user manual Geratherm oxy control
Contents
1. Keep the oximeter in a dry environment 10 The following factors can affect the SpO2 measurements and lead to inaccurate values e Significant levels of dysfunctional hemoglobin such as carboplatin hemoglobin or methemoglobin e Intravascular dyes such as indocyanine green or methy lene blue e High ambient light the sensor area protected from direct sunlight e Excessive patient movement e Venous pulsations e Placement of a sensor on an extremity with a blood pres sure cuff an arterial catheter or intravascular line e Patient has hypotension severe vasoconstriction severe anemia or hypothermia e Patient has a cardiac arrest or is in shock e Nail polish or artificial fingernails e Too cold or dirty fingers APPLICATION OF THE PRODUCT AND INTENDED USE Geratherm pulse oximeter is a portable non invasive device intended for spot checking of oxygen saturation of arterial he moglobin SpOz and pulse rate of adult and pediatric patients in hospitals hospital type facilities and home environments It is not for continuous monitoring 17 y BA indd 17 24 09 2013 11 31 83 HOW TO REPLACE THE BATTERY 1 Install two AAA batteries into the battery compartment Match the plus and minus signs in the compartment If the polarities are not matched damage may be caused to the oximeter 2 Slide the battery door cover hori zontally along the arrow shown as the picture Note The pole orientation of the2. are 6 display modes shown as follows SpOx PR 198 77 O Pulse Oximeter wyd ods o 2 8 o Pulse Oximeter Pulse Oximeter 4 S 6 Press the power button for a longer time more than a second to adjust the brightness of the display By holding the power button the display gradually changes the brightness of the oxi meter There are 10 levels of brightness Level 4 is the default brightness The pulse oximeter comes with a protective sleeve to protect it from dirt and impacts EVALUATION OF THE MEASURED VALUES GB Healthy patients have an oxygen saturation of 96 98 Values below 95 can already show a disease indication and require a medical treatment If your oxygen saturation is below 95 ple ase consult your doctor Normal pulse rates depend on the age and fitness level of a person Below are some reference values for a normal pulse rate e Children under 1 year 100 160 bpm e Children 1 10 years 70 120 bpm e People over 10 years 60 100 bpm e Trained people athletes 40 60 bpm 19 y BA indd 19 24 09 2013 11 31 83 y BA indd 20 SPECIFICATIONS 1 10 Model Nummer GT 300C203 Anzeigetyp 1 colored OLED display SpO2 Display range 0 to 99 Measuring range 70 to 99 Accuracy 70 to 99 3 0 to 69 no definition Resolution 1 Pulse Rate Display range 0 to 254BPM Measuring range 30 to 235 BPM Accurac
3. 11 31 4 GUIDANCE AND MANUFACTURER S DECLARATI ON ELECTROMAGNETIC IMMUNITY a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the mea sured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal per formance is observed additional measures may be necessary such as reorienting or relocating the device b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m wal Geratherm Medical AG FahrenheitstraRe 1 98716 Geschwenda Germany www geratherm com 26 y BA indd 26 24 09 2013 11 31 4
4. A m 3A m Power frequency magnetic frequency fields should be at levels 50 60 Hz characteristic of a typical magnetic location in a typical field IEC commercial or hospital 61000 4 8 environment Recommended separation distances between portable and mobile RF communication equipment and the device The device is intended for use in an electromagnetic environ ment where radiated RF disturbances are under control User can help prevent electromagnetic interference by keeping the device at a minimum distance from portable and mobile RF communications equipment transmitters Below table details the maximum output power of transmitter Rated Separation distance according to frequency maximum of transmitter m output power of transmitters ORAR 80 MHz 800 MHz 800 MHz 2 5 GHz d 1 2VP d 2 3VP oo 0 1167 0 2334 Ji 0 3689 0 7378 1 1 1667 2 3334 19 3 6893 7 3786 oy 11 6667 23 3334 For transmitters rated at a maximum output power not listed abo ve the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer 24 BA indd 24 24 09 2013 11 31 4 NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electro magnetic propagation is affec
5. Fingertip Pulse Oximeter Geratherm Oy COMO INSTRUCTION FOR USE Please read carefully before using GT 300C203 C 0197 yBA indd 15 24 09 2013 11 31 83 TABLE OF CONTENTS General Description 16 Precautions 17 Application of the product and intended use 17 How to replace the battery 18 Description of Display 18 How to operate 18 Evaluation of the measured values 19 Specifications 20 Possible problems and solutions 21 Cleaning Instructions 22 Disposal 22 Warranty 22 Symbol Index 22 Appendix 23 GB GENERAL DESCRIPTIONS Oxygen Saturation is a percentage of Oxyhemoglobin HbO2 Capacity compounded with oxygen by all combinative hemo globin Hb capacity in blood In other words it is consistency of Oxyhemoglobin in blood It is a very important parameter for the Respiratory Circulation System Many respiratory disea ses can result in oxygen saturation being lowered in human blood Additionally the following factors can reduce oxygen saturation Automatic regulation of organ dysfunction caused by Anesthesia Intensive Postoperative Trauma injuries caused by some medical examinations That situation might result in light headedness asthenia and vomiting Therefore it is very important to know the oxygen saturation of a patient so that doctors can find problems in a timely manner The fingertip pulse oximeter features low power consumption convenient operation and portability Place one fingertip into the photo
