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H E Y E R P a s i t h e c

Rev. 0.2 Draft – 12/09

HEYER Pasithec, Operator’s manual

9 / 106

Bell cancel

Variability of rotational
adjustment

Bell

Non-ionizing
electromagnetic radiation

△

Alarm, general

Date of manufacture

△

Urgent alarm

Address of manufacturer

EC Representative

PENDING

The system, with this label
under the stipulations in the
operating manual, complies
with the requirements
related from 93/42/EEC.

Содержание Pasithec

Страница 1: ...A n e s t h e s i a S y s t e m Operator s Manual Rev 0 2 Draft 12 09 INNOVATION IN DESIGN AND TECHNOLOGY...

Страница 2: ......

Страница 3: ...1 6 Ventilation Mode Setup 41 4 1 7 Breathing Parameters Setup 41 4 2 Start Mechanical Ventilation 41 4 2 1 Stop Mechanical Ventilation 41 4 3 Start Manual Ventilation 42 4 3 1 Stop Manual Ventilation...

Страница 4: ...l Alarm 83 9 3 Troubleshooting 86 10 Specifications and Operation Theory 87 10 1 Physical Specification 87 10 2 Environment Requirements 87 10 3 System s Technical Specifications 88 10 3 1 Gas Supply...

Страница 5: ...ccur Repairs for these malfunctions are not covered by the warranty HEYER has the rights to replace any content in this manual without notice 1 1 Manufacturer Responsibility HEYER is responsible for t...

Страница 6: ...the product and is required for a return Enclose a letter containing the product number type and the reason for the return 2 Transportation charges Transportation and insurance charges must be prepaid...

Страница 7: ...or middle of this system for added functions For more information with respect to the existing product please contact your local representatives WARNING All Pasithec users must be trained WARNING HEY...

Страница 8: ...rent Type B Applied Part DC Direct current Attention consult accompanying document Protective earth Dangerous Voltage Equipotentiality Rotation in two directions Movement in one direction Movement in...

Страница 9: ...ity of rotational adjustment Bell Non ionizing electromagnetic radiation Alarm general Date of manufacture Urgent alarm Address of manufacturer EC Representative 0 0 0 0 PENDING The system with this l...

Страница 10: ...ter L min Liters Per Minute Manual Manual ventilation ml Milliliter MRI Magnetic Resonance Imaging MV Minute Volume Paw Airway Pressure Pb Plumbum PEAK Peak Pressure PLAT Plat Pressure MEAN Mean Press...

Страница 11: ...C60601 2 13 O2 monitor in accordance with ISO 21647 CO2 monitor in accordance with ISO 21647 ANESTHETIC monitor in accordance with ISO 21647 WARNING To avoid explosion hazards flammable anesthetic age...

Страница 12: ...User Interface UI 2 Arm 3 Aux O2 Flowmeter 4 Aux O2 Outlet 5 Breathing System 6 Flexible Top Light 7 Top Board 8 Flowmeter 9 Vaporizer Mount 10 Pneumatic and Electronic Switch 11 Main tray 12 Cylinder...

Страница 13: ...r Function of electricity main switch When system is shut off the assistant power and controller are started with the main switch The machine performs a system self test and after the test the startup...

Страница 14: ...ev 0 2 Draft 12 09 Figure 3 2 Side view Legend 16 GCX Mounting Rail 17 UI Signal Cable 18 Power Cable 19 Bellows Assembly 20 Absorber Circle Assembly 21 O2 Flush O2 22 O2 Sensor Socket 23 Driving Gas...

Страница 15: ...tton to supply the breathing system with O2 at a high flow rate 22 O2 Sensor Socket Socket to connect Oxygen Sensor for monitoring oxygen concentration of absorber circle When monitoring patient oxyge...

