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Guidelines and manufacturer's declaration

–

Electromagnetic emissions

METRAX GmbH

DefiMonitor XD 21324 / GB / K05

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electromagnetic environment with regards to the stationary transmitters, a study of the location

should be considered. If the field strength measured at the location in which the PRIMEDIC™

DefiMonitor XD is operated exceeds the conformance levels for HF listed above, the

PRIMEDIC™ DefiMonitor should be monitored to ensure that it is functio

ning correctly. If

unusual performance characteristics are observed, then it may be necessary to take additional
measures, such as change the orientation or the location where the PRIMEDIC

DefiMonitor

XD is being used.

Above the frequency range of 150 kHz to 80 MHz, the field strength should be less than 3

V/m.

Содержание DefiMonitor XD

Страница 1: ...Operating instructions MGA21324 GB K05 DefiMonitor XD ...

Страница 2: ...RAX GmbH reserves all rights to these operating instructions Without approval from METRAX GmbH these operating instructions may not be duplicated or made accessible to third parties The same applies to individual parts or excerpts of these operating instructions Non compliance with this gives rise to a right to claim damages and can have consequences under criminal law refer to DIN 34 ...

Страница 3: ... 4 1 General description 20 4 2 Description of device details 22 4 3 Capacity display 33 4 4 Data management 34 4 5 Description of the accessories 35 4 5 1 Paddles 35 4 5 2 PRIMEDICTM SavePads Connect cable 36 4 5 3 PRIMEDICTM SavePads 36 4 5 4 ECG patient cable 3 pin 37 4 5 5 SpO2 Sensor only for PRIMEDIC DefiMonitor XD3 XD30 XD300 XD330 38 5 Preparatory measures before initial start up 39 5 1 Un...

Страница 4: ...ositioning the ECG self adhesive electrodes 58 8 2 3 Positioning the PRIMEDIC SavePads Connect for pacing 58 8 3 Removing hair growth from chest 60 8 4 Drying the skin 60 8 5 Placing the electrodes 60 8 6 Checking the electrodes 61 8 7 Changeover of ECG source 62 9 Auto mode AED mode 63 9 1 Voice output by the device Preliminary examination of the patient 63 9 2 Carrying out ECG analysis in Auto m...

Страница 5: ...4 List of error codes 81 15 Disposal 87 16 Technical Data 88 17 Accessories 92 18 Warranty conditions 93 19 Depiction of the current time function 94 20 Rhythm detection system in AED mode 101 21 General information on the use of pulse oximeters 104 22 Guidelines and manufacturer s declaration Electromagnetic emissions 106 23 General instructions and rules for using PRIMEDIC AkuPaks 111 24 Safety ...

Страница 6: ...ducts we are at your entire disposal You will find our contact address on the masthead at the start of these operating instructions 1 2 Validity The information given in these operating instructions applies to all models in the defibrillator range PRIMEDIC DefiMonitor XD made by METRAX GmbH Please note that depending on its specific configuration your device may not correspond in all details to th...

Страница 7: ... device with the protective covers removed or when there is obvious damage to cables and or electrodes Non compliance with the instructions in these operating instructions with regard to operation maintenance and repair of the equipment Using accessories and spare parts made by other manufacturers Autonomous intervention repairs or constructional changes to the device Autonomous overrunning of the...

Страница 8: ...r even death It is imperative that you follow these instructions CAUTION Texts marked with CAUTION indicate a possible dangerous situation which could lead to minor injuries or damage to property It is imperative that you pay attention to these texts Note This symbol indicates text which contains important advice comments or tips This point identifies the first step of a sequence of actions you sh...

Страница 9: ...device in domestic refuse Dangerous electric voltage high voltage Degree of protection CF in connection with ECG patient cable 10µA patient leakage current NC normal condition 50µA patient leakage current SFC single fault condition 100µA patient leakage current SFC defibrillation outputs according to IEC60601 1 and IEC60601 2 4 Fig 1 Brief instructions on use of devices with AED mode Fig 2 Brief i...

Страница 10: ... Batch ID Only for adults Order number Storage temperature in Celsius and Fahrenheit 1 8 Image mark on the encompassing packaging Sticker on the encompassing packaging for the PRIMEDIC AkuPak LITE for airfreight despatch Sticker on the encompassing packaging for the PRIMEDIC AkuPak LITE for road rail marine despatch ...

Страница 11: ...ECG electrodes are used instead of the defibrillation pads dual channel monitoring is possible A random appropriate selection of 2 signals from the Einthoven I II III or Goldberger aVR aVL aVF analogue derivations can be displayed This requires correct positioning of the electrodes as described in the operating instructions A further configuration of the device is to equip it with an SPO2 module a...

Страница 12: ...cause interference as a result of the increased electromagnetic emission In this case the limitations described in the operating instructions apply or where possible shut off or screen the sources of the interference WARNING Any use above or beyond this is not considered as intended use and can lead to personal injury or damage to property The PRIMEDIC DefiMonitor XD may only be used as described ...

Страница 13: ...defibrillator unit of the PRIMEDIC DefiMonitor XD must not be used if the patient is conscious or the patient is breathing normally or a normal pulse can be felt or asystolia or electrical activity without a pulse is detected For automatic mode is a child under the age of 8 or weighing less than 25 kg respectively 2 2 Possible complications WARNING Irritation of the skin or even burns if for examp...

