System components 10 The Accu-Chek Inform Ii system includes the following components and accessories:
A B c D Meter Code key reader Base unit with power supply Accessory box (shown with consumables not included in scope of delivery}
The system can be configured by:two different methods:
1 2 Configuration via the:Setup function on the meter
(see Chapter 9) Configuration via data management system Note: Not all options can-be.configured using the Setup function. The'meter:performs the following tasks within the system:
Serves:as.the primary operator interface through the touchscreen and on/off button Scans barcodes (patient and operator IDs) in a variety of supported formats Displays test results from patient tests and mea~
surements with control solution Transfers stored data to the data management system via wireless communication (WLAN, optional) or the base unit (LAN) Overview of the meter Antroduction ae re The meter has the following elements:
1 Test strip port Insert the test strip here. Touch screen
(touch-sensitive display) This screen allows you to perform patient tests, per-
form controls tests, and review results. To view any of them, simply touch the button on the screen. On/Off button Press this button to turn the:meter on or off. In addi-
tion, you can activate or deactivate the backlight with this button. :
Barcode scanner (faser} :
The integrated:barcode'scanner can be used to read operator and patient IDs. Battery Pack. Powers the device:
Reset button Use this button to restore the device to its previ-
ausly-configured state. Charging contacts These contacts are used. to charge the batteries wtien the meter is in the:base unit. Infrared interface Supports data communication with code key reader.and base unit. Cover for RF card If your.meter is equipped with this.option, the RF card for the wireless network (WLAN) is located behind this cover. W i i
t t
i Wireless network connection
{RF card) Introduction The optional RF card for a wireless network connection allows the meter to send data (test results, patient IDs, operator IDs, etc.) to the data management system with~
out the need to return the meter to the base unit or con-
nect the meter by cable. The device conforms with the WLAN standard IEEE 802.11b. This feature must be configured by the system adminis-
trator. Observe the guidelines of your facility for using wireless network connections. For information about how to temporarily enable or dis-
able this function, refer to page 23. Note.on the use of the Accu-Chek Inform II blood glucose monitoring system within the European Union: - : :
The use of the:Accu-Chek Inform II blood glucose monitoring system in.conjunction: with a wireless net-
work connection:(RF.card) is allowed in:Europe.only in Belgium, Germany, Great Britain, and Sweden. In
.other European countries, the'RF-card must first be registered with the relevant authorities, This device complies with Part.15 of the FCC Rules and.with RSS-210 of.industry:Canada. Operation is subject to.the following two conditions: 5
(1) this device may not catise harmful interference;
and 4
(2) this device must accept any interference received, including interference that may cause undesired :
operation. :
Changes or modifications made to this equipment not expressly approved by Roche Diagnostics Germany. may void the FCC. authorization to operate this equip-
ment. 19 Heriot 20 This equipment has been-tested and found to comply:
with the limits for a Class B digitat device, pursuant to Part 15.0f the FCC Rules. These limits are designed to provide reasonable. protection-against harmful. inter-
ference in a residential installation. This:equipment generates, uses.and can radiate radio, frequency energy-and, if not installed and used in accordance
-with the instructions, may cause harmful interference to radio.communications. However, there is no guar-
antee that interference will not-occur in a particular installation. If: this equipment does cause harmful interference to radio or television reception, which can be determined:by turing the equipment off.and. on, the user-is encouraged to.try to correct the inter-
ference by one:or more of the following measures:
Reorientor relocate the receiving antenna.
+ Increase the separation between the equipment and: receiver, : :
* Connect the equipment into an outlet on a circuit different.from. that to. which the receiver is con-
nected: :
+. Consult the dealer or an-experienced radio/TV technician for help. This Class B digital apparatus complies with Canadian p ICES-003. ": :
Radiofrequency radiation exposure information: :
This equipment complies with FCC radiation exposure limits set forth for. an uncontrolled. environment. This equipment should be installed and operated with Minimum distance of 20.cm.between the radiator and your body. This transmitter must not be co-located or operating in conjunction with. any other antenna or transmitter. ~-
12 General preduct information Technical data Specification tree Leia) ag rechargeable Height 47mm / 1.85 in 105 mm / 4.13 in 34mm /1.34.in +
AC plug (28-40 mm /
1.1-1.6 in}
Width 92 mm / 3.62 in 150 mm /5.91.in 52.mm / 2.05 in Length 190 mm / 748 in 150 mm / 5.91 in 88 mm / 3.46 in Weight 350 g (with rechargeable |615 g with wallmount N/A batter if ry) User interface Touch screen and LED (tricolor; orange, N/A barcode scanner green, blue) Display resolution 320 x 240 pixel N/A N/A
(touch screen) single color Result memory At least 4,000 results. N/A N/A Operating temperature [3 to 50C 310.50 C 0 to 40C
(review functions only) {37 to 122 F 37:t0122F 32 to 104 F Measurement 6 to 42C SIN/A N/A temperature 43.10:108 F y Charging temperature [3 to'40:C. N/A N/A
{battery pack) 37 to 104.F. Operating temperature | 12 to 47 C N/A N/A
(RF card, if installed) 54 to 117 F Storage temperature 2to 25C -25 to 69 C ~40 to 70C 36 to 77 F -13 to 156 F -40 to 158 F L Humidity (operating) 90% RH at 32C / 90F |N/A N/A
(noncondensing) Air pressure 0,7 to 1.06 bar 0.7 to 1.06 bar N/A 70 to 106 kPa 70 to.106 kPa Relative humidity < 95% < 95% N/A
(storage) Battery voltage/type 3.7 volt fithium polymer |N/A N/A 125 General product in Specification Base unit Lara) hag Input voltage +75 V DC +75 V DC 90 to 264'V AC Input frequency oC joc 50 to 60 Hz Input current 1.7 A (max) 1.7 A (max) 400.mA (max) at 100-240 VAC / 50 Hz Lithium ION battery 13 measurements N/A N/A Code 93, EAN 13, Interleaved 2 of 5, Codabar. charge rate possible after 90 min of _[enarging Interfaces Charge contacts Charge contacts DC connector IR port IR port Replaceable Barcode scanner RJ45 Ethernet AC input contacts RF card USB type B Data transfer rate RF card: 11Mbps IR: 9.6K - 115K bps N/A Ethemet: 10 Mbps. USB: 12 Mbps Min. barcode width 4 mil N/A : N/A CDRH/IEC CDRH Class i N/A N/A Supported barcodes Code 128, Core 39, N/A: N/A Specification Accessory box Code key reader Height 85 mm /3.35in 18.4 mm / 0.72 in Width 280 mm /-1-4.02 in 34.8 mm / 1.37 in Length 272 mm / 10.71 in 70.7 mm /2,78 in Weight 1100 g 28g Storage temperature -25 to 69C 2 to 25C
-13 to 156 F. 36 to 77 F Relative humidity < 95% < 93%
(storage) Battery voltage/type N/A 3V / CR2450 Interfaces N/A IR port a Code key socket 126 B Appendix Appendix:
Option: Wireless network (WLAN) Application area Benefits of wireless connectivity The optionally available module for wireless network con-
nectivity (RF card) allows facilities to connect to their data management system on a continuous basis. Wire-
less connectivity can help to ensure that changes to information in the data management system are sent immediately to all networked meters. With the integrated RF card, the mter has to be returned to the base unit only for recharging or communicating with the data management system in.an area not wireless capable. The following information:is:transmitted by the RF card: :
= Test results a Informationon consumables needed by the meter
(strips, reagents; linearity kit) Operator lists Patient lists Configuration information Lists of comments 145