User Manual - Bioresonator Good Eye
Contents
1. BioResonator Good Eye User Manual ART Manual Applanation Resonance Tonometer for clinical use 1011 ART MUM en A IMPORTANT Read all instructions and warnings before use ART Manual operators must be trained before using the system A WARNING Never lift the instrument by its head the measurement sensor can be damaged BioResonator will only accept liability for effects on the safety usability and design of the equipment if The equipment is used in accordance with its intended use and maintenance and repair are performed by persons authorized by BioResonator and installation and configuration of software are performed by persons authorized by BioResonator and noother software is installed in the system and the device is used according to the production documentation and the equipment is used fitted as designed to a slit lamp and biomicroscope as per this manual chapter 4 and the equipment is checked before use as per this manual and the equipment may not be used if it is damaged in any way 2 ARTG Manual User Manual ART en doc The following labels and markings on ART Manual contain warning texts together with mandatory information and instructions ART Manual mm BioResonator Good Eye AB 0413 Tvistevagen 47 SE 907 19 Umea SWEDEN Nameplate on the exterior of the battery cover contains information relating to the mandatory requirement to re2. 40 ART R is an accessory that allows the ART to be hung from the slit lamp The slit lamp biomicroscope must have a pole for an R bracket supplied by the respective lamp manufacturer fitted to it before the R mount can be used Figure 2 5 R mount See section 4 1 2 for instructions on fitting the ART unit using the R mount 12 ART Manual User Manual ART en doc 3 Safety rules 3 1 Intended use The ART unit is designed to measure intraocular pressure IOP during eye examinations by direct measurement of intraocular pressure on an anaesthetised cornea The unit is intended to be used by personnel specifically trained in its operation For training and information about the ART Manual contact your local dealer see section 6 7 and 8 5 3 2 General Safety rules The unit is not supplied with the battery installed The battery should never be installed in the unit during transport but should instead be stowed in its intended compartment in the case Never keep the unit close to heat sources or places where the unit may heat up unsupervised or unknowingly e g in direct sunlight there is a risk of burn injuries where patients and or users touch hot components In order to minimize the risk of external interference on the ART unit it must not be used close to strong sources of electromagnetic radiation e g diathermy equipment 3 3 Patient safety Use of the ART unit must always be base
3. R E Se RENE enter Nd 12 2 3 1 R moOUurit 5 iie tete tieu E UR ee PE ERE eek dodo 12 3 Safety r le5 4 rr We PER ERU Ree eire 13 3 1 intend d Br M 13 3 2 General Safety r l s in amer en oet sea aret lan leve 13 3 3 Patient safety 13 3 4 Eunctlonal safety 4 de e e ae 14 4 Haridling ctor tr ei rt toot pet Ee da 15 4 1 Tan o D AAE E E EEA b AS E EENE tpe eleg Maa a ares ne 15 4 1 1 Fitting of ART unit on slit lamp biomicroscope 15 4 1 2 T mount 4 1 3 R mount 4 2 Battery charging and handling eene 18 4 3 Control panel 20 4 4 Visual information ce ec aceti cech rero de a ete re at 22 4 4 1 Aligning light symbol esses 22 4 4 2 Battery symbol e ar ea tie aai reiii nennen nns 23 4 4 3 Messages E EA A E T 23 4 4 4 Error Messages ss 25 4 5 Audible signals enne 25 5 NURSES 26 5 1 Prepare for measurement mentale iste 26 5 2 Measuring procedure 26 5 3 Interpretation of quality index 28 5 4 Measurement flowchart ss 29 6 Care and maintenance 30 4 ART Manual User Manual ART en doc 6 1 OVerVieW irse ne terne nee road a tee au LR en ES 6 2 Safety check before during use 6 3 Cleaning and disinfection 6 3 1 Cleaning the casing E E 6 3 2 Cleaning of sensitive parts 31 6 4 Battery 6 5 Storage 6 6 Automatic system check
4. RT unit s components parts or accessories may be exposed to sterilisation processes The unit and its accessories are not cleaned disinfected when supplied but this must take place before initial use 6 3 1 Cleaning the casing The instrument housing the sensor housing the sensor arm and any accessories must be cleaned at regular intervals the recommended interval is once daily more frequently in the presence of suspected contamination All components must be cleaned before storing in their storage case The recommended method of cleaning these parts is drying with an alcohol swab or soft cloth towel e g Kleenex towel lightly moistened in alcohol 70 96 Ethanol Isopropanol Note that the cloth must not be dripping wet as this may damage the unit 6 3 2 Cleaning of sensitive parts The sensor tip the sensor element and the connector at the end of the sensor housing must be cleaned as described below before the first ART Manual 31 User Manual ART en doc measurement between patients after a completed measuring period i e at the end of the day and also before the unit is packed away in its storage case 1 Moisten a clean dry cloth with spirit 70 ethanol isopropanol Make sure the cloth is sufficiently moist to clean properly but not dripping wet 2 Carefully clean the entire sensor tip the part of the sensor element that is accessible and all round the entire connector See Figure 6 2 Avoid direc