Страница 14: ...se of the defibrillator can lead to ventricular fibrillation asystolia or other dangerous dysrhythmia The operator of the PRIMEDIC DefiMonitor XDs is responsible for ensuring that the PRIMEDIC DefiMonitor XD is only used by authorised and trained specialist personnel Note The guidelines governing the application of emergency treatment in the event of cardiac arrest may change The device described ...

Страница 15: ...ER For this reason we emphatically advise that before using for the first time all those who are supposed to use this device or want to use it must be instructed in a training session about the medical background of defibrillation and the indications or contraindications and thus need to be authorised need to read and take note of these operating instructions and in particular the safety tips and ...

Страница 16: ...eration and Use of Medical Devices MPBetreibV According to the Ordinance on the Operation and Use of Medical Devices MPBetreibV the device is to be subjected to the regular checks explained in the appendix According to the Ordinance on the Operation and Use of Medical Devices MPBetreibV a medical devices log needs to be kept for the device Regular checks of the device are to be documented in it Fo...

Страница 17: ...ion devices which present unintended paths for the defibrillation current Although the DefiMonitor XD and its original accessories are defibrillation protected we recommend that you do not touch them while defibrillation is being carried out with another device 3 4 Safety notes for protection of the patient DANGER Do not use the device on a patient unless you have ensured its operational safety be...

Страница 18: ...illation proof and are used on the patient Keep the defibrillation electrodes and the ECG electrodes away from other electrodes metal objects and earthed objects Do not use the device in AED mode on children under the age of 8 or children with an estimated body weight of less than 25 kg Position the electrodes precisely according to the description Dry the chest and carefully remove any large amou...

Страница 19: ...pairs changes extensions and installations of the PRIMEDIC DefiMonitor XD may only be carried out by personnel authorised and trained by METRAX The PRIMEDIC DefiMonitor XD does not have any parts that can be repaired by the user Use only accessories which meet the requirements of the relevant laws EU directives and other standards This applies in particular to the SPO2 sensor self adhesive electro...

Страница 20: ...led by the user No electric shock is generated if the device does not detect an abnormal rhythm requiring defibrillation In manual mode the doctor or trained user decides whether defibrillation is necessary The following models are available A completely manual defibrillators DefiMonitor XD1 Model with Monitor and 6 channel ECG DefiMonitor XD3 Model with monitor and 6 channel ECG and pulse oximete...

Страница 21: ...Monitor XD is only intended for the purpose of identifying ECG rhythms in the course of emergency medical treatment The defibrillator unit has been optimised to be safe and quickly ready to use PRIMEDIC DefiMonitor XD is powered by rechargeable batteries with nickel cadmium cells or via a power supply unit independent of the respective model The charging electronics incorporate state of the art te...

Страница 22: ...24 GB K05 METRAX GmbH 4 2 Description of device details A completely manual defibrillators Fig 3 PRIMEDIC DefiMonitor XD 1 3 Front view 1 Carrying handle 2 Paddle 3 Paddle cable detachable 4 Operating membrane 5 Monitor 6 Microphone 7 Status display ...

Страница 23: ... device METRAX GmbH DefiMonitor XD 21324 GB K05 23 116 Fig 4 PRIMEDIC DefiMonitor XD 10 30 Front view 1 Carrying handle 2 Paddle 3 Paddle cable detachable 4 Operating membrane 5 Monitor 6 Microphone 7 Status display ...

Страница 24: ...onitor XD 21324 GB K05 METRAX GmbH B Manual defibrillators with AED mode Fig 5 PRIMEDIC DefiMonitor XD 100 300 Front view 1 Carrying handle 2 Paddle 3 Paddle cable detachable 4 Operating membrane 5 Monitor 6 Microphone 7 Status display ...

Страница 25: ...device METRAX GmbH DefiMonitor XD 21324 GB K05 25 116 Fig 6 PRIMEDIC DefiMonitor XD 110 330 Front view 1 Carrying handle 2 Paddle 3 Paddle cable detachable 4 Operating membrane 5 Monitor 6 Microphone 7 Status display ...

Страница 26: ...GB K05 METRAX GmbH Fig 7 PRIMEDIC DefiMonitor XD rear view 1 Opening for hook of the one hand quick release 2 Specification plate 3 Quality seal Fig 8 PRIMEDIC DefiMonitor XD view from below 1 SaveCard cover 2 Release button to remove the power module ...

Страница 27: ...of device METRAX GmbH DefiMonitor XD 21324 GB K05 27 116 3 Power module Fig 9 PRIMEDIC DefiMonitor XD side view 1 Loudspeaker 2 Jack for electrode connectors 3 Jack for SpO2 sensor optional 4 Jack for paddle cable ...

Страница 28: ...Monitor XD 21324 GB K05 METRAX GmbH Fig 10 PRIMEDIC DefiMonitor XD side view 1 Unlocking lever for printer cover 2 Printer cover 3 Mains connection jack 4 Attachment device for bag optional Fig 11 PRIMEDIC DefiMonitor XD status display ...

Страница 29: ...use by date if necessary replace power pack Battery symbol flashes during operation Internal buffer battery empty The device is still operational Send the device to the dealer for the replacement of the internal buffer battery PRIMEDIC AkuPak sufficient capacity Carry out extensive self test by reinserting PRIMEDIC AkuPak or switching the device on again Device defective Have the device repaired b...

