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Hamilton-C2-Manual

1. Flow Sensor Mask Co Whisper valve Single limb Figure 2 5 LiteCircuit single limb patient breathing circuit for use with NIV or NIV ST 624131 04 2 11 2 Preparing for ventilation Expiratory valve membrane Holding the expiratory valve housing Figure 2 6 upside down seat the silicone mem brane onto the housing The metal plate goes toward the ventilator Position the housing and twist clockwise until it locks into place SS o Figure 2 6 Installing the expiratory valve 2 12 624131 04 Expiratory valve housing Expiratory valve membrane Metal plate toward ventilator Flow Sensor Insert a Flow Sensor between the Y piece of the breathing circuit and the patient connection Figure 2 7 The blue tube is closest to the patient Con nect the blue and colorless tubes to the Flow Sensor con nectors in the front panel The blue tube goes to the blue connector The colorless tube goes to the silver connector Position the Flow Sensor upright to prevent kinking and moisture buildup NOTE To prevent inaccurate Flow Sensor readings make sure the Flow Sensor is correctly installed e The blue Flow Sensor tube must be toward the patient e The Flow Sensor tubings must be upright e The Flow Sensor tubings must not be kinked e The Flow Sensor tubings must be secured with clamp included with Flow Sensor 624131 04 2 13 2 Preparing for ventilation
2. 002000000000 G 7 Interfacing hardware for patient monitors H 4 Requirements for interfacing PDMSs H 6 624131 04 624131 04 General information 1 1 1 2 1 3 1 4 Introduction 1 2 Functional description 1 4 1 2 1 System overview 1 4 1 2 2 Gas supply and delivery 1 5 1 2 3 Gas monitoring with the Flow Sensor 1 7 Physical description 1 8 1 3 1 Breathing circuits and accessories 1 8 1 3 2 Ventilator unit 1 11 1 3 3 Screen 1 18 Symbols used on device labels and packaging 1 20 1 1 1 1 1 2 General information Introduction The HAMILTON C2 is designed for intensive care ventilation of adult and pediatric patients Ventilation modes This full functioned intensive care ventila tor offers a complete range of modes PCV PSIMV and SPONT are conventional pressure controlled modes S CMV and SIMV delivered by an adaptive volume controller com bine the attributes of pressure controlled with volume tar geted ventilation DuoPAP and APRV are two related forms of pressure ventilation designed to support spontaneous breath ing on two alternating levels of CPAP ASV adaptive support ventilation guarantees that the patient receives the selected minute ventilation with the optimal breath pattern lowest pressure and volume optimal rate to minimize work of breath ing and intrinsic PEEP NIV noninvasive ventilation and NIV ST spontaneous timed noninvasive ventilat
3. Figure 2 7 Installing the Flow Sensor Colorless tube away from patient Blue tube towards patient Flow sensor 2 5 installing a pneumatic nebulizer The nebulization feature provides a stable driving pressure to power a pneumatic nebulizer connected to the nebulizer out let optimally specified for 8 l min flow Connect the nebulizer and accessories as shown in Figure 2 8 Table 1 1 has information about compatible nebulizers 2 14 624131 04 NOTE e Do not use an expiratory filter or HME in the patient s breathing circuit during nebulization Nebu lization can cause an expiratory side filter to clog substantially increasing flow resistance and impairing ventilation e Connect the nebulizer in the inspiratory limb per your institution s policy and procedures Connecting the nebulizer between the Flow Sensor and the endotracheal tube increases dead space ventilation e To prevent the expiratory valve from sticking due to nebulized medications use only medications approved for nebulization and regularly check and clean or replace the expiratory valve membrane Inspiratory Nebulizer limb K x Connector Tube Figure 2 8 Installing a pneumatic nebulizer 624131 04 2 15 2 Preparing for ventilation 2 6 Installing the optional Aeroneb Pro nebulizer NOTE Connect only approved piezo nebulizers to the HAMIL TON C2 ventilator The Aerogen Aeroneb Pro nebulizer system is available as an option for
4. Qo sensor Oz mixer 02 valve Pambien sensor Nebulizer ppyyNebulizer Tinst restrictor Xvalve Noise d i en oise dampening sensor Pvent_monitor Paw sensor sensor Inspiratory valve L Pflow sensor Auto zero Oxygen Autozero Autozero ll valve AA ce valve Q Quent Sensor Ambient valve Les Xpiratory valve buli TAH From proximal Nebulizer LA Flow Sensor Standard From patient rinse flow To patient 624131 04 F 1 Pneumatic diagram 624131 04 APPENDIX G 624131 04 Parts and accessories Table G 1 through Table G 2 and Figure G 1 through Figure G 2 show the operator replaceable HAMILTON C2 parts For additional parts and accessories contact your HAM ILTON MEDICAL representative G 1 G Parts and accessories Table G 1 Ventilator parts and accessories Item no ad Figure G 1 Description Support arm HAMILTON C2 for standard trol 160153 ley 2 Patient breathing set A0 C2 HME HAMILTON 260080 C2 adult reusable A0 Patient breathing set A1 C2 single water trap 260081 HAMILTON C2 adult reusable for use with in spiratory limb heater wire Patient breathing set A2 C2 double water 260082 trap HAMILTON C2 adult reusable for use without heater wires Patient breathing set PO C2 HME HAMILTON 260083 C2 pediatric reusable Patient breathing set P1 C2 single water trap 260084 HAMILTON C2 pediatric reusabl
5. 2 Wait for 2 min 3 Disconnect the oxygen supply 624131 04 VERIFY that the Oxygen concentration displayed in the monitoring window decreases VERIFY that the Low oxy gen alarm activates Wait 30 s or until the oxygen concentration falls below 40 Reconnect the oxygen supply VERIFY that the Low oxygen alarm resets The Low oxy gen alarm should reset when the measured oxygen exceeds 45 3 5 4 Disconnection on patient side 1 2 Disconnect the demonstration lung VERIFY that the Disconnection on patient side alarm is activated Reconnect the demonstration lung VERIFY that the alarm resets and that the HAMILTON C2 automatically resumes ventilation 3 5 5 Loss of external power 1 2 3 624131 04 With the HAMILTON C2 connected to ac power start it up Disconnect the power cord VERIFY that the Loss of external power alarm is acti vated and that the HAMILTON C2 is powered by its backup batteries Reconnect the HAMILTON C2 to ac power VERIFY that the alarm resets and that the HAMILTON C2 is again powered by ac 3 17 3 Tests calibrations and utilities 3 5 6 Exhalation obstructed 1 2 3 Block the expiratory valve exhaust port Observe the pressure rise VERIFY that the Exhalation obstructed alarm is acti vated 3 5 7 Apnea 3 18 1 Mm BB Ww N Put the ventilator into SPONT mode Make sure apnea backup ventilation is disabled Wa
6. List of figures XX 624131 04 List of tables Compatible parts and accessories 0 0 0 0 ee eee Symbols used on device labels and packaging Breathing circuit parts according to Pat height When to perform tests and calibrations Settings during back up mode PCV 0 0 0 0 0002 eee Setting during back up mode SIMV 0 0000000 Control settings mode additions and ranges Alarm limit settings and ranges 22 20055 Monitored parameters 00 00000 cee eee Dynamic Lung normal values 00200000 0000 ue Vent Status parameters enaa a Arni ne eE ee Alarm indications in HAMILTON C2 aoaaa aaan Alarms and other messages o n anana aaa Decontamination methods for HAMILTON G2 PaftSnaa cee eee eR aa a a aa Preventive maintenance schedule 0 00000 Physical characteristics 0 0 eee Environmental requirements 0000000 2 eee Pneumatic specifications 0 0 00020 cee eee ee Electrical specifications 0 2 0 ee Control setting ranges and resolutions 0 Controls active in HAMILTON C2 ventilation modes Monitored parameter ranges resolutions and ACCULACIES ot rei Ge heeds ug wa sie bees aldo de ee A8 Real time CUIVES osee cio a ened Lak Relves oR ences A 9 Adjustable alarm ranges and resolutions A 10 Configuration specifications 000 022
7. mea PSM ro 10 12 PEEP CPAP Oxygen Figure 8 2 Activate Standby window 624131 04 8 3 8 Special functions The Standby window Figure 8 3 opens During standby the window shows the elapsed time since standby was started To end standby either select Start ventilation or press and quickly release the power switch Ventilation resumes with the previous settings New patient Last patient IBW 705 Figure 8 3 Standby window 8 4 624131 04 8 2 8 3 624131 04 100 O gt The 100 O function delivers 100 oxygen for 2 min This is useful for pre oxygenation before tracheal suctioning or for other clinical applications To start oxygen enrichment press the 100 O key The ventilator starts delivering 100 oxygen Afterwards the ventilator resets the concentration to the previous operator set value To terminate delivery of 100 O before the 2 min period press the key again The HAMILTON C2 resumes ventilation at the set oxygen concentration CAUTION e Prolonged exposure to high oxygen concentra tions may cause irreversible blindness and pul monary fibrosis in pediatrics NOTE Oxygen alarms are suppressed during the 100 O3 function Manual breath inspiratory hold This function lets you deliver a manually triggered breath or perform an inspiratory hold maneuver To deliver a manual breath only press and release the key during exhalation Do not press the key qu
8. vi Fire and other hazards To reduce the risk of fire or explosion do not place the ven tilator in a combustible or explosive environment for exam ple around flammable anesthetics or other ignition sources Do not use it with any equipment contaminated with oil or grease To reduce the risk of fire do not use high pressure gas hoses that are worn or contaminated with combustible materials like grease or oil To reduce the risk of fire use only breathing circuits intended for use in oxygen enriched environments Do not use antistatic or electrically conductive tubing In case of fire immediately secure the patient s ventilatory needs switch off the ventilator and disconnect it from its gas and electrical sources Service and testing To ensure proper servicing and to prevent possible physical injury only HAMILTON MEDICAL authorized service person nel should attempt to service the ventilator To reduce the risk of electrical shock diconnect electrical power from the ventilator before servicing Be aware that battery power remains even after the mains is discon nected Be aware that if the power switch is off some parts still carry high voltage Do not attempt service procedures other than those speci fied in the service manual Use replacement parts supplied by HAMILTON MEDICAL only Any attempt to modify the ventilator hardware or software without the express written approval of HAMILTON MEDI CAL automa
9. 2009 HAMILTON MEDICAL AG All rights reserved Printed in Switzerland No part of this publication may be reproduced or stored in a database or retrieval system nor transmitted in any form or by any means electronic mechanical by photocopying recording or otherwise without the prior written permission of HAMILTON MEDICAL This manual may be revised or replaced by HAMILTON MEDICAL at any time and without notice You should ensure that you have the most current applicable version of this manual if in doubt contact HAMILTON MEDICAL AG Marketing Department Nothing in this manual shall limit or restrict in any way HAMILTON MEDICAL right to revise or otherwise change or modify the equipment including its software described herein without notice In the absence of an express written agreement to the contrary HAMILTON MEDICAL has no obligation to furnish any such revisions changes or modifications to the owner or user of the equipment including software described herein The equipment must be operated and serviced only by trained profes sionals HAMILTON MEDICAL sole responsibility with respect to the equipment and its use is as stated in the Limited Warranty provided in this manual ASV is a trademark of HAMILTON MEDICAL in some countries Other product and company names mentioned herein may be the trade marks of their respective owners HAMILTON MEDICAL will make available on request circuit diagrams component parts
10. Figure 1 3 shows the HAMILTON C2 with its breathing circuit and accessories Contact your HAMILTON MEDICAL represen tative for details on breathing circuits and accessories supplied by HAMILTON MEDICAL See Table 1 1 for information on other compatible breathing circuits and accessories NOTE To ensure proper ventilation operation use only parts and accessories specified in Table 1 1 1 8 624131 04 624131 04 Figure 1 3 HAMILTON C2 with accessories Graphic user interface Support arm Breathing circuit see figures 2 6 through 2 9 for details Humidifier Standard trolley option Breathing circuit connections 1 9 1 General information Table 1 1 Compatible parts and accessories Patient breath e HAMILTON MEDICAL patient breathing circuits ing circuit e Other circuits that meet the ventilator breathing system specifications in Appendix A Circuits must comply with ISO 5367 HAMILTON MEDICAL face masks Other face or nasal masks except those incorporating an expiratory valve Inspiratory filter HAMILTON MEDICAL inspiratory bacteria filter Other filters that have a 22 mm female conical inlet con nector and a 22 mm male conical outlet connector and that meet the ventilator breathing system specifications in Appendix A Humidification Fisher amp Paykel humidifier for example MR810 or device MR850 Any active humidifier with a flow capability of up to 120 l min that is approved for
11. Figure C 14 Three different relationships between rate and WOB are plotted for a hypothetical lung purely resistive load causes WOB to rise with rate x purely elastic load creates highest load at low rates o the total lung shows a clear minimum which can be calculated according to the equation below The following equation was found to represent the rate where WOB is minimum fe V1 2ax RCex MinVol f x Vd Vd 1 axRCe where a is a factor that depends on the flow waveform For sinusoidal flows a is 22 60 C 29 G ASV adaptive support ventilation The corresponding tidal volume is calculated as Vt MinVol f Example A 70 kg male patient with normal lungs Rtotal 5 cmH20 l s expiratory resistance hose and valve 5 cmHO s Crs 50ml cmH20 may have a measured RCexp of 0 5 s an estimated VDaw of 154 ml and an operator set MinVol of 100 With these values the target MinVol becomes MinVol 100 x 70 kg x 0 1 I min kg 7 I min Next Otis equation is applied with the following parameters MinVol 7 l min VDaw 154 ml RCexp 0 5s a 2n7 60 f 10 b min determined using Table C 6 The result is a new rate f 1 f 1 15 b min This rate is again inserted into Otis equation the calculation is performed again and the next estimate for rate f 2 is obtained This procedure is repeated until the difference between subsequent results for rate f becomes lower than 0 5 b min In t
12. volume fraction of 2 5 2 5 of actual reading A 18 624131 04 Table A 12 Other technical data continued Measuring and display devices Pressure and volume measurements Type Differential pressure transducer variable orifice Sensing position Patient Y piece Measurements See Table A 7 Time measurements Type Microprocessor Sensing position Inside ventilator Measurements See Table A 7 Oxygen measurement Type Galvanic cell Sensing position Inspiratory pneumatics Measurement Delivered oxygen concentration range 18 to 103 Response time lt 12 s to reach 90 of final oxygen concentration Initialization time time from switching on until operating performance lt 40 s Display of settings alarms and monitored data Type TFT color Size 640 x 480 pixels 10 4 in 264 mm diagonal Oxygen cell life 1 year or 5000 h nominal Actual cell life depends on operating environment Oper ation at higher temperatures or higher oxygen concentrations shortens cell life 624131 04 A 19 A Specifications Table A 12 Other technical data continued Parameter Specification Alarm loudness 50 to 65dB A at 1 m Tests and special functions Tightness test oxygen cell calibration Flow Sensor calibration 100 O3 manual breath inspiratory hold maneuver nebuli zation 30 min 8 I min communications interface compensation of breathing cir cuit resistance and compliance 1 Actua
13. 9to 11 15 0 6 20 0 12 to 14 15 0 7 20 0 15 to 20 15 0 8 20 0 21 to 23 15 0 9 15 7 24 to 29 15 1 15 7 30 to 39 15 1 14 7 40 to 59 15 1 12 6 60 to 89 15 1 10 5 90 to 99 18 1 5 10 5 gt 100 20 1 5 10 5 624131 04 C 33 C C 7 C 34 ASV adaptive support ventilation References Hewlett AM Platt AS Terry VG Mandatory minute volume A new concept in weaning from mechanical ventilation Anaesthesia 1977 32 163 9 Radford EP Jr Ventilation standards for use in artificial respiration N Engl J Med 1954 251 877 83 Otis AB Fenn WO Rahn H Mechanics of breathing in man J Appl Physiol 1950 2 592 607 Marini JJ Crooke PS Truwit JD Determinants and limits of pressure preset ventilation a mathematical model of pressure control J Appl Physiol 1989 67 1081 92 Slutsky AS Consensus conference on mechanical ventilation January 28 30 1993 at Northbrook Illinois USA Int Care Med 1994 20 64 79 Lourens MS Van den Berg BV Aerts JGJ Verbraak AFM Hoogsteden HC Bogtaard JM Expiratory time constants in mechanically ventilated patients with and without COPD Int Care Med 2000 26 1612 8 Quan SF Parides GC Knoper ST Mandatory Minute Volume MMV Ventilation An Overview Resp Care 1990 35 898 905 Belliato M Maggio M Neri S Via G Fusilli N Olivei M lotti G Braschi A Evaluation of the adaptive support ventilation ASV mode in paralyzed patients Int Care Med 2000 26 Suppl 3 327 Su
14. Consider the following when compensating dead space e A shorter than standard endotracheal or tracheostomy tube has a minor effect and probably does not require compensation e Varying the size of endotracheal tube probably has a minor effect and probably does not require compensation e A much longer than normal catheter mount may be significant and may require compensation e A bacterial filter or an HME may have a significant effect The volume of these devices for an adult is on average 50 to 60 ml but may be as high as 95 ml Mallinckrodt Hygroster A simple rule of thumb is to add 10 to the IBW by adjusting the Pat height control if using an HME NOTE Changes in alveolar dead space due to ventilation perfusion mismatch must be compensated via the MinVol control 624131 04 c 9 C ASV adaptive support ventilation Step 4 Adjusting ventilation maintaining adequate ventilation Once ASV is started the HAMILTON C2 calculates an optimal breath pattern and associated target values for tidal volume and rate according to the rules in Section C 4 ASV then adjusts the inspiratory pressure Pinsp and machine rate fControl to achieve the targets Once the set targets are reached the result of the ventilation needs to be assessed All HAMILTON C2 monitored parameters can be used for this purpose However to assess respiratory acid base status it is recommended that arterial blood gases be measured and minut
15. Saporito LR Intermittent positive pressure ventilation via the mouth as an alternative to tracheostomy for 257 ventilator users Chest 1993 103 174 182 D 7 D Clinical application of noninvasive ventilation D 8 Alarms Volume alarms are less meaningful in noninvasive than in other modes because of the unpredictable gas leakage in these modes These alarms are based on the returned expiratory gas volume measured at the Flow Sensor this value may be significantly lower than the delivered tidal volume because the delivered tidal volume is the sum of the displayed VTE and the leakage volume To avoid nuisance volume alarms set the low Vt and ExpMinVol alarms to a low level Because the noninvasive modes are pressure modes however do pay attention to the pressure related alarms If the defined PEEP and inspiratory pressure can be maintained the ventilator is compensating the gas leak sufficiently D 9 Monitored parameters D 8 NOTE Due to the changing and unpredictable amount of leakage these numeric monitoring parameters cannot be used for reliable analysis of patient conditions ExpMinVol RCexp Rinsp Insp Flow AutoPEEP and Cstat Close monitoring of the clinical parameters and patient comfort is therefore of critical importance Due to the leakage at the patient interface displayed exhaled volumes in the noninvasive modes may be substantially smaller than the delivered volumes The Flow Sensor a bidirectional
16. als If these materials are not available contact your HAMILTON MEDICAL representative for replacement materials 624131 04 9 15 9 Maintenance 9 16 624131 04 APPENDIX A Specifications A 1 Physical characteristics A 2 A 2 Environmental requirements A 3 A 3 Pneumatic specifications A 3 A 4 Electrical specifications A 4 A 5 Control settings A 5 A 6 Monitored parameters A 9 A 7 Alarms A 13 A 8 Configuration specifications A 15 A 9 Ventilator breathing system specifications A 17 A 10 Other technical data A 18 A 11 Standards and approvals A 21 A 12 EMC declarations IEC 60601 1 2 A 22 A 13 Warranty A 28 624131 04 A 1 A Specifications A 1 Physical characteristics Table A 1 Physical characteristics Weight 9 5 kg 21 lb 38 5 kg 85 Ib with standard trolley 46 HN 66 cm 18 1 in 4 28 0 in Figure A 1 HAMILTON C2 dimensions A 2 624131 04 A 2 Environmental requirements Table A 2 Environmental requirements Temperature Operating 5 to 40 C 41 to 104 F Storage 20 to 60 C 4 to 140 F Relative humidity Operating storage 10 to 95 noncondensing Altitude Up to 4000 m 13 120 ft above sea level A 3 Pneumatic specifications Table A 3 Pneumatic specifications High pressure oxygen Pressure 2 8 to 6 bar 280 to 600 kPa 41 to 87 psi inlet Flow 40 to 120 I min STPD Connector DISS CGA 1240 or NIST Low pressure oxygen Peak pressure lt 6 bar 600 kPa 87 psi inlet Flow
17. and Table A 15 The customer or the user of the HAMILTON C2 ventilator should ensure that it is used in such an environment The HAMILTON C2 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the HAMILTON C2 can help pre vent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the HAMILTON C2 as recom mended in Table A 15 according to the maximum output power of the communications equipment Table A 13 Guidance and manufacturer s declaration electromagnetic emissions eee Compli Electromagnetic environment Emissions test ance guidance RF emissions Group 1 The HAMILTON C2 ventilator uses CISPR 11 RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interfer ence in nearby electronic equipment RF emissions Class A The HAMILTON C2 ventilator is suitable CISPR 11 for use in all establishments other than domestic and those directly connected Harmonic emissions Class A to the public low voltage power supply IEC 61000 3 2 network that supplies buildings for Voltage fluctuations Complies GornestleDAIPeSes flicker emissions IEC 61000 3 3 A 22 624131 04 Table A 14 Guidance and manufacturer s declaration electromagnetic immunity Immunity test IEC
