MEDTRUM TECHNOLOGIES TY015 Transmitter User Manual Rev1

MEDTRUM TECHNOLOGIES Inc. Transmitter Rev1

User Manual Rev1

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S6#EasySense# #
Disposable#CGM#System#
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Medtrum#Technologies#Inc.##
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Contents#
Contents#....................................................................#0!
Introduction#...............................................................#0!
Before#You#Begin#...................................................#0!
Indications#............................................................#0!
Contraindications#..................................................#1!
User#Safety#............................................................#1!
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&$6$%D8!;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;!-!
`P$%D1(69!3$2P$%D1'%$!CD69$!;;;;;;;;;;;;;;;;;;;;;;;!F!
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aJ%DV#/!0C:#!D6)!G3!E4D6#!;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;!K!
G76#'2DQ8$#!;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;!.!
CD)(7!?%$b'$64V!RC?T!G722'6(4D1(76!;;;;;;;;;;;;;;;;!.!
_D1$%!;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;!>!
E17%D9$!;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;!A!
Warranty#Information#...........................................#9!
Basics#of#the#S6#EasySense#System#............................#12!
How#the#S6#EasySense#System#Works#...................#12!
Key#Features#of#the#S6#EasySense#System#.............#14!
>J)DV!E$6#7%!;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;!-K!
07Q(8$!<PP!076(17%(69!;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;!-.!
C$47%)$%!U7%!O$D8154D%$!]%7=()$%#!;;;;;;;;;;;;;;;;;;;;!-.!
How#to#Change#the#Sensor#........................................#17!
Remove#the#Current#Sensor#and#Disconnect#the#
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Transmitter#..........................................................#17!
Insert#a#New#Sensor#.............................................#19!
E$8$41!D6!:6#$%1(76!E(1$!;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;!-M!
]%$PD%$!15$!:6#$%1(76!E(1$!;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;!+,!
C$27=$!15$!&8'47#$!E$6#7%!U%72!15$!]D4cD9$!;!+-!
C$27=$!15$!]%71$41(=$!d(6$%!U%72!15$!E$6#7%!
E'PP7%1!07'61!;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;!++!
d74D1$!15$!E$6#7%!E'PP7%1!07'61!;;;;;;;;;;;;;;;;;;;;;!++!
C$27=$!15$!EDU$1V!d74c!;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;!+F!
:6#$%1!E$6#7%!;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;!+K!
C$27=$!:6#$%1$%!;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;!+.!
G5$4c!15$!E$6#7%!E'PP7%1!07'61!;;;;;;;;;;;;;;;;;;;;;;!+I!
W(#4D%)!15$!E$6#7%!:6#$%1$%!EDU$8V!;;;;;;;;;;;;;;;;;;;;;!+I!
Attach#Your#Transmitter#.......................................#27!
3DP$!15$!E$6#7%!E'PP7%1!07'61!R`P1(76D8T!;;;;;;!+A!
How#to#Use#Medtrum#EasyTouch#Mobile#App#...........#30!
Install#the#App#......................................................#30!
Login/Register#......................................................#32!
Connect#Transmitter#With#App#.............................#33!
Monitor#Sensor#Status#..........................................#36!
Calibrate#Your#Sensor#...........................................#41!
Sensor#Trend#Graph#.............................................#42!
Understand#the#Statistics#.....................................#45!
E$6#7%!`=$%8DV!;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;!KI!
3%$6)!<6D8V#(#!;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;!K>!
E&!W(#1%(Q'1(76!;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;!KA!
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S=$61!W(#1%(Q'1(76!;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;!KM!
d79!E'22D%V!;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;!.,!
Enter#the#Logs#......................................................#52!
Set#Your#Reminders#..............................................#59!
Customize#Your#Settings#.......................................#61!
G&0!EV#1$2!E$11(69#!;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;!I+!
<8$%1!E$11(69#!;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;!I+!
E1D1(#1(4#!E$11(69#!;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;!IK!
&$6$%D8!E$11(69#!;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;!II!
Remote#Viewing#...................................................#67!
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Safety#System#and#Alerts#......................................#72!
d(#1!7U!<8$%1#!;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;!>+!
Manufacturer’s#Declaration#......................................#78!
Electromagnetic#Emissions#...................................#78!
Electromagnetic#Immunity#...................................#79!
Appendix#I:#Symbols#and#Icons#..................................#80!
Product#Label#Symbols#.........................................#80!
Appendix#II:#Specifications#........................................#84!
Transmitter#Specifications#....................................#84!
Glucose#Sensor#Specifications#..............................#85!
CGM#System#Accuracy#..........................................#85!
Glossary#....................................................................#87!