Страница 30: ...iption of device 30 116 DefiMonitor XD 21324 GB K05 METRAX GmbH Fig 12 Panel foil PRIMEDIC DefiMonitor XD 1 10 3 30 completely manual defibrillators Fig 13 Panel foil PRIMEDIC DefiMonitor XD 100 110 300 330 ...

Страница 31: ...e lead upper ECG curve Selector switch to scroll downwards in the monitor menu alternatively to decrease the parameter alternatively to select the lead lower ECG curve 7 Mains connection LED display 8 LED display Charge battery 9 Trigger button for defibrillation Shock button 10 Printer On Off online print 11 Paper feed 12 Event button 13 ECG source changeover switch 14 Alarm acknowledgement butto...

Страница 32: ...4 Indicator heart rate and alarm limits 5 Indicator Pulsoximeter and alarm limits 6 Status line for indicating patient impedance time microphone battery charge pacer status CF card capacity printer status paper status 7 Indicator ECG channels max 2 8 SpO2 curve messages information 9 Calibration peak height corresponds to 1mV display size depends upon the sensitivity of the ECG ...

Страница 33: ...ed area on the left side of the capacity display If the device is being used the corresponding audible warning will be repeated once a minute in the selected language Note In order to ensure that the device is always ready for immediate operation we recommend that you have a charged replacement battery with you at all times Depending on the situation in which this voice message is issued you shoul...

Страница 34: ...the SaveCard is exhausted no further data will be saved The device remains ready for operation even if the memory is exhausted and even without a SaveCard The SaveCard supplied with the device is already formatted and can be used straight away in case of problems with the present SaveCard as well as in case of a new CF card it must be formatted using FAT16 or FAT32 file system To attain the greate...

Страница 35: ...nscrew the large electrodes on both paddles by turning them anticlockwise You now have a reduced electrode surface suitable for children The adult paddles are screwed on in clockwise direction over the child paddles Clean the child paddles after use and before screwing on the adult paddles again Make sure that the adult paddles engage securely over the child paddles to ensure good contact Fig 15 L...

Страница 36: ...5 METRAX GmbH 4 5 2 PRIMEDICTM SavePads Connect cable Fig 16 PRIMEDIC SavePadsConnect cable 2 pin 1 Connector 2 Connecting clips for SavePads Connect 4 5 3 PRIMEDICTM SavePads Fig 17 PRIMEDICTM SavePads Connect Defibrillation electrodes with protective film ...

Страница 37: ...device METRAX GmbH DefiMonitor XD 21324 GB K05 37 116 4 5 4 ECG patient cable 3 pin Fig 18 ECG patient cable 3 pin 1 3 pin ECG electrode cable with connector 2 Electrode clips red green yellow 3 ECG electrodes Ag AgCl ...

Страница 38: ...nly for PRIMEDIC DefiMonitor XD3 XD30 XD300 XD330 Fig 19 SpO2 sensor and adapter cable 1 Cable for SpO2 sensor 2 Reusable SpO2 sensor 3 Plug for connecting the sensor cable to the adapter cable 4 Jack with locking device 5 Plug for connecting the adapter cable to the device 6 Adapter cable ...

Страница 39: ...contact your transport company dealer or directly contact technical services at METRAX GmbH stating the device number and describing the damage to the device DANGER Definitely do not use the device if you know of any damage Endangering health cannot be ruled out Satisfy yourself that the scope of delivery is complete in accordance with the enclosed delivery note 5 2 Inserting Changing the SaveCard...

Страница 40: ... be downloaded and filed externally after each deployment Once the storage capacity of the SaveCard is exhausted no further data will be saved The device remains ready for operation even if the memory is exhausted and even without a SaveCard 5 3 Power supply PRIMEDIC DefiMonitor XD has two possibilities of power supply Rechargeable power module PRIMEDIC AkuPak with power cable plugged into the mai...

Страница 41: ...ngages securely with the tongue on the power module The power module should now be in fully inserted position flush with the front housing of the device It should not fall out when the device is moved If it does it is not securely engaged Note The device switches on automatically when the PRIMEDIC AkuPaks battery is inserted and performs an automatic self test Monitor the Status Display If the dis...

Страница 42: ...Note Only change the power module when the device is switched off and electrode plug is disconnected Procedure Lay the device on its back and press the release button in the direction shown by the arrow 1 until the tongue on the power module is released and the power module snaps out of the slot Turn the power module in the direction of arrow 2 and then pull it out of the device ...

Страница 43: ... 2 Fig 23 PRIMEDIC AkuPak Battery charge indicator 1 Battery charge indicator 2 push button to activate battery charge indicator Battery charge indicator 1 means 81 100 charged 41 60 charged 1 20 charged Note Of the two charging possibilities mentioned above PRIMEDIC AkuPak will be automatically recharged in case the charge should fall below 80 of its charging capacity This 80 limit can temporaril...

Страница 44: ... temperature is within the valid range This prevents harmful overcharging of the PRIMEDIC AkuPaks battery If the PRIMEDIC AkuPak battery is not charged the PRIMEDIC DefiMonitor XD can be operated using the integrated mains power pack The PRIMEDIC AkuPaks are charged automatically during operation of the PRIMEDIC DefiMonitor XD For further information on NiCd batteries and how to charge them see ch...

