corpuls³ Safety Technical Test, Test instruction and test report 1/16 Safety Technical Test For legal requirements and periods of Safety Technical Tests see chapter 9.4.1 of Operators Instruction. Implementation of Safety Technical Tests is only accepted when carried out according to both, this test instruction and the Operators Instruction, and at least documented according to this test report. Warning Implementation of Safety Technical Tests implies the occurrence of high voltages which may result in severe injuries or death. Only authorized qualified personnel are permitted to carry out Safety Technical Tests. Attention Safety Technical Tests should only be carried out by authorized personnel with calibrated measuring equipment and simulators. Test equipment, adapters and facilities Description Safety analyzer to perform protective earthing-, device leakage current-, isolation resistance measurement and high voltage test Defibrillator/Pacer analyzer Multi parameter/ecg simulator Digital multimeter Digital fine manometer Mains charger with magnetic plug, 12 volts DC / 9 amp. Test cable set for Safety Technical Test Patient Box corpuls³ Test cable set for Safety Technical Test Defibrillator Unit corpuls³ Test cable for Safety Technical Test Display Unit corpuls³ with LAN Paddle holder for leakage current and H/V testing, corpuls³ Paddle for leakage current and high voltage testing corpuls³ (2 pcs. required) Test cable Safety Technical Test Charger with magnetic plug corpuls³ Manufacturer or supplier Model EKU Elektronik GmbH, D-56291 Leiningen MTP 6000 (or comparable) Fluke Biomedical Division, Everett, WA 98203, U.S. Impulse 7000 (or comparable) Fluke Biomedical Division PS420 (or comparable) Fluke Corporation Series 80V (or comparable) GREISINGER electronic GmbH, D-93128 Regenstauf GMH 3160-07 (or comparable) GS Elektromedizinische Geräte G. Stemple GmbH, D-86916 Kaufering Part no. 04501.120 W0029.14100 W0029.24100 W0029.34100 W0029.031263 W0029.04326 W0029.04501
corpuls³ Safety Technical Test, Test instruction and test report 2/16 Adapter for leakage current test W4212.00002 Masimo Rainbow Module T-connector cable 04325.09 Test instruction for Safety Technical Test 1 Check of external mechanical intactness of the device 1.1 Check of mechanical intactness. The device must neither have form cracks nor fractures. In case of damage, present the device to an authorized national or local GS representative for repair. Swivel the complete device about 30. The mechanisms must neither be too rough-running nor automatically tilting. 1.2 Check covers and fasteners for completeness. 1.3 Check of shock paddles intactness. The paddles must be free from form cracks in their synthetic material; the helix cable, the electrode plates and the safety electrodes must be free of any damage; rubber caps of the buttons must be available and undamaged, labels must be available. The connector must easily and surely be lockable with the therapy cable. The electrode surfaces should be free of gel leftovers and other contamination. 1.4 Check of attached cables and sensors. Check cleading of cables and sensors for insulating damage; if necessary remove paste-on labels installed by the operator. Continued use of broken cables and sensors is forbidden. 1.5 Check printer assembly, lid and locking mechanism. The printer lid should easily release and lock. 1.6 Check of labels, warning and safety instruction plates for completeness and readability. Check of type plates for readability. Note the serial numbers of each single component to be tested in the test report sheet. 1.7 Check interlocking mechanisms between the single components. Therefore unlock and relock the components. The interlocking mechanism must be free of damage. 1.8 Check the magnetic connector contact panels of the of the single components for damage and pollution. Clean the panels if necessary. 1.9 Shaking test. Shake each of the single components to detect loose parts inside. Warning Do not open the device! Inner parts may be under high voltage. Disregarding may cause severe injuries or death! In case of defect contact your authorized national or local GS representative for inspection and potential repair.