18. gt 50 ml High priority VTI measured at the airway lt 1 2 delivered VTI and delivered VTI gt 50 ml High priority End expiratory pressure gt set PEEP CPAP 5 cmH 0 Check the patient Check the breathing circuit for a disconnection between the patient and the Flow Sensor or for other large leaks for example ET tube bron chopleural fistula CAUTION A fan failure could result in oxygen enrichment inside the ventilator and a sub sequent fire hazard Check the breathing circuit for a disconnection between the ventilator and the Flow Sensor or for other large leaks for example breathing circuit humidifier Reconnect and calibrate the Flow Sensor Check the patient Check the expiratory limb for occlusion Check the expiratory valve membrane and cover Check the Flow Sensor tubes for occlusion Adjust breath timing controls to increase the expiratory time Have the ventilator serviced 7 Responding to alarms Table 7 2 Alarms and other messages continued Exhalation port occluded External Flow Sensor failed Fan failure High fre quency High min ute volume High oxy gen 7 14 High priority The baseline cir cuit flow is lt 5 l min for a period of 1 min Active only in NIV and NIV ST High priority The external flow sensor doesn t work properly Medium priority The cooling fan is malfunctioning Medium priority The mea sur
19. have passed e Itis the clinician s responsibility to ensure that all ventilator settings are appropriate even when automatic features such as ASV or standard settings are used This section tells you how to set up the HAMILTON C2 for ven tilation on an individual patient Prepare the ventilator as instructed in Section 2 You must be familiar with using the touchscreen and knob to select activate and confirm parameters For details see Sec tion 2 14 4 2 624131 04 4 2 624131 04 Patient setup After you initiate ventilation the patient setup window Figure 4 1 is shown The default settings are shown Select adjust and activate the desired items Make sure the ventilator is configured with the appropriate breathing circuit parts as described in Section 2 4 1 If you haven t already done so run the Preop check Sec tion 3 2 Select New patient to start up with default settings or select Last patient to start up with the last active venti lation parameters in use If you selected New patient adjust the Gender and Pat height settings The ideal bodyweight IBW is automati cally calculated and displayed Select Start ventilation to start ventilation The IBW based on Pennsylvania Medical Center adults and Traub SL Am J Hosp Pharm 1980 pediatric patients is calculated as follows IBW Ideal Body Weight kg BH Body Height cm BH lt 70cm IBW 0 125 x BH 0 75 70 lt
20. lt 15 l min Connector Quick coupling system compatible with Colder Products Company CPC PMC Series Air supply Integrated turbine Gas mixing system Delivered flow 240 l min peak flow 120 l min con tinuous flow 4 to 20 l min continuous base flow Delivered pressure 0 to 60 cmH 0 Inspiratory outlet T Connector ISO 15 mm female 22 mm male conical patient port Expiratory outlet From Connector on expiratory valve ISO 15 mm female patient port 22 mm male conical 624131 04 A 3 A Specifications A 4 Electrical specifications Table A 4 Electrical specifications Input power 100 to 240 V ac 10 50 60 Hz or 12 to 24 V dc 10 Power con 50 W typical 150 W maximum sumption Batteries Electrical specifications for battery 1 or 2 14 4 V dc 6 6 Ah 3 5A Type Lithium ion supplied by HAMILTON MEDICAL only Operating time with one battery in use with turbine in use and with these settings C 15 ml cmH 0 Rate 10 b min Pinsp 10 cmH20 PEEP CPAP 5 cmH 0 2 h minimum 2 5 h typical This operating time applies to a new fully charged battery not exposed to extreme temperatures The actual operating time depends on battery age and on how the battery is used and recharged Recharge time for battery 1 and or 2 4 h minimum while ventilator is connected to either dc between 20 and 27 V or ac Storage 20 to 60 C lt 95 relative humidity Storage place should be free from vibration dust dire
21. ol 7 0 min Flowtrigger Darmin 60 Figure C 2 ASV basic controls C 6 624131 04 15 otal b min 228 ml Figure C 3 ASV more controls Step 1 Preoperational procedures Prepare the HAMILTON C2 for clinical use according to Section 2 This includes but is not limited to performing the preoperational procedures and testing indicated Step 2 Preparing the HAMILTON C2 before connecting a patient Prepare the ventilator for use on a patient as follows 1 Remove the demonstration lung when a demonstration lung is used and silence the alarm 2 Activate ASV in the Modes window and then Confirm the mode change The Controls window automatically opens 624131 04 C 7 C C 8 ASV adaptive support ventilation 3 Make the following control settings Pat height The Pat height setting is used to deter mine IBW which ASV uses in its calculations MinVol A logical starting point is a MinVol that will result in the same minute volume as a previous mode if applicable The MinVol for a normal patient might be 100 for a COPD patient 90 for an ARDS patient 120 and for other patients 110 Add 20 if body temperature gt 38 5 C 101 3 F and 5 per 500 m 1640 ft above sea level Pasvlimit Enter the maximum pressure to be applied as Pasvlimit For the ASV controller to function correctly Pasvlimit must be at least 15 cmH gt 0O greater than PEEP CPAP NOTE
22. than what is specified herein including without limitation obligations and or liabilities for alleged negligence or for strict liability In no event shall the company be liable for incidental or consequential damages either direct or contingent 624131 04 624131 04 This Limited Warranty shall be void and not apply A If the product has not been installed and connected by an authorized local representative of HAMILTON MEDICAL in accordance with the instructions furnished by HAMILTON MEDICAL and by a HAMILTON MEDICAL representative B If replacements and or repairs have not been performed by authorized or properly trained personnel C If no evidence is present that the occurrence of damage repair happened within the certified warranty period D If the serial number has been altered effaced or removed and there is no bill of sale or evidence to verify the product s purchase date E If the defects arise from misuse negligence or accidents or from repair adjustment modification or replacement made outside HAMILTON MEDICAL s factories or other than an authorized service center or authorized service representative F If the product has been modified or in any nature altered without prior written authorization from HAMILTON MEDICAL Replacements and or repairs furnished under this Limited Warranty do not carry a new warranty but carry only the unexpired portion of the original Limited Warranty The warranty of rep
23. the gas intake port s and the patient con nection port together with the fresh gas inlet and exhaust port s if fresh gas inlet or exhaust ports are pro vided as described in ISO 4135 2001 An Intelligent Panel that visualizes six parameters related to the patient s ventilator dependency including oxygen ation CO elimination and patient activity Tidal volume a control setting an alarm setting and a monitored parameter in the Vent Status panel 624131 04 VTE Expiratory tidal volume a monitored parameter It is the integral of all negative flow measurements during exhala tion VTI Inspiratory tidal volume a monitored parameter 624131 04 Glossary 9 Glossary Glossary 10 624131 04 Index Numerics 100 O function details 8 5 100 O key description 1 12 A Accessories general information 1 8 1 9 part numbers G 1 G 5 specifications for compatible 1 10 Adaptive support ventilation See ASV Aeroneb Pro ultrasonic nebulizer sys tem how to install 2 15 Airway pressure mean See Pmean Alarm buffer 7 6 7 7 Alarm lamp description 1 11 Alarm loudness window 4 21 Alarm silence key description 1 12 Alarm tests 3 15 3 17 Alarms alarm buffer 7 6 7 7 audible specifications A 18 how to respond to 7 1 7 18 how to set 4 18 4 20 loudness how to adjust 4 21 messages list 7 9 7 19 See also name of specific alarm settings and definitions 4 22 4 23 settings and ranges adjustable A 11 A 12 visual and
24. 1 Bl Standby ie slike ete Dawe kee cee ea teh eed 8 2 82 OO OF i ah ele hes rte se vei IN atin tackle 8 5 8 3 Manual breath inspiratory hold 8 5 8 4 NebUIIZER 8 eeccck har ke eed Bese RR AY eee s 8 6 Maintenances iii oii sk eee eee dk dees 9 1 Dele VIMMOGUCIION fii ea a E e fake Geb bees 9 2 9 2 Cleaning disinfection and sterilization 9 2 9 2 1 General guidelines for cleaning 9 6 9 2 2 General guidelines for chemical disinfection 9 7 9 2 3 General guidelines for autoclave ETO or plasma sterilization ma obviate anes packhaga eae Sia oe 9 7 9 3 Preventive maintenance 0 0 00 e eee eee 9 8 9 3 1 Servicing the air intake and fan filters 9 10 9 3 2 Replacing the batteries 9 12 9 3 3 Charging and calibrating the batteries 9 13 9 3 4 Replacing the oxygen cell 9 14 QA STORAGC oe nt teh ie Ba tie dia ea eee at hg eee 9 15 9 5 Repacking and shipping 0 05 9 15 xi Table of contents A xii SPECITICATIONS viet metas iets pee weses ad A 1 A 1 Physical characteristics 2 2 0 0 0000000000 cea A 2 A 2 Environmental requirements 0000 A 3 A 3 Pneumatic specifications 202005 A 3 A 4 Electrical specifications 0 0 00000002005 A 4 A 5 Control settings 0 000000 A 5 A 6 Monitored parameters 00 0000002 A 9 AZA Alan 2 2 Sene
25. 1 2 3 624131 04 Gas monitoring with the Flow Sensor The HAMILTON C2 accurately measures flow volume and pressure in the patient s airway with the HAMILTON MEDICAL Flow Sensor This proximal Flow Sensor lets the HAMILTON C2 sense even weak patient breathing efforts Between its highly sensitive flow trigger and fast response time the HAMILTON C2 helps minimize the patient s work of breathing The Flow Sensor contains a thin diamond shaped membrane within the outer housing and has a pressure port on either side The membrane allows bidirectional flow through its vari able orifice Figure 1 2 Figure 1 2 Flow Sensor variable orifice The area of the orifice changes depending on the flow rate It opens progressively as the flow increases creating a pressure drop across the orifice The pressure difference is measured by a high precision differential pressure sensor inside the ventila tor The pressure difference varies with flow relationship deter mined during Flow Sensor calibration so the patient s flow is determined from the pressure drop The HAMILTON C2 calcu lates volume from the flow measurements The Flow Sensor is highly accurate even in the presence of secretions moisture and nebulized medications The HAMIL TON C2 continuously flushes the sensing tubes with mixed gases rinse flow to prevent blockage 1 7 1 General information 1 3 Physical description 1 3 1 Breathing circuits and accessories
26. 21 POWErSWITCN 2 ea nerka ha Rees ae bee Reg Me le eh eee ae 2 22 Info WINdOW 4s eanan tae lea Bt a ahh wad aoe nae ae 3 5 Tests amp calib Window sp ane da terp E a AARE Ea 3 6 Sensors on off WINdOW oaoa s aaaea ee 3 10 Date amp time window 0 0000 cee eee 3 11 Configuration window 0 0 0 0 00 000 cee eee 3 12 Data transfer WindOW sna eit oe a inate Beware See 3 14 Patient setup window n saaana anaran 4 4 Modes window 0 44 045 5045 8 ee dt a 4 5 Basic Controls WiINdOW 0 0 00 000 eee 4 8 MOE WINGOW 2 020 eee cle halved ES ee eae ae 4 9 Aphea WIndOW E E ae e oti ee Hee Geeree REE A Re oe oe 4 10 Basic window during mode change ASV mode change 4 11 Limits 1 WINdOW s ee eee tere a kay Dae ge ee tee Ge 4 22 Emte WINDOW sae er bac Find ce ok der oe eine Oey 4 23 Loudness WINdOW o naaus aaae 4 24 HAMILTON G2 Sreema tapya aad aa i ada ane d i 5 3 624131 04 xv List of figures 5 2 5 3 5 4 5 5 5 6 5 7 5 8 6 1 6 2 6 3 6 4 6 5 6 6 7 1 7 2 7 3 7 4 7 5 7 6 8 1 8 2 8 3 9 1 9 2 9 3 9 4 A 1 B 1 B 2 B 3 B 4 B 5 B 6 xvi Values window 1 aaau asasan aeea 5 4 Values WINdOW Zec acces peated Teagan iae drai e a de 5 5 Values WINKOW S cc ox ary Miner ashe Baa ne pated we abate edule 5 6 Graphics WINKOW arora gous veges eee Sateen are Sato ele D 5 8 Pressure waveform display 0 0000 eee eee 5 9 Trends display i ere selya dines ba fe
27. 24 hour trends You will see the trend displays Figure 5 7 including all data since you switched on the ventilator for the past 1 6 12 or 24 hours From the time you switch on power to the HAMILTON C2 the HAMILTON C2 continually stores the monitored parameters in its memory so you have access to any of this data even after standby If the HAMILTON C2 is switched off the data of the last patient appears from the memory when power is switched on again The freeze and cursor measurement function may also be used to examine points on trend waveforms When trends are frozen the time axis shows elapsed time relative to the present and the corresponding value of the monitored parameter 624131 04 624131 04 All monitoring parameters can be trended The following parameters are trended in combination Ppeak PEEP fTotal fControl ExpMinVol MVSPONT f Controls b min Alarm s Monitoring Figure 5 7 Trend display Current time Mean or median value green Elapsed time relative to present 5 11 5 Monitoring 5 4 6 Loops The Hamilton C2 can display a dynamic loop based on the following parameter combinations Pressure Volume Pressure Flow Flow Volume Figure 5 8 Loop display P max Pressure limitation Dynamic loop waveform 5 12 624131 04 5 5 Table of monitored parameters NOTE The HAMILTON C2 automatically measures inspiratory resistance Rinsp compliance Csta
28. 3 9 maintenance 9 9 part number G 3 Oxygen fittings location 1 14 Oxygen monitored parameter defini tion 5 13 Oxygen monitoring how to enable dis able 3 10 Oxygen setting definition 4 15 Oxygen supply failed alarm 7 16 Index 5 Index Oxygen supply how to connect 2 20 2 21 Oxygen Vent Status parameter defini tion 6 7 P Parts and accessories G 1 G 5 Pasvlimit ASV pressure limit setting definition 4 15 Pat height patient height setting def inition 4 15 Patient breathing circuit See Breathing circuit Pcontrol pressure control setting function and range 4 15 PCV mode description B 12 B 13 Peak expiratory flow See Exp Flow Peak inspiratory flow monitored param eter See Insp Flow Peak proximal airway pressure See Ppeak PEEP Vent Status parameter definition 6 7 PEEP CPAP monitored parameter defi nition 5 13 PEEP CPAP setting definition 4 15 Piezo nebulizer See Aeroneb Pro nebu lizer system Pinsp parameter definition 5 13 Pinsp Vent Status parameter defini tion 6 7 Pressure maximum pressure alarm set ting definition 4 23 Pmean mean airway pressure moni tored parameter definition 5 13 Pneumatic specifications A 3 Port exhaust location from patient location 1 13 See also Connector to patient location 1 13 Power specifications A 4 Power switch description 1 16 Index 6 Ppeak peak proximal airway pressure monitored parameter definition 5 13 P ramp pressure
29. 60 to 89 15 0 1 2 90 to 99 18 0 1 2 gt 100 20 10 1 2 1 The maximum o 2 The maximum o has never set any value the setting is based on IBW the set Psupport Pinsp or the value as listed the last set value i n any ventilation mode or if the user 624131 04 Table 4 2 Settings during backup mode SIMV IBW kg v Riisa I E 3to5 lt 35 1 2 6 to 8 lt 35 1 2 9 to 11 lt 35 1 2 12 to 14 lt 35 1 2 15 to 20 lt 35 1 2 21 to 23 lt 35 1 2 24 to 29 lt 35 1 2 30 to 39 lt 35 1 2 40 to 59 lt 35 1 2 60 to 89 lt 35 1 2 90 to 99 lt 35 1 2 2100 lt 35 1 2 1 The last set value in any ventilation mode or if the user has never set any value the setting is calculated based on Vykg configuration 2 The maximum of the last set value in any ventilation mode or if the user has never set any value the setting is based on IBW but always lt 35 b min 624131 04 4 15 4 Ventilator settings 4 4 4 Table of control settings mode additions and ranges Table 4 3 Control settings mode additions and ranges A function that provides ventilation after the On or Off adjustable apnea time passes without breath attempts Applies in SIMV PSIMV SPONT NIV and NIV ST APRV DuoPAP Expiratory trigger sensitivity The percent of 5 to 70 of peak inspiratory flow at which the ventilator inspiratory cycles from inspiration t
30. 60601 1 2 test level Compliance level Electromagnetic environment guidance Electrostatic dis 6 kV contact 6 kV contact Floors should be wood charge ESD 8 kV air 8 kV air concrete or ceramic tile IEC 61000 4 2 If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast 2 kV for 2 kV for Mains power quality transient burst power supply power supply should be that of a typi IEC 61000 4 4 lines lines cal commercial or hospi 1 kV for 1 kV for tal environment input output input output lines lines Surge 1 kV line s to 1 kV line s to Mains power quality IEC 61000 4 5 line s line s should be that of a typi cal commercial or hospi tal environment Voltage dips lt 5 Uy lt 5 Uy Mains power quality short interrup gt 95 dip in gt 95 dip in should be that of a typi tions and volt Ur for Uy for cal commercial or hospi age variations 0 5 cycle 0 5 cycle tal environment If the on power sup 40 Uz 60 40 U 60 user requires continued ply input lines dip in Uz for dip in Uy for operation during power IEC 61000 4 11 5 cycles 5 cycles mains PEE is recommended that the 70 Ur 30 70 Uy 30 ventilator be powered dip in Ur for dip in Ur for from an uninterruptible 25 cycles 25 cycles power supply or a bat lt 5 Ur lt 5 Ur tery gt 95 dip in gt 95 dip in Uy for 5s Uy for
31. Absolute pres 0 to sure includes PEEP 60 cmH 0 Pressure additional to PEEP CPAP to be 5 to applied during the inspiratory phase 60 cmH20 Applies in PSIMV and NIV ST above PEEP CPAP P low Applies in APRV 0 to 35 cmH20 4 18 624131 04 Table 4 3 Control settings mode additions and ranges continued 624131 04 Pressure ramp Time required for inspiratory pressure to rise to the set target pressure The P ramp setting lets you fine tune the initial flow output during a pressure controlled or pressure supported breath to match the ventilator flow to the patient s demand Short P ramp settings 0 to 50 ms provide higher initial flow rates and result in faster attainment of the target pressure This may benefit patients with elevated respiratory drive Setting the P ramp too low especially in combination with a small ET tube high resistance may result in a noticeable pressure overshoot during the early stage of inspiration and a Pressure limitation alarm Setting the P ramp too high may prevent the ventilator from attaining the set inspiratory pressure A square rectangular pressure profile is the goal Lower P ramp values have been correlated with reduced work of breathing in certain patients Applies to all breaths NOTE To prevent possible pressure overshoot in pediatric applications it is recommended that P ramp be set to at least 75 ms Pressure support Pressure additional to PE
32. Activated To scroll through a log using the scroll bar or arrows touch the scroll bar to select Scroll and activate it or turn the knob to select the bar scroll bar it is framed in yellow and then press it to activate your selection Your selec tion becomes red when activated Now turn the knob to scroll through the log Touch the scroll bar or press the knob to deactivate 624131 04 2 25 2 Preparing for ventilation 2 26 624131 04 3 Tests calibrations and utilities 624131 04 3 1 3 2 3 3 3 4 3 5 Introduction 3 2 Running the preoperational check 3 3 System functions 3 5 3 3 1 Info Viewing device specific information 3 5 3 3 2 Tests amp calib Running sensor calibrations and the tightness test 3 6 3 3 3 Sensors on off Enabling disabling oxygen monitoring 3 11 3 3 4 Date amp time Setting date and time 3 12 Utilities 3 12 3 4 1 Configuration Configuring the ventilator 3 13 3 4 2 Data transfer Copying event log data toa USB memory device 3 14 Alarm tests 3 16 3 5 1 High pressure 3 16 3 5 2 Low minute volume 3 16 3 5 3 Low oxygen alarm 3 16 3 5 4 Disconnection on patient side 3 17 3 5 5 Loss of external power 3 17 3 5 6 Exhalation obstructed 3 18 3 5 7 Apnea 3 18 3 1 3 Tests calibrations and utilities 3 1 Introduction The tests and calibrations described in this section help verify the safety and reliability of the HAMILTON C2 Perform the HAMILTON C2 s tests and calibrations
33. BH lt 128 IBW 0 0037 x BH2 0 4018 x BH 18 62 BH gt 129 Male IBW 0 9079 x BH 88 022 Female IBW 0 9049 x BH 92 006 4 Ventilator settings New patient IBW o Patient height Start ventilation power standby key gt 3 s Figure 4 1 Patient setup window 4 4 624131 04 4 3 Modes window Setting the ventilation mode NOTE For details on modes consult Appendix C for adaptive support ventilation ASV Appendix D clinical applica tion details for noninvasive ventilation or Appendix B for all other modes The active ventilation mode is displayed at the top right hand corner of t he screen Change the mode as follows 1 Open the Modes window Figure 4 2 2 Select a mode f Modes S CMV SPONT b min Alarms Monitoring Utilities Events System Figure 4 2 Modes window Active mode New selected mode 624131 04 4 5 4 Ventilator settings 3 Confirm the mode The controls window Figure 4 3 opens automatically Review and confirm the control set tings see Section 4 4 2 If the control settings are not con firmed the window automatically closes after a period of time The new mode selection will not be valid and the previous settings remain in effect 4 4 Controls windows Setting controls including apnea backup ventilation NOTE e In addition to control settings the Basic window displays breath timing parameters determined from timing contro