Страница 16: ...a s i t h e c 16 106 HEYER Pasithec Operator s manual Rev 0 2 Draft 12 09 Figure 3 3 Rear View Legend 25 Fuses 26 Aux Power Sockets 27 Power Cable 28 Pipeline Gas Inlet Module 29 Gas Cylinder Yokes 29...

Страница 17: ...breathing system used together with the anesthetic gas supply system shall be in accordance with ISO 8835 2 Figure 3 4 Breathing System Legend 1 Absorber Canister 2 Inspiratory Port 3 Inspiratory Valv...

Страница 18: ...re 3 5 Ports of bellows assembly 12 Exhaust Gas Port 13 Nut drain plug Loosen the nut to drain the water when absorbent natrium lime in absorber has been commixed with water WARNING Never connect exha...

Страница 19: ...f the anesthetic system from individual components shall be provided by the assembler of the anesthetic system For more detailed information about the vaporizer please refer to the instructions for th...

Страница 20: ...lay configurations of the Spirometry Loop Window described in section 4 5 The first key press shall display the Pressure Volume loop display configuration The second key press shall display the Flow V...

Страница 21: ...knob is the cursor The cursor can be used to select any menu item on which it lands Operating method Move the cursor to the item you wish to select Press the knob One of the following four situations...

Страница 22: ...city when fully charged 2 If in charging the Battery icon shows capacity alternately AC power down 1 The Battery icon shows the current capacity 2 The Battery can supply power for the machine for abou...

Страница 23: ...Pressing the navigator knob selects the parameter setting which is displayed as white text within a black field Parameter settings shall be in normal video unless the parameter tile has been selected...

Страница 24: ...e 3 8 Rear Panel Legend COM A Interface Communication extension interface communicates with the IRMA COM B Interface Communication extension interface is used for connecting external communication equ...

Страница 25: ...e process will be displayed on the screen The following diagram is an example Step 1 When the MENU key is pressed a Menu window is displayed on the screen Note The Menu window opens in the last viewed...

Страница 26: ...0 2 Draft 12 09 Step 3 Press the knob to enter the setting the background will appear as white text on a black background Step 4 Turn the knob to select the setting Step 5 Press the knob to save the s...

Страница 27: ...ep 6 Turn the knob and select Return to set other parameters Follow the above directions to select the corresponding submenu Press the MENU key to exit the screen The default alarm setting in the manu...

Страница 28: ...ess the knob to save the Disabled setting The patient s pressure tidal and asphyxiation alarms will not be displayed 3 5 2 Menu Diagram Figure 3 9 to Figure 3 13 displays each submenu in the Menu wind...

Страница 29: ...H E Y E R P a s i t h e c Rev 0 2 Draft 12 09 HEYER Pasithec Operator s manual 29 106 Figure 3 9 Alarm submenu Page 1 Figure 3 10 Alarm submenu Page 2 Figure 3 11 System submenu...

Страница 30: ...ER Pasithec Operator s manual Rev 0 2 Draft 12 09 Figure 3 12 Calibrate submenu Figure 3 13 Service submenu CAUTION A password is needed for the Service submenu Only an authorized engineer can access...

Страница 31: ...as properly connected to the machine and can be used When the gas sensor is in Disabled mode it was not properly connected prior to starting the machine and cannot be used The Gas Sensor settings can...

Страница 32: ...lay is in Flow mode flow time wave is displayed When the Wave Display is in CO2 mode CO2 time wave is displayed The Wave Display default setting is Flow when the machine is turned on To adjust Wave Di...

Страница 33: ...H E Y E R P a s i t h e c Rev 0 2 Draft 12 09 HEYER Pasithec Operator s manual 33 106 Step 3 Press the knob to save the setting...

Страница 34: ...urn on the cylinder valve of the standby gas supply and turn off the flowmeters of O2 N2O Air and Aux O2 Step 2 Turn on the Power Switch Turn the Power Switch to ON The UI will power on and perform a...

