USER INSTRUCTIONS
Contents
1. 42 0 C 93 2 107 6 F 0 2 C 0 4 F for other ranges Dimensions ___ 80 2mm x 60 2mm x 18 0mm 8 16 x2 87 x0 77 Weight 69 grams 2 4 oz including batteries Alarm Audible Alarms are activated when temperature reaches the Hi Low and Visual alarm setting Operating Temperature 26 C 50 C 14 0 F 122 F Conditions Humidity 10 83 Storage Temperature 26 C 60 C 14 0 F 140 F Conditions Humidity 10 83 Low battery Replace the batteries if the low battery symbol appears Standards CE 0118 Conformity DIN EN ISO 13485 2003 DIN EN 12470 4 Clinical thermometers Part 4 Perfor mance of electrical thermometers for continuous measure ment EN 60601 1 2 2006 harmonized Electromagnetic Compatibility ASTM E1112 00 2006 Electronic Thermometer for Intermit tent Determination of Patient Temperature 11 Testing and Calibration We recommend that the accuracy of your DataTherm Il is checked every two years this is a legal requirement in Germany Geratherm Medical AG is able to provide calibration services for a fee Guarantee Geratherm Medical AG provides a guarantee that is restricted to two years from the date of sale on manufacturing defects for the DataTherm Il unit Geratherm Medical AG or its authorised representatives will repair or replace faulty DataTherm II units which have material or manufacturing faults This guarantee does not cover any damag2. II al lows the patient or doctor to view and email stored temperature information NOTE 1 Only a qualified individual should use this device 2 Do not use this monitor as a substitute for a physician s advice This device complies with Part 15 of the FCC Rules and is subject to the following conditions 1 This device does not emit harmful electromagnetic RF interference 2 This device resists electromagnetic RF interference including interference that may cause undesirable operation Precautions AN 1 The DataTherm II probes are intended to be disposable The manufacturer does not recommend reuse Should they be reused do not boil heat or auto clave the probe Clean by wiping with a cloth dampened with mild detergent and water Disinfect the probe with ethyl or isopropyl rubbing alcohol 2 Do not drop the temperature monitor or expose it to heavy shock 3 Do not store the unit under direct sunlight at high temperature high humidity or in dusty conditions Performance may be degraded 4 Do not use the monitor if it operates erratically or if the display window malfunc tions Keep out of the reach of children Always clean the monitor before storing Do not attempt to disassemble the unit except when replacing the batteries lf the monitor has been stored in a sub freezing environment for any length of time allow it and its components to slowly warm to room temperature prior to using 9 I
3. II Press mode button once to advance through each of the 10 set up modes Press A or Y button to make the changes in the values for each mode Confirm all changes High temp alarm setting press mode key once Figure 1 Low temp alarm setting press mode key 2 times Figure 2 Hour setting mode press mode key 3 times Hour will flash Figure 3 Minute setting mode press mode key 4 times Minute will flash Figure 4 Memory data capture interval hour selection press mode key 5 times Hour will flash Figure 5 Memory data capture interval minute selection press mode key 6 times Minute will flash Figure 6 Celsius and Fahrenheit scale selection mode press mode key 7 times Figure 7 Visible LED alarm On Off mode press mode key 8 times Figure 8 Audible buzzer alarm On Off mode press mode key 9 times Figure 9 0 Delete memory and accept changes mode press mode key 10 times Figure 10 Y accept new settings and deletes memory N retain existing data Pe a o gt Ze Note Changes in the Memory Data Capture Interval Modes 5 and 6 above require the user to advance to mode 10 and press A Y button Caution This will erase any stored data Figure 3 Figure 7 Figure 8 Figure 9 Figure 10 Connecting the DataTherm Il to PC Be sure to install the software prior to connecting the DataTherm Il to the PC When first connected the DataTherm
4. 19 20 21 23 24 25 g Data Therm DataTherm Time Temperature Fl es eg 15 15 08 UNIT al Figure 14 SP Save new data with this existing PID File name Warning Downloading data to a file using the same PID name will overwrite the existing file Figure 15 I WARNING Y Yes will overwrite any file stored with the same PID name f UpdateSetting M Update DataTherm Tine 17 42 Warning Modify the DataTherm time will clear the memory Update Record terval Ohm Uni Mint Figure 16 Update PID Mary 20 Characters max UpdateSetting Accessing Stored Data 1 The DataTherm II provides 140 memory sets that include temperature sequential day time information Click the A or Y button to scroll by time sequence through the data The maximum number of data sets that can be stored is 140 When the data bank is full the oldest record will be erased automatically Note The memory data will be erased when the batteries are replaced Be sure to transfer the data before replacing batteries Turning Off the DataTherm ll Turn off the measurement and storage functions by clicking the On Off key Actually the device is always on When turned Off the monitor goes into standby mode and the display shows the time only Pressing the On Off button once while in standby begins a self test of internal circuitry and all LCD displays The circuit test lasts no mo