34. C 2 624131 04 Contrary to what may be believed ASV does not eliminate the need for a physician or clinician However ASV alleviates the need for tedious tasks and laborious readjustments of the ventilator thus it is a modern tool for the clinician As such ASV does not make clinical decisions ASV executes a general command from the clinician and the clinician can modify it This command can be summarized as follows where the modifiable parts are in bold Maintain a preset minimum minute ventilation take spontaneous breathing into account prevent tachypnea prevent AutoPEEP prevent excessive dead space ventilation fully ventilate in apnea or low respiratory drive give control to the patient if breathing activity is okay and do all this without exceeding an applied pressure of Pasvlimit This appendix explains in practical terms how to use ASV at the patient s bedside and provides a detailed functional description Since Otis equation Otis 1950 is the cornerstone of the optimal breath pattern calculation this equation is included and described A table of detailed technical specifications and pertinent references is also given NOTE This appendix describes ASV as it is implemented in the HAMILTON MEDICAL HAMILTON C2 ventilator It does not replace the clinical judgment of a physician and should not be used for clinical decision making 624131 04 C 3 C ASV adaptive support ventilation C
35. Maintaining PEEP and preventing autotriggering Significant leakage may be present in noninvasive ventilation which may serve to reduce the actual applied PEEP CPAP and give rise to autotriggering If you cannot achieve the set PEEP CPAP check the mask fit If the mask fit cannot be improved select an alternative treatment method The HAMILTON C2 maintains PEEP with the expiratory valve in combination with a compensating base flow delivered by the inspiratory valve through the breathing circuit The Loss of PEEP alarm alerts you to uncompensated leaks that is when the measured PEEP CPAP is 3 cmH 0 lower than the set PEEP CPAP Checking mask fit and position For noninvasive ventilation to function as intended the mask must fit well and remain in place It is desirable to maintain a good seal and minimize leakage D 9 D Clinical application of noninvasive ventilation Check the mask position regularly and adjust as necessary If the mask slides away from the mouth and nose patient disconnection reinstall and secure it React promptly and appropriately to any alarms The ventilator s Leak parameter provides one indicator of mask fit You can also check the proper fit of the mask by verifying that the patient can trigger and flow cycle inspiration and by verifying that Ppeak PEEP CPAP Psupport Pinsp 3 cmH 30 CO rebreathing in noninvasive ventilation CO rebreathing per breath may increase in noninvasive venti
36. a condition is critical enough to possibly com promise safe ventilation the HAMILTON C2 is placed into the ambient state The ambient and expiratory valves are opened letting the patient inspire room air through the ambient valve and exhale through the expiratory valve The HAMILTON C2 has several means to ensure that safe patient or respiratory pressures are maintained The maximum working pressure is ensured by the high pressure alarm limit If the set high pressure limit is reached the ventilator cycles into exhalation The ventilator pressure cannot exceed 60 cmH 0 1 2 2 Gas supply and delivery The HAMILTON C2 uses room air and low or high pressure oxygen Figure 1 1 Air enters through a fresh gas intake port and is compressed together with the oxygen by the blower Oxygen enters through a high or low pressure inlet High T HAMILTON C2 pressure oxygen jp Low Breathing circuit Inspiratory valve l l l Patient l l Expiratory Flow valve Toroom Sensor F air Only one oxygen source high or low pressure is required Figure 1 1 Gas delivery in the HAMILTON C2 1 High pressure oxygen Maximal Pressure 600kPa Maximal Flow 120I min 2 Low Pressure oxygen Maximal Pressure 600kPa Maximal Flow 15 l min 624131 04 1 5 General information Within the ventilator the gas enters the HAMILTON C2 s pneu matic system If high pressure oxygen is supplied a mixer valve provides f
37. and TI control settings define the breath timing For spontaneous breaths the expiratory trigger sensitivity ETS setting defines the percentage of peak flow that cycles the HAMILTON C2 into exhalation Breaths can be triggered by the ventilator patient or user B 21 B Modes of ventilation Psupport LE 1 2 0 TE 4 005 Figure B 16 SIMV basic controls B 22 624131 04 Figure B 17 SIMV more controls 624131 04 B 23 B Modes of ventilation 0 Basic Backup mode Backu fTotal p P SIMV b min Figure B 18 SIMV apnea controls B 5 2 PSIMV and NIV ST modes The PSIMV pressure controlled SIMV and NIV ST spontane ous timed noninvasive ventilation modes deliver pressure con trolled time cycled mandatory breaths and pressure supported flow cycled spontaneous breaths PSIMV com bines attributes of the PCV and SPONT modes while NIV ST combines attributes of the PCV and NIV modes SIMV like SPONT is designed for an intubated patient while NIV ST like NIV is designed for use with a mask or other noninvasive patient interface See Appendix D for clinical application infor mation on the noninvasive modes As with the PCV mode PSIMV and NIV ST both deliver a preset pressure but do not guarantee a fixed tidal volume especially during changes in respiratory system compliance air way resistance AUtoPEEP or the patient s respiratory activity B 24 624131 04 If the patient trigg
38. audible indications 7 3 All events log 7 8 Ambient state 7 2 Apnea alarm 7 9 Apnea backup ventilation description 4 12 4 13 how to enable disable 4 11 mode and control settings 4 12 Apnea time alarm setting definition 4 22 Apnea ventilation alarm 7 9 Apnea ventilation ended alarm 7 9 624131 04 APRV airway pressure release ventila tion B 36 B 40 controls B 39 B 40 discription B 37 B 38 introduction B 36 ASV adaptive support ventilation C 1 C 34 adjustment to maintain adequate ventilation C 10 C 11 alarm settings C 11 C 12 detailed functional description C 17 C 28 how to monitor patient C 12 C 15 initialization of ventilation C 33 introduction C 2 C 3 Otis equation C 29 C 30 references C 34 target graphics panel C 13 use in clinical practice C 4 C 16 weaning C 16 ASV Cannot meet target alarm 7 10 ASV monitored data window C 14 Autoclave sterilization general guide lines 9 7 AutoPEEP monitored parameter defini tion 5 11 Backup setting definition 4 13 Backup ventilation See Apnea backup ventilation Base flow specifications A 16 Batteries backup description 2 18 2 20 how to replace 9 11 9 12 specifications A 4 Battery 1 calibration required alarm 7 10 Battery 1 failed alarm 7 10 Battery 1 over temp alarm 7 10 Battery 1 temperature high alarm 7 11 Index 1 Index Battery 2 calibration required alarm 7 10 Battery 2 failed alarm 7 10 Battery 2 over temp alarm 7 11 Battery 2 temperature high a
39. breaths TE is mea sured from the start of exhalation as dictated by the ETS set ting until the patient triggers the next inspiration TE may differ from the set expiratory time if the patient breathes spontaneously 624131 04 5 17 5 Monitoring Table 5 1 Monitored parameters continued Parameter Definition unit TI s VTE ml VTI ml 5 18 Inspiratory time In mandatory breaths TI is measured from the start of breath delivery until the set time has elapsed for the switchover to exhalation In spontaneous breaths TI is measured from the patient trigger until the flow falls to the ETS setting for the switchover to exhalation TI may differ from the set inspiratory time if the patient breathes sponta neously Expiratory tidal volume The volume exhaled by the patient It is determined from the Flow Sensor measurement so it does not show any volume added due to compression or lost due to leaks in the breathing circuit If there is a gas leak at patient side the displayed VTE may be less than the tidal vol ume the patient actually receives Inspiratory tidal volume The volume delivered to the patient It is determined from the Flow Sensor measurement If there is a gas leak at the patient side the displayed VTI may be larger than the displayed VTE 624131 04 6 Intelligent Panels 624131 04 6 1 6 2 6 3 6 4 Introduction Dynamic Lung panel 6 2 1 Tidal volume Vt 6 2 2 Compliance
40. calculated as IBW in kg x NormMinVent in I min kg x MinVol 100 where NormMinVent is the normal minute ventilation from Figure C 7 For example with a MinVol 100 and an IBW 70 kg a target MinVol of 7 l min is calculated This target can be achieved with a number of combinations of tidal volume Vt and respiratory rate f This is shown in Figure C 8 where all possible combinations of Vt and f lie on the bold line the target minute volume curve 2000 1500 1000 Vt ml 500 0 20 40 60 f b min Figure C 8 MinVol 7 I min All possible combinations of Vt and f which result in a minute ventilation of 7 l min lie on the bold line C 18 624131 04 C 3 3 Lung protective rules strategy 624131 04 Not all combinations of Vt and f shown in Figure C 8 are safe for the patient The high tidal volumes would overdistend the lungs and the small tidal volumes may not produce alveolar ventilation at all Another risk lies in inadequate respiratory rates High rates could lead to dynamic hyperinflation or breath stacking and thus inadvertent PEEP Low rates may lead to hypoventilation and apnea It is therefore necessary to limit the number of possible combinations of Vt and f In limiting the possible combinations of Vt and f ASV uses a double strategy e The operator input for ASV determines the absolute boundaries e Internal calculations based on patient measurements further narrow the limits to counter
41. change the safety limits change accordingly and as defined in Section C 3 3 The safety limits are updated on a breath by breath basis For example if the lungs stiffen the high Vt limit is lowered proportionally and the high Rate limit is increased according to Otis s equation see Appendix C 3 4 This dynamic adjustment ensures that ASV applies a safe breathing pattern at all times In graphical terms the dotted rectangle changes as shown in Figure C 12 2000 1500 1000 Vt ml 500 O 20 40 60 f b min Figure C 12 Lung protective limits are changed dynamically and according to the respiratory system mechanics However the limits derived from the operator input are never violated C 26 624131 04 C 3 6 624131 04 Dynamic adjustment of optimal breath pattern Once calculated the optimal breath pattern is revised with each breath according to the RCexp measurement Otis equation is applied and a new target breathing pattern is calculated Under steady state conditions the targets do not change However if the patient s respiratory system mechanics change the target values also change For example if the bronchi of our normal 70 kg patient being ventilated at 15 b min and with a Vt of 467 ml constrict due to asthma the expiratory resistance increases to values higher than 5 cmH gt O I s For this reason more time is needed during exhalation for the lungs to reach the end expiratory equilibrium
42. ground Figure H 3 RS 232 connector pinout Figure H 4 RS 232 cable PN 157354 wiring diagram H 7 Communications interface 624131 04 APPENDIX 624131 04 Configuration 1 1 Introduction l 2 I 2 Accessing configuration l 2 1 3 General Selecting the language units of measure and oxygen source l 3 1 3 1 Language Selecting the default language I 3 1 3 2 Units Selecting the default unit of measure for pressure display l 4 1 3 3 More Selecting the oxygen source and enabling the communications interface 1 5 Graphics window l 6 1 4 1 MMP Selecting the default main monitoring parameter display l 6 Settings window l 7 1 5 1 Use settings Selecting the default start up settings l 7 Vent Status Configuring the Vent Status panel l 10 1 1 1 2 Configuration Introduction During configuration you set up the ventilator with a default language main monitoring parameter display startup settings for a new patient and unit of measure for pressure You also specify that oxygen will come from either a high or low pres sure source and you enable the communications interface Accessing configuration Open the Configuration gt Utilities window with the Utilities tab Simultaneously press the blank key and select Configuration Select the desired configuration function as described in the next subsections Blank key 624131 04 1 3 General Selecting the language units of measur
43. gt 21 21 to 23 5 15 1 2 gt 21 24 to 29 5 15 1 2 gt 21 30 to 39 5 14 1 2 gt 21 40 to 59 5 12 1 2 gt 21 60 to 89 5 10 1 2 gt 21 90 to 99 8 10 1 2 gt 21 gt 100 20 10 1 2 gt 21 1 Set PEEP plus circuit resistance 5 cmH20 B 42 624131 04 APPENDIX C ASV adaptive support ventilation C 1 Introduction C 4 C 2 ASV use in clinical practice C 4 Step 1 Preoperational procedures C 7 Step 2 Preparing the HAMILTON C2 before connecting a patient C 7 Step 3 Compensation for changes in apparatus dead space C 9 Step 4 Adjusting ventilation maintaining adequate ventilation C 10 Step 5 Alarm settings review and special ASV alarms C 11 Step 6 Monitoring ASV C 12 Step 7 Weaning C 16 C 3 Detailed functional description of ASV C 17 C 3 1 Definition of normal minute ventilation C 17 C 3 2 Targeted minute ventilation C 17 C 3 3 Lung protective rules strategy C 19 C 3 4 Optimal breath pattern C 22 C 3 5 Dynamic adjustment of lung protection C 26 C 3 6 Dynamic adjustment of optimal breath pattern C 27 C 4 Minimum work of breathing Otis equation C 29 C 5 ASV technical data C 31 C 6 Initialization of ventilation C 33 C 7 References C 34 624131 04 C 1 G ASV adaptive support ventilation C 1 Introduction In 1977 Hewlett et al introduced mandatory minute volume MMV The basic concept is that the system is supplied with a metered preselected minute volume of fresh gas from whic
44. lists descriptions calibration instructions or other information that will assist the user s appropriately trained personnel to repair those parts of the equipment designated by HAMILTON MEDICAL to be repairable Manufacturer Distributor in USA HAMILTON MEDICAL AG HAMILTON MEDICAL Inc Via Crusch 8 4990 Energy Way CH 7402 Bonaduz P O Box 30008 Switzerland Reno NV 89520 Phone 41 81 660 60 10 Phone 775 858 3200 Fax 41 81 660 60 20 Toll free 800 426 6331 info hamilton medical com Fax 775 856 5621 www hamilton medical com marketing hamilton medical net 624131 04 HAMILTON C2 software information The software version for the HAMILTON C2 is visible in the System gt Info window The software version on the screen should match the version on the title page of this manual See Section 3 3 1 for details Definitions CAUTION Indicates a potentially hazardous situation which if not avoided could result in minor or moderate injury NOTE Emphasizes information of particular importance 1 Caution as defined by ISO 624131 04 iii General cautions and notes Intended use The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics Intended areas of use e In the intensive care ward or in the recovery room e During secondary transport from one hospital to another e During transfer of ventilated patients within the hospital The HAMILTO
45. pattern Trigger Se Ee e a Operational logic Every breath is pressure controlled and mandatory Operational logic Mandatory breaths are pressure controlled Operational logic Every breath is spontaneous Operational logic Every breath is volume targeted and mandatory Operational logic Mandatory breaths are volume targeted T time F flow V volume P pressure N A not available 624131 04 B 3 B Modes of ventilation Table B 1 Classification of HAMILTON C2 ventilation modes continued Breathing pattern Mandatory breaths Control type Trigger Operational logic See Appendix C for a complete description Operational logic Every breath is spontaneous Leakage is compensated for Operational logic Mandatory breaths are pressure controlled Leakage is compensated for Operational logic Mandatory breaths are pressure controlled Leakage is compensated for Every breath is pressure controlled and mandatory T time F flow V volume P pressure N A not available 1 A designator that combines the primary control variable PC pressure control for the mandatory breaths or in CSV for the spontaneous breaths with the breath sequence CMV continuous mandatory ventilation a breaths are mandatory IMV intermittent manda tory ventilation spontaneous breaths between mandatory breaths CSV continuous spontaneous ventilation a breaths
46. pressure gas inlet fittings Noninvasive ventilation a ventilation mode Glossary 5 Glossary NIV ST NPPV O2 Oxygen Pasvlimit Pat height Paw Pcontrol PCV PEEP CPAP Phigh Pinsp Plow Pressure Pmean PN Ppeak Glossary 6 Spontaneous timed noninvasive ventilation a ventilation mode Noninvasive positive pressure ventilation Oxygen Oxygen concentration of the delivered gas a control set ting monitored parameter and in LPO mode an alarm setting Maximum pressure to be applied in ASV a control setting A control setting It is used to compute the patient s ideal body weight IBW in calculations for ASV and start up settings Airway pressure Pressure control a control setting in PCV mode Pressure additional to PEEP CPAP to be applied during the inspiratory phase Pressure controled ventilation PEEP positive end expiratory pressure and CPAP contin uous positive airway pressure a control setting and mon itored parameter PEEP and CPAP are constant pressures applied during both the inspiratory and expiratory phases High pressure in APRV and DuoPAP mode Inspiratory pressure the target pressure additional to PEEP CPAP to be applied during the inspiratory phase It is operator set in the PSIMV and NIV ST and a displayed parameter in the Vent Status panel and the ASV target graphics panel Low pressure in APRV mode Maximum pressure allowed in the pati
47. primary power source e HAMILTON MEDICAL recommends that the ventila tor s batteries be fully charged before you ventilate a patient If the batteries are not fully charged and AC power fails always pay close attention to the level of battery charge Two backup batteries one standard and the other optional protect the HAMILTON C2 from low or failure of the primary power source When the primary power source either AC mains or a DC power supply fails the ventilator automatically switches to operation on backup battery with no interruption in ventilation An alarm sounds to signal the switchover You must silence the alarm to confirm notification of the power system change this resets the alarm If the optional battery battery 2 is available and adequately charged the ventilator switches to this battery first When battery 2 is depleted or not installed the ventilator switches to the standard battery bat tery 1 The batteries power the ventilator until the primary power source is again adequate or until the battery is depleted Each battery powers the ventilator typically for 2 5 h 2 19 2 2 20 Preparing for ventilation As a further safeguard the HAMILTON C2 provides a low bat tery alarm It also has a capacitor driven backup buzzer that sounds continuously for at least 2 min when battery power is completely lost The ventilator charges the batteries whenever the ventilator is connected to either AC or gt 20
48. range r4 deme 0050s wae TET PEEP gt Time 5 cmH 0 Figure B 6 Breath delivery by the adaptive volume controller 624131 04 B 11 B Modes of ventilation B 3 2 PCV mode The PCV pressure controlled ventilation mode provides pressure controlled mandatory breaths The mode s biphasic nature allows free breathing at both the PEEP and the Pcontrol pressure levels The control settings active in the PCV mode are shown in Figure B 7 through Figure B 8 The pressure control Pcontrol setting defines the applied pressure The Rate and I E control settings determine the breath timing Breaths can be triggered by the ventilator patient or user Pcontrol E PEEP CPAP Th 2 005 TE 4 005 Flowtrigger Monitoring Figure B 7 PCV basic controls B 12 624131 04 Figure B 8 PCV more controls 624131 04 B 13 B Modes of ventilation B 4 Spontaneous modes SPONT and NIV The spontaneous or pressure support modes SPONT and NIV noninvasive ventilation deliver soontaneous breaths and user initiated manual mandatory breaths SPONT is designed for an intubated patient while NIV is designed for use with a mask or other noninvasive patient interface See Appendix D for clinical application information on the noninvasive modes In SPONT and NIV the ventilator functions as a demand flow system The patient s spontaneous breathing efforts can also be supp
49. source of ventilatory support is available during this test The patient must be dis connected from the ventilator during it e To cancel the tightness test while it is in progress select Tightness again Description This test checks for leakage in the patient breath ing circuit and determines the circuit s compliance compensa tion factor The ventilator is pressurized to 50 cmH 0 The circuit is considered tight if this pressure can be maintained If there is a leak the pressure falls in proportion to the size of leak Procedure 1 Set the ventilator up as for normal ventilation complete with the LiteCircuit 2 Disconnect the Whisper valve together with Flow Sensor from the circuit 3 Activate Tightness test from the Tests amp calib window 4 The message line displays Tighten system Block the opening with a clean gauze covered finger 5 Wait and VERIFY that the message line displays Tightness test OK If the message line displays Tightness test failed check the circuit connections Replace leaking parts and repeat the tightness test 6 Reconnect the Whisper valve with Flow Sensor 7 Repeat the Tightness test as described above steps 3 to 5 8 Wait and VERIFY that the message line displays Tightness test failed If the message line displays Tightness test OK check the Whisper valve and repeat the tightness test 3 7 3 3 8 Tests calibrations and utilities 9 Reconnect the patient 3 3
50. target combination In fact Figure C 9 shows considerable room for selection within the dotted rectangle The selection process is an exclusive feature of ASV The basic assumption is that the optimal breath pattern is identical to the one a totally unsupported patient would choose naturally provided that patient is capable of maintaining the pattern 624131 04 According to textbooks of physiology the choice of breathing pattern is governed by either work of breathing or the force needed to maintain a pattern ASV uses the original equation by Otis Otis 1950 and calculates the optimal rate based on operator entries of MinVol and the IBW based on the Pat height setting as well as on the measurement of RCexp see Section C 4 For example with the 70 kg patient a setting of 100 MinVol and a measured RCexp of 0 5 s the optimal rate is 15 b min according to Otis equation Once the optimal rate is determined the target Vt is calculated as Vt target MinVol optimal rate 4 In the example of the 70 kg patient the target Vt becomes 467 ml see Section C 4 for details Figure C 10 summarizes the calculations done in the previous subsections and shows the position of the target breathing pattern as well as the safety limits imposed by the lung protective rules strategy 2000 1500 1000 Vt ml 0 20 40 60 f b min Figure C 10 Anatomy of the ASV target graphics panel The rectangle shows the safet