Страница 35: ...tem Self Test Complete interface will appear when the self test is complete Figure 4 3 System Self Test Complete interface Select the Continue option to perform the Leak Test procedure Select Bypass t...

Страница 36: ...to Test Port T 2 Install the Manual Bag 3 Adjust APL valve to 30 cmH2O 4 Adjust all flowmeters to zero 5 Set Fresh Gas switch to Circle absorber 6 Select Continue Figure 4 5 Manual Leak Test Perform...

Страница 37: ...Operator s manual 37 106 4 1 3 Safety Valve Test Click the Continue to perform Safety Valve Test as shown in Figure 4 6 Figure 4 6 Safety Valve Test in progress When test is complete screen will displ...

Страница 38: ...t When the Safety Valve Test is complete the Automatic Leak Test is displayed on the screen Figure 4 8 Automatic Leak Test Click Continue to perform the Leak Test Figure 4 9 Automatic Leak Test in pro...

Страница 39: ...form the Compliance Test Figure 4 11 Compliance Test Perform the Compliance Test according to the instructions pictured in Figure 4 11 1 Set O2 flow to 5 L min 2 Select Continue to start test or selec...

Страница 40: ...er the Compliance Test is complete Figure 4 13 Compliance Test Complete interface Complete the Compliance Test according to the instructions shown in Figure 4 13 1 Set O2 flowmeter to zero 2 Select Co...

Страница 41: ...he knob to save the setup 4 1 7 Breathing Parameters Setup Step 1 Turn the knob and point the cursor to the corresponding parameter CAUTION Exit the menu before carrying out this step Step 2 Press the...

Страница 42: ...inflate the reservoir bag 4 3 1 Stop Manual Ventilation Set Ventilation Mode to STANDBY mode Manual ventilation can also be stopped by not pinching the reservoir bag or by pressing the MANUAL AUTO ke...

Страница 43: ...e c Rev 0 2 Draft 12 09 HEYER Pasithec Operator s manual 43 106 3 CO2 t Waveform Y Axis CO2 X Axis time Figure 4 17 CO2 t waveform 4 Pressure Volume Loop Y Axis tidal volume X Axis pressure Figure 4 1...

Страница 44: ...ess Save Reference when either a loop is currently being displayed or no loop is being displayed and the next complete loop inspiration and expiration will be saved as a reference After Save Reference...

Страница 45: ...rvice representative 5 1 1 Check System WARNING Ensure the breathing circuit is connected correctly and in good condition Make sure 1 Equipment is in good condition 2 All the components are correctly...

Страница 46: ...ch off O2 supply Make sure the O2 pressure gauge is reset to zero The low O2 supply alarm should sound when pressure drops 5 3 Monitoring Flow Control WARNING Refer to Step 1 to 14 of Monitoring witho...

Страница 47: ...table The O2 flow must be higher than the minimum flow limit N2O flow liters per minute O2 flow must be higher than the minimum flow liters per minute 1 5 0 5 3 1 6 2 9 3 6 Test the function of the li...

Страница 48: ...systems Only adjust testing of control N2O in step 6 and O2 in step 7 Adjust flow according to order N2O first O2 second The oxygen sensor must be calibrated correctly 6 To test the flow increase of t...

Страница 49: ...zer so that it is locked 3 Lift the vaporizer straight up to separate it from the bypass valve but do not pull the vaporizer forward Be careful not to rotate it on the bypass valve 4 As the vaporizer...

Страница 50: ...st upper limit of O2 concentration to 50 again Press O2 Flush to charge the breathing system the High FiO2 alarm should sound Adjust upper limit of O2 concentration to 100 the alarm should stop Let O2...

Страница 51: ...lator Test 1 Connect the simulation lung to the patient end 2 Turn on Power Switch 3 Set control options Ventilation mode CMV mode Ventilator VT 700 ml f 20 bpm I E 1 2 Plimit 40 cmH2O Anesthetic mach...