corpuls³ Safety Technical Test, Test instruction and test report 3/16 2 Protection against electrical shock hazard Attention Attention During following measurements, all single components must be separated from electrical power supply (power supply pack). Take the batteries out of the single components! Performance of both the leakage current measuring of application parts (item 2.6) and the high voltage test (item 2.7) requires the application of the specified GSspecific adapters and facilities. Using other adapters and facilities may result in device damage and termination of warranty rights! 2.1 Check of protective earthing of the external power supply pack (IEC 62353:2007, item 5.3.2.2, image 1, protection class I). Connect the mains plug to the safety tester and measure with the probe at the minus pole of the corpuls magnet connector using the test cable P/N W0029.04501 to activate the switch inside the male connector. Testing current must be not less than 200 ma and must not exceed a limit of 10 A. This step must not be done for power supplies with part number 04500.1202 and 04501.1201. 2.2 Measuring of device leakage current of external power supply pack (IEC 62353:2007, item 5.3.3.2.3, image 4, protection class I) (direct measurement). 2.3 Measuring of insulation resistance of the external power supply pack (IEC 62353:2007, item 5.3.4, image 9). Testing voltage 500 V (DC). 2.4 Measuring of line resistance between potential equalization plug and minus pins of power contact field of the Defibrillator Unit (by using a Hirschmann clip or an alligator clip). Remove cover if required. Testing current must be not less than 200 ma and must not exceed a limit of 10 A. The potential equalization plug may be covert by a plastic cover. 2.5 Measuring of line resistance between safety electrodes of connected shock paddles and potential equalization plug by using a resistance measuring gauge. Testing current must not exceed a limit of 1 A. 2.6 Measuring of leakage current of application parts (IEC 62353:2007, item 5.3.3.3.1, image 6, protection class I). Application parts at which is not currently measured, must be grounded (to the potential equalization plug of the Defibrillator Unit or to minus contact of the corpuls magnet connector of the Patient Box). Measure between: 2.6.1 High voltage output of therapy cable/therapy socket with connected shock paddles and potential equalization plug (connect the shock paddles to the therapy cable/therapy socket and put on the adapter P/N w0029.031263). 2.6.2 High voltage output of therapy cable/therapy socket with connected T-connector cable (P/N 04325.09) and potential equalization plug. The measuring is only required if internal shock electrodes (shock spoons) are applied. 2.6.3 High voltage output of test signal connector and potential equalization plug.
corpuls³ Safety Technical Test, Test instruction and test report 4/16 2.6.4 Short-wired test contact pins of the paddle trays and potential equalization plug (if the test contact pins were replaced by accessory bags Part no. 04322.50 and 04322.51, the original condition must be restored for the time of measurement). 2.6.5 ECG inputs (4-pole and 6-pole connected) and minus contact of the corpuls magnet connector of 2.6.6 SpO 2 input and minus contact of the corpuls magnet connector of 2.6.7 CO 2 input and minus contact of the corpuls magnet connector of the Patient Box. 2.6.8 Input Temp1 and minus contact of the corpuls magnet connector of 2.6.9 Input Temp2 and minus contact of the corpuls magnet connector of 2.6.10 Input IBP1 and minus contact of the corpuls magnet connector of 2.6.11 Input IBP2 and minus contact of the corpuls magnet connector of 2.6.12 CPR input and minus contact of the corpuls magnet connector of 2.6.13 LAN connector and minus contact of the corpuls magnet connector of the Display Unit. 2.7 High voltage test of application parts (IEC 60601-2-4:2002, item 20, image 107). Application parts at which is not currently measured, must be grounded (to the potential equalization plug of the Defibrillator Unit or to minus contact of the corpuls magnet connector of the Patient Box). Set the current limiter of the high voltage generator to 500 µa. No high voltage flashover must appear; no release of the current limiter. Apply 5 kv (DC) for 30 sec each between: 2.7.1 High voltage output of therapy cable/therapy socket with connected shock paddles and potential equalization plug (connect the shock paddles to the therapy cable and put on the adapter P/N w0029.031263). 2.7.2 High voltage output of test signal connector and potential equalization plug. 2.7.3 Short-wired test contact pins of the paddle trays and potential equalization plug (if the test contact pins were replaced by accessory bags Part no. 04322.50 and 04322.51, the original condition must be restored for the time of measurement). 2.7.4 ECG inputs (4-pole and 6-pole connected) and minus contact of the corpuls magnet connector of 2.7.5 SpO 2 input and minus contact of the corpuls magnet connector of 2.7.6 CO 2 input and minus contact of the corpuls magnet connector of the Patient Box. 2.7.7 Input Temp1 and minus contact of the corpuls magnet connector of 2.7.8 Input Temp2 and minus contact of the corpuls magnet connector of