5. II LCD will display Figure 11 first then display Figure 12 The DataTherm II control buttons are automatically locked when it is con nected to the PC Figure 11 Figure 12 Software Instructions The DataTherm r Il software is compatible with Windows XP and Windows Vista 1 Download the DataTherm II software program from the mini disc to the PC Follow the instructions on the screen to complete the installation To start the program either double click the icon found C Program Files DataTherm as seen below DataTherm m Datathermi or the DataTherm II shortcut icon found on the Desk Top 2 The initial window display will look like Figure 13 pg 8 Ihe DataTherm II must be turned On and your PC must be linked before current temperature is displayed or data downloaded Activate Link of computer screen tab definitions functions Once linked the screen will look like Figure 14 3 To change the temperature scale from C to F or F to C click the UNIT F button on the computer screen outer Screen Tab Definitions Functions e Open Opens previously archived data dat files e Link Links PC to the DataTherm II unit See Figure14 displays current temperature DataTherm Il must be turned On e Download Downloads DataTherm II stored data to the PC and asks if you want to save the file as the existing PID Patient ID name displayed or a new P
6. DataTherm I 24h TEMPERATURE MONITOR CONTINUOUS TEMPERATURE MONITOR USER INSTRUCTIONS Model KD 2300 CE 0118 Geratherm Medical AG FahrenheitstraBe 1 D 98716 Geschwenda Germany EBENE na ne an ee T OE AE OA E TE ner 2 IDEEN een ee Eee 2 See TO USE nennen ee 2 Proe Ue ee ee ee ee ee 3 Aroni IDEE Bd E a se nore Seeek a SO m rr tr moe Sere seas Oe nt nee ee 4 Battery Installation Replacement eurssnnaanunnnnnnunnnnnnnnnnnnunnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnen 5 DataTherm II Programming 2u 22u0220200n0000n000nuun0nnu0nnunnnuunnnnnnnnnnnnnnnnunnnnnnnnunnnnnnnnnnnnn 5 Connecting the DataTherm Il to a PC uuuuusnuunnununnunnannnnnunnnnnnnnunnnnnnnnunnnnnnnnnnnnnnnnnnnnnnnnnn 6 ST A TRS UN EEE ER EEE EEOEBRINENSERTERENCER IEIPEINNTEEREBE SEEENE 6 Computer Screen and Tab Definitions and FUNCTIONS eu2uuu00 an000nannuonnnnnen 7 Accessing Sred Data u a ae 9 Ten Off Mme Data Bog een 9 Creating a patient file and downloading temperature readings to your PC 9 Using the tabs at the top of the menu bar uuusnnauunnnnnonnanonnnnnnnnnnunnununnnnnennanennnnnn 9 Emailing downloaded files by changing to Excel or text formats nuusennnnnennnnnnn 9 Deleting stored readings and Saving New Settings ccccssssseecssesseesseenseeeseeeeneesees 10 MAIDEN A A IEEE E E A EE E N AN euere 10 Error iC ON S ne eier 11 E E O aA E EE EEA 11 Testing and Callbra
7. ID See figure 15 The download feature copies data stored in the DataTherm II to the archived data folder as a new dat file All data is retained in the DataTherm II until memory is manually erased using mode 10 batteries are changed time 24 hour clock is updated from the PC See Figure 16 or manually changed in modes 3 or 4 See Figures 3 amp 4 Update Updates DataTherm II time allows memory reading interval change pa tient ID change See Figure 16 Export 1 Exports the data dat file to txt or xls Excel format and or 2 Accesses previously stored txt and xls files Note An existing dat file must be be active on the main screen before Export tab will function After clicking the Export tab select either txt or xls file choices at the bottom of the export file window and manually Name and Save a new file in either txt or xls formats To open previously saved records for each of the archived file types select the format and Right Click the file Then select among the options in the drop down window to Open Send To Rename etc Additionally the text Excel files may be accessed directly from the DataTherm program by opening Windows Notepad for txt or Excel for xIs files Help Help 5 Data Therm DataTherm Time Temperature No 1 u u u n amp 3 13 33 32 UNIT z Er 2 Figure 13 14 18 16 17 18
8. Settings Go into the 10th or last set mode on the DataTherm Il see a flashing Y and N and press the A Y button to delete data and save mode setting changes N will retain old settings and stored data Maintenance Do not drop the unit Do not modify or disassemble the unit or probe Do not twist or pull the probe Use a cloth moistened with water or neutral detergent to clean the body of the unit and then wipe it dry To disinfect the body use ethyl or isopropyl instead of water Avoid petroleum based solvents or other harsh cleaners Avoid storing at high temperature in direct sunlight high humidity or dust Remove the batteries for long term storage 10 Error Indicators Interpretation The temperature measured was higher than the specified operating range Please measure again LO The temperature measured was lower than the specified operating range Please measure again Probe connection error Please ensure the probe is con nected The memory function error The unit has a circuit error DO NOT USE Contact customer service Low Battery Symbol or No display Replace two 1 5V AAA size batteries Specifications 2 AAA size batteries Measuring range 17 0 45 0 C 62 6 113 F Below 17 0 C 62 6 F displays L C F Above 45 0 C 113 F displays H C F Display Resolution 0 01 C 0 1 F Accuracy 0 1 C 0 2 F 34 0