Страница 52: ...e sure that the breathing system is correctly connected WARNING Flush the anesthesia machine for at least one minute by using O2 with 5 L min flow speed to remove unnecessary mixed gas and objects in...

Страница 53: ...g circuit components are non poisonous do not cause an allergic reaction in the patient and do not create dangerous by products by reacting with the anesthesia gas or the anesthetic WARNING To prevent...

Страница 54: ...may be restored when not in use Refer to the labels on the absorbent for additional details Carbon monoxide is released if completely dried absorbent comes into contact with the anesthetic Replace th...

Страница 55: ...TION CO2 monitor in accordance with ISO 9918 should be connected at Y piece of patient end CAUTION Anesthetic machine should be used with anesthetic agent monitor Anesthetic agent monitor e g Datex oh...

Страница 56: ...ector to the bottom of the oxygen sensor Connect the other end of the cable round connector to the oxygen sensor port at the side of the machine 6 2 1 Connect CO2 Monitor Step 1 Connect one end of the...

Страница 57: ...when they are connected to an auxiliary main socket outlet they constitute a medical electrical system It is essential that operators are aware of the risks of increased leakage currents when equipmen...

Страница 58: ...h the anesthesia machine to backup battery in case of AC failure alarm and prompt an alarm message to display on the screen 6 3 2 Aux Mains Outlet CAUTION No more than four auxiliary mains socket outl...

Страница 59: ...achine 5 GND Signal Ground Common 9 5V DC5V power provide output power in gas monitor module 200mA In data communication this pin and the RI output signal of RS232C indicates electrical compliance Oth...

Страница 60: ...ctrical components Do not allow liquids to enter the equipment Do not immerse the synthetic rubber components more than 15 minutes any longer will cause inflation or accelerate aging Only the componen...

Страница 61: ...ed When replacing ensure new products have the same specifications Corrugated tubing and bag repetitious Wash to sterilize 7 3 Absorber Circle Component Wiping method Soap water Cleaning method Soap w...

Страница 62: ...astors of the machine to prevent movement Step 2 Turn the handle arrow pointed of absorb circle 90 counter clockwise from closed state Step 3 Hold the handle see arrow of absorb circle with two hands...

Страница 63: ...s 80 C 176 F Put the soda lime into the absorber after drying tighten the knob Clear all soda lime debris 7 3 1 2 Airway Pressure Gauge Clean the Airway pressure gauge with a soft cloth soaked with a...

Страница 64: ...ly board Push the supply board and absorber circle together to ensure a tight seal with seat module Turn the handle see arrow of absorber circle 90 clockwise from open to lock the circle 7 3 2 Bellows...

Страница 65: ...perform the steps in Disassembling the Bellows Assembly in reverse order 1 Bellows assembly is fixed on the absorber cycle Turn counterclockwise and remove the bellows housing 2 Detach the folding gas...

Страница 66: ...the diaphragm and the valve seat in a pressure relief valve 2 To prevent component damage clean lightly with recommended non enzyme mild agent for use with latex and plastic in hot water CAUTION Do n...

Страница 67: ...ce with the isolated disposal stipulation Collect and leave all the used bellows assembly components during the operation process in the operating room Immerse the bellows assembly components in the 1...

Страница 68: ...e that component worn by use and daily cleaning are replaced in a timely manner Test by eyes Separate the bellows assembly and anesthesia machine Disassemble the bellows assembly WARNING Never separat...

Страница 69: ...After repair test the equipment to ensure that it is functioning properly and in accordance with the manufacturer s published specifications To ensure full reliability have all repairs and service do...

Страница 70: ...ment and operating requirements Main unit 5 years Components 5 years Vaporizer 5 years Absorb circle 5 years 8 2 3 Replacement of Consumable Parts Parts are replaced at multiple intervals from the dat...

Страница 71: ...ARNING Do not perform the calibration steps when the system is connected to a patient When calibrating O2 sensor ambient pressure must be equal with monitoring pressure of delivering O2 in the patient...