corpuls³ Safety Technical Test, Test instruction and test report 5/16 2.7.9 Input IBP1 and minus contact of the corpuls magnet connector of 2.7.10 Input IBP2 and minus contact of the corpuls magnet connector of 2.7.11 CPR input and minus contact of the corpuls magnet connector of 2.7.12 LAN connector and minus contact of the corpuls magnet connector of the Display Unit. 3 General functions (charging, network connection) For all following checks reinstall the batteries to the single components. The single components will automatically switch on. Shutdown the single components by operating the PWR on/off buttons and reassemble them to a compact device. 3.1 Switch on the compact device by operating the PWR button of the Display Unit. Wait for boot-up (approx. 20 sec) then check network status. 3.2 Separate Defibrillator Unit, and then separate Patient Box from Display Unit (modular mode). Check network status. 3.3 Check network status on the LCD of Patient Box. 3.4 Connect power supply pack to corpuls magnet connector of Defibrillator Unit. Check charging control lamp of Defibrillator Unit. 3.5 Connect power supply pack to corpuls magnet connector of Patient Box. Check charging control lamp of Patient Box. 3.6 Reassemble Patient Box with Display Unit (semi-modular mode). Check charging control lamp of Display Unit. 3.7 Connect power supply pack to corpuls magnet connector of the Display Unit. Check charging control lamp of Display Unit. 3.8 Reassemble all single components to a compact device; connect power supply pack to corpuls magnet connector of Defibrillator Unit. Check charging control lamp of Display Unit. 4 Device function Display Unit For following tests operate the device in modular mode. 4.1 Check acoustics and keyboard of the Display Unit. Push every button of the keyboard. The speaker must answer with a tone. 4.2 Check printer functionality. Select menu item Test page. 4.3 Check alarm and printer stop in case of lack of paper. Remove paper reel and start printer operation. 4.4 Check visual alarm indication. In case of an alarm, the alarm lamp in the jogdial must light up. 4.5 Check GSM function. Install SIM and establish a connection to a fax recipient. Transmit a diagnosis ECG to the fax recipient. 4.6 Check the Health Insurance Card Reader. Insert an applicable card into the card reader slot; patient s data must appear on the screen. 4.7 Check the LAN function. Compare the MAC address of the device with the papers of the device. Connect the device to a DHCP server. Dial the assigned IP address of the device using the ping networking utility.
corpuls³ Safety Technical Test, Test instruction and test report 6/16 5 Device function Patient Box For following tests operate the device in modular mode. 5.1 ECG Monitoring 5.1.1 Connect the 4-pole ECG cable to an ECG simulator and to the Patient Box. Select a sinus waveform and call-up the function Resting ECG at the Display Unit. The derivations I, II, III, avr, avl and avf must appear. 5.1.2 Connect a 6-pole ECG cable additionally to the ECG simulator and to The derivations V1 up to V6 must appear as well. 5.1.3 Check alarm function ECG electrode off. Disconnect each single wire from simulator and check the alarm. The alarm may fail to appear if the black wire is disconnected. 5.1.4 Operate the button at the Patient Box as often until the LCD of the Patient Box indicates the heart rate. 5.2 Pulse oximeter 5.2.1 Depending on the Masimo Rainbow SET/Masimo SET module, connect the appropriate SpO2 /SpCO/SpHb/SpMet finger sensors to Apply the sensor to a proband. The parameters listed below must be indicated on the Display Unit (curves or vital parameter view boxes must be configured if necessary): - the arterial oxygen saturation SpO2 (>90 %), - the peripheral pulse rate PP, - the perfusion index PI, - the plethysmogram, - the carboxyhemoglobin concentration SpCO (< 10%), - the hemoglobin SpHb (10-17 g/dl), - the methemoglobin concentration SpMet (< 3%) Note: Reading of SpHb value takes about 2 ½ minutes. 5.2.2 Check alarm functions SpO2 sensor off and SpO2 cable off. First pull out the finger from the sensor, and then after release of the alarm, pull the cable out from 5.3 Capnometer 5.3.1 Fix an airway adapter to the CO2 sensor, then connect the CO2 sensor to Breathe through the airway adapter. The parameters listed below must be indicated on the Display Unit (curves or vital parameter view boxes must be configured if necessary): - the CO2 partial pressure, - the respiratory rate, - the capnogram. 5.3.2 Check alarm function CO2 apnoea and CO2 cable off. First, discontinue breathing through the airway adapter, and then after release of the alarm, pull the cable out from 5.4 Temperature measurement