51. technical specialist or safety inspector in your hospital for more information The HAMILTON C2 can transmit data from the ventilator to a PDMS or other computer system through its RS 232 connector Data from the ventilator can ultimately be manipulated using software such as Microsoft Excel This is a useful tool for data management and clinical studies This application requires the hardware shown in Figure H 2 It also requires the DataLogger software and manual contact your HAMILTON MEDICAL representative For more information about the communications protocol contact HAMILTON MEDICAL PDMS or other computer system RS 232 cable 9M x 9F shielded and grounded on monitor side only PN 157354 See Figure H 4 for cable wiring diagram Figure H 2 HAMILTON C2 connected to a computer system 624131 04 H 5 H Communications interface Table H 2 Requirements for interfacing PDMSs Interfacing hardware Centricity Critical Centricity Ethernetbox and Formerly known as Care Clinisoft care cables Datex Ohmeda S S station CCIMS Capsule DataCaptor Device Interfaces RS 232 to XML HL7 Technologie PDMS DDIs iMDsoft Consult iMDsoft representative MetaVision Clinical Information System H 4 Connector pin assignments Figure H 3 shows the location of the RS 232 connector and its pinout H 6 624131 04 624131 04 1 GND RxD TxD DTR GND signal ground DSR RTS CTS Oo ON DN KR WN Shield Chassis
52. 0 Pinsp inspiratory 5 to 60 cmH20 1 cmH20 Table C 6 pressure added to PEEP CPAP Psupport pressure 0 to 60 cmH 0 1 cmH 20 15 cmH 20 support added to PEEP CPAP Phigh DuoPAP O to 60 cmH20 1 cmH20 15 cmH 0 APRV Plow APRV 0 to 35 cmH20 1 cmH20 Rate 4 to 80 b min 1 b min Table C 6 S CMV PCV 5 to 80 b min PSIMV NIV ST 1 to 80 b min SIMV DuoPAP Thigh DuoPAP 0 1 to 40s APRV TI inspiratory time 0 3to 125 0 A 6 624131 04 2 s for DuoPAP for APRV see Table B 2 0 15 1s 1s in ASV 2 s in all other modes Table A 5 Control setting ranges and resolutions continued F A Default TI max maximum 1 0 to 3 05 0 15 1 55 inspiratory time spontaneous breaths NIV and NIV ST Tlow APRV 0 2 to 40s see Table B 2 V tidal volume 20 to 2000 ml 10 ml for lt 700 ml 1000 ml 50 ml for gt 1000 ml 1 Configurable in the operating range 624131 04 A 7 HUIASEd 31 D ds IAUN f ASY qybley ed Japua uabBAXO dwel d Jabbuymol4 dd 9 d4dd dYdD dddd xew L S14 sy ea1q snoau uioddns d ejuods JOJJUOId sy eaiq Alo epueN LAN Noas sapow yoddns ainssaig AddV dWdOnd Sepow AINIS sepow ozepuenN SOPOW UO L NUAA ZD NOLTINWH U APL sjo4UO0D 9 Y aIGeL Nidy dvdona is vin_ f tawis tawisa tanas a asy apon A 8 624131 04 A Specification
53. 0 12 14 Limits 2 Loudness Buffer Pressure Exp tinv ol Apnea time Controls Figure 4 7 Limits 1 window Red bar indicates the monitored value is out of range Actual monitored value 4 22 624131 04 Low oxygen Modes PSIMV 10 Total b min Oxygen Controls A l arms Figure 4 8 Limits 2 window 624131 04 4 23 4 Ventilator settings 4 5 2 Loudness Adjusting alarm loudness NOTE e If the alarm loudness was set to lt 5 before the venti lator was powered off the loudness setting will default to 5 when the HAMILTON C2 is powered on e f you decrease the alarm loudness during the night shift do not forget to return it to its daytime setting Adjust the alarm loudness as follows 1 Open the Alarms gt Loudness window Figure 4 9 2 Adjust the Loudness value as desired Test the loudness as desired 3 Repeat the process as required E PSM 10 fTotal b min Loudness Figure 4 9 Loudness window 4 24 624131 04 4 5 3 Buffer Viewing alarm information See Section 7 3 for a description of the alarm buffer 4 5 4 Table of alarm limit settings and ranges Table 4 4 Alarm limit settings and ranges ExpMinVol low and high fTotal low and high Oxygen low and high 624131 04 The maximum time allowed from the begin ning of one inspiration to the beginning of the next inspiration If the patient does not trigger a breath during thi
54. 0 b min Flowtrigger P ramp Figure B 33 APRV more controls 624131 04 B 39 A Modes APRV Backup mode Q baxu APVsimv Controls Alarms Monitoring Utilities System Figure B 34 APRV apnea controls B 9 SAFETY mode and ambient state In case of some technical failure the HAMILTON C2 switches to SAFETY mode This gives the user time for corrective actions such as organizing a replacement ventilator The turbine runs constant to create Pinsp Table B 2 The expi ratory valve switches system pressure levels between PEEP and inspiratory pressure Patient sensing is nonfunctional during safety ventilation You must switch off ventilator power to exit safety ventilation 624131 04 B 40 624131 04 If the technical fault alarm is serious enough to possibly com promise safe ventilation the ventilator enters the ambient state The inspiratory valve is closed and the ambient and expi ratory valves are opened letting the patient breathe room air unassisted You must switch off ventilator power to exit the ambient state Safety ventilation 385002 SAFETY Alarms Utilities Events System Figure B 35 Display SAFETY mode B 41 B Modes of ventilation Table B 3 Safety mode settings kg emo at ole 02 3to5 5 30 1 2 gt 21 6to8 5 25 1 2 gt 21 9t011 15 20 1 2 gt 21 12 to 14 5 20 1 2 gt 21 15 to 20 5 20 1 2
55. 04 outlet Flow Sensor connectors Inspirator filter Humidifier Cle ed O From patient Ne Expiratory valve membrane Expiratory valve cover Expir limb Kue l Inspiratory limb atory DA t COUOT Water trap Ho 2 3 3 D I i In place of the flex tube shown a 15 x 22 adapter may be used to attach the Flow Sensor to the ET tube Figure 2 3 Patient breathing circuit for use without heater wires 624131 04 2 9 2 Preparing for ventilation Nebulizer outlet mT GH oD 9 e Expiratory valve membrane Expiratory valve cover Flow Sensor connectors rom patient Flow Sensor Coman Inspiratory limb Y piece HME a a Y In place of the flex tube shown a 15 x 22 adapter may be used to attach the Flow Sensor to the HME or ET tube Figure 2 4 Patient breathing circuit for use with HME 2 10 624131 04 To Os Ed Flow Sensor connectors Inspiratory ilter
56. 1 Reassemble Inspect NOTE Sterilize using a validated sterilization procedure e g autoclave at 134 C or 273 F for 10 min ETO sterilize at 55 C or 131 F or plasma sterilize at 37 to 50 C or 99 to 122 F Perform any required tests 9 7 9 Maintenance 9 3 Preventive maintenance Perform preventive maintenance on your HAMILTON C2 according to the schedule in Table 9 2 The following subsections provide details for some of these preventive maintenance procedures NOTE e HAMILTON MEDICAL recommends that you docu ment all maintenance procedures e Dispose of all parts removed from the device accord ing to your institution s protocol Follow all local state and federal regulations with respect to envi ronmental protection especially when disposing of the electronic device or parts of it for example oxy gen cell batteries Table 9 2 Preventive maintenance schedule Interval Part accessory Procedure Between Breathing circuit Replace with sterilized or new sin patients and including mask gle use parts Run the tightness test according to inspiratory filter Flow and the Flow Sensor calibration hospital pol Sensor nebulizer jar Section 3 3 2 icy expiratory valve cover and membrane Entire ventilator Run the preoperational check Sec tion 3 2 Every 2 days Breathing circuit Empty any water from breathing or accord tubes or water traps ing to hospi Inspect parts
57. 1 04 1 19 1 General information 1 4 Symbols used on device labels and packaging Table 1 2 Symbols used on device labels and packaging Power on off switch Manufacturer Date of manufacture Type B applied part classification of medical electri cal equipment type B as specified by IEC 60601 1 Consult operator s manual Refer to the operator s manual for complete information This label on the device points the user to the operator s manual for complete information In the operator s manual this symbol cross references the label CE Marking of Conformity seal of approval guaran teeing that the device is in conformance with the Council Directive 93 42 EEC concerning medical devices Indicates the degree of protection against electric shock according to IEC 60601 1 Class II devices have double or reinforced insulation as they have no provision for protective grounding Indicates the degree of protection provided by enclosure according to IEC 60601 1 Canadian Standards Association and National Rec ognized Test Laboratory approval Dispose according to Council Directive 2002 96 EC or WEEE Waste Electrical and Electronic Equip ment 1 20 624131 04 Table 1 2 Symbols used on device labels and packaging continued This way up Fragile handle with care Keep dry Temperature limitations Humidity limitations Atmospheric pressure limitations at transport and storage Stacking limitations Recyclab
58. 10 of actual reading for leak volumes between 100 and 200 ml Time E 1 99 to 9 9 1 1 for 1 99 to 1 10 0 1 for 1 9 9 to 9 9 1 fTotal fSpont 0 to 999 b min 1 b min 0 00 to 99 9 s 0 01 s for lt 0 15 10 0s 0 1 s for gt 10 05 Other calculated and displayed parameters 0 to 0 1 ml cmH20 200 ml cmH20 for lt 100 ml cmH20 1 ml cmH20 for gt 100 ml cmH 20 A 10 624131 04 Table A 7 Monitored parameter ranges resolutions and accuracies continued RCexp 0 0 to 99 9 s 0 01 s for lt 10 0s 0 1 s for gt 10 0 s Rinsp 0 to 1 cmH2O s 999 cmH gt O l s Oxygen Oxygen 18 to 104 1 volume frac tion of 2 5 2 5 of actual reading Vent Status panel MinVol 0 to 350 of 5 normal minute ventilation expressed in l min RSB 10 to 1 1 min 400 1 min fSpont 100 to 0 1 Other calculated and displayed parameters IBW 3 to 139 kg 1 kg 624131 04 A 11 A Specifications Table A 8 Real time curves and loops Real time curves Volume V 0 to 3200 ml Flow 300 to 300 l min Airway pressure Paw 10 to 60 cmH20 Time Oto 15s Loops Pressure Volume x 0 to 3200 ml y 10 to 60 cmH 0 Volume Flow x 0 to 3200 ml y 300 to 300 I min Pressure Flow x 300 to 300 l min y 10 to 60 cmH 70 A 12 624131 04 A 7 Alarms Table A 9 is an alphabetical list of the adjustable alarm ranges and resolutions Table 7 2 describes other nonadjustable alarms Table A 9 Ad
59. 10 24 5 For Pat height gt 210 cm 83 in 0 5 5 624131 04 6 5 6 Intelligent Panels 6 3 Vent Status panel 6 6 The Vent Status panel Figure 6 6 visualizes six parameters re lated to the patient s ventilator dependency including oxygen ation CO elimination and patient activity A floating indicator floater moving up and down within the column shows the value for a given parameter When the indicator is in the light blue weaning zone a timer starts showing how long that value has been in the weaning zone When all values are in the weaning zone the Vent Status panel is framed in green indi cating that weaning should be considered The panel is updat ed breath by breath Table 6 2 describes the parameters shown in the Vent Status panel You can configure the weaning zone ranges in the configuration mode Table A 10 lists the weaning zone ranges and defaults CO2 Elimination Spont Activity Figure 6 6 Vent Status panel Group title Monitored graphic value floater Light blue weaning zone with user configurable limits Numeric monitored value Elapsed time value has been in weaning zone 624131 04 Table 6 2 Vent Status parameters Oxygen Oxygen setting See Table 4 3 PEEP cmH20 PEEP CPAP setting See Table 4 3 MinVol l min Pinsp cmH 0 RSB 1 l min fSpont Normal minute ventilation defined in Appendix C 3 1 Inspiratory pressure the targe
60. 2 2 Tightness test NOTE e Make sure another source of ventilatory support is available during this test The patient must be dis connected from the ventilator during it e To cancel the tightness test while it is in progress select Tightness again Description This test checks for leakage in the patient breath ing circuit and determines the circuit s compliance compensa tion factor The ventilator is pressurized to 50 cmH 0 The circuit is considered tight if this pressure can be maintained If there is a leak the pressure falls in proportion to the size of leak Procedure 1 Set the ventilator up as for normal ventilation complete with the breathing circuit 2 Activate Tightness test from the Tests amp calib window 3 Disconnect patient is now displayed Disconnect the breathing circuit at the patient side of the Flow Sensor Do not block the open end of the Flow Sensor 4 Tighten patient system is now displayed Block the opening a finger covered with an alcohol pad may be used 5 Connect patient is now displayed Reconnect the patient 6 VERIFY that there is a green check mark in the box beside Tightness Corrective action Troubleshoot any alarms as described in Section 7 624131 04 3 3 2 3 Flow Sensor calibration 624131 04 NOTE e Make sure another source of ventilatory support is available during this calibration The patient must be disconnected from the ventilator during it e To
61. 2 ASV use in clinical practice C 4 ASV does not require a special sequence of actions It is used in much the same way as are conventional modes of ventilation Figure C 1 summarizes how to use ASV while the subsequent subsections explain it in detail Figure C 2 shows the control settings active in the ASV mode 624131 04 Prepare ventilator for clinical use 1 Set MinVol and Pasvlimit 2 Set all other alarm limits appropriately 5 Ventilate patient for a period of time A 7 N N A oont flarget NO A A 0 AND A gt t 10 b min OR N gt Ae 45 mmH NO Patient is stable gt 60 min NO S aa aN longer for hard to N PaCO gt 45 mmHg y Ns mmHg with COPD longer tor hard to wean 7 NS Pa So Pa NS patients 4 NS NS 7 N a N K i Escalation De escalation Pa NS MinVol 20 MinVol MinVol 10 Pa FiO lt 40 not higher than 300 MinVol not lower than lt AND 70 NQEEP lt 8 mh 07 N f Pa N Push to wean 7 NO MinVol 10 lt i gt gt N Fine lt 10 nO 7 MinVol not lower than N A 709 NS Pa Le Consider extubation Stable means fControl 0 b min AND PaCO lt 45 mmHg 50 mmHg with COPD Figure C 1 Clinical use of ASV The numbers in parentheses are step numbers which are explained in the next subsections 624131 04 C 5 C ASV adaptive support ventilation Pasvlimit Min ol Patient height IBW 70 kg Min
62. 2s A 11 Ventilator breathing system specifications Aez Other techincal datarie ssn oie Seat in NER E EEE ER oes A 13 Guidance and manufacturer s declaration electromagnetic EMISSIONS 2 wise ka dts LEE AG ed tee a SE A 14 Guidance and manufacturer s declaration electromagnetic ON Sse Rod tac Barta gn aw oleae onion yale adi eae ed ana 2 A 15 Recommended separation distances between portable and mobile RF communications equipment and the HAMILTON C2 VEMUUIATOR setae ans are EE e cles ead whe Sud ented nee E aE i ONNAMAAAHHPHHRBWNZ Sas a N Sy Qo Ro OR TA LN PPPPPPPDP NOUBRWN 624131 04 xxi List of tables xxii Classification of HAMILTON C2 ventilation modes B 3 Control parameters for initialization of APRV B 38 SAFETY MOde settingS eseis back roe ke ee ee ba wed B 42 Blood gas results and other conditions with possible ASV AC USTMOENTSS cdot oon e owe dod Shae QO a wwe C 10 Interpretation of breathing pattern at 100 MinVol setting C 14 Interpretation of breathing pattern at much lower than 100 MinVolisetiinG wens Sods a SHEER oe et nen bees C 15 Interpretation of breathing pattern at much higher than 100 MInVGlSetting onsen eet ce Sie ee Dee m oa ade keys C 15 ASN t chini al datal s i ced os nde et ena es eee ek C 31 Initial breath pattern 2 ee C 33 Ventilator parts and accessories 00 0000 cee eee G 2 Universal transport trolley parts
63. 31 04 A 15 A Specifications Table A 10 Configuration specifications continued Graphics MMP Pmean PEEP CPAP Ppeak Ppeak ExpMinVol ExpMinVol 1 VTE 1 VTI VTE VLeak fTo flotal tal fSpont Oxygen Cstat Rinsp Settings All mode control Table A 5 and alarm settings plus alarm loudness setting 6 to 12 ml kg 10 mi kg Vent Status Oxygen 21 to 100 21 MinVol 25 to 350 50 0 40 12 PEEP 0 to 35cmH O 0 to 10cmH 0 3 o 150 Pinsp 0 to 60cmH O 0 to 8 cmH0 RSB O to 150 1 min 10 fSpont 0 to 100 75 1 The default setting is configurable 2 The low Oxygen setting is always 21 3 The low PEEP setting is always 0 cmH 0 4 The high fSpont setting is allways 100 A 16 o 100 1 l min 0 100 4 624131 04 A 9 Ventilator breathing system specifications Table A 11 lists specifications for the HAMILTON C2 ventilator breathing system Table A 11 Ventilator breathing system specifications Resistance Adult circuit 19 mm ID flow of 60 I min Inspiratory limb lt 6 cmH 0 60 l min Expiratory limb lt 6 cmH 0 60 l min Pediatric circuit 15 mm ID flow of 30 l min Inspiratory limb lt 6 cmH 0 30 l min Expiratory limb lt 6 cmH30 30 l min Coaxial circuit flow of 60I min Inspiratory limb lt 2 05 cmH 20 60 l min Expiratory limb lt 2 3 cmH 0 60 l min Compliance Adult circuit 19 mm ID Approximately 2 ml cmH 0 Pediatric circuit 15 mm ID App
64. 37 B 8 3 Sustained high pressure recruitment manoeuvres B 38 B 8 3 Controls of APRV 000 0 000002 eee eee B 39 B 9 SAFETY mode and ambient state B 40 ASV adaptive support ventilation Gell TIDTOOUGUON estou h tee ech ea Past Nd be Ath A ate aaa C 2 ASV use in clinical practice 2 2 eee C 3 Detailed functional description of ASV C 3 1 Definition of normal minute ventilation C 3 2 Targeted minute ventilation C 3 3 Lung protective rules strategy C 3 4 Optimal breath pattern C 3 5 Dynamic adjustment of lung protection C 3 6 Dynamic adjustment of optimal breath pattern C 4 Minimum work of breathing Otis equation C 5 ASV technical data 0 000000 022 e eee C 6 Initialization of ventilation 0 7 IRETEFCNGeS a0 Weta ete CO R AE ete IA des AY Clinical application of noninvasive ventilation Dat MIATROGUGHONS sapie daan ihe Banded AR Gece D 2 Benefits of noninvasive ventilation D 3 Required conditions for use 2 2 2 eee D 4 Contraindications 2 2 2 0 00 0000 000 eee D 5 Potential adverse reactions 00 000000 D 6 Selecting a patient interface 0 0 20 D7 Control settings 34 nies hohe ieee ite sie ub neha eae DS VAa ft ak i aan pi hehe arcana Byte 5 yet E D 9 Monitored parameters 0000 0002 ee
65. 4 624131 04 B Low tidal volume limit The minimum target Vt in ASV see B in Figure C 9 is determined by the IBW calculated from the Pat height which corresponds to 4 4 ml kg Thus in a 70 kg patient the minimum target Vt is 308 ml The danger with low tidal volumes is insufficient alveolar ventilation The determining parameter for alveolar ventilation is dead space VDaw Tidal volume must always be larger than VDaw It is widely accepted that a first approximation of dead space can be obtained by the following simple equation Radford 1954 VDaw 2 2 IBW 1 The lower limit for tidal volume is based on this equation and calculated to be at least twice the dead space In other words the minimum Vt is 4 4 x IBW C High rate limit The maximum rate see C in Figure C 9 is derived from the operator set MinVol and the calculated IBW which is calculated from the operator set Pat height The equation used to calculate the maximum rate is as follows fmax target MinVol minimum Vt 2 For example the 70 kg patient described above would have a maximum rate of 22 b min when MinVol is set to 100 However if the operator chooses an excessively high MinVol of say 350 the maximum rate becomes 77 b min To protect the patient against such high rates ASV employs a further safety mechanism which takes into account the patient s ability to exhale A measure of the ability to exhale is the expiratory time co
66. 4 B 33 B Modes of ventilation Pressure Spontaneous breath pressure supported Psupport PEEP CPAP a All spontaneous breaths pressure supported Pressure Spontaneous breath pressure supported Psupport EP CPAP A Phigh Time b Only spontaneous breaths at PEEP CPAP pressure supported Figure B 27 Pressure support in DuoPAP B 7 4 Synchronization To adapt easily to the patient s spontaneous breathing pattern the change overs from low to high pressure level and vice versa are synchronized with the patient s spontaneous breathing The frequency of the change over is kept constant even with patient synchronization by defining a trigger time window with a fixed time constant B 34 624131 04 B 7 5 Controls of DuoPAP kE 1 1 1 T low 2 29 s DuoPAP Figure B 29 DuoPAP more controls 624131 04 B 35 B Modes of ventilation i Modes DuoPAP Backup mode PJ asup APVsimv Controls Alarms Monitoring Utilities Events System Figure B 30 DuoPAP apnea controls B 8 APRV Airway pressure release ventilation B 8 1 B 36 Introduction APRV produces alveolar ventilation as an adjunct to CPAP Set airway pressure Phigh is transiently released to a lower level Plow after which it is quickly restored to reinflate the lungs For a patient who has no spontaneous breathing efforts APRV is similar to pressure controlled inverse ratio ventilation APRV al
67. 5 sets Each set includes 2 air 160215 intake dust filters and 1 fan filter Filter air intake HEPA 160216 624131 04 G 3 G Parts and accessories Table G 1 Ventilator parts and accessories continued Item no Figure G 1 Description Cable HAMILTON C2 serial connector to com 160336 puter 2 5 m 8 2 ft Shielded on male ventila tor side only Lo Hose high pressure oxygen supply white 281431 4m Pte canoe 1 Not shown G 4 624131 04 Rear view Side view Figure G 1 Ventilator parts and accessories standard trolley 624131 04 G 5 G Parts and accessories unl can i i L ae Figure G 2 Ventilator parts and accessories standard trolley G 6 624131 04 Table G 2 Universal transport trolley parts Item no Figure Universal transport trolley 160157 2 Support arm HAMILTON C2 to universal trans 160160 port trolley Description Part no Support arm Philips to universal transport trol 160161 ley Cylinder mount for 10 cylinder 160158 Cylinder mount for two 3 cylinders 160159 1 This trolley is released for the CE market only 2 Not shown 624131 04 G 7 G Parts and accessories Figure G 3 Universal transport trolley parts G 8 624131 04 APPENDIX H Communications interface 624131 04 H 1 H 2 H 3 H 4 Introduction Patient monitor Patient data management system PDMS or other computer system Conn
