GlucoMen Day PENCAP, User Manual

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