9. e which has been caused by misuse improper treatment or failure to obey written instructions or any damage caused by unauthorised persons of damage occurring during transportation Guarantee work does not prolong the guar antee period of two years from the original date of sale The guarantees provided by the various manufacturers cover the accessories found in the DataTherm II kit Any direct or indirect liability claims are excluded from this guarantee The manufacturer does not make any explicit or implicit assurances that go beyond what is written here In the case of guarantee claims please get in touch with the service department of Geratherm Medical AG by phoning 0049 36205 98 205 in order to obtain a transac tion number Please pay attention to the current rules and regulations when disposing of the unit or the batteries Manufactured by Geratherm Medical AG Fahrenheitstrasse 1 D 98716 Geschwenda Germany x
10. liQn eee teeemeeenn rer tt othr ener nnEss ere tne aiaa 12 AEE A T I A EEE EA A E T A E O anata ae 12 Introduction The DataTherm ll is a lightweight portable continuous temperature monitor that provides three functions 1 Display of current temperature in Fahrenheit or Celsius 2 Alert with visual and or audible alarms that are automatically activated when the patient s temperature rises above or falls below user adjustable levels 3 Store up to 140 temperature time date data records at regular intervals to al low for recall and assessment of temperature trends The DataTherm II uses disposable probes which significantly reduce the risk of cross contamination The instrument may be connected to a PC Personal Computer for the purpose of archiving display of data graphic representation or emailing of one or more temperature series that may have been taken from different patients or at different times Indications for Use The DataTherm II Continuous Temperature Monitor is used to measure human body temperature and store data at adjustable preset time intervals The DataTherm II can continuously monitor and store up to 140 temperature readings The DataTherm II features both high and low adjustable temperature alarm settings manifested by a beeping sound and flashing light when the measured temperature exceeds the high 2 temperature setting or falls below the low temperature setting The DataTherm
11. ncase of a discharged battery or complete failure of the device for another rea son there will be no warning when body temperature is abnormal 10 To ensure accurate and consistent temperature measurement proper probe po sition should be checked periodically by the caregiver DN oF el About the Device Probe Temperature probe USB cable DataTherm II KD 2300 Unit on off button Battery cover mode button LED lock button on off amp mode function USB plug Sensor plug The LCD Temperature Temperature Scale en ar a Mode selection Date Time 0 Lock Unlock Low Battery Battery installation replacement 1 Remove battery cover by sliding the lock to the open position and lift the battery cover open 2 Install replace two new 1 5 V Size AAA batteries into the battery compartment Note Be sure that the batteries are installed with the correct polarity 3 Do not store the unit under direct sunlight at high temperature high humidity or in dusty conditions Performance may be degraded Note Re set the date and time after battery removal or replacement Battery removal will erase the memories DataTherm Il Programming Note The probe must be connected to the DataTherm II before setting up the device Program the operating parameters according to the following steps Press the On Button There are 10 modes used to set the operating parameters of the DataTherm
12. re than 2 seconds Creating a patient file and downloading temperature readings to your PC 1 Activate the DataTherm Il Program on the PC 2 Turn DataTherm II ON with the sensor probe attached to the unit Note the DataTherm Il will continue to display the current patient or room tempera ture on the PC screen every 4 seconds 3 Connect the USB cable to the port on the top of the DataTherm II and connect the opposite end into USB port on the PC Using the tabs at the top of the menu bar 4 Click Link tab note it will now convert to unlink 5 Click on Download tab if there are existing files saved in the program you will see a prompt to save new data with this existing PID file name click NO enter a new file name click OK Emailing downloaded files by changing to Excel or text formats 4 2 3 4 5 6 Click on Export tab Note Save as type and select format text or Excel at the bottom of the window Enter the file name you previously selected without the dat file designation Click Save to close the window Click the Export tab and right click on desired file to Open Send to mail recipient if desired you may now use the Excel Graph function to represent data in a graphic format 7 The download is complete Disconnect the USB cable from your DataTherm Il and PC Deleting stored readings and Saving New
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