68. 5s 624131 04 A 23 A Specifications Table A 14 Guidance and manufacturer s declaration electromagnetic immunity continued IEC 60601 1 2 Compliance Electromagnetic Immunity test environment test level level guidance Power fre 3 A m 3 A m The power frequency quency 50 60 magnetic field should be Hz magnetic at levels characteristic of field a typical location in a IEC 61000 4 8 typical commercial or hospital environment Portable and mobile RF communications equip ment should be used no closer to any part of the HAMILTON C2 ventila tor including cables than the recommended separation distance cal culated from the equa tion applicable to the frequency of the trans mitter Recommended separa tion distance Conducted RF 3 Vrms 3 Vrms d 0 35 P IEC 61000 4 6 150 kHz to 80 MHz outside ISM bands 10 Vrms 10 Vrms d 1 2 P 150 kHz to 80 MHz in ISM bands A 24 624131 04 Table A 14 Guidance and manufacturer s declaration electromagnetic immunity continued Immunity test Radiated RF IEC 61000 4 3 IEC 60601 1 2 test level 20 V m 80 MHz to 2 5 GHz Compliance level 20 V m Electromagnetic environment guidance 80 MHz to 800 MHz d 1 15 P 80 MHz to 2 5 GHz d 0 6 P where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufac turer and d is the
69. ASV Cannot meet target Performance specifications Response time 90 of steady state lt 1 min typical Overshoot undershoot lt 20 Maximum pressure change per breath 2 cmH70 Lung protective rules Maximum Vt Depends on Pasvlimit and volume pressure ratio V P However normally MinVol 5 but always lt 22 ml kg x IBW Minimum Vt 4 4 x IBW Maximum machine rate 22 b min x MinVol 100 but always lt 60 b min Minimum target rate 5 to 15 b min see Table C 6 Maximum Pinsp Pasvlimit Minimum Pinsp 5 cmH20 above PEEP CPAP Minimum inspiratory time TI 0 5 s or RCexp whichever is longer Maximum inspiratory time Tl 25s Minimum expiratory time Te 2 x RCexp Maximum expiratory time Te 125 I E range 1 4 to 1 1 624131 04 C 6 Initialization of ventilation When ASV is started the HAMILTON C2 delivers three test breaths in the synchronized intermittent mandatory pressure ventilation mode The HAMILTON C2 automatically selects the values for SIMV rate inspiratory time TI inspiratory pressure Pinsp and minimum target rate based on the calculated IBW which is determined from the operator set Pat height and Gender settings and according to Table C 6 Initial breath pattern IBW kg aol TI s gia rdet rate b min 3to5 15 0 4 30 5 6 to 8 15 0 6 25 2
70. Accordingly the HAMILTON C2 s pneumatics were designed to permit the patient s free spontaneous breathing The ventilator never forces the patient into a preset breathing pattern but always yields to spontaneous breathing This is achieved through a special valve control system independent of any trigger mechanism This concept is called biphasic because gas can flow into and out of the patient at any time The biphasic concept applies in all HAMILTON C2 ventilation modes Implementation of the biphasic concept improves patient breathing comfort as spontaneous breathing is encouraged less sedation is required even with prolonged inspiratory phases and there is a free delivery of flow to the patient at any time The decelerating inspiratory waveform improves gas distribution oxygenation and lowers peak pressures 343 6 1 Cinnella G Conti G Lofaso F Lorino H Harf A Lemaire F Brochard L Effects of assisted ventilation on the work of breathing volume controlled versus pressure controlled ventilation Am J Respir Care Med 1996 Mar 153 3 1025 33 2 Kuhlen R Putensen C Editorial Maintaining spontaneous breathing efforts during mechanical ventilatory support Int Care Med 1999 25 1203 5 3 Sydow M Burchardi H Ephraim E Zielmann S Crozier TA Long term effects of two different ventilatory modes on oxygenation in acute lung injury Comparison of airway pressure release ventilation and volume controlled inverse ratio v
71. B 8 2 Initialization of APRV B 37 B 8 3 Sustained high pressure recruitment manoeuvres B 38 B 8 4 Controls of APRV B 39 B 9 SAFETY mode and ambient state B 40 624131 04 B 1 B B 1 B 2 Modes of ventilation Introduction This section discusses the principles of operation for the HAM ILTON C2 ventilation modes It lays the groundwork by describ ing the biphasic concept which is at the heart of the device s pneumatic design and which is vital to understanding how the HAMILTON C2 ventilates in all modes The HAMILTON C2 has a full range of ventilation modes that provide full and partial ventilatory support Table B 1 classifies these modes according to a scheme developed by Branson et al The table classifies modes based on primary breath type and characteristics of mandatory breaths in that mode Table A 6 lists the controls active in all modes Volume modes in the HAMILTON C2 are delivered by an adaptive volume controller Combining the advantages of pressure controlled ventilation with volume targeted ventilation the adaptive volume controller ensures that the target tidal volume is delivered but without undue application of pressure even when lung characteristics change The operation of the adaptive volume controller is described as part of the S CMV mode description Section B 3 1 The HAMILTON C2 modes have these general characteristics e Mandatory breaths See Table B 1 for information on mandatory breaths as th
72. CAUTION e Always check the status of the oxygen cylinders or other supply before using the ventilator during transport e Make sure oxygen cylinders are equipped with pressure reducing valves e To minimize the risk of fire do not use high pres sure gas hoses that are worn or contaminated with combustible materials like grease or oil 624131 04 2 21 2 Preparing for ventilation NOTE e To prevent damage to the ventilator connect only clean dry medical grade oxygen e Before starting ventilation make sure the appropri ate oxygen source either high pressure oxygen HPO mode or low pressure oxygen LPO mode was selected during configuration see Appendix I Oxygen for the HAMILTON C2 can come from a high or low pressure source High pressure oxygen Flow lt 120 l min Pressure 2 8 to 6 bar 280 to 600 kPa 41 to 87 psi provided by a central gas supply or a gas cylinder is supplied through DISS or NIST male gas fittings With the optional cylinder holder you can mount oxygen cylinders to the trolley If you use gases from cylinders secure the cylinders to the trolley with the accompanying straps Low pressure oxygen Flow lt 15 l min Pressure lt 6 bar 600 kPa 87 psi is provided by a concentrator or liquid cylinder For information about connecting low pressure oxygen see Appendix E Connect the oxygen hose to the HAMILTON C2 s high pressure or low pressure oxygen inlet fitting shown in Figur
73. Changing Pasvlimit or the Pressure alarm limit automatically changes the other Pressure is always 10 cmH 0 greater than Pasvlimit This prevents nuisance alarms when the ASV controller delivers a sigh breath for example Flowtrigger Suggested setting is 2 I min or you can leave the previous setting if applicable ETS A suggested setting is 25 40 for a COPD patient or you can you can leave this unchanged if applicable Other settings Set PEEP CPAP and Oxygen values according to clinical requirements You can leave the P ramp setting at its standard value unless clinical judg ment calls for adjustment To set it see Section 4 4 Confirm the settings 5 Connect the patient to the ventilator if applicable This will initiate three test breaths 624131 04 Step 3 Compensation for changes in apparatus dead space The HAMILTON C2 calculates the anatomical or series dead space based on the IBW calculated from the Pat height input Dead space is calculated as 2 2 ml per kg 1 ml per Ib This dead space is a nominal value that is valid on average for intubated patients whose endotracheal tube is connected to the Y piece of the ventilator by a standard catheter mount If this dead space is altered by an artificial airway configuration such as a the use of a heat and moisture exchange filter HME or nonstandard tubing modify the Pat height setting accordingly to take into account the added or removed dead space
74. Cstat 6 2 3 Patient triggering Muscle 6 2 4 Resistance Bronchial tree Vent Status panel ASV target graphics panel 6 3 7 3 6 4 6 4 6 5 6 8 6 1 6 6 1 6 2 Intelligent Panels Introduction You can lay out the ventilator screen to display any of the three types of Intelligent Panel which are described in the following subsections Figure 6 1 shows the screen with the Dynamic Lung panel EE PSM 0 Rinsp cmH2O ls 19 4 Cstat ml cmH20 174cm Male Figure 6 1 Ventilator screen with Dynamic Lung panel 624131 04 6 2 Dynamic Lung panel 6 2 1 624131 04 The Dynamic Lung panel Figure 6 2 visualizes tidal volume lung compliance patient triggering and resistance in real time The lungs expand and contract in synchrony with actual breaths Numeric values for resistance Rinsp and compliance Cstat are also displayed If all values are in a normal range the panel is framed in green b min Monitoring Utilities Events System Figure 6 2 Dynamic Lung panel Normal lungs reference Numeric parameters Bronchial tree O Patient trigger Tidal volume Vt The Dynamic Lung expands and contracts to show tidal volume Vt in real time It moves in synchrony with actual breaths based on the proximal Flow Sensor signal The lung size shown is relative to normal size for the patient s height IBW based ona normal value of 10 ml kg A disconnection alarm is visualized by
75. D 10 Additional notes about using noninvasive ventilation Dati HRETEREN CESS coe st crancahits S EEE Bereta Low pressure OXygen 02 eee ee eens Pneumatic diagram 2 2000 eee eee Parts and accessories 220 e eee eeee Communications interface 2 005 Het Introductio srei meet ated Bee aie oe amp eke se Wien H2 Patient MONMOP sc 2 4 views we os ae ee Atcha hee ae H 3 Patient data management system PDMS or other COMPUTE SYSTEM d eeso ce eG re buwe so de APES a Table of contents xiv H 4 Connector pin assigNnMentS s a aaa aaua aea H 6 Configuration toc we ia dete Soa Coe ee es l 1 1 1 troduction 2 24 eit aai A cy duet Saye teed l 2 1 2 Accessing configuration 020000005 l 2 1 3 General Selecting the language units of measure and OXYGEN SOUICE ba sey elt eee oe anges Kees l 3 1 3 1 Language Selecting the default language 3 1 3 2 Units Selecting the default unit of measure for pressure display 00000 e eee eee l 4 1 3 3 More Selecting the oxygen source and enabling the communications interface l 5 4 Graphics window nasasa aaa l 6 1 4 1 MMP Selecting the default main monitoring parameter display 0000000 000 l 6 L5 Settings WINdOW anasan aaan l 7 1 5 1 Use settings Selecting the default startup settings l 7 1 6 Vent Status Configuring the Vent Status panel I 10 GlOSSalY on otk Gout
76. EP CPAP to be applied during the inspiratory phase Pressure support helps the patient counteract the flow resistance of the breathing circuit and endotracheal tube It compensates for the decreasing tidal volume and rising respiratory rate of a spontaneously breathing patient Applies to spontaneous breaths in SPONT NIV and SIMV O to 200 ms 0 to 60 cmH 20 above PEEP CPAP 4 19 4 Ventilator settings Table 4 3 Control settings mode additions and ranges continued Rate Respiratory frequency or number of breaths per minute Applies in S CMV PCV Applies in PSIMV NIV ST Applies in SIMV DuoPAP b min Sigh Breaths delivered at a regular interval every 50 On or Off breaths at a pressure up to 10 cmH20 higher than nonsigh breaths as allowed by the Pres sure alarm limit During sigh breaths the Pres sure and Vt alarm limits remain in effect to help protect the patient from excessive pressures and volumes Applies in all modes except DuoPAP and APRV T high Applies in DuoPAP and APRV 0 1 to 40s Time to deliver the required gas time to reach 0 3 to 12s the ERS set Vt or Pcontrol value Applies in SIMV PSIMV and NIV ST TI max m inspiratory time 1 0 to 3 0 s n NIV and NIV ST PAPEY 210405 Tidal volume delivered during inspiration 20 to plies in S CMV and SIMV 2000 ml 4 20 624131 04 4 5 Alarms windows 4 5 1 624131 04 You can s
77. IS ecesas bw es ole a ee eid taf et B 27 PSIMV apnea controls 0 2 0 000 cee B 28 NIV ST basie controls e cess va nade be beet oad aoe be Meee B 29 NIV ST more controls re er seret onsa eee B 30 NIV ST apnea controls 0 2 0 2 00000 eee B 31 DUOPAP pressure CUVE sis et eda boy car wad B 32 Pressure support in DUOPAP APRV 2 20055 B 34 DuoPAP basic controls ss erae er e e ne B 35 DUGPAF MOTE CODTOS s mek hua C OE ee es B 35 DuoPAP apnea controls n nananana B 36 APRV breath timing 0 0000 cece eee eee B 37 APRV basi cOntrlS vein see ik Sis Vad atu cae hens See B 39 APRV more COntrols 35 200 taO be Be noe Hew eae B 39 APRV apnea controls 00000 e eee ete B 40 Display SAFETY mode and ambient state B 41 Clinical use of ASV The numbers in parentheses are step numbers which are explained in the next subsections C 5 ASV DanC Controls ssh ite are ea ad pa Ra woes Bee C 6 ASV NOE CONTIONS nasasa sey Se a Lohan Bead wane 4s C 7 Hypothetical example of high MinVol setting incompatible with the lung protective rules strategy The open circle denotes the actual target the closed triangle never shown on the ventilator denotes the energetically optimal target according to Otis equation The HAMILTON C2 will alarm and inform the user that the ASV target cannot be achieved C 12 ASV target graphics panel 0 000000020 C 13 624131 04
78. MHz the separation distance for the higher frequency range applies 4 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz 5 An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas 624131 04 A 27 A Specifications A 13 Warranty A 28 LIMITED WARRANTY THE WARRANTY DESCRIBED IN THIS AGREEMENT IS IN LIEU OF ANY AND ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE HOWEVER IMPLIED WARRANTIES ARE NOT DISCLAIMED DURING THE PERIOD OF THIS LIMITED WARRANTY HAMILTON MEDICAL guarantees its products to be shipped free from defects in material and workmanship The warranty does not include disposable items Disposable items and consumable products are considered to be of single use or of limited use only and must be replaced regularly as required for proper operation of the product following the operator s manual HAMILTON MEDICAL and the manufacturer shall have no obligations nor liabilities in connection with the product other
79. N C2 ventilator is a medical device intended for use by qualified trained personnel under the direction of a physician and within the limits of its stated technical specifica tions Caution USA only e Federal law restricts this device to sale by or on the order of a physician e Not intended to be used during secondary transport from one hospital to another The intended patient population ranges from pediatric patients with 30 cm height 3 kg ideal body weight up to adults with 250 cm height 139 kg ideal body weight The minimum tidal volume delivered shall be larger or equal to 20 ml This does exclude the application on neonatal patients General operation notes e The displays shown in this manual may not exactly match what you see on your own ventilator e Familiarize yourself with this operator s manual before using the ventilator on a patient e Displayed information that is ghosted is not active and may not be selected e Dashes displayed in place of monitored data indicate that valid values are not yet available or do not apply 624131 04 e If aventilator control does not respond when selected by touch or by the turn of a knob the control is not active in this particular instance or the function is not implemented Monitoring and alarms e The HAMILTON C2 is not intended to be a comprehensive vital sign monitor for patients on life support equipment Patients on life support equipment should be appropriat
80. See S CMV Synchronized intermittent mandatory ventilation mode See SIMV or PSIMV T TE expiratory time monitored parame ter definition 5 14 Technical event alarm 7 18 Technical fault alarm 7 19 description 7 2 Tests calibrations and utilities 3 1 3 17 alarm tests 3 15 3 17 data transfer to USB memory device 3 13 3 14 date and time function 3 11 Flow Sensor calibration 3 8 oxygen cell calibration 3 9 preoperational check 3 3 3 4 tightness test 3 7 Index 7 Index viewing operating hours options and versions 3 5 when to run 3 2 TI inspiratory time monitored parame ter definition 5 15 TI inspiratory time setting definition 4 17 TI max maximum inspiratory time set ting definition 4 17 Tidal volume setting or alarm See Vt Tightness test 3 7 Time constant expiratory See RCexp Time expiratory monitored parame ter See TE Time inspiratory monitored parame ter See Tl Timing parameters displayed in Con trols window 4 8 To patient port location 1 13 Total respiratory rate See fTotal Trends 5 10 5 11 Trigger symbol description 1 19 Troubleshooting alarms 7 9 7 19 Turn the Flow Sensor alarm 7 19 U Ultrasonic nebulizer See AeroNeb Pro ultrasonic nebulizer system Units of measure how to configure l 4 USB connector how to transfer data via 3 13 location 1 17 USB power out of tolerance alarm 7 19 V Valve expiratory See Expiratory valve Vent outlet temperature high alarm 7 19 Ve
81. Selects and adjusts ventilator settings and selects monitored data A green ring around the knob is lit when power is switched on Expiratory valve cover and membrane ex From patient port The expiratory limb of the patient breathing circuit and the expiratory valve are connected here To patient port The inspiratory filter and the inspiratory limb of the patient breathing circuit are connected here lt 4 Flow sensor connection Always attach the blue tube to the blue connector and the clear tube to the silver connec tor The blue tube should always be toward the patient Pneumatic nebulizer output connector Oxygen cell with cover 624131 04 1 13 1 General information MMAM Figure 1 5 Rear view o Pe powercomedor 1 14 624131 04 Item Description Low pressure oxygen connector High pressure oxygen DISS or NIST inlet fitting 624131 04 1 15 1 General information Figure 1 6 Left side view Graphical user interface tilt assembly Expiratory valve cover exhaust port 1 16 624131 04 Figure 1 7 Right side view Battery door 2 USB connector For software update and event log x NOTE The USB connector is intended for pas sive memory devices only 624131 04 1 General information 1 3 3 Screen You can directly access all the windows for mode controls alarms and monitoring from the screen during normal ventila tion The default scr
82. V and the spontaneous timed noninvasive ventilation mode NIV ST are HAMILTON C2 s implementation of noninvasive positive pressure ventilation NPPV NPPV may use as its patient interface a mask mouthpiece or helmet type interface rather than an invasive conduit such as an endotracheal tube Used for years in home care and subacute care settings NPPV can also benefit intensive care ventilation patients by decreasing the need for intubation and promoting early extubation Benefits such as reduced mortality COPD patients reduced ventilation time COPD and ARF patients and reduced complication rates of ventilator associated pneumonias have been clearly demonstrated 1 Mehta S et al Noninvasive ventilation Am J Respir Crit Care Med 2001 Feb 163 2 540 77 2 Hess DR The evidence for noninvasive positive pressure ventilation in the care of patients in acute respiratory failure a systematic review of the literature Respiratory Care 2004 Jul 49 7 810 25 624131 04 Intended for actively breathing patients noninvasive ventilation is provided through a nonvented or nonported mask interface Because this open breathing circuit permits air to leak around the mask or through the mouth the ventilator achieves and maintains the prescribed pressure by adjusting the inspiratory flow If the leak is large the ventilator s inspiratory flow can be large up to 180 l min thus compensating at least in part for most leaks Th
83. V DC with or without the ven tilator power switch on The battery charge indicator Figure 2 11 lights show that the batteries are being charged Start Ventilation Controls JFF press stand by key gt 3 sec Alarms Utilities Events System Figure 2 11 Power source symbols and battery charge indicator Battery charge indicator Crossed out battery 1 means standard battery not available AC mains symbol or DC Frame indicates current power source 624131 04 The power source symbols in the bottom right hand corner of the screen show the available power sources A frame around a symbol indicates the current ventilator power source Green indicates the level of battery charge Check the battery charge level before putting the ventilator on a patient and before unplugging the ventilator for transport or other purposes A green symbol indicates a fully charged bat tery A red and green symbol indicates a partially charged bat tery If battery symbol 1 is crossed out the standard battery is discharged or defective If battery symbol 2 is not shown the optional battery is not installed If a battery is not fully charged recharge it by connecting the ventilator to the primary power source for a minimum of 4 h until the battery charge level is 80 to 100 Alternatively the battery can also be charged with the external charger Section 9 3 2 describes how to replace the batteries 2 10 Connecting the oxygen supply
84. a deflated lung An Exhalation obstructed alarm is visualized by an inflated lung 6 3 6 Intelligent Panels 6 2 2 Compliance Cstat The Dynamic Lung shows compliance Cstat breath by breath relative to normal values for the patient s height Figure 6 3 As the figure shows the shape of the lungs changes with compliance The numeric value is also displayed Low compliance Normal compliance High compliance Figure 6 3 Compliance shown by the Dynamic Lung 6 2 3 Patient triggering Muscle The muscle in the Dynamic Lung shows patient triggering Figure 6 4 Figure 6 4 Patient triggering shown by the Dynamic Lung muscle Muscle 6 4 624131 04 6 2 4 Resistance Bronchial tree The bronchial tree in the Dynamic Lung shows resistance Rinsp breath by breath relative to normal values for the patient s height Figure 6 4 The numeric value is also displayed Normal resistance Moderately high High resistance resistance Figure 6 5 Rinsp shown by the bronchial tree of the Dynamic Lung Table 6 1 Dynamic Lung normal values Parameter Definition of normal value Tidal volume 10 ml kg IBW calculated from Pat height Vt Compliance For Pat height between 30 and 135 cm 11 and 53 in Cstat 0 000395 Pat height 78 For Pat height gt 135 cm 53 in 0 0028 Pat height 1 3493 Pat height 84 268 Resistance For Pat height lt 210 cm 83 in 1 993 0 0092 Pat height Rinsp
