BA oxy control 4c 09-10-22_D.indd, page 8 @ Preflight
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1. Please use medical alcohol to clean the synthetic material touching the finger inside the oximeter and clean the test finger before and after using Please clean the surface of the pulse oximeter before each use LIMITED WARRANTY This pulse oximeter is guaranteed for 2 years from the date of purchase against manufacturer s defect under conditions of normal use Following the instructions precisely will ensure that the device functions reliably for many years If your pulse oximeter does not function properly due to defective parts or assembly we will repair it free of charge All parts of the pulse oximeter are covered by this warranty The warranty does not cover dama ge to your unit due to improper handling The manufacturer recommends that the accuracy of the device be checked by an authorized laboratory every 2 years in Germany this is a statutory requirement You must adhere to the applicable regulations when disposing of the device Manufacturer Geratherm Medical AG FahrenheitstraBe 1 X 98716 Geschwenda Germany Cc 0118 242. RANGE OF APPLICATION The Geratherm oxy control 4c can be used to measure human haemoglobin saturation levels and the heart rate via a finger The product is suitable for use at home in hospital including clinical use in internal medicine surgical wards in anaesthesia paediatrics intensive care units etc in social medical institutions or in sports medicine it can be used before and after sporting activity use during sporting activi ties is not recommended BATTERY INSTALLATION 1 Place the two AAA bat teries inside the battery compartment ensuring correct polarity 2 Slide the battery cover on horizontally as shown by the arrow Notes Batteries must be inserted with the correct polarities Otherwise damage might be caused to the device Please insert or remove batteries in the correct order or the device bracket may be damaged Please remove the batteries if the oximeter will not be used for a long period When the battery status indicator appears replace the bat teries in good time 16 DESCRIPTION OF FRONT PANEL Battery Perfusion Index PI SpO2 PR bpm Pulse frequency Pulse rate indicator SpO oxygen saturation SpO2 PR bpm status indi calor 9 7 74 Graphic repre sentation of Tre SpO The pulse frequency indicator flashes on and off in accor dance with the pulse rate displayed INSTRUCTIONS FOR USE Insert two AAA batteries into the battery compartme
3. Fingertip Pulse Oximeter Geratherm oxy control 4c Instruction manual GT 300C320 CE 0118 TABLE OF CONTENTS General Description 14 Precautions 15 Range of Application 16 Battery Installation 16 Description of Front Panel 17 Instructions for Use 17 Evaluation of Pulse Oximetry 20 Specification 21 Possible Problems and Solutions 22 Cleaning Instructions 24 Limited Warranty 24 GENERAL DESCRIPTION Haemoglobin saturation is the percentage of oxygen bea ring haemoglobin HbO molecules in proportion to the amount of oxygen that the haemoglobin Hb is capable of carrying in the blood It expresses the concentration of oxy haemoglobin in the blood and is a very important parameter of the respiratory and circulation system Many respiratory diseases can result in a decline in haemoglobin saturation levels In clinical medicine it is very important to determine a patients haemoglobin saturation level in good time so as to detect problems sufficiently early Pulsoximetry is a non invasive monitoring procedure for the determination of oxygen saturation in arterial oxygenated blood by means of a photosensor To obtain a diagnosis it is only necessary for the patient to lay one of his fingers on a photoelectric sensor The display screen shows the measured value of haemoglobin saturati on Clinical experiments have demonstrated the high degree of precision and repeatability of this procedure 14 PRECAUTIONS 1 Do no
4. g normal pulse rates Infants under 1 year 100 160 bpm Children between 1 and 10 years 70 120 bom People over 10 years 60 100 bpm Highly trained individuals athletes 40 60 bpm 20 SPECIFICATION 1 Display type 4 colour LCD display 2 SpO Measurement range 70 99 Accuracy 2 between 80 and 99 3 between 70 and 80 3 Pulse rate Measurement range 30 235 bpm Accuracy 2 bpm or 2 Pulse intensity Pulse rate indicator 4 Power requirements Two alkaline batteries type AAA 1 5 V 6 00mAh Power consumption Less than 40mA Battery status indicator Battery life up to 30 hours in continual use 5 Dimensions Length 60mm Width 34mm Height 30mm Weight 50g including two AAA batteries 6 Environmental requirements Operating temperature 5 40 C Storage temperature 10 40 C Humidity 15 80 in operation 10 80 in storage 7 Quality standards Certification in compliance with EN ISO 13485 Conformity in compliance with EN 9919 2005 Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oxime ter equipment for medical use EN60601 1 EN60601 1 2 standard Council Directive 93 42 EEC 21 POSSIBLE PROBLEMS AND SOLUTIONS Problems Possible reason Solution SpO or PR cannot be shown nor mally 1 Finger is not inserted cor rectly Patient s oxy haemoglobin level is too l