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Introduction#
Before#You#Begin#
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Indications#
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Contraindications#
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User#Safety#
Warnings#and#Precautions#
General#
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X_rays,#MRIs#and#CT#Scans#
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Consumables#
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Please take attention that changes or modification not expressly
approved by the party responsible for compliance could void
user’s authority to operate the equipment
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GLUCOSE ALERTS
High Glucose
Low Glucose
Glucose Alert Limits
00:15
00:15
Glucose Limits for Statistics
4.0 mg/dL/min
ALERT SETTINGS
High Predicted
Low Predicted
Rapid Rise
Rapid Fall
STATISTICS SETTINGS
Time Segments
4.0 mg/dL/min
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NORMAL
CAL 90%
2D 22H 40M left
90 mg/dL
19:00 Today
24h
Calibration Button Transmitter Signal
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Log#Summary#
O$%$! #57N#! 15$! 879! #'22D%V! (6! D! 9(=$6! P$%(7);!
Event Distribution
14 D 30 D 90 D More7 D
Mon, 24/08/15
HIGH GLUCOSE 12345
# of high (percentage)
1 (10%)
2 (20%)
3 (30%)
4 (40%)
Basal Decrease
Dawn Phenomenon
High Preceding Low
Bolus with Rising
Glucose
LOW GLUCOSE 12345
# of low (percentage)
1 (10%)
3 (30%)
4 (40%)
Basal Increase
Multiple Boluses
Delivery Suspend
1 (10%)
1 (10%)
Nocturnal Hypo
Bolus with Falling
Glucose
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Settings
CGM System
Insulin Pump
General
Account Security
About Us
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CGM#System#Settings#
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Alert#Settings#
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CGM System
CGM System
Add Transmitter
GLUCOSE ALERTS
High Glucose
Low Glucose
Glucose Alert Limits
00:15
00:15
Glucose Limits for Statistics
4.0 mg/dL/min
ALERT SETTINGS
High Predicted
Low Predicted
Rapid Rise
Rapid Fall
STATISTICS SETTINGS
Time Segments
4.0 mg/dL/min
!
IF!
!
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Glucose Alert Limits
High Glucose
Start - End
Low Glucose
High Limit Low Limit
0:00-24:00
Add Time Segment
13.3 4.4
(mmol/L)
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Statistics#Settings#
Glucose# Limits# (for# Statistics)\! 35$#$! =D8'$#! D%$!
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Event# Distribution;!Z7'! 4D6!#$1!)(UU$%$61!98'47#$!
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Time#Segments\! !
-; 0$D8!E1D%1!3(2$!E$11(69#\!E$1!15$!P$%(7)#!N(15(6!
N5(45!Breakfast/!Lunch/!D6)!Dinner##1D%1#;!SD45!
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F; B(951!E$11(69#\!E$1!15$!#1D%1!D6)!$6)!1(2$!7U!
6(951;! !
Glucose Limits for Statistics
High Limit Low Limit
Before Breakfast 7.8 4.4
(mmol/L)
After Breakfast 13.3 4.4
Before Lunch 7.8 4.4
After Lunch 13.3 4.4
Before Dinner 7.8 4.4
After Dinner 13.3 4.4
!
II!
!
!
General#Settings#
Z7'! 4D6! #$8$41! D! )(#P8DV! 8D69'D9$/!1'%6! 76X7UU!
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Vibrate!76;!:U!V7'!1'%6!15$2!Q715!7UU/!V7'!2(951!
Time Segments
Breakfast 07:00 08:00
Lunch 11:30 12:00
Dinner 18:00 19:00
MEAL START SETTINGS
The period before meal is fixed to 1h.
AFTER MEAL SETTINGS
After
Breakfast 44min 1h55min
After
Lunch 1h 3h
After
Dinner
to
to
1h 3hto
NIGHT SETTINGS Start End
Night 23:00 06:00
to
to
to
!
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!
2(##!D6!D8$%1XD8D%2;!
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Remote#Viewing#
Remote#View#Other#Accounts#
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#4%$$6;!
General
Language
Audio
Vibrate
Snooze 00:20
English
AUDIO OPTIONS
UNIT SETTINGS
Glucose
Weight
Height
mg/dL mmol/L
cm feet
kg stlb
!
IA!
!
3DP!15$!#N(145!17!1'%6!76!Remote#View;!3DP!Add#
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Patient 1
Patient 2
Disconnect
Connect
Add Account
Account
Enter the account you want to remote
view.
Apply to remote view
!
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!
Allow#Others#to#Remote#View#Your#Account#
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Account Security
Username
Password
Passcode Lock
User288
Remote View Permission
Logout
!
>,!
!
!
Remote View Permission
Family1
Family 3
Edit
Delete
!
>-!
!
!
>+!
!
!
Safety#System#and#Alerts#
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List#of#Alerts#
Condition#
App#Message#
Actions#to#Take#
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98'47#$;!
Note\! _5$6! Transmitter#Error!744'%#/! 15$!
(6)(4D17%!8(951!76!15$!3%D6#2(11$%!U8D#5$#!%$);!
!
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!
#
Manufacturer’s#Declaration#
35$! EI! SD#VE$6#$! W(#P7#DQ8$! G&0! #V#1$2!
R476#(#1(69! 7U! 0WJ3ZJ,-.! 3%D6#2(11$%!D6)!