85. ably from alveolar pressure if airway flow is high 624131 04 Table 5 1 Monitored parameters continued Parameter Definition unit RCexp Expiratory time constant The rate at which the lungs empty s as follows Actual TE emptying 1 x RCexp 63 2 x RCexp 86 5 3 x RCexp 95 4 x RCexp 98 RCexp is calculated as the ratio between VTE and flow at 75 of the VTE ASV uses RCexp in its calculations In adults an RCexp value above 1 2 s indicates airway obstruction and a value below 0 5 s indicates a severe restrictive disease Use RCexp to set optimal TE Goal TE gt 3 x RCexp e In passive patients Adjust rate and I E e Inactive patients Increase Psupport and or ETS to achieve a longer TE These actions may reduce the incidence of AutoPEEP Rinsp Resistance to inspiratory flow caused by the endotracheal cmH20 l s tube and the patient s airways during inspiration It is calcu lated using the LSF method applied to the inspiratory phase NOTE Actively breathing patients can create artifact or noise which can affect the accuracy of these measurements however To minimize patient participation during these measurements you may want to increase Psup port by 10 cmH 0O After completion return this con trol to its former setting Expiratory time In mandatory breaths TE is measured from the start of exhalation until the set time has elapsed for the switchover to inspiration In spontaneous
86. according to your institution s protocol Table A 10 lists the weaning zone ranges and defaults To change the settings open the Vent Status window then select a parameter and adjust the value Repeat for any other desired parameters Configuration Oxygen AMin ol Settings Vent Status Boo Minvol Pinsp fSpont Monitoring Figure I 8 Vent Status configuration window l 10 624131 04 CO Elimination Spont Activity PEEP MinVol Pinsp 5 3 5 cmH20 Vmin cmH20 1 04min Figure l 9 Vent Status intelligent panel 624131 04 l 11 Configuration l 12 624131 04 Glossary A AC alarm buffer alarm lamp alarm silence key ambient state apnea Apnea time APRV ASV ASV target graph ics panel ASV monitored data window ATPD AutoPEEP Backup backup buzzer 624131 04 Ampere a unit of current Alternating current Contains information on the four most recent alarm occurrences Lamp atop the HAMILTON C2 that lights in a color corre sponding to the active alarm Silences alarm sound for 2 min An emergency state in which the ventilator opens the ambient and expiratory valves and closes the inspiratory valves This lets the patient breathe room air unassisted by the ventilator Cessation of breathing The maximum time allowed without a breath trigger an alarm setting Airway Pressure Release Ventilation Adaptive support ventilation a positive pressure vent
87. aching the target 624131 04 Figure C 11 shows a possible scenario after the three initial test breaths The actual breath pattern which is plotted as a cross shows clear deviation from the target The task of ASV is now to move the cross as close to the circle as possible 2000 1500 1000 Vt ml 500 0 20 40 60 f b min Figure C 11 Example of a situation after the three initial breaths The cross marks the actual measured values for Vt and rate To achieve the target the following strategy is used e f actual Vt lt target Vt the inspiratory pressure is increased e If actual Vt gt target Vt the inspiratory pressure is decreased e lf actual Vt target Vt the inspiratory pressure is left unchanged e lf actual rate lt target rate the SIMV rate is increased e If actual rate gt target rate the SIMV rate is decreased e lf actual rate target rate the SIMV rate is left unchanged As a result the cross in Figure C 11 moves toward the circle The actual Vt is calculated as the average of inspiratory and expiratory volumes of the last 8 breaths This definition compensates in parts for leaks in the breathing circuit including the endotracheal tube C 25 C ASV adaptive support ventilation C 3 5 Dynamic adjustment of lung protection The operator preset values are not changed by ASV and the corresponding safety limits remain as defined above However if the respiratory system mechanics
88. act possible operator errors and to follow changes of respiratory system mechanics The effect of the strategy is shown in Figure C 9 and explained in the subsequent subsections C 19 C C 20 ASV adaptive support ventilation 2000 1500 1000 Vt mil 500 0 20 40 60 f b min Figure C 9 Lung protective rules strategy to avoid high tidal volumes and pressures A low alveolar ventilation B dynamic hyperinflation or breath stacking C and apnea D A High tidal volume limit The tidal volume applied by ASV is limited see A in Figure C 9 by two operator settings Pasvlimit and Pat height The operator is required to set the Pasvlimit before connecting a patient to the HAMILTON C2 It was recommended by a group of physicians Slutsky 1994 that the plateau pressure not exceed 35 cmH 0O For example a normal 70 kg normal post operative patient would have a compliance of about 50 ml cmH 0 With a PEEP level of 5 cmH0 and a Pasvlimit of 35 cmH 0 the effective pressure swing would be 30 cmH30 This in turn would lead to an effective Vt of equal to or less than 1500 ml If the patient s lungs stiffen say to a compliance of 30 ml cmH 0 the maximum tidal volume becomes 900 ml If the operator sets the Pasvlimit to a very high pressure say 50 cmH 0 the target volume is limited by the second criterion 22 x IBW For the 70 kg sample patient a maximum target volume of 1540 ml results 624131 0
89. aired and or replaced components does not exceed the Limited Warranty of the device To obtain service under this Limited Warranty claimant must promptly notify the country s sales partner of HAMILTON MEDICAL regarding the nature of the problem serial number and the date of purchase of the Product Except as stated above HAMILTON MEDICAL shall not be liable for any damages claims or liabilities including but not limited to personal bodily injury or incidental consequential or special damages A Specifications A 14 Miscellaneous The general terms and conditions of HAMILTON MEDICAL shall be applicable This agreement shall be governed by and contrued in accordance with the laws of Switzerland and may be enforced by either party under the jurisdiction of the court of Chur Switzerland A 30 624131 04 APPENDIX B Modes of ventilation B 1 Introduction B 2 B 2 The biphasic concept B 5 B 3 Mandatory modes B 9 B 3 1 S CMV mode or APVcmv B 9 B 3 2 PCV mode B 12 B 4 Spontaneous modes SPONT and NIV B 14 B 5 SIMV modes B 20 B 5 1 SIMV mode or APVsimv B 21 B 5 2 PSIMV and NIV ST modes B 24 B 6 Adaptive support ventilation ASV B 31 B 7 DuoPAP Duo positive airway pressure B 32 B 7 1 Introduction B 32 B 7 2 The many faces of DuoPAP B 33 B 7 3 Pressure support in DuoPAP breaths B 33 B 7 4 Synchronization B 34 B 7 5 Controls of DuoPAP B 35 B 8 APRV Airway pressure release ventilation B 36 B 8 1 Introduction B 36
90. al standards bodies Kilogram a unit of mass Kilopascal a unit of pressure Liter a unit of volume Liters per minute a unit of flow 624131 04 Ib Leak Loops Loudness LPO LSF m mandatory breath manual breath mbar MinVol MinVol ml ms MVSpont NIST NIV 624131 04 Pound a unit of weight Leakage percent a monitored parameter Special graphic type Alarm loudness a control setting Low pressure oxygen Least squares fitting a mathematical procedure for find ing the best fitting curve to a given set of points by mini mizing the sum of the squares of the offsets of the points from the curve Meter a unit of length A breath for which either the timing or size is controlled by the ventilator That is the machine triggers and or cycles the breath A user triggered mandatory breath started by pressing the manual breath key Millibar a unit of pressure 1 mbar equals 1 hPa which is approximately equal to 1 cmH30 Percentage of minute ventilation a control setting in ASV mode Minute volume a calculated and monitored parameter used in ASV mode Based on the operator set MinVol the ventilator calculates the target MinVol in I min then measures and displays it in the ASV target graphics panel Milliliter a unit of volume Millisecond a unit of time Spontaneous expiratory minute volume a monitored parameter Noninterchangeable screw thread a standard for high
91. also name of specific setting or Ventilator settings Controls and indicators 1 11 1 13 See also name of specific control or indicator Cstat static compliance monitored pa rameter definition 5 11 Curves See Waveforms D Data Logger software using to commu nicate with a computer H 5 Data transfer to USB memory device 3 13 3 14 Date amp time function 3 11 Device temperature high alarm 7 11 Dimensions ventilator A 2 Disconnection alarm 7 12 Disconnection on patient side alarm 7 12 Disconnection on ventilator side alarm 7 12 Disinfection chemical general guide lines 9 7 Dynamic Lung panel 6 3 6 5 how to interpret compliance 6 4 how to interpret resistance Rinsp 6 5 624131 04 how to interpret tidal volume Vt 6 3 patient triggering 6 4 DuoPAP duo positive airway pressure B 32 B 36 controls B 35 B 36 discription B 33 B 35 introduction B 32 E Electrical specifications A 4 EMC declarations IEC EN 60601 1 2 A 20 A 25 Environmental specifications A 3 ETS expiratory trigger sensitivity set ting definition 4 13 Event log 7 8 Exhalation obstructed alarm 7 12 Exhalation port occluded alarm 7 12 Exp Flow peak expiratory flow moni tored parameter definition 5 11 Expiratory filter using with the HAMIL TON G5 2 16 Expiratory flow See Exp Flow Expiratory minute volume See ExpMin Vol Expiratory tidal volume See VTE Expiratory time constant See RCexp Expiratory time monitored parameter See TE Expira
92. amp time window Figure 3 4 Select and adjust a parameter Repeat as necessary Apply the changes PSIMV 09 27 26 Date 2008 06 20 Month Minutes Figure 3 4 Date amp time window 3 4 Utilities You can configure the ventilator and transfer event log data to a USB memory device from the Utilities window 3 12 624131 04 3 4 1 Configuration Configuring the ventilator Open the Utilities gt Configuration window Figure 3 5 Select Configuration while pressing the unlabled button to access the configuration mode described in Appendix l PSIMV Configuration Figure 3 5 Configuration window 624131 04 3 13 3 3 14 Tests calibrations and utilities 3 4 2 Data transfer Copying event log data to a USB memory device You can save the event and service logs to a USB memory device The device must have a FAT or FAT32 format and it must not have an operating system or a security system installed To save the logs place the ventilator into standby and insert a memory device into the USB connector Figure 1 7 Open the Utilities gt Data transfer window Figure 3 6 and select Copy to USB Remove the memory device when File transfer successful is displayed A foler named C2_sn lt Serial Number gt will be created containing all eventlog and servicelog files NOTE devices only BH e The USB connector is intended for passive memory e If you remove the memory device before the fi
93. ands ac sie heats Angele a pas wes 3 15 3 5 1 High pressure 2 2 0 000 eee 3 15 3 5 2 Low minute volume 0 200 5 3 15 3 5 3 Low oxygen alarm 0 000000000 e ee 3 15 3 5 4 Disconnection on patient side 3 16 3 5 5 Loss of external power 00 3 16 3 5 6 Exhalation obstructed 3 17 3 DADEA A seu datna te a a daa ang a a A 3 17 4 Ventilator settings ssssansassnnnnnn 4 1 A1 Nodu OM ait E a a E he stk Ae ea 4 2 AZ Patlent setups ise a Let ae aut a 4 3 4 3 Modes window Setting the ventilation mode 4 5 4 4 Controls windows Setting controls including apnea backup ventilation 0 0000 cece eee 4 6 4 4 1 Adjusting and confirming control settings without mode change 0 0000 e eee eee eee 4 7 4 4 2 Adjusting and confirming control settings after mode changes endet tac ae ee da ee chee 4 10 4 4 3 About apnea backup ventilation 4 12 4 4 4 Table of control settings mode additions and ages 44 e272 os ee wna ted fee eine OTa EnA 4 16 4 5 Alarms windows 0000 cece eee eee 4 21 4 5 1 Limits 1 and Limits 2 Setting alarm limits 4 21 4 5 2 Loudness Adjusting alarm loudness 4 24 4 5 3 Buffer Viewing alarm information 4 25 4 5 4 Table of alarm limit settings and ranges 4 25 5 Monitoring essaia eee Sa ig eee Pe 5 1 Bil SIMTPOAUCUON fete ei tates ot aera tat eluate Cue wenn
94. are spontaneous The control variable is the indepen dent variable that the ventilator manipu lates to cause inspiration 2 The way pressure and volume are controlled within or between breaths Setpoint means the ventilator output automatically matches a constant unvarying operator preset input value like the production o breath Optimum is a control scheme ratory mechanics change Adaptive control means one set mize other variables as respi point e g the pressure limi to maintain another setpoin tory system change 3 A trigger variable starts insp B 4 a constant of the ven inspiratory pressure or tidal volume from breath to hat uses automatic adjustment of setpoints to opti tilator is automatically adjusted over several breaths t e g the iration arget tidal volume as the mechanics of the respira 624131 04 4 A limit variable can reach and maintain a preset level before inspiration ends but it does not end inspiration 5 Acycle variable is a measured parameter used to end inspiration B 2 The biphasic concept 624131 04 It is widely accepted that early spontaneous breathing is beneficial for many ventilated patients provided the device lets the patient inspire and exhale whenever the respiratory muscles contract and relax In other words the ventilator needs to be in synchrony with the patient s muscle contractions regardless of how the ventilator s controls are set
95. arm condition from the alarm messages referring to Table 7 2 For low medium and high priority alarms when the alarm triggering condition is corrected the ventilator automatically resets the alarm For a technical fault alarm switch off ventilator power first then correct the problem 7 3 Alarm buffer The alarm buffers show up to six alarm messages 7 6 If there are currently active alarms the alarm buffer shows the most recent active alarms Figure 7 4 The associated alarm messages also alternate in the message bar Active alarms are in boxes with rounded corners If no alarms are active the alarm buffer shows the most recent inactive alarms Figure 7 5 Inactive alarms are in boxes with square corners Open the Alarms gt Buffer window with the Buffer tab by touching the message bar in the upper left hand corner or by touching the inactive alarm indicator Figure 7 5 The most recent alarm is at the top You can clear the alarm messages for all inactive alarms with the Reset button Closing the buf fer does not erase its contents 624131 04 f 2A x Limits 1 w minute volume Controls Alarms Monitoring Utilities Events System Figure 7 4 Alarm buffer with active alarms Active alarms alternate in message bar Touch to open alarm buffer Low or medium priority alarm yellow background High priority alarm red background Box with rounded corners 624131 04 7 7 7 Respondi
96. as described in Table 3 1 If a test fails troubleshoot the ventilator as indicated or have the ventilator serviced Make sure the tests pass before you return the ventilator to clinical use Table 3 1 When to perform tests and calibrations When to perform Test or calibration Before placing a new patient on the Preoperational check ventilator CAUTION To ensure the ventilator s safe operation always run the full preoperational check before using the ventilator on a patient If the ventilator fails any tests remove it from clinical use immedi ately Do not use the ventila tor until necessary repairs are completed and all tests have passed After installing a new or decontami Tightness test Flow Sensor calibration nated breathing circuit or component including a Flow Sensor After installing a new oxygen cell or Oxygen cell calibration when a related alarm occurs As desired Alarm tests 3 2 624131 04 3 2 Running the preoperational check CAUTION To prevent possible patient injury disconnect the patient from the ventilator before running this test Make sure another source of ventilatory sup port is available When to perform Before placing a new patient on the venti lator Required materials Use the setup below appropriate to your patient type To ensure that the ventilator also functions according to specifications on your patient we recommend that your test circuit be equivalent to th
97. atmospheric pressure Pressure A Psupport Phigh y 1 Rate Figure B 26 DuoPAP pressure curve B 32 624131 04 B 7 2 The many faces of DuoPAP With different patients and with different combinations of control settings DuoPAP can be made to resemble a variety of conventional ventilation modes At conventional settings and in the absence of spontaneous breathing DuoPAP resemble PCV As you decrease the rate keeping Thigh short relative to the time at the lower pressure level the modes look more like PSIMV with spontaneous breaths following mandatory breaths If you set the breath cycle time to a total of 7 5 to 15 s with just enough time at the low level to allow full or near full exhalation these mode looks like APRV By setting PEEP CPAP and Phigh equal to one another and adjusting other parame ters the mode can be made to resemble SPONT B 7 3 Pressure support in DuoPAP breaths Pressure support can be set to assist spontaneous breaths in DuoPAP whether they occur at the PEEP CPAP or Phigh level Psupport is set relative to PEEP CPAP the target pressure becomes PEEP CPAP That means that spontaneous breaths at the Phigh level are supported only when this target pressure is greater than Phigh Figure B 27 a shows the situation where breaths at both the PEEP and Phigh level are pressure supported Figure B 27 b shows the situation where only breaths at the PEEP CPAP level are pressure supported 624131 0
98. bulizer 2 15 2 7 Using an expiratory filter 0 0 000 0 0 0 2 16 2 8 Connecting to primary power source 2 17 2 8 1 Connecting to AC power 205 2 17 2 8 2 Connecting to DC power 004 2 18 About the batteries 0 0 0000 020 000055 2 18 Connecting the oxygen supply 2 20 Connecting to an external patient monitor or other COVIG E235 aa peak 5 Rg cine he Sere cent ie alae 2 21 2 12 Starting up the ventilator 2 22 2 13 Shutting down the ventilator 2 23 2 14 Display navigation guidelines 2 23 Tests calibrations and utilities 3 1 3 1 WINtOGUCTION pss 26 ee eae a4 haw dd ead oP er eae gt 3 2 3 2 Running the preoperational check 3 3 373 Systm TUNCHONS worsted carmaker Dae dae ag 4 3 5 3 3 1 Info Viewing device specific information 3 5 3 3 2 Tests amp calib Running sensor calibrations and the TQNINESS TST rons eo ete ene eae ee aed eae G 3 6 3 3 3 Sensors on off Enabling disabling oxygen MONITONIAG crak ee ae eal et aoe eee aw 3 10 3 3 4 Date amp time Setting date and time 3 11 Table of contents Bd WO tiliteS es 2G ce eine Gane colds An eG Cea ee 3 12 3 4 1 Configuration Configuring the ventilator 3 12 3 4 2 Data transfer Copying event log data to a USB memory device 2 0 3 13 3 5 Alarm teStSiaiv b
99. ca tions in the ventilator circuit When nebulization is active the nebulizer flow is synchronized with the inspiratory phase of each breath for 30 min Nebulization can be activated in all modes of ventilation To start nebulization press the nebulizer on off key To termi nate nebulization before the set time press the key again 624131 04 624131 04 For effective nebulization use a pneumatic nebulizer jar as specified in Table 1 1 Section 2 5 describes how to install the nebulizer 8 7 8 8 Special functions 624131 04 624131 04 Maintenance 9 1 9 2 9 3 9 4 9 5 Introduction Cleaning disinfection and sterilization 9 2 1 General guidelines for cleaning 9 2 2 General guidelines for chemical disinfection 9 2 3 General guidelines for autoclave ETO or plasma sterilization Preventive maintenance 9 3 1 Servicing the air intake and fan filters 9 3 2 Replacing the batteries 9 3 3 Charging and calibrating the batteries 9 3 4 Replacing the oxygen cell Storage Repacking and shipping 9 2 9 6 9 7 9 7 9 8 9 10 9 12 9 13 9 14 9 15 9 15 9 1 9 Maintenance 9 1 Introduction Follow these maintenance procedures to ensure the safety and reliability of the HAMILTON C2 All the procedures in this man ual are intended to be performed by the operator For further maintenance contact your service representative 9 2 Cleaning disinfection and sterilization CAUTION e To minimiz
100. ca aos ait ees et ad hha tte AD A 13 A 8 Configuration specifications 0 A 15 A 9 Ventilator breathing system specifications A 17 A 10 Other technical data 0 200200200 A 18 A 11 Standards and approvals 200 A 21 A 12 EMC declarations IEC 60601 1 2 A 22 A13 Warranty x oh ct aie i a Wott a SR RE eh ME A ice A 28 Modes of ventilation 2 0005 B 1 Bali IMtrOGUCTION xe den 44 24 Soe bad noe baled nd nei B 2 B 2 The biphasic concept 0000002 e eee eee B 5 B 3 Mandatory modes 0 000000 cee eee eee B 9 B 3 1 S CMV mode 00000 B 9 Bi3 2 PEV4 Moden ony 20 i ca8 a ba Peh ee oe ak B 12 B 4 Spontaneous modes SPONT and NIV B 14 B 5 SIMMV MOd S c 82 phar Nasi E did O a aR B 20 B 5 1 SIMV mode 0 2000000 e eee eee B 21 B 5 2 PSIMV and NIV ST modes B 24 B 6 Adaptive support ventilation ASV B 32 B 7 DuoPAP Duo Positive Airway Pressure and B 32 B 7 1 Introduction 2 2 0 0 ee B 32 B 7 2 The many faces of DUOPAP B 33 B 7 3 Pressure support in DuoPAP breaths B 33 B 74 Synchronization sesane e a eae B 34 B 7 5 Controls of DuoPAP onana auaa aaea B 35 B 8 APRV Airway Pressure Release Ventilation B 36 B 8 1 Introduction 2 2 0 0 B 36 B 8 2 Initialization of APRV 0 0 00202005 B
101. calibration You may continue to use the battery High priority The ventilator is running on its battery and the battery can support lt 10 min ventilator operation High priority The battery tem perature is higher than expected High priority The battery tem perature is higher than expected Check the patient Check the control settings Consider decreasing the MinVol setting or increasing Pasvlimit to an appropriate level Consider suctioning or other therapy NOTE Display the ASV target graphics panel to help troubleshoot this alarm Calibrate the battery Calibrate the battery Connect the ventilator to its primary power source Install charged batteries Remove the ventilator from the sun or other heat source Install a new battery Remove the ventilator from the sun or other heat source Install a new battery Battery High priority No battery is Insert a battery power loss present 624131 04 7 Responding to alarms Table 7 2 Alarms and other messages continued Battery 1 Wrong bat tery Battery 2 Wrong bat tery Check Flow Sensor Check Flow Sensor tub ing Device tem perature high Disconnec tion 7 12 Low priority The battery in use is not a HAMILTON C2 Li lon battery Low priority The battery in use is not a HAMILTON C2 Li lon battery High priority Flow Sensor measurements are out of expected range The ventilator switche