5. ad the manual before using the ART Manual and that on disposal of the instrument it is obligatory to follow the WEEE directive See also chapter 8 5 The Battery nameplate on the battery contains a warning not to incinerate or disassemble the battery short the battery terminals or expose the battery to temperatures greater than or equal to 100 C since this involves risk of fire or explosion The nameplate also includes information regarding the mandatory requirement to dispose of the instrument according to the WEEE directive see also chapter 8 5 The nameplate on the inside of the battery compartment contains information about the type of battery Varta EasyPack L and arrows indicating in which way the battery contact plates should be oriented ART Manual 3 User Manual ART en doc Contents 1 Introductions nes ence tite ete ie dre rte 6 1 1 D finitions Msn EE 6 1 2 General description ss 6 1 3 Witendbd usb code SRL Nana nee p eI SN tt 6 1 4 A Pa ST Led PEDE 7 1 5 Contraindications nr 1 6 Died ii mr y 1 7 ITEMS RTS aeree pred exe one e uctus dai nn o P 7 1 8 The Manual 8 2 System descriptions cer ero tanins ER Reges 9 2 1 The ARTO Unite atten Cree ne tte aks ehe eie inate tes ati tes ant 9 2 2 Standard accessories geoin anie ieii aa aE 11 22t T mo nt eem we 11 2 2 2 Battery and battery charger 11 2 3 ACCeSSOF GS 4 252 c ed PS de cede e eee REO e PA NE
6. against cornea Tone Short high M Correct measurement Figure 5 1 ART Manual 29 User Manual ART en doc 6 Care and maintenance 6 1 Overview The user must visually manually inspect the unit and its accessories prior to use The following points must be checked Status of the battery cover the cover must not be loose Sensor housing and sensor arm must be undamaged and not subject to any strain Instrument housing no scratches or damage to the control panel No visible fluids moisture on any part of the unit or accessories R T mount correctly attached to the unit R T mount and unit firmly mounted on the slit lamp 6 2 Safety check before during use The following points must be checked before use while using the ART unit to take a measurement series and also if there are any doubts concerning the function or safety of the instrument See Figure 6 1 below for guidelines Tip these checks may be performed at the same time as the unit is cleaned disinfected as per section 6 3 30 Check that the unit is properly attached to the adapter in use R or T mount The unit must be firmly attached to the adapter and the adapter must be firmly and securely mounted on the slit lamp Check that the sensor tip is undamaged and properly located ART Manual User Manual ART en doc Sensor tip Sensor housing Figure 6 1 6 3 Cleaning and disinfection None of the A
7. art up system started tone Measuring mode measurement commenced stop applanation Medium length high pitched tone Measuring mode New measuring series commenced Measuring mode result accepted relieve cornea Long multi tone Measuring mode measuring series finished Long dull tone Measuring mode the measuring result is not accepted try again Other modes an error has occurred ART Manual User Manual ART en doc 25 5 Measuring 5 1 Prepare for measurement Install a charged battery section 4 2 in the unit and attach the unit to the slit lamp section 4 1 3 or 4 1 2 The unit must be checked as described in section 6 1 and 6 2 must be done before the first patient between patients and if there is a suspected fault with the unit The unit must be cleaned disinfected as per instructions in section 6 3 Moisten a clean dry cloth with spirit 70 ethanol isopropanol Make sure the cloth is sufficiently moist to clean properly but not dripping wet Carefully clean the entire sensor tip 5 2 Measuring procedure When the ART unit is fitted on the slit lamp and the preparations as per section 5 1 completed the unit is ready to use 1 Anaesthetise the patient s cornea s and wait for the anaesthetic to achieve its full effect I 2 Switch the unit on using the Off On button Q 3 Waituntil the display shows Ready to measure 4 Position the
