

TOB09

PT

VAPE-Z27

15

BTCHTPL

Battery Charging Temperature Limits

DESIGN PARAMETER TESTING

198

C

198

C

1

Week 01

16

TOB09

PT

VAPE-Z27

16

BTDCTMPL

Battery Discharge Temperature Limits

DESIGN PARAMETER TESTING

19

C

19

C

1

Week 0

1

17

TOB09

PT

VAPE-Z27

17

BTENDCV

Battery End of Discharge Voltage

DESIGN PARAMETER TESTING

3.03

V

3.03

V

1

Week 0

1

18

TOB09

PT

VAPE-Z27

18

BTMXCHC

Battery Maximum Charging Current

DESIGN PARAMETER TESTING

23.5

mA

23.5

mA

1Week 0

	1
19	TOB09	PT	VAPE-Z27	19		BTMXDCC	Battery Maximum Discharging Current		DESIGN PARAMETER TESTING		2696	mA	2696	2696	mA	1

Week 01

20

TOB09

PT

VAPE-Z27

20

BTULCHV

Battery Upper Limits Charging Voltage

DESIGN PARAMETER TESTING

4.21

V

4.21

V

1

Week 01

21

TOB09

PT

VAPE-Z27

21

PDUVOR

PDU Voltage Operating Range

DESIGN PARAMETER TESTING

3.65

V

3.65

V

1

Week 01

22

TOB09

PT

VAPE-Z27

22

PDUCOR

PDU Current Operating Range

DESIGN PARAMETER TESTING

1202

mA

1202

mA

1

Week 01

23

TOB09

PT

VAPE-Z27

23

PDUWTORPDU Wattage Operating RangeDESIGN PARAMETER TESTING75W7575W1Week 0124TOB09

PTVAPE-Z272425

PDUTCTOF

PDU Temperature Cut-off

DESIGN PARAMETER TESTING

69.9

C

69.9

C

1

Week 01

24

TOB09

PT

VAPE-Z27

2526

24

AIRFLRT

Airflow Rate

DESIGN PARAMETER TESTING

727

L/min

727

L/min

1

Week 01

25

TOB09

PT

VAPE-Z27

2627

25

PDUCRCOF

PDU Current Cut-off

DESIGN PARAMETER TESTING

34.8

mA

34.8

mA

1

Week 01

26

TOB09

PT

VAPE-Z27

27

26

INHAERT

Inhaled Aerosol Temperature

DESIGN PARAMETER TESTING

36.9

C

36.9

C

1

Week 0128

27

TOB09

PT

VAPE-Z27

28

27

VENTLTN29

VENTLTOT

Total Ventilation

DESIGN PARAMETER TESTING

51

%

51

%

1

Week 01

28

TOB09

PT

VAPE-Z27

2930

28

ELQDVISC

E-Liquid Viscosity

Test performed at 20 degrees Celsius

DESIGN PARAMETER TESTING

496

mPa/s

496

mPa/s

1

Week 01

29

TOB09

PT

VAPE-Z27

3031

29

ELQDVOL

E-liquid Volume

DESIGN PARAMETER TESTING

60.1

mL

60.1

mL

1

Week 01

30

TOB09

PT

VAPE-Z27

31

30

PNUMCNC

Particle Number Concentration

DESIGN PARAMETER TESTING

511

/cm3

511

/cm3

1

Week 0132

31

TOB09

PT

VAPE-Z27

3233

31

CTMDDIAM

Count Median Diameter

DESIGN PARAMETER TESTING

202

nm

202

nm

1

Week 01

32

TOB09

PT

VAPE-Z27

33

32

PM2.5

Particulate Matter 2.5

DESIGN PARAMETER TESTING

24.4

ug/m3

24.4

ug/m3

1Week 0

1

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