Roche Diagnostics Diabetes Care GW Accu-Chek Solo micropump User Manual regulatory information

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Document ID	3771840
Application ID	SGfkO6u+LsSBDKZT/aToRg==
Document Description	Users Manual regulatory information
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	15.02kB (187711 bits)
Date Submitted	2018-03-07 00:00:00
Date Available	2018-03-07 00:00:00
Creation Date	2018-03-06 14:57:55
Producing Software	Adobe PDF Library 15.0
Document Lastmod	2018-03-06 14:57:56
Document Title	Users Manual regulatory information
Document Creator	Adobe InDesign CC 2015 (Windows)

18
18
Appendix
18.1 Guarantee
18.3 Radio Frequency Communication
The statutory provisions on rights in consumer goods sales in the
country of purchase shall apply.
This device complies with Part 15 of the FCC Rules and with
Industry Canada licence-exempt RSS standard(s).
Operation is subject to the following two conditions:
1. this device may not cause harmful interference, and
2. this device must accept any interference received, including
interference that may cause undesired operation.
Any changes or modifications to the micropump system not
expressly approved by Roche could render your operating
guarantee for the Accu-Chek Solo micropump system invalid.
18.2 Licence Information
Licence agreement for open source software:
This product contains open source software components. For
more information on open source software, see the System
information item in the Settings menu of the diabetes manager.
Changes or modifications made to this equipment not expressly
approved by Roche Diabetes Care may void the FCC authorization
to operate this equipment.
Le présent appareil est conforme aux CNR d'Industrie Canada
applicables aux appareils radio exempts de licence. L'exploitation
est autorisée aux deux conditions suivantes:
1. l'appareil ne doit pas produire de brouillage, et
2. l'appareil doit accepter tout brouillage radioélectrique subi,
même si le brouillage est susceptible d'en compromettre le
fonctionnement.
327
Appendix
18.4 Connecting Non-System Devices
Additional equipment connected to the diabetes manager must
demonstrably comply with the relevant IEC or ISO standards (e.g.
IEC 60950 or IEC 62368 for data processing equipment).
Moreover, all configurations must comply with the normative
requirements for medical systems (see section 16 of the latest
edition of IEC 60601-1). Anyone who connects additional
equipment to medical electrical equipment is deemed to be the
system configurer, and is therefore responsible for ensuring that
the system complies with the normative requirements for
systems. If you have any questions, please contact your local
authorised dealer or technical customer support.
328
18.5 Customer Support and Service
Centre
If you encounter problems, have questions regarding operation or
need additional information about the Accu-Chek Solo micropump
system, contact your Customer Support and Service Centre.
Contact details for the responsible Customer Support and Service
Centre are provided below.
Do not attempt to repair or modify the components of the
micropump system yourself. Our staff will help solve any
problems you might be experiencing with the micropump system
from Roche.
Supplies and Accessories
18
18.6 Supplies and Accessories
For information on the availability of additional Accu-Chek
products and accessories in your country, contact the responsible
customer support and service centre.
w WARNING
jj Use only the supplied charger and the associated USB
cable, or a certified USB charger (e.g. a laptop certified
according to IEC 60950 or an equivalent safety
standard).
jj Use only the rechargeable battery from Roche.
jj Use only supplies and accessories from Roche and do
not modify them. Otherwise, you risk malfunctions of the
micropump system, incorrect test results and over- or
under-delivery of insulin.
Supplies for the micropump system
jj Accu-Chek Solo reservoir assembly
jj Accu-Chek Solo cannula assembly and micropump holder
jj Accu-Chek Solo pump base
jj Accu-Chek Solo insertion device
Supplies for the blood glucose test
jj Accu-Chek Aviva test strips
jj Accu-Chek Aviva control solutions
jj Accu-Chek FastClix finger pricker
jj Accu-Chek FastClix lancet drums
Accessories
jj Charging cradle for the diabetes manager
jj Carry case/fanny pack for the diabetes manager (Accu-Chek
carry case)
jj Rechargeable battery for the diabetes manager
jj Battery door for the diabetes manager
jj Charger for the diabetes manager
jj USB cable
If you need to replace defective system components or need
another User’s Manual for the micropump system, contact your
Customer Support and Service Centre.
329
Appendix
18.7 Disposing of the Micropump System
w WARNING
All objects which can come into contact with human bodily
fluids carry a potential risk of infection. There is a risk that the
objects may transmit infections. Dispose of used micropump
system components because using them more than once may
result in infections being transmitted.
Since your micropump system may come into contact with
human bodily fluids during use, it carries a risk of infection.
Therefore, it falls outside the scope of the European Directive
2012/19/EU (directive on waste electrical and electronic