8. ay mode after 2 minutes of inactivity If a measurement has commenced this current measurement finishes and the unit goes into display mode l In all modes a 2 second press on the On Off buttons O switches the unit off The message Powering down shows on the display ART Manual 21 User Manual ART en doc 4 4 Visual information The visual information is notified via the display which is divided up as per Figure 4 5 Battery symbol Pressure IOP 212 0 Q3 nz5 1 Aligning light symbol Measuring T Message Quality index Measurement number Figure 4 5 4 4 1 Aligning light symbol The aligning light is only active in measuring mode and the chosen light intensity level is shown in the display when the user adjusts the intensity When the unit is started the light intensity is set at level 1 Four modes of light intensity are available O off 1 2 and 3 ey The aligning light is off level 0 o The aligning light is set at level 1 The aligning light is set at level 2 g The aligning light is set at level 3 Figure 4 6 Indication of aligning light intensity 22 ART Manual User Manual ART en doc 4 4 2 Battery symbol Battery status is indicated by the battery symbol on the display When the battery is fully charged the battery symbol is shown in full decreasing as the battery charge reduces When the battery requires charging a Charge battery message
9. calibration 6 7 Training advice and help ss 7 Troubleshooting orseson arnan ia nennen nnns 7 1 Error Messages 7 2 Common causes of Measurement faileds 8 Appendix eerte te he ee ente iiber aaaea a Haas it 8 1 Technical Specificatigrs 5 Ann nn tel 8 2 Aligning light intensity 8 3 Other accessories items not supplied 36 8 4 Guarantee 36 8 5 Support and service collection 37 ART Manual 5 User Manual ART en doc 1 Introduction 1 1 Definitions ART Applanation Resonance Tonometer IOP Intraocular pressure 1 2 General description The Applanation Resonance Tonometer ART Manual ART the ART unit is a new type of contact tonometer intended for use by ophthalmologists trained and experienced in use of contact tonometers A resonance sensor with an integral aligning light is applied to the centre of the patient s cornea On contact with the cornea the system senses the size of the area applanated by the sensor By continuously measuring the force and the contact surface the intraocular pressure IOP can be calculated The operator hears an audible signal when a sufficient contact surface has been obtained and also when sufficient data has been collected and the sensor tip can be removed from the cornea Numerical results from calculation of IOP and a quality index Q1 Q2 or Q3 are shown on the unit s display The quality index reflects the quality of the mea
10. d on caution and professional medical assessment especially where the patient suffers from an eye disease or condition where contact with the cornea may cause injury or aggravate an existing condition The ART unit must never be used unless the patient s cornea has been anaesthetised ART Manual 13 User Manual ART en doc Before each measurement on a new patient the ART unit must be cleaned and disinfected as per the description in section 6 3 An assessment of the patient s tolerance to light intensity must always take place after which the intensity of the aligning light should be adjusted Section 4 4 1 contains a description of the intensity of the ART unit aligning light 3 4 Functional safety Never dip or immerse any part of the ART unit in any form of liquid If a liquid penetrates any part of the unit it must not be used but instead must be returned to the distributor for testing see section 8 5 Always follow the instructions for cleaning and disinfection in section 6 3 Failure to do so may result in the unit being damaged and or exposure of patients and users to contaminated parts Caution should be observed when touching components of the unit especially the moveable arm and sensor housing since incorrect handling may damage the unit resulting in potential risk to the user or patients No tools are required or should be used when operating the ARTG Any attempt to open or modify the unit inv
11. for the current measured value A measured value usually consists of a consecutive series of three individual two second duration measurements If Q1 is obtained the measurement series is stopped and an IOP value is shown on the display If Q2 or Q3 is obtained the operator can choose to extend the measurement series to a maximum of six repetitions The operator can choose to stop the measurement at any time though a Q index is not obtained until after three individual contacts with the cornea If an insufficient number of measurement points have been collected during one measurement e g due to the patient blinking during the ART Manual 27 User Manual ART en doc measurement the system can still calculate the IOP based on the available data so called dynamic analysis 5 3 Interpretation of quality index Once three measured values have been obtained n 3 a quality index is displayed together with an IOP value Q1 Measuring series with high reliability Q2 Measuring series is OK but the measuring series standard deviation is somewhat high Q3 Measuring series has high standard deviation and should be repeated All measured values are shown in millimetres of mercury mmHg 28 ART Manual User Manual ART en doc 5 4 Measurement flowchart Measuring procedure On Off short press pupa rar l Tone Intermediate I i aig Tone Long low Tone Long high Application