6. batteries must be as shown in the in Figure otherwise the device may be damaged Please insert or remove the batteries in the correct order other wise the devices tab could be damaged Please remove the batteries if the oximeter is no longer in use If the battery status indicator lights up replace the batteries in time A Warning Do not dispose the battery in normal domestic waste Keep out of reach of young children Do not dispose GB of the battery in a fire It may explode DISCRIPTION OF DISPLAY Oxygen Saturation Pulse Rate Power low indicator Th e h eart rate bar flashes according to the Pulse Oximeter displayed pulse SpO2 Waveform Power Switch Pulse bar graph rate HOW TO OPERATE 1 Install two AAA batteries according to the Battery Installation instructions 2 Squeeze the device at the rear to open the front part to accommodate the finger 3 If your finger is in the oximeter your nail must be facing up 4 After inserting the finger release the rear section again E Pre kS 4 5 Press the power switch in the front of LoS the device once 6 While the oximeter is measuring you should not move your finger and keep yourself quiet 7 The display will read the corresponding measured values J ISa 18 BA indd 18 24 09 2013 11 31 3 After turning on the Oximeter each time you press the pow er switch the Oximeter will switch to another display mode There
7. ce and manufacturer s declaration electromagnetic emissions The device is intended for use in the electromagne tic environments listed below and should only be used in such environments Emissions Test Compliance RF emissions Group 1 CISPR 11 RF emissions Class B CISPR 11 Harmonic emissions IEC 61000 3 2 Not applied Voltage fluctu ations flicker emissions IEC 61000 3 3 Not applied y BA indd 23 Electromagnetic environment guidance RF energy is used only to maintain device s operation Therefore its RF emissions are so low that it s not likely to cause any interference in nearby electronic equipment The device is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes 23 24 09 2013 11 31 4 Guidance and manufacturer s declaration electromagne tic immunity The device is intended for use in the electromag netic environments listed below and should only be used in such environments Immunity IEC 60601 Compliance Electromagnetic envi test test level level ronment guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood discharge t 8 kV air 8 kV air concrete or ceramic tile ESD IEC If floors are covered with 61000 4 2 synthetic material the relative humidity should be at least 30 Power 3
8. electric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display It has been pro ven in clinical experiments that it also features high precision and repeatability 16 y BA indd 16 24 09 2013 11 31 83 PRECAUTIONS 1 Do not use the pulse oximeter in an MRI or CT environment 2 The pulse oximeter must be kept out of reach of children Small parts can be detached from the device These can be swallo wed by children or cause suffocation by inhalation of the parts 3 Operating Geratherm oxy control can be influenced by the use of an electrosurgical unit ESU 4 Do not use the pulse oximeter in situations where alarms are required The device has no alarm It is not suitable for con tinuous monitoring Explosion Hazard Do not use the pulse oximeter in an explosive atmosphere 5 Donotuse the device if it has damaged partsExplosion hazard Do not use the pulse oximeter in an explosive atmosphere 6 The pulse oximeter is provided only as an aid for patient dia gnosis It must be used in conjunction with other methods of assessing clinical signs and symptoms 7 Prolonged use or the patient s condition may require changing the sensor site periodically Change the sensor site and check skin integrity circulatory status and correct alignment every 4 hours 8 Inaccurate measurements by autoclaving sterilizing with ethyl oxide or immersing the sensors in liquid may cause inaccurate readings
9. n lamps 1 suddenly go off 2 Error3 or 1 Error4 Displayed on 2 screen Error i displayed on screen 27 yBA indd 21 Possible Reason Finger is not inserted correctly Patient s oxyhaemoglo bin level is too low to be measured Finger might not be inserted far enough Finger is trembling or the patient s body is moving Battery power may be inadequate or not be there at all Batteries may have been inserted incor rectly The oximeter might be damaged There is no finger on the pulse oximeter or finger is not positioned properly The product is automa tically switched off if no signal is detected for longer than 8 seconds Low power Batteries empty Low power Batteries empty Receiving sensor shielded or sensor damaged Low power Batteries empty Infrared sensor damaged 21 2 Have the device tested by Solution 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 precise diagnosis Try inserting the finger again Try not to move Please replace batteries Please reinsert the batteries the manufacturer Place your finger in the oximeter Normal Replace the batteries Insert new batteries Have the device tested by the manufacturer Change the batteries Have the device tes