corpuls³ Safety Technical Test, Test instruction and test report 7/16 5.4.1 Connect a temperature sensor to The ambient temperature must be indicated on the Display Unit (vital parameter view boxes must be configured if necessary). Retake the test with the 2 nd temperature input. 5.4.2 Check alarm Sensor T (x) off. Therefore, pull the temperature sensor out from the respective temperature socket. 5.5 Non-invasive blood pressure measurement Connect a cuff to the Patient Box and measure the blood pressure of a proband. The measuring cycle shall be passed completely and the values of systolic, diastolic and mean effective arterial pressure must be indicated on the Display Unit (one vital parameter view box must be configured if necessary). 5.6 Invasive blood pressure measurement 5.6.1 Connect an invasive blood pressure simulator via an adapter cable to Set atmospherical pressure and calibrate channel P (x). Turn to an arterial pressure progression. The values of systolic, diastolic and mean effective arterial pressure (max. tolerance of ± 2 mmhg) as well as the pressure curve must be indicated on the Display Unit (curves or vital parameter view boxes must be configured if necessary). Retake the test with the three remaining pressure channels. 5.6.2 Check alarm function IBP sensor P (x) off. Therefore, pull the adapter cable out from the respective input or pull the sensor cable out from the intermediate adapter cable. 5.7 Audiovisual CPR Feedback 5.7.1 Connect a CPR sensor to Move the CPR sensor up and down with a frequency of about 100 min -1. Vary the swivel altitude of sensor. The parameters as listed below must be indicated on the Display Unit (curves or vital parameter view boxes must be configured if necessary): - the compression rate (CPR rate), - course of curve of the actual thorax compression. 5.7.2 Check alarm function CPR sensor loose. Therefore, remove the sensor from the plugged CPR cable and, after release of the alarm, reconnect the sensor. Check alarm function CPR cable loose. Therefore, pull the CPR cable out from 5.8 Data recording Insert CompactFlash memory card to the slot of the Patient Box and start a new mission. Alternatively, the record can be started at the beginning of the functional test. Using the Operation Browser check the mission is recorded.
corpuls³ Safety Technical Test, Test instruction and test report 8/16 6 Device function Defibrillator/Pacer For the following tests, operate the device in modular mode. The battery of the Defibrillator Unit must be charged sufficiently for the following tests. If the device is operated w/o shock paddles, shock paddles must be provided for the following tests. 6.1 Function of defibrillator (IEC 60601-2-4:2003, 50) 6.1.1 Check ECG derivation of the Defibrillator/Pacer Unit. Therefore, connect the shock paddle electrodes/the therapy cable/the therapy socket to the defibrillator tester. Set up the analyzer to a sinus wave rhythm of 60 min -1 and check the indication at the Display Unit. 6.1.2 Check output of test signal at the contact pins of the shock paddle trays. Therefore, insert the shock paddles to the trays (if the test contact pins were replaced by accessory bags Part no. 04322.50 and 04322.51, the original condition must be restored for the time of test). 6.1.3 Functional test of the discharging resistors of the shock paddle trays. Insert the shock paddles to the trays and release a shock with maximum energy (if the test contact pins are replaced by accessory bags Part no. 04322.50 and 04322.51, the original condition must be restored for the time of test). 6.1.4 Check output of test signal at the test contacts of the cable base. Therefore plug the therapy cable into the test contact connector of the cable base. 6.1.5 Functional test of the discharging resistors of the cable base test contacts. Plug the therapy cable into the test contact connector of the cable base and release a shock with maximum energy. 6.1.6 Functional test of impedance measuring. Apply the shock paddles to the test pads of a Defibrillator/Pacer analyzer with an impedance of 50 Ω. If no shock paddles are used, perform this test using the T- connector cable P/N 04325.09. 6.1.7 Test of energy output. Set advised energy level, charge, and release the shock immediately after reaching shock readiness asynchronously to the defibrillator tester. Release three shocks of each energy level and note the highest value. 6.1.8 Check of energy output of the baby shock electrodes. Place the baby shock electrodes at the adult shock paddles according to Operators Instruction. Release one shock with maximum energy level and note the value. 6.1.9 Check synchronous defibrillation. Supply a sinus rhythm of the simulator of the defibrillator tester and release a shock. Note the delay time. 6.2 Function of pacer 6.2.1 Connect a terminating resistor of 700 Ω to the therapy cable using the T-connector cable P/N 04325.09. Call up the pacemaker function and set the parameters as advised below: - Mode FIX, - Intensity 30 ma, - Frequency 150 min -1. Measure the preset parameters and note the results. 6.2.2 Increase intensity to 150 ma and note the output current.