Страница 45: ...aper compartment The printer cover can now be folded forward Prepare the roll of paper provided remove adhesive strip unroll approx 5cm of paper Insert the roll of paper into the printer so that the side with the check pattern faces upwards Close the cover Note The cover is designed to spring out of its position without damage if great pressure is exerted from the outside ...

Страница 46: ...f tests to ensure that it is always ready for operation Self testing is only possible if the PRIMEDIC DefiMonitor XD is either connected to the mains or if a charged PRIMEDIC AkuPak has been inserted Frequency Scope of test SHORT Daily Software operating membrane ECG calibration clock internal voltage supply and HV part at 0 V MEDIUM First day of the month Software operating membrane ECG calibrati...

Страница 47: ...n for approximately 2 seconds A continuous warning beep will sound simultaneously The device switches off automatically if it does not detect any signal source for 10 minutes or no button is pressed If the device detects a fault it will automatically switch off to avoid possible injuries 7 2 Selecting the operating mode 7 2 1 Operating modes Depending on the specific model it is possible to select...

Страница 48: ...d off and back on again or when the MAN button is pressed 7 3 Changing the configuration setup The device is configured at the factory Certain parameters can be changed in the setup menu The new configuration remains stored until it is changed again irrespective of whether the device is switched off or the power module replaced Press the selection confirmation key during operation to open the setu...

Страница 49: ... BLS information On Off HLW cycles Number can be selected 1 15 HLW sounds 0 25 50 75 100 Volume 0 25 50 75 100 Systole sound 0 25 50 75 100 Page 3 Auto print On Off Memo print out Printing from printer memory see chapter 7 9 Printing speed 25 mm s 50 mm s Language depends on installed language packages Time 00 00 in 24 h format Date in format DD MM YYYY MMI Test Interactive testing of operating me...

Страница 50: ...onitor XD 50 116 DefiMonitor XD 21324 GB K05 METRAX GmbH Page 5 BQ SW Version x x BQ serial number xxxxxxx Ext MSP SW Version number check sum Ext MSP HW Version number SpO2 Version xxxx Pacer Version SW xxxx Pacer Version HW xxxx ...

Страница 51: ...r operation again 7 4 2 MMI Test Man Machine Interaction In the MMI Test the buttons the display and the acoustic system of the DefiMonitor are tested for correct functioning This function is mainly used for safety inspections and servicing purposes 7 5 Alarms Depending on the equipment the PRIMEDIC DefiMonitor XD monitors the heart rate from the ECG signal and the oxygen saturation of the patient...

Страница 52: ... are retained The ECG Alarm can be deactivated in the Setup menu When the ECG Alarm 0 is deactivated the bell symbol is permanently crossed out If in this case the alarm limits are exceeded no acoustic alarm is initiated but the bell symbol and heart rate flash in order to inform the user Note If the equipment is operated with PRIMEDIC SavePads Connect Electrodes on the patient in auto mode the be...

Страница 53: ...m is suppressed for the duration of one minute During this period of time the bell symbol on the display is crossed out Pressing the button again during this period reactivates the Alarm The alarm limits are retained The SpO2 Alarm can be deactivated in the Setup menu When the SpO2 Alarm 0 is deactivated the bell symbol is permanently crossed out If in this case the alarm limits are exceeded no ac...

Страница 54: ...ed on the monitor If SpO2 measurement is active the SpO2 pulse graph is also displayed 3 channel print Prints 2 ECG channels 1 channel SpO2 simultaneously depending on which monitoring is displayed 6 channel print Prints the maximum possible number of derivations I II III aVR aVL aVF simultaneously depending on the electrodes attached with a maximum of 3 derivations each 5 seconds before and 5 sec...

Страница 55: ... the ECG monitoring is changed during online printing the printer is stopped immediately the header is reprinted and the printout is then continued Data still stored at the time of the changeover are discarded the new printout starts at the time of the changeover 7 8 Automatic printout after each shock Autoprint The PRIMEDIC DefiMonitor XD allows you to record the event automatically each time def...

Страница 56: ...ll relevant parameters A new event will then push the oldest event out of the memory The memory content starting with the last recorded event is printed out in the setup menu Procedure Open the setup menu and select the menu item Memo Print with the cursor keys Press Enter The Memo Print function is activated To stop the printout press the printer On Off button Printout is produced at 25 mm s Note...

Страница 57: ...SavePads Connect on the patient The defibrillation electrodes are positioned On the right chest area below the collar bone 1 and On the left chest area above the apex of the heart on the axillary line 2 Incorrectly positioned electrodes can lead to faulty readings CAUTION Medicinal plasters must be removed before attaching the defibrillation electrodes Note The PRIMEDIC DefiMonitor XD carries out ...

Страница 58: ...es defective or dry electrodes can lead to faulty readings For this reason always use ECG self adhesive electrodes approved by Metrax 8 2 3 Positioning the PRIMEDIC SavePads Connect for pacing Two different electrode positions have proved effective for cardiac stimulation anterior posterior position anterior anterior position The positioning and the polarity of the electrodes has a significant inf...