10. ted by the manufacturer 24 09 2013 11 31 83 yBA indd 22 CLEANING INSTRUCTIONS Please use medical alcohol to clean the synthetic material tou ching the finger inside the oximeter and clean the test finger before and after using Please clean the surface of pulse oxime ter for every use DISPOSAL Observe the applicable regulations when disposing of the device and batteries This product must not be disposed of X together with domestic waste All users are obliged to hand in all electrical or electronic devices regardless of whether or not they contain toxic substan ces at a municipal or commercial collection point so that they can be disposed of in an environmentally acceptable manner Please remove the batteries before disposing of the device unit Do not dispose of old batteries with your household waste but at a battery collection station at a recycling site or in a shop WARRANTY This pulse oximeter is guaranteed for 2 years from the date of purchase against manufacturer s defect under conditions of nor mal 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 are covered by this warranty The warranty does not co ver damage to your unit due to improper handling The manufac turer recommends that the accuracy of the device be checked b
11. ted by absorption and reflection from structures objects and people Guidance and manufacturer s declaration electromagnetic immunity The device is intended for use in the electromagne tic environments listed below and should only be used in such environments Immunity IEC Com Electromagnetic environment test 60601 pliance guidance test level level Radiated 3V m 3 V m Portable and mobile RF communications RF 80 MHz equipment should be used no closer to any IEC 61000 1925 part of the device including cables than 4 3 GHz the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Empfohlener Trennungsabstand d 1 2 VP d 1 2vP 80 MHz to 800 MHz d 2 3VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compli ance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Elec tromagnetic propagation is affected by absorption and reflection from structures objects and people 25 y BA indd 25 24 09 2013
12. y 30 to 99bpm 2bpm 100 to 235bpm 2 Resolution 1BPM Wavelength Radiant Power RED 660 2nm _ 1 8mW IR 940 10nm_ 2 0mW NOTE The information about wavelength range can be es pecially useful to doctors Power Requirement Two AAA 1 5V 600mAN alkaline batteries Power consumption Less than 30mA Battery status indicator Alkaline batteries could be continuously operated as long as 30 hours IP Classification IPX1 Protection against vertically falling drops of water Dimensions Length 58 mm Width 32 mm Height 34 mm Weight 50g including 2 Batteries Environmental Requirements Operation Temperature 5 bis 40 C Storage Temperature 20 bis 55 C Ambient Humidity lt 80 bei Einsatz lt 93 bei Aufbewahrung Atmosphere pressure 86 kPa bis 106 kPa quality Guarantee Geratherm is certified according to Di rective 93 42 EEC and EN ISO 13485 and entitled to the application of the mark C 0197 Notified Body T V Rheinland LGA Products GmbH EN 9919 2005 Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medi cal use 20 24 09 2013 11 31 83 POSSIBLE PROBLEMS AND SOLUTIONS Problem SpO or PR le cannot be shown normally 2 SpO or PR is j shown unstably 2 The oximeter I Cannot be switched On 2 5 Finger out 1 Displayed on screen Indicatio
13. y an authorized laboratory every 2 years Adhere to the applicable regulations when disposing of the device SYMBOL INDEX A Attention consult accompanying documents Type BF applied part ZX No SPO Alarm Sp z a Keep dry ms The device must not be disposed of with household waste Store between 10 and 93 R H A Store between 20 C and 55 C Batch code mm yyyy month year SN Serial number wl Geratherm Medical AG Fahrenheitstrake 1 wl Manufacturer 98716 Geschwenda Germany owl Date of Manufacture www geratherm com 22 24 09 2013 11 31 4 APENDIX Information on electromagnetic compatibility EMC Electronic devices such as PCs and mobile phones can lead to the exposure of medical devices in operation to electromagnetic interference from other devices This can lead to malfunction of the medical device and create a potentially unsafe situation Medical devices should also not interfere with any other devices The EN 60601 1 2 standard regulates the requirements for EMC electromagnetic compatibility and defines the levels of immuni ty to electromagnetic interference and the maximum electromagnetic emission levels for medical devices This pulse oximeter which is manufactured by Geratherm Medi cal AG complies with the EN 60601 1 2 2007 standard in relati on to both immunity and emissions However special precautions should be observed Guidan
Download Pdf Manuals
Related Search