corpuls³ Safety Technical Test, Test instruction and test report 9/16 6.2.3 Increase the terminating resistor to 1000 Ω and note the output current. 6.2.4 Short the electric circuit. The alarm Short circuit must appear on the Display Unit. 6.2.5 Disconnect the electric circuit. The alarm Circuit open must appear on the Display Unit. 7 Device function charging brackets 7.1 Check available charging brackets for mechanical intactness. Perform a visual inspection of connector plugs and cables of charging brackets with power supply. 7.2 Check operational capability of interlocking mechanisms of the brackets. Therefore insert the single components (Display Unit, Patient Box, Defibrillator Unit) to the brackets, then lock and unlock them. 7.3 Check power supply of the charging brackets (only charging brackets with available power connector). Insert the single components to the brackets, connect the brackets to the 12 volts power supply and check the charging lamps of the single components.
corpuls³ Safety Technical Test, Test instruction and test report 10/16 Metrological Controls For legal requirements and periods of Metrological Controls see chapter 9.4.2 of Operators Instruction. Alternative legal regulation of other countries provided. Implementation of Metrological Controls is only accepted when carried out according to both this test instruction and the Operators Instruction, and at least documented according to this test report. Instruction of Metrological Control of function Non-invasive Blood Pressure Measurement (NIBP) 8 Leak tightness test of the pressure system and measuring accuracy test of indication For Metrological Control of the non-invasive blood pressure module the device under test must be connected to a calibrated pressure gauge, to a hand pump with nonreturn valve and release valve, further to a testing volume (inelastic metal tank of 1 liter volume) by using a four-way connector. Alternatively, a blood pressure simulator can be used. All tests require operation in calibration mode (Call up via menu items NIBP Test ). The calibration mode is automatically left after 3 minutes. 8.1 Generate a pressure of approx. 200 mmhg by using the hand pump. Run a pressure compensation sequence of approx. 30 seconds. Memorize the indicated value. After a delay of 60 seconds, read the indicated value; calculate and note the difference. 8.2 Successively generate the pressures 250 mmhg, 200 mmhg, 150 mmhg, 100 mmhg and 50 mmhg by using the hand pump. Wait a few seconds each for pressure compensation. Note values indicated on both, pressure gauge and device under test. Instruction of Metrological Control of function Temperature measuring 9 Measuring accuracy test of indication 9.1 Successively plug test jack connectors with calibrated resistors in temperature socket Temp1 and note the indicated value. Alternatively, a temperature simulator can be used. 9.2 Repeat this sequence for socket Temp2.