Страница 59: ...o attach the self adhesive electrodes in the following order to avoid danger to the user as a result of the stimulation pulse 1 First connect the SavePads Connect cable with the electrode clip to the self adhesive electrodes placed on the patient To do this open the locking lever on the clip and insert the metal plated connection tab into the slit in the electrode clip 2 Snap the upper part of the...

Страница 60: ...sential for the adhesive electrodes to adhere 8 5 Placing the electrodes Fig 26 Removing the protective film from the electrodes 1 Protective film 2 Electrode coated with electrolyte gel In automatic mode the PRIMEDIC DefiMonitor XD gives voice commands instructing you to attach the defibrillation electrodes to the patient Please proceed as follows Open the SavePads packaging by tearing open the p...

Страница 61: ...with the exposed electrodes this could remove the conducting layer of gel from the electrodes WARNING A reduced layer of gel could cause irritation or burns to the skin under the electrodes during defibrillation Observe the brief instructions for use on the packaging of the self adhesive electrodes 8 6 Checking the electrodes CAUTION The message Check electrodes can be issued by the device for sev...

Страница 62: ...itor XD 21324 GB K05 METRAX GmbH 8 7 Changeover of ECG source The ECG can be recorded via the defibrillation paddles or via the self adhesive electrodes Press the ECG source changeover button to switch to paddles or self adhesive electrodes ...

Страница 63: ...ignal is sounded if these buttons are pressed while the device is in automatic mode 9 1 Voice output by the device Preliminary examination of the patient During the course of the voice output you will be asked to examine the patient After the self test has been successfully performed by the device the following instructions are given Call emergency services Apply electrodes one after the other to ...

Страница 64: ... is not continuously pressed as otherwise safety shutdown of the equipment is effected DANGER Observe the patient during the entire reanimation It is possible at any time that the patient may regain consciousness and does not need to be defibrillated If that is the case do not carry out the defibrillation under any circumstances The rhythm identification detector continuously analyses the ECG in t...

Страница 65: ...d in reanimation must step clear of the patient and avoid touching the patient or conductive objects e g parts of the stretcher After defibrillation the device once again undertakes cardio pulmonary resuscitation CPR cycle before carrying out renewed analysis The CPR time is shown on the PRIMEDIC DefiMonitor in the form of a display bar The charge time of the capacitor for defibrillation depends o...

Страница 66: ...ion CPR No shock advised Cardiopulmonary resuscitation Give 30 chest compressions Give 2 rescue breaths etc When the CPR time defined by the set number of CPR cycles has elapsed the device resumes ECG analysis 9 5 Keeping the defibrillator ready for use After a reanimation clean the device replace the SavePads check and if necessary replace the power supply unit to ensure that the device is ready ...

Страница 67: ...gnal error sounds when MAN switch is pushed Note When the device is switched on and has successfully carried out a self test it is in Auto mode If your device is only equipped with manual mode XD1 XD3 XD10 XD30 you will not need to change mode 10 1Carrying out defibrillation Unlike automatic mode where the device programming algorithm analyses the ECG and recommends defibrillation in manual mode t...

Страница 68: ...scharged internally by pressing the energy charging button again during the 15 seconds DANGER Before pressing the trigger button disconnect all equipment which is not defibrillation proof from the patient Before and during energy discharge all persons involved in reanimation must step clear of the patient and avoid touching the patient or conductive objects e g parts of the stretcher Capacitor cha...

Страница 69: ...at maximum power The power module should be replaced immediately once this message appears 10 2SYNC and ASYNC mode If the medical emergency requires cardioversion operation of the defibrillator in synchronous mode this mode must be consciously selected by pressing the SYNC button The defibrillator must be returned to manual mode before you can switch to SYNC mode Then SYNC mode can be activated by...

Страница 70: ...ted If the trigger button is pressed only briefly or no synchromarker has emerged while the button is pressed the energy is retained in the capacitor for 15 seconds and is then automatically discharged within the equipment The energy levels used for cardioversion are usually lower than for asynchronous defibrillation as it is not necessary to depolarise all heart muscle cells The energy required d...

Страница 71: ...e replace the SavePads check and if necessary replace the power supply unit to ensure that the device is ready for operation again as quickly as possible Charge the PRIMEDIC AkuPak to ensure that sufficient energy is available for the device to be used again In the event of faults or doubts contact your nearest service station as soon as possible ...

Страница 72: ... 3 on the SpO2 sensor together and slide the opened sensor over any of the patient s fingers with the cable jack side of the sensor on the fingernail side of the finger The sensor can remain in one measuring point for a maximum of 4 hours provided that the skin characteristics and the correct seating of the sensor are checked regularly As on some patients the sensor may cause skin irritation at th...

Страница 73: ...ameters Operating mode Stimulation rate Stimulation intensity Activate Pacer by pressing the START STOP button The Pacer XD is switched off by pressing the Pacer On Off button At the same time a warning signal is sounded When the Pacer unit is switched on Pacemaker Init may appear on the top left of the Pacer display together with a progress bar This indicates that the Pacer is currently performin...

Страница 74: ...DIC Pacer being operated it switches off automatically 12 2Setting the Pacer operating modes The Pacer can be operated in three different modes DEMAND default setting FIX OVERDRIVE Operating mode Meaning DEMAND Default Stimulation is only carried out as required i e only if the spontaneous heart rate falls below the set DEMAND rate FIX Fixed rate stimulation Independent of the spontaneous heart ra...