12. hnical Specifications These technical specifications are valid for a period of 6 years from the date of purchase providing that all instructions in this manual have been complied with Item number 1460 2AD034 Description Applanation Resonance Tonometer Type of instrument Contact tonometer Name ART Classification Class lla according to MDD 93 42 Certification EU CE Ultrasound intensity estimated 134 mW cm IOP measuring range 7 50 mmHg IOP accuracy of measurement 0 2 mmHg Numerical precision Battery voltage 3 7V Battery model VARTA EasyPack L Battery charger RRC EZPO6DC Usage time for 5 measurements hr At least 8 hours Dimensions 172 H x 83 W x 71 D mm Temperature range in use 10 35 C Temperature range stored 10 55 C Air pressure in use 800 1060 hPa Air pressure stored 700 1060 hPa Ambient humidity in use 30 75 96 Ambient humidity stored 10 95 Weight without with battery 193 221 g approx ART Manual User Manual ART en doc 35 Weight including packaging 3000g with accessories approx 8 2 Aligning light intensity The ART unit has an aligning light which facilitates centring of the sensor on the cornea to ensure correct contact when taking a measurement The light source is a l
13. ight emitting diode LED that produces white visible light The total width of the beam emitted by the LED is 380 800 nm The maximum available energy for powering the LED at maximum intensity is 80 mW and at an optimised efficiency of 25 the normal efficiency for this type of LED is 10 2096 the emitted optical output is approx 20 mW not taking into account loss due to the light s passage through the sensor tip The norm for ophthalmological instruments EN ISO 15004 limits the permitted radiated light intensity in the wavelength range 380 700 nm to 49 mW Consequently 20 mW 49 mW is deemed to be the maximum acceptable radiated light intensity of the ART instrument with regard to possible risks for patient and user 8 3 Other accessories items not supplied e R mount for mounting the ART onto a biomicroscope e Cleaning disinfection agent see section 6 3 for information about recommended agents 8 4 Guarantee For guarantee terms see the separate guarantee slip delivered with the unit or provided by the local distributor 36 ARTG Manual User Manual ART en doc 8 5 Support and service collection All maintenance and servicing of the ART unit and its accessories is to be performed by the local distributor or someone acting on their behalf The ART unit has no parts that can or must be repaired by the operator user Any attempt to repair and or modify the unit represents a breach of the guaran
14. led by means of two buttons located on a control panel that faces the operator Display se W Aligning light intensity O On off Figure 4 4 These buttons have different functions depending on which mode the system is in Mode Description of buttons and display functions in different modes Off No information is displayed on the screen The unit is switched on by pressing briefly on the On Off button Start up The unit is initiated and undergoes a system test The buttons are inactive in this mode 20 ART Manual User Manual ART en doc Measuring mode In this mode the system waits for the sensors to detect a commenced measurement A short press on the l On Off button O discontinues the measurements and moves to the display position vie The VB button changes the intensity of the aligning light Display mode In this mode the measurement value from the current measurement series is displayed A short press on the l On Off button O leaves this mode and switches to Measuring mode The unit can also go into two energy saving modes Standby display n display mode the background light on the display goes off after 2 minutes of inactivity A short press of I the On Off button O switches on the background light After a further 3 minutes the unit switches off Standby measurement In measuring mode before a measurement commences the system returns to displ