5. his can be switched on or off The alarm sounds briefly twice if the measured values exceed the previously set limits Switching the alarm on and off In order to switch the alarm off press the on off button when the audible alarm sounds You will enter alarm mode for a period of 30 seconds thus switching the alarm off However you only switch off the alarm tone not the audible pulse rate indicator The alarm mode is automatically switched off if a new alarm sounds or the measured values are within the normal range Perfusion Index Pl The perfusion index Pl shows the signal strength of the arterial pulse and indicates the proportion of pulsatile signals to non pulsatile signals The bar is highest when the quality of the blood supply is at its best PI is influenced by the strength of the pulse rate the quality of the blood supply to the fingertip and the temperature of the finger If for example the pulse rate is weak the blood supply to the fingertip poor or the finger temperature low the PI will also be low 19 EVALUATION OF PULSE OXIMETRY In healthy patients oxygen saturation levels lie between 96 and 98 Values below 95 can indicate a health disorder and make it necessary to supply the patient with additional oxygen lf your oxygen saturation value is below 95 please consult your physician Normal pulse values depend on the age and fitness level of the individual Here are a few reference values indicatin
6. nt before replacing the cover Press the device atthe gt gt gt rear end so as to open the front section for the lt insertion of a finger When your finger is in the oximeter the nail surface must face upwards After inserting the finger let go of the rear end Press the power button on the front panel once While the oximeter is working you should not move your finger and you should keep still and quiet Read the values shown on the display screen 17 INSTRUCTIONS FOR USE After turning on the oximeter each time you press the power button the oximeter will switch to another display mode There are 6 display modes as follows SpO2 PR bpm SpO2 PR bpm SpO2 PR bpm 197 74 wed yd ds N I wz PRtpm SpO2 O N IT 1 zQds wd Yd gt NJ Press the power button for a fairly long time longer than 1 second in order to set the brightness level of the display panel Holding the button down will cause the brightness of the oximeter to change gradually There are 10 brightness levels The default level is level four 18 INSTRUCTIONS FOR USE Audible pulse rate indicator During the measuring procedure you will hear a tone indica ting your pulse rate Alarm Range SpO lt 90 Pulse rate lt 60 bpm or gt 100 bpm Alarm modes audible and visual alarm Visual alarm The measured pulse and oxygen values flash if they exceed the previously set lower or upper limits Audible alarm T
7. ow to be mea sured 1 Try inserting the finger again Try several more times if you are sure that there is no problem with the device Please go to a hospital in good time to obtain a pre cise diagnosis SpO or PR is shown unstably Finger might not be inserted far enough Finger is trem bling or the patient s body is moving Try inserting the finger again Try not to move The oxime ter cannot be switched on Battery power may be ina dequate or not be there at all Batteries may have been inserted incor rectly The oxime ter might be damaged 22 Please replace bat teries Please reinsert the batteries Have the device tested by the manufacturer POSSIBLE PROBLEMS AND SOLUTIONS Problems Possible reason Solution Indication 1 The product is 1 Normal lamps sud automatically denly go off switched off if no signal is detected for longer than 8 seconds Low power Replace the bat Batteries teries empty Error3 or Low power Insert new batteries Error4 dis Batteries played on empty screen Receiving sen 2 Have the device sor shielded or tested by the sensor dama manufacturer ged Error7 dis 1 Low power Change the bat played on Batteries teries screen empty Infrared sensor Have the device damaged tested by the manufacturer 23 CLEANING INSTRUCTIONS
8. t use the pulse oximeter in an MRI or CT environ ment 2 Explosion hazard Do not use the pulse oximeter in an explosive atmosphere 3 The pulse oximeter is intended only as an ancillary proce dure in patient assessment It must be used in conjunc tion with other methods of assessing clinical signs and symptoms 4 Prolonged use or the patient s condition may require that the sensor site be changed regularly Change the sensor site and check the patient s skin integrity circulatory sta tus and correct alignment at least every 4 hours 5 Inaccurate measurements may be caused by autocla ving ethylene oxide sterilizing or immersing the sensors in liquid which will result in inaccurate readings 6 Store the pulse oximeter in a dry environment 7 The following factors may impair the SpO measure ments and or lead to inaccurate readings Significant levels of dysfunctional haemoglobins such as carboxy haemoglobin or methaemoglobin Intravascular dyes such as indocyanine green or methylene blue High levels of ambient light shield the sensor area against direct sunlight Excessive patient movement Venous pulsations Placement of a sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line The patient has hypotension severe vasoconstriction severe anaemia or hypothermia The patient is in cardiac arrest or is in shock Fingernail polish or artificial fingernails Cold or dirty fingers 15
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