Страница 75: ...e can lead to ventricular fibrillation if the pacemaker impulse is released during heart s vulnerable phase 12 3Setting the stimulation rate Depending on the Pacer operating mode various stimulation rates number of Pacer pulses per minute are available FIX DEMAND 30 180 1 min beats power minute OVERDRIVE 30 250 1 min The following values are preset when the respective modes are activated FIX DEMAN...

Страница 76: ...onitor to determine when the intensity is sufficient 12 5Starting and stopping pacing Note The Pacer operating mode must be selected before pacing is started The operating mode cannot be changed once pacing has started The operating mode is displayed on the monitor Procedure Press the Start Stop button Stimulation with the preset values A signal tone is issued to confirm this The operating mode di...

Страница 77: ...o the device If the SavePads Connect cable is unplugged from self adhesive electrodes or pulled out from the device during pacing stimulation is immediately stopped A warning signal sounds the cause of the fault is displayed on the monitor and a voice message is issued Check electrodes When the fault has been remedied and the device restarted the Pacer is reactivated If an energy button is pressed...

Страница 78: ... sounds as pressing the energy selection button stops stimulation Press the Charge button on the control panel to prepare the defibrillation charge Trigger defibrillation via the self adhesive electrodes by pressing the green lit trigger button on the control panel To reactivate the Pacer after defibrillation it must be switched on again Note Defibrillation can also be carried out via the paddles ...

Страница 79: ...Spitacid WARNING Clean the paddles after every use Soiling as a result of gel residue can result in danger to the user and patients Always remove all traces of gel from the paddles 13 2Servicing Independently of the use of the device we recommend regular visual inspection servicing of the PRIMEDIC DefiMonitor XD and the accessories by the user service technician at least once a year Make sure that...

Страница 80: ...y Have the device repaired as soon as possible by the manufacturer Note For more detailed information on the regular safety and metrological checks in accordance with the Ordinance on the Operation and Use of Medical Devices MPBetreibV refer to Chapter 24 13 3Dispatching the PRIMEDIC DefiMonitor XD Note If the equipment is to be sent out for upgrading or servicing in that case the power module mus...

Страница 81: ... possibly due to an empty accumulator battery charge and or replace the power module if the error persists Return the device for servicing 55 HV VREF voltage failed Error in voltage reference return the device for servicing 56 HV HVPWR voltage failed Error in the voltage supply possibly due to an empty accumulator battery charge and or replace the power module if the error persists Return the devi...

Страница 82: ... 72 HV START net error Error during shock release restart the device if the error persists Return the device for servicing 75 HV HV hardware protection error Error during shock release restart the device if the error persists Return the device for servicing 76 HV Residual voltage after disarm error Residual current to high on the condensator after the discharge restart the device if the error pers...

Страница 83: ...ng 97 AVDD drop Error in the voltage supply possibly due to an empty accumulator battery charge and or replace the power module if the error persists Return the device for servicing 98 CVDD exceed Error in the voltage supply possibly due to an empty accumulator battery charge and or replace the power module if the error persists Return the device for servicing 99 CVDD drop Error in the voltage sup...

Страница 84: ...e the device in a cooler environment 111 Temperature drop Operating temperature too low operate the device in a warmer environment 116 HDQ interface fail Error communicating with power module restart the device if the error persists Return the device for servicing 117 CYCLE time error Error during the shock appliance return the device for servicing 118 VREF exceed Error in the voltage supply possi...

Страница 85: ...f the error persists Return the device for servicing 134 XtBoard err power source Error during the current supply of the expansion board charge and or replace the power module if the error persists Return the device for servicing 135 XtBoard err paddle logic Error during the test of the paddles do not press any paddle buttons when starting the device remove and reinsert the paddles restart the dev...

Страница 86: ...List of error codes 86 116 DefiMonitor XD 21324 GB K05 METRAX GmbH error measurement 141 XtBoard err platform Error during the hardware detection return the device for servicing ...

Страница 87: ...is secure in accordance with the EU directive on the disposal of electronic and electrical equipment WEEE directive In Germany in accordance with legislation on the sale return and environmentally friendly disposal of electrical and electronic devices Elektro und Elektronikgerätegesetz ElektroG Electrical and Electronic Equipment Act ElektroG Metrax is registered with EAR register of old electroni...

Страница 88: ...0 Ohm 15 344 J 343 J 343 J 125 Ohm 15 314 J 316 J 317 J 150 Ohm 15 290 J 293 J 293 J 175 Ohm 15 269 J 272 J 272 J Output energy in MAN mode depending upon the patient impedance Energy to Tolerance 25Ω 50Ω 75Ω 100Ω 125Ω 150Ω 175Ω 5 J 3 J 5 J 5 J 5 J 5 J 5 J 5 J 5 J 10 J 3 J 10 J 10 J 10 J 10 J 10 J 10 J 10 J 20 J 3 J 20 J 20 J 20 J 20 J 19 J 16 J 15J 30 J 15 30 J 30 J 30 J 30 J 28 J 24 J 23 J 50 J ...

Страница 89: ...econds from switching on the unit up to charging the maximum energy in manual mode 33 seconds from switching on the unit up to charging the maximum energy in automatic mode Pacemaker Pacer Operating modes Fix Demand Overdrive Stimulation rate 30 180 pulses min in Fix and Demand mode 30 250 pulses min in OverDrive mode Tolerance 0 5 Stimulation intensity 10mA 180mA tolerance 10 or 3 1 mA Pulse widt...