102. cancel the Flow Sensor calibration while it is in progress select Flow Sensor again e Circuit resistance compensation measured during calibration Description This calibration checks and resets the calibration points specific to the Flow Sensor in use Procedure 1 Set the ventilator up as for normal ventilation complete with breathing circuit and Flow Sensor 2 Activate Flow Sensor test from the Tests amp calib window 3 If you have not already disconnected the patient the message line displays Disconnect patient Disconnect the patient now 4 Follow the instructions displayed in the message line turning the Flow Sensor as indicated NOTE If you are using a LiteCircuit block the opening of the whisper valve with a clean gauze covered finger 5 VERIFY that the message line displays the green tick If the message line displays the red cross rerun the test If the second attempt fails install a new Flow Sensor 6 Reconnect the patient as indicated 3 9 3 Tests calibrations and utilities 3 3 2 4 Oxygen cell calibration NOTE e There is no need to disconnect the patient from the ventilator when performing the oxygen cell calibra tion e The oxygen cell calibration requires that a HAMIL TON MEDICAL oxygen cell be installed and that the ventilator s oxygen monitoring be enabled To check for an oxygen cell see Section 9 3 4 To determine whether oxygen monitoring is enabled check the Syst
103. constriction For clarity the safety limits are omitted For clinical examples see Belliato 2000 weg eraudy Oi ae we pelo he web aicnn ees Benet fhe C 28 Three different relationships between rate and WOB are plotted for a hypothetical lung purely resistive load causes WOB to rise with rate x purely elastic load creates highest load at low rates o the total lung shows a clear minimum which can be calculated according to the equation below C 29 Ventilator parts and accessories standard trolley G 5 Ventilator parts and accessories standard trolley G 6 Universal transport trolley parts 0 000200000 G 8 HAMILTON C2 connected to a patient monitor H 4 HAMILTON C2 connected to a computer system H 5 RS 232 connector pinout 2 2 00 VREER E iy H 7 RS 232 cable PN 157354 wiring diagram 0 H 7 Language configuration window 020 005 3 Units configuration window 0 00202 e eee eee 4 More configuration Window 00 000202 e ee eee l 5 MMP configuration window oaaao naasa aaeeea l 6 624131 04 l 5 Use settings configuration window 20000 l 7 l 6 Mode Ctrls configuration window saaana asaan aaa l 8 l 7 Alarms configuration window n s asana asana l 9 I 8 Vent Status configuration WINdOW a na asasan eaaa l 10 l 9 Vent Status intelligent panel n on nananana l 11 624131 04 X X
104. ct sunlight moisture and corrosive gases and with a recommended temperature range lt 21 C Extended exposure to tempera tures above 45 C could degrade battery performance and life NOTE Battery life specifiations are approximate The actual battery life depends on ventilator settings battery age and level of battery charge To ensure maximum bat tery life maintain a full charge and minimize the num ber of complete discharges A 4 624131 04 A 5 Control settings Table A 5 is an alphabetical list of the HAMILTON C2 s control settings ranges and resolutions Table A 6 lists the control set tings that apply to the various ventilation modes Table A 5 Control setting ranges and resolutions gt Default Apnea backup On Off ETS expiratory trig 5 to 70 of ger sensitivity inspiratory peak flow Flowtrigger Off 1 to 10 l min s CMV and PCV modes 1 to 10I min other modes I MinVol 25 to 350 5 minute volume Mode S CMV ASV SA SIMV PSIMV SPONT ASV NIV NIV ST DuoPAP APRV Pasvlimit 5 to 60 cmH 0 40 cmH 0 100 E DuoPAP 1 9 to 4 1 1 599 to 149 1 624131 04 A 5 A Specifications Table A 5 Control setting ranges and resolutions continued Default Pat height 30t0250cm 3 2cm 174 cm patient height to 139 kg IBW Pcontrol control 5 to 60 cmH20 1 cmH 30 15 cmH 20 pressure added to PEEP CPAP O PEEP CPAP 0 to 35 cmH3 1 cmH 2
105. d Low priority It ist possible that the HAMILTON C2 has been contaminated Low priority The set I E ratio is above 1 1 leading to inverse ratio ventilation High priority reset when silenced The HAMILTON C2 is running on battery power due to loss of its primary power source Check the patient Adjust the Pressure alarm limit Check the breathing circuit and Flow Sensor tubes for kinks and occlusions Provide alternative ventilation once the ventilator enters the ambient state Check the patient Check the breathing circuit Adjust the Pressure alarm limit Consider disabling the sigh function Decontaminate the instru ment Check the timing control set tings Silence the alarm Check integrity of connection to primary power source Check battery status If you have spare batteries prepare to swap if necessary Prepare for possible power loss Obtain alternative venti lation 7 15 7 Responding to alarms Table 7 2 Alarms and other messages continued Low fre quency Low minute volume 7 16 Medium priority Paw lt PEEP CPAP 3 cmH gt 0 for more than 10 s and PEEP CPAP gt 4 cmH 0 Medium priority Measured frotal lt the set alarm limit High priority Measured ExpMinVol lt the set alarm limit High priority Measured Oxy gen is lt the set alarm limit low pressure oxygen or the operator set Oxygen 5 high pressure oxygen Medium priori
106. d by the HAMILTON C2 along with their definitions and sug gested corrective actions These corrective actions are sequenced to correct the most probable malfunction or to present the most efficient corrective action first The proposed actions however may not always correct the particular prob lem Table 7 2 Alarms and other messages High priority No patient trig Check the patient ger within the operator set Apnea time in SPONT SIMV PSIMV NIV or NIV ST mode Consider switching to a man datory mode or increasing the mandatory rate Apnea ven Low priority No breath deliv Apnea backup ventilation has tilation ered for the operator set started The ventilator is in the apnea time Apnea backup is corresponding backup mode on Check the control settings for the backup mode Apnea ven Low priority Backup mode No action required tilation was reset and HAMILTON C2 ended is again ventilating in its origi nal support pre apnea mode 7 10 624131 04 Table 7 2 Alarms and other messages continued ASV Can not meet target Battery 1 calibration required Battery 2 calibration required Battery low Battery 1 tempera ture high Battery 2 tempera ture high Low priority The operator set MinVol cannot be delivered possibly because of setting conflicts Low priority Battery 1 requires calibration You may continue to use the battery Low priority Battery 2 requires
107. d interchangeably Disposal 624131 04 Dispose of all parts removed from the device according to your institution s protocol Follow all local state and federal regula tions with respect to environmental protection especially when disposing of the electronic device or parts of it for exam ple oxygen cell batteries vii Year of manufacture The year of manufacture is shown on the serial number label on the HAMILTON C2 ventilation unit viii 624131 04 General information 2 02e0ee000 1 1 Tet MIMthOGUGUION ate AeG i esate aan dot De T oa a I 1 2 1 2 Functional description 002000000 1 4 1 2 1 System overview i essers pn ha ee a 1 4 1 2 2 Gas supply and delivery nonan anaana aaa 1 5 1 2 3 Gas monitoring with the Flow Sensor 1 7 1 3 Rhysical descriptione nise e E e 1 8 1 3 1 Breathing circuits and accessories 1 8 1 3 2 Ventilator unit 2 0 0 0 0002s 1 11 EE E E ees toad eda stk ea See chad edeetanes 1 18 1 4 Symbols used on device labels and packaging 1 20 Preparing for ventilation 2 1 2 1 UntrOductION s heii ond ea the See he ds haw ed ha 2 2 2 2 Installing the patient tubing support arm 2 4 2 3 Installing the humidifier 0 2 5 2 4 Installing the patient breathing circuit 2 6 2 5 Installing a pneumatic nebulizer 2 14 2 6 Installing the optional Aeroneb Pro ne
108. decreasing or increasing MinVol accordingly lt 8 0 Accept Unsupported breathing Consider able extubation gt 10 0 High Dyspnea Consider increasing MinVol and other clinical treatments Check for autotriggering 624131 04 C 15 G ASV adaptive support ventilation Step 7 Weaning Weaning patients from the ventilator is a clinical task that requires tremendous experience and involves more than just ventilation issues ASV always allows patients to take spontaneous breaths Episodes of spontaneous breathing can occur and are supported by ASV even within a period of fully controlled ventilation In other words weaning can start with ASV so early that it may go unrecognized clinically It is therefore important to monitor the spontaneous efforts of the patient over time If the patient tolerates minimum respiratory support after a period of time with Pinsp lt 8 cmH20 fControl 0 weaning can be considered achieved if minimum fSpont is acceptable ExpMinVol is acceptable What is acceptable must be defined by the clinician It may be necessary to reduce the MinVol setting to 70 or even lower to motivate the patient to resume spontaneous breathing If a patient can sustain minutes or even hours with a low MinVol setting it does not mean that weaning is complete In fact the MinVol setting must always be interpreted in conjunction with the level of Pinsp needed to achieve the set minute
109. dently of ASV It is possible to select a MinVol that is incompatible with the lung protective rules that govern ASV for a detailed description see Section C 3 3 For example the operator might want a high ventilation for a COPD patient in spite of severe pulmonary obstruction In such a case ASV tries to achieve the maximum possible ventilation and alarms that ASV Cannot meet target Such a case is shown in Figure C 4 where a high ventilation 300 at 70 kg was set by the operator for a patient with severely obstructed lungs Raw total airway resistance 40 cmH gt O I s The high ventilation moves the minimum minute volume curve to the right while the obstructive disease causes the safety limit of rate to shift to the left These two effects cause the minute volume curve to lie outside the safety limits as determined by the lung protective rules strategy see functional description below ASV thus chooses the safest point closest to the user set minute volume C 11 C C 12 ASV adaptive support ventilation 2000 1500 1000 Vt ml 500 0 20 40 60 f b min Figure C 4 Hypothetical example of high MinVol setting incompatible with the lung protective rules strategy The open circle denotes the actual target the closed triangle never shown on the ventilator denotes the energetically optimal target according to Otis equation The HAMILTON C2 will alarm and inform the user that the ASV target can
110. des of ventilation PSIMV Backup mode E siMmv Figure B 22 PSIMV apnea controls B 28 624131 04 NIV ST Tl Hp AS TE 3 225 Flowtrigger Figure B 23 NIV ST basic controls 624131 04 B 29 B Modes of ventilation IV ST Noninvasive Figure B 24 NIV ST more controls B 30 624131 04 NIV ST Backup mode l PCV fTotal b min Controls Alarms Figure B 25 NIV ST apnea controls B 6 Adaptive support ventilation ASV See Appendix C for detailed information on this mode 624131 04 B 31 B Modes of ventilation B 7 DuoPAP Duo positive airway pressure B 7 1 Introduction DuoPAP is a related form of pressure ventilation designed to support spontaneous breathing on two alternating levels of CPAP In these mode the ventilator switches automatically and regularly between two operator selected levels of positive airway pressure or CPAP Phigh The patient may breathe freely at either level In DuoPAP pressure support can be added to these spontaneous breaths Cycling between the levels is triggered by DuoPAP timing settings or by patient effort Pressure time curve for this mode is shown in Figure B 26 The control settings active in the DuoPAP mode are shown in Figure B 28 until Figure B 30 In DuoPAP Figure B 26 the switchover between the two levels is defined by pressure settings Phigh and PEEP CPAP and time settings Thigh and Rate Like PEEP CPAP Phigh is relative to
111. device proximal to the patient measures both the delivered volume and the exhaled tidal volume then displays the percentage difference as Leak Use Leak to assess the fit of the mask or other noninvasive patient interface While a leak at the patient interface influences the tidal volume measurement leaks in the breathing circuit itself do not influence the tidal volume measurement Besides all the other clinical parameters TI Poeak PEEP CPAP LE fTotal Pmean and fSpont can be used to assess the patient s ventilatory status 624131 04 D 10 Additional notes about using noninvasive 624131 04 ventilation Due to some unique characteristics of noninvasive ventilation consider the following points when using it As with any mode of ventilatory support monitor the patient closely to evaluate the adequacy of the prescribed therapy IntelliTrig intelligent trigger function With its IntelliTrig function the HAMILTON C2 can automatically adapt to changing breath patterns and system leaks to achieve optimum synchronization between patient and device To achieve this synchronization IntelliTrig compensates any leaks and resistances between the ventilator and the patient and with each breath it measures the leakage at the patient interface mask With this information IntelliTrig adapts the trigger mechanism so that leakage and the changing breath pattern do not influence the operator set trigger sensitivity flow trigger
112. devices be used The operator of the ventilator must still maintain full responsibility for proper ventilation and patient safety in all situations During ventilation you can view patient data on the HAMILTON C2 screen Figure 5 1 You can configure the screen layout with different waveforms or with Intelligent Panel graphics to suit your institution s needs You can access the Monitoring window at any time without affecting breath delivery 5 2 624131 04 Controls Alarms 174cm Male Monitoring Utilities Events Figure 5 1 HAMILTON C2 screen Main monitoring parameters MMP P max Pressure limitation Pressure 10 cmH30 or Pasvlimit Airway pressure pPaw waveform standard graphic 1 Patient trigger indicator Dynamic Lung selectable graphic 2 5 2 Values window Viewing numeric patient data You can view numeric patient data from the Values window Table 5 1 describes the monitored parameters 1 Open the Monitoring gt Values window Figure 5 2 2 Select 1 2 Figure 5 3 or 3 Figure 5 4 or if the ventilator is in the ASV mode ASV monitored data Figure C 6 624131 04 5 3 Monitoring 225 294 P YTI Wes ees 3 5 PEEP CPAP 2 50 ExpMinV ol cmH20 P 1 PoE 0 00 MyPan Vmin Wifelsiimelgiatss Figure 5 2 Values window 1 624131 04 12 fTotal b min 2001 IE 3 40 G2 Sen ee P 87 25 0 fSpont VLeak b min 624131 04 Figure 5 3 Values
113. disinfectants recommended for plastic materials Disinfectants including ASP CIDEX Sch lke amp Mayr Gigasept FF or Henkel Eco lab Incidur have been tested according to the manufacturers guidelines After cleaning visually inspect the Flow Sensor body tubings and internal flap Discard the Flow Sen sor if there is any sign of damage or if it cannot be calibrated Do not steam sterilize Inspect the membrane for damage replace if necessary Replace after 40 autoclave cycles at 134 C or 273 F 624131 04 Table 9 1 Decontamination methods for HAMILTON C2 parts continued How to Expiratory valve Steam autoclave Inspect the membrane for damage housing PA12 replace if necessary Replace after polyamide plastic 40 autoclave cycles at 134 C or 273 F Other breathing Follow the manu circuit parts or facturer s guide accessories lines 624131 04 9 5 9 Maintenance 9 2 1 General guidelines for cleaning NOTE e To prevent damage to breathing circuit parts do not clean with hard brushes pointed instruments or rough materials e To prevent damage to breathing circuit parts follow the soap manufacturer s guidelines Exposure to soap solution that is stronger than recommended can shorten the useful life of some products Soap residue can cause blemishes or fine cracks especially on parts exposed to elevated temperatures during sterilization Clean the HAMILTON C2 parts as f
114. ditions for use CAUTION e To prevent possible patient injury do not use noninvasive ventilation on patients with no or irregular spontaneous breaths Noninvasive ventilation was intended to provide supplemental ventilatory support to patients with regular spontaneous breaths e To prevent possible patient injury do not attempt to use noninvasive ventilation on intubated patients Be sure that the following requirements are met when using noninvasive ventilation e The patient must not be intubated e The patient must be able to trigger the ventilator and must have regular spontaneous breaths e The patient must be conscious e The patient must be able to maintain an adequate airway e The clinician s instructions must be strictly followed e The patient must be monitored by external monitors e Intubation must be possible at any time e The mask should fit face structures well D 4 624131 04 D 4 Contraindications Intolerance of interface Inability to trigger breath Facial or brain injury Recent upper airway or esophageal surgery Hemodynamic instability Gastric distension Inability to protect airway D 5 Potential adverse reactions 624131 04 Skin breakdown from interface pressures sores Aspiration Conjunctivitis Gastric insufflation Claustrophobic reaction Potential hemodynamic instability D 5 D Clinical application of noninvasive ventilation D 6 Selecting a patient interface The qua
115. e for use with inspiratory limb heater wire Patient breathing set P2 C2 double water trap 260085 HAMILTON C2 pediatric reusable for use with out heater wires LiteCircuit Standard adult pediatric single pa 151817 tient use package of 15 LiteCircuit 850 for use with Fisher amp Paykel hu 151819 midifier MR850 adult pediatric single use package of 8 Patient breathing set RT200 for use with Fisher 260039 amp Paykel humidifier MR850 adult single use package of 10 RT200 Coaxial patient breathing set pedriatic to adult 260086 single use package of 20 G 2 624131 04 Table G 1 Ventilator parts and accessories continued Flow Sensor pediatric adult single patient use 279331 package of 10 Flow Sensor pediatric adult reusable package 155362 of 10 1 Demonstration lung assembly with endotra 151815 cheal tube 2 with 15 mm male x 22 mm male connector adult Demonstration lung assembly with endotra 151816 cheal tube 0 5 with 15 mM male x 22 mm male connector pediatric Inspiratory filter Inspiratory filter Expiratory valve assembly reusable Includes Membrane expiratory valve reusable Membrane expiratory valve reusable Humidifier E O Q Standard trolley Humidifier support Oxygen gas cylinder mounting kit Quick lock for tubing support arm Oe Oxygen cell HAMILTON C2 396200 Battery standard optional 369102 C Filter set Includes
116. e 2 12 Figure 2 12 Oxygen inlet fittings Oxygen high pressure inlet fitting Oxygen low pressure fitting 2 22 624131 04 2 11 Connecting to an external patient monitor or other device NOTE All devices connected to the HAMILTON C2 must be for medical use and meet the requirements of standard IEC 60601 1 You can connect your ventilator to a patient monitor a PDMS or a computer via the RS 232 port See Appendix G for details on the communications interface 2 12 Starting up the ventilator 1 Switch on the ventilator power switch Figure 2 13 The ventilator will run a self test Standby eas Figure 2 13 Power switch Power switch 2 After a short time you will see the patient setup window Figure 4 1 Set up the ventilator as described in Section 4 2 624131 04 2 23 2 Preparing for ventilation CATON To ensure the ventilator s safe operation always run the preoperational check before using the ven tilator on a patient If the ventilator fails any tests remove it from clinical use immediately Do not use the ventilator until necessary repairs are com pleted and all tests have passed 3 Run the preoperational check Section 3 2 NOTE If the HAMILTON C2 is new be sure it has been properly configured for default language alarms and others see Appendix l 2 13 Shutting down the ventilator To shut the HAMILTON C2 down press and quickly release the power switch
117. e NIV modes were also designed to minimize nuisance leak related alarms NIV is an adaptation of the HAMILTON C2 s SPONT mode while NIV ST is an adaptation of the HAMILTON C2 s PSIMV mode The primary difference between SPONT and NIV or PSIMV and NIV ST is that SPONT and PSIMV are designed for an intubated patient while the NIV modes are designed for use with a mask or other noninvasive patient interface See Appendix B for technical details about the HAMILTON C2 s noninvasive modes D 2 Benefits of noninvasive ventilation 2 Noninvasive ventilation offers these short term benefits e Relieves respiratory symptoms e Optimizes patient comfort e Reduces work of breathing e Improves or stabilizes gas exchange e Improves patient ventilator synchrony e Minimizes risks associated with aspiration intubation injury to the mucus membranes and teeth and circulatory reactions 1 Mehta S et al Noninvasive ventilation Am J Respir Crit Care Med 2001 Feb 163 2 540 77 2 Hess DR The evidence for noninvasive positive pressure ventilation in the care of patients in acute respiratory failure a systematic review of the literature Respiratory Care 2004 Jul 49 7 810 25 624131 04 D 3 D Clinical application of noninvasive ventilation Noninvasive ventilation offers these long term benefits e Improves sleep duration and quality e Maximizes quality of life e Enhances functional status e Prolongs survival D 3 Required con
118. e and oxygen source 1 3 1 Language Selecting the default language Open the General gt Language window Figure l 1 and select the desired language for screen display Select the naming of the volume controlled pressure adaptive modes S CVM SIMV or APVcmv APVsimv English v CMY SIMV Alarms Monitoring Figure l 1 Language configuration window 624131 04 l 3 Configuration 1 3 2 Units Selecting the default unit of measure for pressure display Open the General gt Units window Figure l 2 and select the unit of measure for pressure display Configuration PEEP CPAP Figure l 2 Units configuration window l 4 624131 04 1 3 3 More Selecting the oxygen source and enabling the communications interface Open the General gt More window Figure l 3 Select the applicable oxygen source HPO mode for high pres sure oxygen or LPO mode for low pressure oxygen Enable or disable Communications interface see Appendix H as desired Configuration Language HPO mode LPO mode Vent Status R5232 GALILEO identifier ON Monitoring Figure l 3 More configuration window 624131 04 l 5 Configuration 1 4 Graphics window 1 4 1 MMP Selecting the default main monitoring parameter display Open the Graphics gt MMP window Figure l 4 Select a parameter position from the left hand side of the window then select the desired parameter to be displayed in that positi