Страница 72: ...select Calibrate submenu Press the knob and the cursor appears on the O2 Sensor Calibration option Step 3 Press the knob and a new window appears right side Perform the operation in accordance with th...

Страница 73: ...displays on the screen Calibration successful will be displayed on the window after the O2 Sensor calibration is successfully completed Replace the O2 sensor and press Finish to continue If 21 calibra...

Страница 74: ...the knob to select CO2 sensor Calibration in the Calibrate submenu Step 2 Press the knob and a new window appears on the right side Perform the operation according to the prompts on the screen Discon...

Страница 75: ...NEXT to perform the calibration In the process of calibration the word Calibrating displays on the screen Calibration successful will be displayed on the window after the calibration is completed succ...

Страница 76: ...librate submenu Step 2 Press the knob and a new window appears on the right side Perform the operation according to the prompt on the screen Disconnect the Gas Sensor from the Y piece and place it in...

Страница 77: ...its life The O2 sensor s useful life is 12 months SV 03A is the O2 sensor recommended by the manufacturer CAUTION For more detailed information refer to technical data that is regularly updated by the...

Страница 78: ...acid battery Charge 8 hours typically Cautions Charge Connect mains supply the system will maintain auto charging battery Charging time is more than 8 hours Battery supply will last 120 minutes The a...

Страница 79: ...2 It has two airway adapters one for an adult and one for a child Never sterilize or immerse the IRMA airway adapters in liquid They can be cleaned using a cloth moistened with ethanol or isopropyl al...

Страница 80: ...at Yellow background 1 Display until alarm stops Yellow When two or more alarms with equal priority are generated at the same time the signals will be displayed in turn The operator can hear the alarm...

Страница 81: ...e Sensor Data incorrect Startup only Call Service Representative O2 Supply Failure High Drive gas pressure is lower than 2 9 psi 15 Startup and Runtime Check pipeline gas supply Replace O2 cylinder Po...

Страница 82: ...rd software versions are inconsistent with released set Startup only Call Service Representative Service Rep needed Keyboard Communication Failure Low No communication between UI and Keyboard Startup...

Страница 83: ...continues please contact eligible service representative High Airway Pressure High Paw greater than upper limit for 2 consecutive breath cycles Settings of VT higher Patient airway blocked Exhalation...

Страница 84: ...APNEA High The measured expiratory tidal volume is 20 ml for patient Type Child or 150 ml for patient Type Adult For a period of 60 seconds Vent Mode MANUAL or 35 seconds Vent Mode SIMV or PS and Brea...

Страница 85: ...Condition Disabled In Manual Mode Operator Action Repair High PEEP Mid Exp pressure 5 cmH2O above PEEP for 2 breaths or Exp Pressure 5 cmH2O above PEEP in pressure support mode for more than 30 second...

Страница 86: ...stem is occluded Patient s respiratory tract is occluded Maximum pressure setting is too low Ventilator parameters changed Check and adjust Breathing System Check the patient Readjust the alarm settin...

Страница 87: ...5 mm H 485 mm W 325 mm D Display 10 4 TFT LCD Cylinder gauge O2 Scale 0 to 25 MPa 0 to 3500 psi Resolution 1 MPa Accuracy 2 5 of full scale Cylinder gauge N2O Scale 0 to 10 MPa 0 to 1400 psi Resolutio...

Страница 88: ...ipeline inlets must be 280 600 kPa when gas flow stops in the anesthetic gas delivering system 10 3 2 Flowmeter Flow rate Gas component Scale thin tube Scale thick tube O2 0 05 1 L min 1 1 10 L min N2...

Страница 89: ...2 OD 15 ID Exp Port connector 22 OD 15 ID Breathing System to AGSS 30 OD 10 5 Electromagnetic Compatibility Changing or reassembling this equipment without authorization may cause electromagnetic comp...