equipment) and cannot be disposed of with other electronic
devices.
Dispose of the used micropump system components according to
local regulations.
Rechargeable battery of the diabetes manager
Dispose of the battery correctly and recycle it according to local
regulations.
330
Bolus Calculation
18
18.8 Bolus Calculation
The bolus advice feature calculates your insulin doses based on
different pieces of information. Examples:
jj Your current blood glucose result
jj Your current blood glucose target value
jj Your current insulin sensitivity
jj Your estimated carbohydrate amount for a meal
jj Your current carbohydrate ratio
jj Your current health events
jj Correction insulin that is still acting in the body
jj Your bolus and/or meal history
Consider the following information when calculating bolus advice:
jj How you are currently feeling: It may happen that the values
entered when setting up bolus advice do not match how you
are currently feeling. Increase or decrease the suggested bolus
amount according to your current needs.
jj Bolus amounts and meals that were delivered or consumed,
but not entered in the diabetes manager.
jj If you have delivered a bolus without using bolus advice, you
can manually enter the bolus information in the electronic
logbook. It is important that you enter bolus and carbohydrate
information in the logbook in order to obtain accurate bolus
advice recommendations.
18.8.1 Correction Bolus
If your current blood glucose level does not match your blood
glucose target value, a correction bolus is suggested. The
correction bolus calculation is based on your current blood
glucose result and your insulin sensitivity in the current time
block. Your insulin sensitivity is stated in insulin units per drop in
blood glucose, e.g. 1 U : 40 mg/dL.
Calculation:
(Current BG - target BG) x insulin sensitivity
Example
Current BG: 149 mg/dL
Target BG: 110 mg/dL
Insulin sensitivity: 1 U : 30 mg/dL
Correction bolus = (149 mg/dL - 110 mg/dL) x (1 U : 30 mg/dL)
= 1.3 U
331
Appendix
18.8.2 Meal Bolus
18.8.3 Correction Bolus After a Meal
A meal bolus is the amount of insulin that needs to be delivered
to compensate for the amount of carbohydrates you are planning
to eat.
The carbohydrate ratio is specified in insulin units per
carbohydrate amount, for example, 1 U : 12 g.
After a meal, it is normal for your blood glucose level to increase
even if you delivered the correct meal bolus. The allowed
increase in the blood glucose level is called meal rise. After a
certain period of time, the so-called offset time, the meal rise
decreases slowly. The period of time from the start of the meal
rise until it goes away is defined as the acting time.
During this time, a correction bolus is only recommended if the
increase in your blood glucose level exceeds the allowed meal
rise value.
Calculation:
Meal bolus = carbohydrate amount x carbohydrate ratio
Example
Carbohydrate amount: 63 g
carbohydrate ratio: 1 U : 12 g
Meal bolus = 63 g x (1 U : 12 g) = 5.25 U
332
Bolus Calculation
Chart
The dotted line in the adjacent graph shows how your blood
glucose level might change after a meal bolus. Bolus advice
tolerates an increase in your blood glucose level within the
allowed meal rise range (green). If your blood glucose result is
within the green range, a correction bolus will not be
recommended. If your blood glucose result is above the green
range, a correction bolus will be recommended.
If you enter a carbohydrate amount that is greater than the snack
size, the meal rise is added to the current target blood glucose
value. Since the meal rise is not taken into account when
calculating bolus advice for meals up to the snack size, an
increase in the blood glucose result above the target range is not
tolerated after eating a snack.
The shape of the meal rise (the width of the green area) is
determined by the offset time and the acting time.
BG
18
Time
Current BG values
Allowed BG value: Meal rise
Meal
Bolus
1 Above target range
2 Within target range
3 Below target range
4 Acting time
5 Offset time
6 Target range
7 Meal rise
333
Appendix
18.8.4 Subsequent Correction Bolus
A delivered correction bolus covers the difference between your
current blood glucose level and your blood glucose target value
for a certain amount of time. When the correction bolus begins to
act, your current blood glucose level should drop; after the delay,
the difference between your current blood glucose level and your
blood glucose target value will diminish. At the end of the acting
time, your blood glucose level should have reached the target
limit value again. You will only receive a recommendation for an
additional correction bolus if your current blood glucose result is
higher than the blood glucose value currently permitted.
Chart
The first correction bolus at 12:00 noon remains active during the
acting time (width of the blue area). If the blood glucose value at
14:00 is below the blood glucose value currently permitted (upper
edge of the blue area), no additional correction bolus will be
calculated.
334
BG
Time
Current BG values
Allowed BG value: Corrected BG
Bolus
No bolus required
1 Above target range
2 Within target range
3 Below target range
4 Acting time
5 Offset time
6 Target range
7 Corrected BG

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