corpuls³ Safety Technical Test, Test instruction and test report 11/16 Test report of Safety Technical Test corpuls³ Nr of test report Operator Ambulance service/hospital Nr, street Single module Serial nr Inventory nr Software Display Unit Patient Box Defibrillator Unit Power supply City code City Accessories: Battery S/N 4-pole ECG cable CO2 sensor Battery S/N 6-pole ECG cable Temperature probe(s) Battery S/N SpO2 sensor Mounting Defibrillator Unit Shock paddles SpO2/SpCO/SpMet sensor Mounting Monitor Unit Baby shock electrodes SpO2/SpHb/SpMet sensor Mounting Patient Box Delete items where inapplicable! Pos Test description required result realized result passed failed 1 Check of external mechanical intactness of the device 1.1 Check of mechanical intactness, swivel mechanism no damages, 30 swiveling 1.2 Covers and fastening parts complete 1.3 Shock paddles undamaged 1.4 Cables and sensors undamaged 1.5 Printer (locking mechanism) fully functional 1.6 Labels, safety instruction plates, type plates complete, legibly 1.7 Locking mechanism between the single modules fully functional 1.8 Magnetic plug connector undamaged unpolluted 1.9 Shaking test no loose parts
corpuls³ Safety Technical Test, Test instruction and test report 12/16 Pos Test description required result realized result passed failed 2 Protection against electrical shock hazard 2.1 Check of protective earthing of pwr supply < 0.3 Ω Ω 2.2 Device leakage current of power supply < 500 µa S.F.C. µa 2.3 Isolation resistance of power supply > 70 MΩ MΩ 2.4 Protective conductor potential equalization Ground contact Defibrillator Unit < 0.1 Ω Ω 2.5 Resistance of safety electrodes < 0.6 Ω Ω 2.6 Leakage currents between device ground (potential equalization) and following application parts: 2.6.1 Therapy cable with shock paddles (BF) < 500 µa S.F.C. µa 2.6.2 Therapy cable/therapy socket (CF) < 100 µa S.F.C. µa 2.6.3 Test signal output (BF) < 500 µa S.F.C. µa 2.6.4 Test contact pins (BF) < 500 µa S.F.C. µa 2.6.5 ECG inputs (4-pole + 6-pole) (CF) < 50 µa S.F.C. µa 2.6.6 SpO2 input (BF) < 500 µa S.F.C. µa 2.6.7 CO2 input (BF) < 500 µa S.F.C. µa 2.6.8 Input Temp1 (BF) < 500 µa S.F.C. µa 2.6.9 Input Temp2 (BF) < 500 µa S.F.C. µa 2.6.10 Input IBP1 (CF) < 50 µa S.F.C. µa 2.6.11 Input IBP2 (CF) < 50 µa S.F.C. µa 2.6.12 CPR input (BF) < 500 µa S.F.C. µa 2.6.13 LAN connector < 500 µa S.F.C. µa 2.7 High voltage test 5 kv (30 sec) between device ground (potential equalization) and: 2.7.1 Therapy cable/therapy socket no flashover 2.7.2 Test signal output no flashover 2.7.3 Test contact pins no flashover 2.7.4 ECG inputs (4-pole + 6-pole) no flashover 2.7.5 SpO2 input no flashover 2.7.6 CO2 input no flashover 2.7.7 Input Temp1 no flashover 2.7.8 Input Temp2 no flashover 2.7.9 Input IBP1 no flashover 2.7.10 Input IBP2 no flashover 2.7.11 CPR input no flashover 2.7.12 LAN female connector no flashover 3 General functions (Charging, network connection) 3.1 IrDA network connection as compact device Indication Display
corpuls³ Safety Technical Test, Test instruction and test report 13/16 Pos Test description required result realized result passed failed 3.2 3.3 Radio network connection in modular mode Radio network connection in modular mode Indication Display Indication Patient Box 3.4 Power supply connected to Defibrillator Unit (modular mode) 3.5 Power supply connected to Patient Box 3.6 Power supply connected to Patient Box 3.7 Power supply connected to Display Unit 3.8 Power supply connected to Defibrillator Unit (compact device) 4 Device function Display Unit Charging indicator Defibrillator Unit on Charging indicator Patient Box on Charging indicator Display Unit on Charging indicator Display Unit on Charging indicator Display Unit on 4.1 Acoustics/keyboard Sound audible 4.2 Test printout 4.3 Paper deficiency function Total printing span readable Printer stops, alarm appears 4.4 Visual alarm indication Alarm lamp on 4.5 GSM function 4.6 Function of Health Insurance Card Reader Fax transmission successful Data appear on the screen 4.7 LAN function MAC address 5 Device function Patient Box 5.1 ECG Monitoring 5.1.1 Resting ECG with 4-pole ECG cable 5.1.2 Resting ECG with 4+6-pole ECG cables 5.1.3 Alarm ECG Electrode off LAN connection is established Derivations I, II, III, avr, avl, avf Derivations V1 to V6 Practicable with each wire 5.1.4 Indication Patient Box Heart rate 5.2 Pulse oximeter 5.2.1 Indication Display Unit SpO2 value Pulse rate PI value Plethysmogram