Страница 90: ...h can transfer O2 N2O AIR and inhalation anesthetic drugs Airway parts can use O2 N2O and AIR and the O2 N2O and AIR which is needed reduce to 280 kPa 600 kPa can enter into the machine through a high...

Страница 91: ...H E Y E R P a s i t h e c Rev 0 2 Draft 12 09 HEYER Pasithec Operator s manual 91 106 10 6 1 Pneumatic System Figure 10 1 Operation principle diagram of system...

Страница 92: ...ce of flow 0 1 to 0 5 kPa Leakage of connector Resistance of flow 50 ml min APL valve close fully Resistance of check valve Dryness 0 15 kPa The pressure generated by a wet unidirectional valve 0 14 k...

Страница 93: ...5 1 8 0 5 1 2 Unavailable for SIMV IPPV mode TINSP 0 2 5 0sec 0 1 sec 1 sec Child 2 sec Adult Only available for SIMV mode PEEP Off 3 30 cmH2O 1 cmH2O Off Unavailable for SIMV PCV PS IPPV mode FreqMI...

Страница 94: ...CO2 High 1 10 or 1 75 mmHg 1 or 1 mmHg 6 or 50 mmHg Unavailable for STANDBY mode INSCO2 High 1 10 mmHg 1 mmHg 5 mmHg Unavailable for STANDBY mode Hal Low 0 8 3 0 1 Unavailable for STANDBY mode Hal Hig...

Страница 95: ...veform Pressure monitoring range 0 to 80 cmH2O Paw t waveform display pressure axis varies with the upper alarm limit of Paw Range Gain 0 to 10 cmH2O 5 cmH2O 0 to 30 cmH2O 10 cmH2O 0 to 80 cmH2O 20 cm...

Страница 96: ...ess than 0 5 VOL 10 10 IRMA Probe Specification 10 10 1 Intended Use The IRMA main stream multi gas probe is intended to be connected to other medical devices for display of real time and derived moni...

Страница 97: ...pressure 500 to 1200 hPa Mechanical strength Withstands repeated 1m IRMA CO2 1 8 m drops on a hard surface Complies with requirements for road ambulances according to prEN1789 2004 clause 6 4 and req...

Страница 98: ...typically 10 seconds Total system response time 1 second Accuracy specifications during standard conditions Range Gas CO2 AX Accuracy CO2 0 15 15 25 0 10 10 20 0 2 vol 2 of reading Unspecified N2O 0 1...

Страница 99: ...al interface with the COM A below the UI 2 Snap the IRMA sensor head on top of the IRMA airway adapter it will click into place when properly seated 3 A green LED indicates that the IRMA probe is read...

Страница 100: ...strument to transmit a Zero reference command to the IRMA probe Special care should be taken to avoid breathing near the airway adapter before or during the Zeroing procedure The presence of ambient a...

Страница 101: ...way adapters shall not be reused Used disposable airway adapter shall be disposed of in accordance with local regulations for medical waste Do not use the IRMA Adult Pediatric airway adapter with infa...

Страница 102: ...of the device on the basis of technical defects of individual components The warranty obligation can only be recognized by us if the device has been used properly and according to its intended use and...

Страница 103: ...H E Y E R P a s i t h e c Rev 0 2 Draft 12 09 HEYER Pasithec Operator s manual 103 106 NOTES...

Страница 104: ...H E Y E R P a s i t h e c 104 106 HEYER Pasithec Operator s manual Rev 0 2 Draft 12 09 NOTES...

Страница 105: ......

Страница 106: ...C a r l H e y e r S t r 1 3 D 5 6 1 3 0 B a d E m s T e l 4 9 0 2 6 0 3 7 9 1 3 F a x 4 9 0 2 6 0 3 7 0 4 2 4 E M a i l i n f o h e y e r m e d i c a l d e w w w H e y e r M e d i c a l d e...

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