Страница 90: ...ecision 15 Alarms System EKG SpO2 defibrillator power supply data memory Physiological schockable rhythm Analysis duration one battery approx 7 sec to identify schockable rhythm for a battery with 90 of the nominal capacity Monitor Monitor type high resolution LCD monitor Monitor size 115 x 86 mm diagonal 144 mm 5 7 Resolution 320 x 240 pixels pixel size 0 36 x 0 36 mm Displays Heart rate number o...

Страница 91: ...t and complies with the EC Directive 93 42 EEC Other operating conditions 0 50 C 30 95 rel humidity but without condensation 700 hPa 1060 hPa continuous mode Storage conditions 20 70 C 20 95 rel humidity but without condensation 500 hPa 1060 hPa continuous mode Dimensions 33 x 16 x 29 cm W x D x H Weight 5 3 kg without power module Standards applied Standards for licensing in the EU the correspond...

Страница 92: ...mbH 17 Accessories The PRIMEDIC DefiMonitor XD is supplied with the following accessories fitted at the factory Paddle set PRIMEDIC SavePads Connect Power module PRIMEDIC AkuPak For details of further accessories see separate list of accessories price list ...

Страница 93: ... of normal wear and tear e g consumables such as PRIMEDIC AkuPak or damages caused after transfer of risk as a result of incorrect or negligent handling excessive wear or caused by special external influences which are not provided for according to the contract The same applies if inappropriate changes or incorrect repair work is carried out by the buyer or by a third party All other claims agains...

Страница 94: ...owing diagrams show the graphs for the defibrillation pulse in manual mode depending on the load resistance Time ms Time ms Time ms I A 5 Joule 25 Ohm 5 Joule 50 Ohm 5 Joule 75 Ohm I A 5 Joule 100 Ohm 5 Joule 125 Ohm 5 Joule 150 Ohm I A 5 Joule 175 Ohm 10 Joule 25 Ohm 10 Joule 50 Ohm I A 10 Joule 75 Ohm 10 Joule 100 Ohm 10 Joule 125 Ohm ...

Страница 95: ...05 95 116 I A 10 Joule 150 Ohm 10 Joule 175 Ohm 20 Joule 25 Ohm I A 20 Joule 50 Ohm 20 Joule 75 Ohm 20 Joule 100 Ohm I A 20 Joule 125 Ohm 20 Joule 150 Ohm 20 Joule 175 Ohm I A 30 Joule 25 Ohm 30 Joule 50 Ohm 30 Joule 75 Ohm I A 30 Joule 100Ohm 30 Joule 125 Ohm 30 Joule 150 Ohm ...

Страница 96: ... GmbH I A 30 Joule 175 Ohm 50 Joule 25 Ohm 50 Joule 50 Ohm I A 50 Joule 75 Ohm 50 Joule 100 Ohm 50 Joule 125 Ohm I A 50 Joule 150 Ohm 50 Joule 175 Ohm 100 Joule 25 Ohm I A 100 Joule 50 Ohm 100 Joule 75 Ohm 100 Joule 100 Ohm I A 100 Joule 125 Ohm 100 Joule 150 Ohm 100 Joule 175 Ohm ...

Страница 97: ...16 I A 200 Joule 25 Ohm 200 Joule 50 Ohm 200 Joule 75 Ohm I A 200 Joule 100 Ohm 200 Joule 125 Ohm 200 Joule 150 Ohm I A 200 Joule 175 Ohm 300 Joule 25 Ohm 300 Joule 50 Ohm I A 300 Joule 75 Ohm 300 Joule 100 Ohm 300 Joule 125 Ohm I A 300 Joule 150 Ohm 300 Joule 175 Ohm 360 Joule 25 Ohm ...

Страница 98: ...Depiction of the current time function 98 116 DefiMonitor XD 21324 GB K05 METRAX GmbH I A 360 Joule 50 Ohm 360 Joule 75 Ohm 360 Joule 100 Ohm I A 360 Joule 125 Ohm 360 Joule 150 Ohm 360 Joule 175 Ohm ...

Страница 99: ...rams show the graphs for the defibrillation pulse in AUTO mode displayed depending on the load resistance Time ms Time ms Time ms 25 Ohm I A 1 Shock 2 Shock 3 Shock 50 Ohm I A 1 Shock 2 Shock 3 Shock 75 Ohm I A 1 Shock 2 Shock 3 Shock 100 Ohm I A 1 Shock 2 Shock 3 Shock 125 Ohm I A 1 Shock 2 Shock 3 Shock ...

Страница 100: ...Depiction of the current time function 100 116 DefiMonitor XD 21324 GB K05 METRAX GmbH 150 Ohm I A 1 Shock 2 Shock 3 Shock 175 Ohm 1 Shock 2 Shock 3 Shock ...

Страница 101: ... pulse and the system ascertains a shockable rhythm With all other ECG rhythms including asystolia and normal sinus rhythms the rhythm detection system in the device does not recommend defibrillation Operator control of the output of defibrillation shocks The rhythm detection system of the device initiates automatic device charging if it detects a shockable heart rhythm Optical and acoustic messag...