15. nced in eye examinations involving use of contact tonometers All users must be trained to operate the unit For training and information about the ART Manual contact your local dealer see section 6 7 and 8 5 ART Manual 7 User Manual ART en doc 1 8 The Manual Before using the ART unit the operator must study the information contained in this manual in order to ensure that the function and properties of this unit are taken into consideration when using it Failure to comply with the instructions contained in this manual may entail some risk for the patient and or the user The following symbols are displayed on the marking on the unit and their meanings are explained below Symbol Meaning Type BF applied part R IEC 60601 1 Read and follow the instructions for use A Failure to observe the instructions may involve some risk to the patient and or the user CE marking Conformit Europ enne M M 0413 SN The unit serial number Electrical and electronic products that must be disposed off separately in accordance with the WEEE Directive Lid A flowchart is also supplied as reference when using the ART unit This chart is not intended to replace the manual and all the rules and instructions contained in the manual must be followed when using the unit 8 ART Manual User Manual ART en doc 2 System description 2 1 The ARTe unit The ART system is
16. olves a potential risk to the user and or the patient Handle the battery and the charger with care and ensure that the battery is charged at regular intervals Only accessories supplied with the unit or by an official distributor may be used Using accessories from any other source may involve a safety risk 14 ART Manual User Manual ART en doc 4 Handling 4 1 Assembly 4 1 1 Fitting of ART unit on slit lamp biomicroscope The ART unit can be fitted on a slit lamp biomicroscope in two different ways by using an R mount see section 4 1 3 and by using a T mount see section 4 1 2 The ART unit has currently been tested for use with Haag Streit 900 and CSO 990 slit lamps although it can be used with most other brands When fitted with any of the adapters the unit s display is visible to the operator and the control panel is accessible ART Manual 15 User Manual ART en doc 4 1 2 T mount To be compatible with the ART unit with T mount the slit lamp requires 8 0 mm diameter centre hole fixing track on the front edge of the fastening 9 6 mm and outer diameter on the fixing plate of gt 42 mm Fitting of ART unit on slit lamp with T mount 1 Locate the ART unit on the adapter and adjust it so that the hole in the adapter marries up with the hole in the bottom of the unit 2 Fix the adapter to the unit with the two screws provided see Figure 4 1 Use a T25 Torx wrench 3 Fit the ART unit
17. on the slit lamp by placing the pin on the T mount in the hole in the plate on the slit lamp Check that the unit is level and stable Figure 4 1 16 ART Manual User Manual ART en doc 4 1 3 R mount To be compatible with an ART unit with an R mount the R bracket attachment shaft must have a diameter of 12 0 mm Fitting the ART unit on slit lamp biomicroscope with R mount 1 Remove the two cover plugs which sit over the screws see 4 2 2 Fixthe R mount on the ART unit with the two included screws see 4 2 after removing the two cover plugs which sit over the screws Use a T25 Torx wrench 3 Attach the R mount on the fitting axle for R fixing 4 Check the unit s stability by swinging it in both directions and then returning it to its central position i e with the sensor housing facing forwards Figure 4 2 ART Manual 17 User Manual ART en doc 4 2 Battery charging and handling The battery is charged in a separate charger supplied with the unit The battery must be charged before initial use Instructions for use of the supplied battery charger can be found in the separate manual supplied with the unit Always follow these instructions in order to avoid damaging the battery or the charger A full charge is indicated by a constant green light on the charger Remove the battery from the unit by opening the battery cover on the left side of the unit as seen from the front and pulling the projecting pa
18. rt of the cover straight out Never open the battery cover with the compartment facing down since the battery may fall out and break If the battery is stuck for some reason carefully tilt the unit onto its side with the battery compartment facing downwards Be careful and be prepared for the battery to suddenly come loose make sure that it does not fall and knock into anything A damaged battery may cause damage to the unit and or personal injury to the patient and or operator The battery cover in the ART unit must be kept closed during charging to prevent any moisture or dust getting in These instructions are reversed to replace the battery insert the battery in the unit with the contacts on the side of the battery facing inwards see 4 3 Shut the cover An audible click indicates that the cover is properly shut and is locked Check that the battery has been inserted properly by switching the unit on and off 18 ART Manual User Manual ART en doc Figure 4 3 The unit is not supplied with the battery installed The battery should never be installed in the unit during transport but should instead be stowed in its intended compartment in the case For optimum battery life and performance the battery should be charged at least once every six months The first charge should take place no later than one year after delivery ART Manual 19 User Manual ART en doc 4 3 Control panel The ART unit is control
