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16

Technical specifica

tion 

 

/

 

English

RoHS Directive 2011/65/EU

 - IEC 62321:2008

Electromagnetic compatibility

CFR 47: part 15 sub part b (Radio Module FCC ID: WAP4008 see FCC 

NOTICE below)

ICES 003of 2016; IC (Industry Canada) 

Radio Module IC ID: 7922A-4008 see note below

ANSI 63.4 of 2014

RED – Radio Equipment Directive 2014/53/EU – pre-certified by supplier

The full text of the EU Declaration of Conformity is available at the fol-

lowing internet address: www.red.menarinidiagnostics.com

FCC (USA) - Radio Module FCC ID: WAP4008 FCC NOTICE:

This Device complies with Part 15 of the FCC Rules. The Device meets the 

requirements for modular transmitter approval as detailed in FCC public 

Notice DA00-1407.Transmitter Operation is subject to the following two 

conditions:

(1)

 This Device may not cause harmful interference.

(2)

 This device must accept any interference received, including interfe-

rence that may cause undesired operation.

IC (Industry Canada) Radio Module IC ID: 7922A-4008

The Device meets the requirements for modular transmitter approval as 

detailed  in  RSS-GEN.  Operation  is  subject  to  the  following  two  condi-

tions:

(1)

 This Device may not cause harmful interference.

(2)

 This Device must accept any interference received, including interfe-

rence that may cause undesired operation.

/ 7.3

 

Declarations

This device has been tested to meet the electrical and safety require-

ments of:

Medical Electrical Equipment

EN61000-6-3 : 2007+A1:2011, EN61000-6-1 : 2007, EN61000-4-2 : 2008, 

IEC61000-4-3 : 2006+A1:2007+A2:2010, IEC61000-4-6 : 2013 

IEC61000-4-8 : 2009, EN62479:2010, 

EN55142:1997+A1:2001+A2:2008

Radio

Certified Bluetooth

®

 Module FCC 

ID: WAP4008 Tx & Rx freq.: 2400 

-2800 MHz Max. Tx power:3dBm

/ 7.2

 

Environment and operating conditions

Normal operation

0 to 40 °C (32 to 104 °F),  

45-85% RH

Transport and storage

-10 to 60 °C (14 to 140 °F), 

45-85% RH

Charging

10 to 45 °C (50 to 113 °F),  

45-85% RH

Altitude & Atmospheric Pressure

< 3000 m (< 9840 ft.) 

&  70-106 kPa

Degree of enclosure protection

IP22

Vibration / Shock / Bump / Drop 

/ Free fall

Transportation worldwide by air, 

road, ship and train

Содержание Day PENCAP

Страница 1: ...User Guide...

Страница 2: ...If you have any questions about this product please consult our website www glucomenday com CAUTION Read all instructions and warnings before use A Menarini Diagnostics only accepts responsibility fo...

Страница 3: ...Maximum number of pairings 3 8 Clearing paired devices 3 9 Changing Pen 3 10 Factory reset 3 11 Powering off 3 12 Powering on 3 13 Cleaning and care 3 14 Long term storage 1 1 1 1 1 1 1 2 2 3 3 4 4 5...

Страница 4: ...you have to decide when to perform an insulin injection The Device is designed to be used in common domestic environments such as your home office or school 1 4 Intended Users GlucoMen Day PENCAP is i...

Страница 5: ...kaging is damaged or opened Degree of enclosure protection Protect Device from moisture Avoid using the Device under direct sunlight Range of temperature upper and lower limit to which the Device can...

Страница 6: ...2 3 GlucoMen Day PENCAP terminology The following images describe the key components of Insulcheck Connect 1 Display screen Timer and other information is displayed on it 2 Charging indicator Display...

Страница 7: ...odel of pen The abbreviation for the pen name the Device is designated for is embos sed on the sleeve The following table provides a list of pen models supported by GlucoMen Day PENCAP together with t...

Страница 8: ...tions 3 1 First time use 1 Peel off the labels a First from underneath the Device and then from the touch area and di splay CAUTION Part of this label prevents acciden tal powering on of the Device du...

Страница 9: ...actual injections Its operation is based on sensing the changes in the position of the dose knob when the user interacts with it during injections Playing or fiddling with the dose knob of the pen is...

Страница 10: ...ons is stored on the De vice for up to 30 days You can transmit this information to the GlucoLog RapidCalc app via Bluetooth 1 On your app or phone activate Bluetooth and scan for available devices 2...

Страница 11: ...t smartphones or apps When you pair with a four th client device your GlucoMen Day PENCAP will automatically drop the first client device you connected with to accommodate the new client You can clear...

Страница 12: ...the GlucoMen Day PENCAP memory as well as the pairing data can be deleted by doing a Factory Reset GlucoMen Day PENCAP also reboots as a result of a factory reset 1 Unmount the Device from the pen 2 T...

Страница 13: ...vice can be powered on by the following methods Connecting the Device to a charger Mounting the Device on a pen Clicking the sleeve without pen to engage the mounting mechanism 3 13 Cleaning and care...

Страница 14: ...Day PENCAP radio equipment such as phones computers wireless devices antennas an tenna cables etc should not be used closer than 30 cm 12 inches from the Device This distance should also be observed...

Страница 15: ...5 Unsuccessful pairing There are a number of reasons for an unsuccessful Bluetooth pairing The most common reasons are 1 It may be that the passkey was mistyped into the app or pho ne Repeat the proc...

Страница 16: ...warning is displayed for a few seconds before displaying the timer When a charger is connected to the Device and the battery is not fully charged this ani mation is displayed for a few seconds before...

Страница 17: ...Zed Ltd NovaUCD Belfield Innovation Park Belfied Dublin 4 Ireland By Scandinavian Healthcare Ltd Taiwan 6 3 Warranty Your GlucoMen Day PENCAP is guaranteed to be free of material and workmanship defec...

Страница 18: ...function or are da maged due to obvious tampering misuse alteration neglect unau thorized maintenance or failure to operate the GlucoMen Day PENCAP in accordance with the instructions There is no othe...

Страница 19: ...on IC Industry Canada Radio Module IC ID 7922A 4008 The Device meets the requirements for modular transmitter approval as detailed in RSS GEN Operation is subject to the following two condi tions 1 Th...

Страница 20: ...www glucomenday com 51971 09 20 EN...

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