Страница 102: ...re ventricular contractions PVC asystolia and pacemaker pulses All records are valid for evaluation of the VT VF rhythm detector with respect to used electrode systems and ECG signal processing characteristics For validation the ECG was converted to an analogue signal and put out to the device under test The detection result was than read back by the validation system and compared to the reference...

Страница 103: ...ed Specificity Number of correct not shockable algorithm decisions Total number of ECGs where shock is not clinically recommended False positive rate Number of incorrect shockable algorithm decisions Total number of ECGs where shock is not clinically recommended Positive predictive value Number of correct shockable algorithm decisions Total number of ECGs in which administering an impulse is recom...

Страница 104: ...O2 value The normal attachment points for sensors are Fingertip Toe Earlobe Heel Why are different types of sensor used Different sensors must be used for different patients in order to ensure precise and reliable measurement The following factors should be considered when selecting which type of sensor to use Weight of the patient Degree of activity of the patient Duration of measurement Perfusio...

Страница 105: ...ously Injected contrast media e g indiocyanine green or methylene blue High quantity of dysfunctional haemoglobin e g carboxihaemoglobin Incorrect location of sensor e g where there is a venous pulse Use of the pulse oximeter near strong energy sources such as MRT scanners Sensor fitted too tightly Arterial occlusion in the vicinity of the sensor Blood stasis e g as a result of arterial catheter o...

Страница 106: ...ic environment code of practice HF emissions as per CISPR 11 Group 1 The PRIMEDICTM DefiMonitor XD uses HF energy exclusively for internal functions This means that its HF emission is very low and it is unlikely that equipment in the vicinity will be disrupted HF emissions as per CISPR 11 Class B The PRIMEDICTM DefiMonitor XD is suitable for use in all facilities including residential areas and th...

Страница 107: ...urges according to IEC 61000 4 5 1 kV normal mode voltage 2 kV common mode voltage 1 kV normal mode voltage 2 kV common mode voltage The quality of the voltage supply should correspond to that of a typical business and hospital environment Voltage dips short breaks and fluctuations in the supply voltage according to IEC 61000 4 11 5 UT 95 dip in the UT for cycle 40 UT 60 dip in the UT for 5 cycles...

Страница 108: ...distance in metres m b The field strength of stationary radio transmitters should be less that the conformance level for all frequencies in accordance with an inspection on location d Interference is possible in the vicinity of devices which have the following pictogram NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines will not be applicable in all cases The s...

Страница 109: ...n which the PRIMEDIC DefiMonitor XD is operated exceeds the conformance levels for HF listed above the PRIMEDIC DefiMonitor should be monitored to ensure that it is functioning correctly If unusual performance characteristics are observed then it may be necessary to take additional measures such as change the orientation or the location where the PRIMEDICTM DefiMonitor XD is being used d Above the...

Страница 110: ... 69 12 65 1 90 3 64 100 11 67 40 00 6 00 11 50 For transmitters with a maximum power rating that is not given in the table above the distance can be determined by using the equation that belongs to the respective column whereby P is the maximum power rating of the transmitter in Watts W according to the manufacturer of the transmitter NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies...

Страница 111: ...tteries in rotation to replace the battery in the device in order to avoid long storage times Memory effect If the NiCd battery is only slightly discharged over a long period and then recharged the typical Memory effect takes place The practical consequence of the Memory effect is that the battery although it has a large nominal charging capacity behaves like a small battery with low capacity An e...

Страница 112: ...have been terminated due to overheating Battery does not take up the charge since the battery temperature is below 0 C or above 40 C Bring the battery temperature within the charging temperature range of 0 C and 40 C Charge LED does not light up immediately after plugging in the PRIMEDIC ClipChargers Charger There may be a delay of up to 5 min before the charging cycle begins Continue to monitor t...

Страница 113: ...see chapter 13 2 Metrax GmbH also prescribes every two years a technical safety check by Metrax or by a person authorised by Metrax The test protocols necessary for the checks can be provided by Metrax Only authorised persons can operate the device Please consider also the national directives in your country about safety technical checks ...

Страница 114: ...al defibrillators 30 Fig 13 Panel foil PRIMEDIC DefiMonitor XD 100 110 300 330 30 Fig 14 Monitor display 32 Fig 15 Locking the adult paddles in place over the electrodes for children 35 Fig 16 PRIMEDIC SavePadsConnect cable 2 pin 36 Fig 17 PRIMEDICTM SavePads Connect 36 Fig 18 ECG patient cable 3 pin 37 Fig 20 SpO2 sensor and adapter cable 38 Definitely do not use the device if you know of any dam...

Страница 115: ...Index of diagrams METRAX GmbH DefiMonitor XD 21324 GB K05 115 116 Contact details METRAX GmbH Rheinwaldstr 22 D 78628 Rottweil Tel 0741 257 0 info primedic com www primedic com ...

Страница 116: ...re familiar with PRIMEDIC as a guarantor for the highest quality and innovative medical technology Hersteller Firmensitz METRAX GmbH Rheinwaldstr 22 D 78628 Rottweil Germany Tel 49 741 257 0 Fax 49 741 257 235 www primedic com info primedic com Repräsentanzen METRAX GmbH Shanghai Rep Office Room 720 Block B Urbank 88 Office Park No 88 North Zhangjiabang Road Pudong Shanghai 200122 P R China Tel 86...

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