corpuls³ Safety Technical Test, Test instruction and test report 14/16 Pos Test description required result realized result passed failed SpCO value SpHb value SpMet value 5.2.2 Alarms SpO2 Sensor off SpO2 cable off 5.3 Capnometer 5.3.1 Indication Display Unit 5.3.2 Alarms 5.4 Temperature measuring 5.4.1 Indication of room ambient temperature 5.4.2 Alarm Sensor T (x) off CO2 partial pressure Respiratory rate Capnogram CO2 Apnoea CO2 cable off Indication T1 Indication T2 Sensor T1 off Sensor T2 off 5.5 Not invasive blood pressure measuring realistic results 5.6 Invasive blood pressure measuring 5.6.1 Values and pressure curve 5.6.2 Alarm IBP Sensor P (x) off 5.7 CPR Feedback 5.7.1 Indication Display Unit 5.7.2 Alarms Channel P1 Channel P2 Channel P3 Channel P4 Sensor P1 off Sensor P2 off Sensor P3 off Sensor P4 off CPR curve CPR rate CPR sensor loose CPR cable loose 5.8 Data recording on CompactFlash card Data available 6 Device function Defibrillator Unit 6.1 Function of defibrillator 6.1.1 Heart rate 59 61 min -1 min -1
corpuls³ Safety Technical Test, Test instruction and test report 15/16 Pos Test description required result realized result passed failed 6.1.2 Test signal via shock paddles mounting 6.1.3 Discharging resistors of shock paddles mounting 6.1.4 Test signal via test contacts cable base 6.1.5 Discharging resistors of test contacts cable base differentiated rectangular signal Shock released differentiated rectangular signal Shock released 6.1.6 Impedance measuring Indication OOKO 6.1.7 Energy output 20 J (16 24 J) J 100 J (90 110 J) J 200 J (180 220 J) J 6.1.8 Energy output baby shock electrodes 20 J (18 22 J) J 6.1.9 Delay synchronous defibrillation < 35 msec msec 6.2 Pacer function 6.2.1 Rate 148 152 min -1 min -1 Impulse width 22.4 23.5 msec msec Output current (30 ma @ 700 Ω) 27 33 ma ma 6.2.2 Output current (150 ma @ 700 Ω) 143 157 ma ma 6.2.3 Output current (150 ma @ 1000 Ω) 143 157 ma ma 6.2.4 Alarm Pacer short circuit Alarm appears 6.2.5 Alarm Pacer circuit open Alarm appears 7 Device function charging mountings 7.1 Check of mechanical intactness undamaged 7.2 Interlocking mechanisms fully functional 7.3 Power conveyance Charging indicator on 8 Metrological Control of non-invasive blood pressure measuring module (valid to: ) 8.1 Tightness of pressure system Difference < 6 mmhg 8.2 Accuracy of indication - 250 mmhg (± 3 mmhg) - 200 mmhg (± 3 mmhg) - 150 mmhg (± 3 mmhg) - 100 mmhg (± 3 mmhg) - 50 mmhg (± 3 mmhg) Indication Display Indication pressure gauge
corpuls³ Safety Technical Test, Test instruction and test report 16/16 9 Metrological Control of temperature module (valid to: ) 9.1 Input Temp1-24 C or 30 C or C - 37 C - 40 C or 42 C or C ± 0.1 K Indication Display C C C 9.2 Input Temp2-24 C or 30 C or C - 37 C - 40 C or 42 C or C ± 0.1 K Indication Display C C C Result of Safety Technical Test Device is free of defects. Slight defects which should be occasionally fixed by an authorized service representative: - - Serious safety-related deficiencies which forbid any continued operation. The device must be repaired by an authorized service representative before restart of operation. - Appointed date for next Safety Technical Test: The Safety Technical Test has been carried out by (Name of the examiner): Date: Signature: Name and address of the responsible company (company stamp)