19. sensor tip close to the patient s eye a distance of about 5 10 mm is suitable with the tip centred relative to the cornea 5 Adjust the aligning light intensity as required using the 1 Aligning light intensity button 6 Carefully move the tip forwards in a gentle movement towards the patient s eye stopping when you hear a tone A short high 26 ART Manual User Manual ART en doc pitched tone confirms that a measurement has been started a long dull tone indicates an error in measurement and measurement is then repeated 7 Once the system has sufficient data to calculate the IOP the unit emits a high pitched light tone once again and the sensor tip must then be withdrawn from the cornea If the measurement was conducted correctly and the measurements have been accepted the calculated values are shown on the display and the message Ready to measure is shown once again If a measurement fails a dull tone is emitted and the system ignores the data collected An error message displays for 3 seconds and the system then returns to measuring mode The message Ready to measure is then redisplayed 8 Repeat steps 6 7 up to five more times to obtain a complete measurement series The user may stop the measurement at any time by pressing the I On Off button O When the measurement series is concluded the messages Measure complete displays and the system returns to display mode
20. shows on the display The battery is fully charged a The battery is half full The battery is empty 4 4 3 Messages The following illustrations show examples of various values and messages that are shown on the unit s display L 1 Figure 4 7 Off no information is displayed ART1 Software Version 1 0 2010 06 30 BioResonator 2010 System Starting Figure 4 8 Start up system information is displayed ART Manual 23 User Manual ART en doc do Ready to measure Figure 4 9 Measuring mode before first measurement 1 UI be Ready to measure Figure 4 10 Measuring mode after accepted measurement measurements 1 and 2 o1 Jmm Q2 n 3 Ready to measure Figure 4 11 Measuring mode after accepted measurements 3 4 5 and 6 a quality index is also given 24 ARTG Manual User Manual ART en doc o1 I Q1 Measure complete n 4 Figure 4 12 Display mode Following completion of a measurement series the unit switches to display mode and the measured value and quality index are displayed 444 Error Messages Any error messages are presented on the display See section 7 1 for a list of error messages and their content 4 5 Audible signals The system produces audible signals that notify the operator of the unit s status These signals vary depending on what mode the system is in Signal Mode Meaning Short high pitched St
21. supplied in a case containing ART tonometer T bracket for slit lamp an R bracket is available as an accessory Battery Battery charger Torx wrench T25 Sensor housing _ __Sensor tip Sensorarm Instrument housing Figure 2 1 ART Manual User Manual ART en doc Display Control panel Battery cover Figure 2 2 The battery provides power to the unit during operation It is charged outside the unit in a separate charger 10 ART Manual User Manual ART en doc 2 2 Standard accessories Standard accessories are understood to mean the accessories included in the standard version of the ART unit 2 2 1 T mount The unit is supplied with a T mount item 1030 ART T which is used to fit the ART unit standing on the slit lamp Figure 2 3 T mount See section 4 1 2 for instructions on setting up the ART unit using the T mount 2 2 2 Battery and battery charger The unit is supplied with a battery Varta EasyPack L item 1051 ART B and a charger item 1050 ART BC with a mains lead The charger can operate on mains supplies of 100 240 V AC 50 60 Hz Figur 2 4 Battery and battery charger See section 4 2 for description of battery charging and handling ART Manual 11 User Manual ART en doc 2 3 Accessories Accessories refers to attachments compatible with the ART unit For information contact the manufacturer see section 8 5 2 3 1 R mount The R mount item 10