0WJ^ZJ,,I!&8'47#$!E$6#7%T!(#!(61$6)$)!U7%!'#$!(6!
15$!$8$41%72D96$1(4!$6=(%762$61!#P$4(U($)!Q$87N;!
35$! 4'#172$%! 7%! 15$! '#$%! 7U! 15$! G&0!EV#1$2!
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$6=(%762$61;!
Electromagnetic#Emissions#
Emissions#Test#
Compliance#
C?!$2(##(76#!
SB! I,I,-J-J+\+,,>H<G\+,-,/! :SG!
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Electromagnetic#Immunity#
Immunity#Test#
IEC#60601#
Test#Level#
Compliance#
Level#
S8$41%7#1D1(4!
)(#45D%9$!RSEWT!
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Appendix#I:#Symbols#and#Icons#
Product#Label#Symbols#
Symbol#
Meaning#
!
d71!6'2Q$%!
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C$U$%$64$!6'2Q$%!
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LOT
REF
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GD'1(76\!E$$!:6#1%'41(76#!
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2
REPEC
0197
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Appendix#II:#Specifications#
Transmitter#Specifications#
Model\!0WJ3ZJ,-.!
Size\!FI;-!22!L!-M;K!22!L!-+!22!
Weight\!K;A!9!
Operating#Temperature#Range\!H.hG!rHK,hG!
Operating#Relative#Humidity#Range\!+,krM,kCO!
Operating#Atmospheric#Pressure\!>,,r-,I,!5]D!
Storage#Temperature#Range\!J-,hGrH..hG!
Storage#Relative#Humidity#Range\!+,krM,kCO!
Storage#Atmospheric#Pressure\!>,,r-,I,!5]D!
Battery\!@'(81J(6!F;,![!Q'1176!4$88!QD11$%V!
Waterproof#Rating\!:]aA!R+;.!2/!-!57'%T!
Category\! 3VP$! @?! $b'(P2$61/! G761(6'7'#!
7P$%D1(76!
Data# Storage\! <'172D1(4D88V!#17%$#! 15$! P%$=(7'#!
-.!)DV#g!)D1D!
Wireless#Communication#Distance\!-,!2!
Duration#of#Use\!K!#$6#7%!#$##(76#!
Limited#Warranty\!-!V$D%!
!
A.!
!
!
Glucose#Sensor#Specifications#
Model\!0WJ^ZJ,,I!
Storage#Temperature#Range\!H+hG!rHF,hG!
Storage#Relative#Humidity#Range\!+,krM,kCO!
Storage#Atmospheric#Pressure\!>,,r-,I,!5]D!
Glucose#Range\!+;+r++;+!2278Xd!RK,rK,,!29X)dT!
Sterilization#Method\!@V!%D)(D1(76!
Sensor#Life\!"P!17!>!)DV#!
!
!
CGM#System#Accuracy#
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Glossary#
App#
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AUC#
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BG#
<QQ%$=(D1(76! U7%! Q877)! 98'47#$;!
E$$!Blood%Glucose;!
Blood#
Glucose#
(BG)#
35$!D27'61!7U!98'47#$!P%$#$61!(6!
15$!Q877);!
Calibration#
35$! P%74$##! 7U! '#(69! D! 2$1$%!
Q877)! 98'47#$! %$D)(69! 17!
4D84'8D1$!#$6#7%!98'47#$!=D8'$#;!
Carb#
35$!472P8$L!4D%Q75V)%D1$!#1D%45!
!
AA!
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7%! #(2P8$! 4D%Q75V)%D1$#/! #'45! D#!
#'9D%;!
Continuous#
Glucose#
Monitoring#
(CGM)#
<! E$6#7%!(#! (6#$%1$)! '6)$%! 15$!
#c(6! 17! 45$4c! 98'47#$! 8$=$8#! (6!
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#$6)#! #$6#7%! 98'47#$! %$D)(69#! 17!
D!)(#P8DV!)$=(4$;!
Glucose#
Limits#for#
Alerts#
35$! =D8'$#! V7'! #$1! 17! )$1$%2(6$!
N5$6!15$!#V#1$2!N(88!D8$%1!V7'!7U!
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476)(1(76;!
Glucose#
Limits#for#
Statistics#
35$! =D8'$#! V7'! #$1! 17! )(#1(69'(#5!
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High#Limit#
35$! =D8'$! V7'! #$1! 17! )$1$%2(6$!
N5$6!15$!#V#1$2!N(88!D8$%1!V7'!7U!
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Hypo#
Z7'%! 98'47#$! 8$=$8! (#! '6)$%! F;-!
2278Xd!R.I!29X)dT;!
Low#Limit#
35$! =D8'$! V7'! #$1! 17! )$1$%2(6$!
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Note#
<! 671$! P%7=()$#! 5$8PU'8!
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Sensor#
Glucose#
35$! D27'61! 7U! 98'47#$!15D1! (#!
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Sensor#
Session#
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Smart#
Device#
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