22. surement series with Q1 being the highest quality and Q2 being good quality It is recommended that Q3 level readings be repeated The user is provided with information via both a visual display and audible signals 1 3 Intended use The ART unit is designed to measure intraocular pressure IOP during eye examinations by direct measurement of intraocular pressure on an anaesthetised cornea 6 ART Manual User Manual ART en doc The unit is intended for use by personnel trained specifically in use of this unit For training and information about the ART Manual contact your local dealer see section 6 7 and 8 5 1 4 Indications Indications for use include the diagnosis and follow up of patients with suspected abnormal intraocular pressure 1 5 Contraindications Use of the unit is contraindicated where contact with the cornea may cause or aggravate injuries and or pathological conditions or cause unnecessary suffering for the patient Contact lenses must be removed before the anaesthetic is applied Medical diagnoses should not be made solely on the basis of measured intraocular pressure 1 6 Normal use ART Manual is intended for routine clinical use and it is used as an aid in diagnosing and monitoring intraocular pressure The unit is intended to be used by personnel specifically trained in its operation 1 7 Intended users The unit is intended for use by medically trained personnel experie
23. t contact with the fingers Check that the sensor tip is undamaged 3 Note that the sensor element contains a small proportion of nickel 4 Allow all cleaning agents fluids to evaporate before using the unit Sensor tip Flange Sensor housing Sensor element Figure 6 2 Never use cleaning agents that are applied by means of a spray can or similar as this may damage the unit Never use any kind of tool or brush for cleaning as this may damage the unit 32 ART Manual User Manual ART en doc If you are at all uncertain about cleaning its effect or the unit s function and or safety stop using the unit and contact the distributor for advice see section 8 5 6 4 Battery To obtain optimum battery life and performance the battery should be charged at least once every six months 6 5 Storage The climate in which the unit is stored must meet the criteria stated in the technical specifications in section 8 1 6 6 Automatic system check calibration When the unit is switched on from the off mode the system runs a self check This includes checking the resonance sensor the power indicator and other system parameters If the system should detect an error or deviated value the user is presented with an error message If this happens stop using the unit and report the fault to the distributor see section 8 5 The unit is calibrated on supply from the distributor and no new calibration is required
24. tee terms and as a result the function and safety of the unit cannot be guaranteed For local distributor visit www bioresonator com Manufactured by Address BioResonator Good Eye AB Tvistevagen 47 Box 7952 SE 907 19 Umea Sweden URL http www bioresonator com E mail address info bioresonator com Note that the unit contains substances that may be harmful to people animals and the environment The unit may not be disposed of by the user but it must instead be returned to the distributor Used batteries that can no longer be fully charged must be disposed of in accordance with local laws and regulations ART Manual 37 User Manual ART en doc ce BioResonator 2014 10 10 Good Eye
25. with normal use If you suspect deviating results and or incorrect function as a consequence of incorrect calibration stop using the unit and report the fault to the distributor see section 8 5 6 7 Training advice and help All operators must undergo training for the ART Manual unit approved by BioResonator AB For training advice and help with the ART Manual unit and its accessories contact your local distributor For contact information see section 8 5 ART Manual 33 User Manual ART en doc 7 Troubleshooting 7 1 Error Messages The following error messages may be displayed when taking measurements using the ART unit Error message Meaning cause Measurement failed See 7 2 for usual causes Charge battery The battery needs charging Technical problem contact Fault in resonance sensor distributor contact distributor see 8 5 7 2 Common causes of Measurement faileds There are a number of reasons why the unit may give erroneous measurement results or indicate errors in measurement Frequent causes are found below e Object between the sensor tip and the cornea surface e g hair strand part of the eyelid etc e The patient blinked during the measurement procedure e The patient moved during the measurement procedure and the sensor tip lost contact with the eye e The patient has abnormally moist or dry corneas 34 ART Manual User Manual ART en doc 8 Appendix 8 1 Tec
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