119. e circuit used for venti lation Adult patients Pediatric patients 624131 04 Breathing circuit 22 mm ID with 22F con nectors Flow Sensor pediatric adult Demonstration lung 2 with adult ET tube between Flow Sensor and lung PN 151815 or equivalent Breathing circuit 15 mm ID with 22F con nectors Flow Sensor pediatric adult Demonstration lung 0 5 with pediatric ET tube between Flow Sensor and lung PN 151816 or equivalent 3 3 3 Tests calibrations and utilities Procedure Do or observe 1 Connect ventilator to ac or dc power and oxygen supply Assemble the patient breathing circuit 2 Switch on power 3 Make sure the ventilator is in standby and select Preop check from the Patient setup window 4 Open System gt Tests amp calib window Figure 3 2 Select and run the Tightness test then the Flow Sensor calibration Follow all prompts 5 If necessary run 02 cell calibration Close window 6 Generate an alarm for example by disconnecting mains power 7 Resolve the alarm situation for example reconnect mains power Verify Breathing circuit is assembled correctly When ventilator is switched on buzzer sounds and the red alarm lamp flashes After the self test is passed the alarm lamp flashes red again These tests pass These tests pass Corresponding alarm message in message bar for example Loss of external power Alar
120. e oxygen NOTE To prevent possible malfunction of the oxygen s control system do not supply both high and low pressure oxy gen to the ventilator simultaneously NOTE e Make sure the ventilator is configured for low pres sure oxygen e The 100 O function is inactive when low pressure oxygen is used e The pneumatic nebulizer is inactive when low pres sure oxygen is used The HAMILTON C2 ventilator may be connected to an inde pendent low pressure oxygen source such as an oxygen con centrator or liquid oxygen cylinder The oxygen source must be approved for medical purposes and suitable for supplying the patient directly as the ventilator cannot regulate the oxygen concentration the ventilator s Oxygen control is inactive The low pressure oxygen source must provide a flow not greater than 15 l min and a pressure not greater than 6 bar 600 kPa 87 psi When using low pressure oxygen connect it to the ventilator as described in Section 2 10 Configure the ventilator for low pressure oxygen Section 1 3 3 Follow the instructions for use of the low pressure oxygen source To modify the delivered gas oxygen concentration adjust the concentrator s flow and the ventilator s minute ventilation Set the ventilator s low and high Oxygen alarms appropriately E 2 624131 04 APPENDIX F Pneumatic diagram Oz high O low pressure inlet pressure inlet Air intake Low pressure Q 0 filter
121. e the risk of bacterial contamination or physical damage handle bacteria filters with care e To prevent patient exposure to sterilizing agents and to prevent premature deterioriation of parts sterilize parts using the techniques recommended in this section only e To reduce the risk of electrical shock disconnect electrical power from the ventilator before cleaning NOTE e Do not reuse single use breathing circuit parts and other accessories including Flow Sensors They must be discarded after single use e Do not attempt to sterilize the interior of the ventila tor e Do not attempt to sterilize the whole ventilator with ETO gas e Exposure to sterilizing agents may reduce the useful life of certain parts Using more than one sterilization technique on a single part may damage a part 9 2 624131 04 624131 04 NOTE Because sanitation practices vary among institutions HAMILTON MEDICAL cannot specify specific practices that will meet all needs or be responsible for the effec tiveness of these practices This manual provides general guidelines only and with validated cleaning disinfec tion and sterilization methods only It is the user s responsibility to ensure the validity and effectiveness of the actual methods used The following subsections provide general guidelines for clean ing and decontaminating parts Table 9 1 tells you the specific methods that are applicable to each HAMILTON C2 part For parts
122. e ventilation be adjusted accordingly Table C 1 provides examples of how to adjust the MinVol setting CAUTION It is inappropriate to adjust the IBW through the Pat height control to change minute volume Always use the MinVol control to adjust ventilation Table C 1 Blood gas results and other conditions with possible ASV adjustments Condition MinVol change Remarks Normal arterial None blood gases High PaCO Increase MinVol Pay attention to inspiratory pressures Low PaCO3 Decrease MinVol Pay attention to mean pressures and oxygenation status 624131 04 624131 04 Table C 1 Blood gas results and other conditions with possible ASV adjustments continued Condition MinVol change Remarks High respiratory Consider increase Consider sedation drive in MinVol analgesia or other treatments Low O saturation None Consider increase in PEEP CPAP and or Oxygen Step 5 Alarm settings review and special ASV alarms To monitor the breathing pattern you must review the alarm settings periodically and set them according to clinically acceptable values As described below ASV changes the breathing pattern according to the respiratory system mechanics and within the boundaries resulting from the operator s settings for ASV However you can closely monitor ASV s actions through the alarm system since the alarm settings work totally indepen
123. eaks and discon nects If the ventilator is in ASV con sider suctioning check for a kinked ET tube or consider the possibility of acute asthma Calibrate the oxygen cell Install a new oxygen cell MN To ensure that oxygen monitoring is always fully functional replace an exhausted or missing oxygen cell as soon as possible or use an external monitor that complies with ISO 21647 Low priority There is no signal from the oxygen cell Install an oxygen cell or use an external monitor according to ISO 21647 7 Responding to alarms Table 7 2 Alarms and other messages continued O2 cell not system compatible Oxygen supply failed Pressure limit has changed Pressure limitation 7 18 Definition Action needed CAUTION To ensure that oxygen monitoring is always fully functional replace an exhausted or missing oxygen cell as soon as possible or use an external monitor that complies with ISO 21647 NOTE To prevent leakage within the ventilator make sure an oxy gen cell is installed at all times even if you use an external monitor or disable oxygen monitoring Low priority The incorrect type of oxygen cell is installed High priority Oxygen source flow lower than expected Low priority You have changed either the Pressure or Pasvlimit in ASV Changing either setting automatically changes the other Pressure is always 10 cmH 0 greater than Pasvlimit Medium priori
124. ector pin assignments H 1 H Communications interface H 1 Introduction The communications interface lets the HAMILTON C2 send monitored data ventilator settings and alarms to a patient monitor a patient data management system PDMS or other computer system through an RS 232 connector NOTE e All devices connected to the HAMILTON C2 must be for medical use and meet the requirements of IEC 60601 1 e This interface includes an EMl protective cover for the connector When the connector is not in use make sure the cover is installed H 2 624131 04 H 2 Patient monitor To prevent possible patient injury when using a patient monitor check the patient and the ventilator whenever the monitor reports a ventilator alarm Not all monitors provide detailed alarm message information NOTE Your monitor may not recognize and report all modes and parameters for example ASV mode peak pressure monitoring parameter It also may not recognize some specific alarms but report them as general alarms In such cases HAMILTON MEDICAL recommends that you read the data directly from the HAMILTON C2 screen Silencing the HAMILTON C2 s audible alarm does not automatically silence the audible alarm of the remote patient monitor To connect your HAMILTON C2 to a monitor other than those described below contact the monitor manufacturer With the communications interface the HAMILTON C2 ventilator can send data to various patie
125. ed frotaj gt the set alarm limit High priority The measured ExpMinVol gt the set alarm limit High priority Measured Oxy gen is gt the set alarm limit low pressure oxygen or the operator set Oxygen 5 high pressure oxygen Check the LiteCircuit for leak age Change the flow sensor Disconnect the ventilator from the patient Have the ventila tor serviced Check the patient for ade quate ventilation VTE Check the alarm limits If the ventilator is in ASV refer to Appendix C 2 Check the patient Check and adjust the ventila tor settings including alarms Calibrate the oxygen cell Install a new oxygen cell 624131 04 Table 7 2 Alarms and other messages continued High pres sure High pres sure during sigh Instrument maybe con taminated Loss of external power 624131 04 High priority The measured inspiratory pressure gt the set Pressure alarm limit The venti lator immediately closes the inspiratory valve to stop gas flow to the patient and opens the expiratory valve to reduce pressure to the PEEP CPAP level The ventilator attempts to limit patient airway pres sure to 60 cmH 0 but if pres sure climbs to 75 cmH 0 the ventilator enters the ambient state This alarm cannot be silenced Low priority A sigh cannot be fully delivered because exces sive inspiratory pressure Pressure 3 cmH 0 would be required The sigh is partially delivere
126. ed on Power standby switch Powers the ventilator on and off and accesses standby To put the ventilator into standby press and quickly release the switch then select Activate Standby For details on standby see Section 8 1 To switch off ventilator power press the switch quickly to access standby then press the switch again for gt 3 s or if there is a technical fault press and hold the switch for gt 10 s Screen lock unlock key Prevents inadvertent touch screen entries 100 O key Delivers 100 oxygen for 2 min if high pressure is connected Pushing a second time ends the 100 oxygen enrichment period Manual breath inspiratory hold key Triggers a manda tory breath when pressed and released during exhalation Triggers an inspiratory hold when held down during any breath phase For details see Section 8 3 Nebulizer on off key Activates pneumatic nebulizer during the inspiration phase if high pressure oxygen is con nected The indicator is lit whenever nebulization is active Nebulization stops automatically after 30 min You can switch it off earlier by pressing the key again For details see Section 8 4 Alarm silence key Silences the main ventilator audible alarm for 2 min Pushing a second time cancels the alarm silence The red LED beside the key flashes when an alarm is active but unsilenced It is continuously lit while the alarm silence is active 624131 04 Press and turn P amp T knob
127. ee Section 4 4 3 for further details on how apnea backup functions 4 Confirm the entire selection PSIMV Pasvlimit Min ol Patient height PEEP CPAP Fp ee age serge IBW 70 kg Minot 7 0 min L H Flowtrigger Oxygen Confirm Figure 4 6 Basic window during mode change ASV mode change Calculated IBW and MinVol 624131 04 4 11 4 Ventilator settings 4 4 3 About apnea backup ventilation CAUTION HAMILTON MEDICAL recommends that apnea backup ventilation be enabled whenever a mode that allows spontaneous breathing is selected For safety reasons apnea backup is enabled by default The HAMILTON C2 provides apnea backup ventilation a mech anism that minimizes possible patient injury due to apnea or cessation of respiration Apnea can occur in all modes except S CMV PCV and ASV When the HAMILTON C2 is in such a mode and no inspiratory efforts are detected or control breaths are delivered during an operator set interval it declares apnea If apnea backup ventilation is enabled ventilation con tinues When apnea backup ventilation is enabled Apnea backup provides ventilation after the apnea time passes with no breath attempts detected You set the Apnea time in the Alarms window When this occurs the HAMILTON C2 automatically and immediately switches into apnea backup ventilation It annunciates a low priority alarm displays Apnea ventila tion and provides ventilation at the follo
128. een is shown Figure 1 8 Modes PSIMV Vmin cmH Events Figure 1 8 Default basic screen Active mode If NIV or NIV ST is active Noninvasive is also displayed Window buttons tabs Open the associated win dows 2 Main controls The most important controls Open the Controls window via the Controls button to show all ventilator controls 1 18 624131 04 Input power Shows all available power sources The framed symbol indicates the current source AC mains DC DC power supply 1 battery 1 2 battery 2 optional The green part of each battery symbol shows the level of battery charge while the red shows the level of discharge Graphic display Shows the pressure time waveform curve plus one additional user selected graphic includ ing another real time waveform or an Intelligent Panel Trigger symbol Indicates the patient is triggering a breath windows Message bar Displays alarm messages If an alarm is active view the alarm buffer by touching the message bar See Section 7 for further information Maximum Pressure setting Pressure limitation Maximum Pressure 10 cmH 0 or Pasvlimit setting in ASV Inactive alarm indicator Indicates that there is infor mation about inactive alarms in the alarm buffer View the alarm buffer by touching the inactive alarm indicator Q Main monitoring parameters MMP You can view other numeric parameters from the monitored parameter 62413
129. eerie any ee SE Ae ee 5 11 Loops displayi e408 wie ds pak ondk eee ede tin Seg 34 5 12 Ventilator screen with Dynamic Lung panel 6 2 Dynamic Lung panel 000 0000 eee 6 3 Compliance shown by the Dynamic Lung 6 4 Patient triggering shown by the Dynamic Lung muscle 6 4 Rinsp shown by the bronchial tree of the Dynamic Lung 6 5 Vent Status panels iei reini oh ate bh te aia es oe 6 6 Visual alarm indications 00000 00 cece eee 7 4 Safety ventilation screen 2 0 eee 7 4 Fechnical tault screen 22 aun yrs See eda dee eed 7 5 Alarm buffer with active alarms n onanan naaa 7 7 Alarm buffer with inactive alarms 0 2004 7 7 EVentSWINGOW on asl aed baw ee ea ee hae a reed ees 7 8 Special tUMCtION KEYS bese aie weaw stb ees ere es ate 8 3 Activate Standby window 00000 cee eee ee 8 3 Standby WINJOW es ia peee erne iu a eo Be ee raed 8 4 Removing the filter cover nananana eee 9 10 Removing the air intake filters 0 0 0 0 0 0 00008 9 11 Removing battery 2 0 002 c eee 9 12 Replacing the oxygen cell 0 000000 02 eee eee 9 15 HAMILTON C2 dimensions 0000 000 cee eee A 2 Conventional pressure controlled ventilation in a passive patient Flow to patient during inspiration 1 flow from patient during exhalation E ONN oc etic dak a ee ee ES des B 6 Conventional pressure controlled ventilation in an active patie
130. ele a e eee beens Glossary 1 INCOM cee oe Erreg el ee tee ee Index 1 List of figures NM NIONE ooo oo So os A I WN AON A UOBRWDN he u A 2 6 2 7 2 8 2 9 2 10 2 11 2 12 2 13 3 1 3 2 3 3 3 4 3 5 3 6 4 1 4 2 4 3 4 4 4 5 4 6 4 7 4 8 4 9 5 1 Gas delivery in the HAMILTON C2 nauau uaaa 1 5 Flow Sensor variable orifice n nannan anaa 1 7 HAMILTON C2 with accessories n nnana auaa 1 9 BOMEVICW 4 oc t eane oap asha eh a Nairn OA E ntl AEN 1 11 STEEN EE E A E EE E 1 14 LOT SIME VIEW sey 6 tine pt t aa SNE a a eek ee E 1 16 RIGHT SIDG VIEW 6 gee oe eh edeaad a8 eee deers x 1 17 Default basic screen eee 1 18 Installing the patient tubing support arm and humidifier 2 4 Patient breathing circuit for use with inspiratory heater wire 2 8 Patient breathing circuit for use without heater wires 2 9 Patient breathing circuit for use with HME 2 10 LiteCircuit single limb patient breathing circuit for use with NIV Or NIVEST s etae sin creeaceanane ada tag an A ERAR 2 11 Installing the expiratory valve 2 2 ee 2 12 Installing the Flow Sensor 000 000s eee ee eee 2 13 Installing a pneumatic nebulizer 2 ee 2 14 Installing the Aeroneb Pro nebulizer 2 15 Power cord retaining clip 2 6 2 0 000 ee eee 2 17 Power source symbols and battery charge indicator 2 19 Oxygen IMlEtHHEINGS 3 2 f Gk ewe eee Wes eee Bare oe bas 2
131. ely monitored by qualified medical personnel and suitable monitoring devices The use of an alarm monitoring system does not give absolute assurance of warning for every form of malfunction that may occur with the ventilator Alarm messages may not exactly pinpoint a problem the exercise of clinical judgment is necessary e An alternative means of ventilation shall be available when ever the ventilator is in use If a fault is detected in the ven tilator or its life support functions are in doubt disconnect the HAMILTON C2 from the patient and immediately start ventilation with such a device for example a resuscitation bag using PEEP and or increased oxygen concentration when appropriate The ventilator must be removed from clinical use and serviced by a HAMILTON MEDICAL autho rized service engineer e tis recommended that additional independent monitoring devices be used during mechanical ventilation The opera tor of the ventilator must still maintain full responsibility for proper ventilation and patient safety in all situations e Do not silence the audible alarm when leaving the patient unattended e Do not use the exhaust port of the expiratory valve for spirometry Due to the HAMILTON C2 s base flow the exhaust gas output is larger than the patient s actual exhaled volume e Do not puta vessel filled with a liquid on the ventilator If a liquid enters the product a fire and or electric shock may occur 624131 04 v
132. em gt Sensors on off window e If using the low pressure mode disconnect all O gt supplies during calibration After reconnecting the oxygen concentration is realised at 21 Description During this 2 min calibration of the oxygen cell the HAMILTON C2 delivers an increased oxygen concentration if oxygen is connected in the high pressure mode or 21 oxygen if oxygen is connected in the low pressure mode or disconnected It tests the cell and resets the calibration points specific to the cell in use Procedure 1 From the Tests amp calib window select 02 cell 2 VERIFY that there is a green check mark in the box beside 02 cell Corrective action Troubleshoot any alarms as described in Section 7 3 10 624131 04 3 3 3 Sensors on off Enabling disabling oxygen monitoring CAUTION The HAMILTON C2 s oxygen monitoring function can be disabled To prevent possible patient injury due to nonfunctional alarms and monitoring however HAMILTON MEDICAL recommends that oxygen monitoring always be enabled Open the System gt Sensors window Figure 3 3 Select or deselect 02 monitoring as desired ite alime al at s Figure 3 3 Sensors on off window 624131 04 3 11 3 Tests calibrations and utilities 3 3 4 Date amp time Setting date and time NOTE Make sure the date and time are set correctly so that event log entries have accurate time and date stamps Open the System gt Date
133. ent breathing cir cuit an alarm setting Mean airway pressure a monitored parameter Part number Peak airway pressure a monitored parameter 624131 04 P ramp pressure control psi PSIMV Psupport Rate RCexp Rinsp s safety mode SXCMV sigh SIMV SPONT spontaneous breath 624131 04 Pressure ramp a control setting The time required for the inspiratory pressure to rise to the set target pressure Maintenance of a consistent transrespiratory pressure waveform despite changing respiratory system mechan ics Pounds per square inch a unit of pressure Pressure controlled synchronized intermittent mandatory ventilation mode Pressure support a control setting valid during spontane ous breaths in SPONT SIMV and NIV modes Psupport is pressure additional to PEEP CPAP to be applied during the inspiratory phase Breath frequency or number of breaths per minute a control setting Expiratory time constant a monitored parameter Inspiratory flow resistance a monitored parameter Second a unit of time An emergency state that ensures a basic minute ventila tion while giving the user time for corrective actions in case of some technical fault alarms The default inspira tory pressure is maintained the expiratory valve opens as needed to switch system pressure levels between PEEP and inspiratory pressure and patient sensing is nonfunc tional Synchronized controlled mandato
134. entilation Am J Respir Crit Care Med 1994 Jun 149 6 1550 6 B 5 B B 6 Modes of ventilation Figure B 1 through Figure B 3 illustrate this concept Figure B 1 shows a passive patient ventilated by pressure controlled ventilation Gas flows into the patient when pressure rises and gas flows out of the patient when inspiratory pressure falls Pressure Figure B 1 Conventional pressure controlled ventilation in a passive patient Flow to patient during inspiration I flow from patient during exhalation E only Figure B 2 shows a partially active patient during conventional pressure controlled ventilation when the trigger is disabled If respiratory activity is present during the machine determined inspiratory phase gas flows only into the patient Gas flow out of the patient is impossible due to the closed expiratory valve see Flow curve 4 Al Saady N Bennett ED Decelerating inspiratory flow waveform improves lung mechanics and gas exchange in patients on intermittent positive pressure ventilation Int Care Med 1985 11 2 68 75 5 Tharatt R St Allen RP Albertson TE Pressure controlled inverse ratio ventilation in severe adult respiratory failure Chest 1988 Oct 94 4 755 62 6 Davis K Jr Branson RD Campbell RS Porembka DT Comparison of volume and pressure control ventilation is flow waveform the difference J Trauma 1996 Nov 41 5 808 14 624131 04 Figure B 2 Conventional pressure controlled vent
135. erence in intensive care medicine Paris France 13 14 April 2000 Reanimation 2001 10 112 25 D Clinical application of noninvasive ventilation D 12 624131 04 APPENDIX E Low pressure oxygen 624131 04 CAUTION To reduce the risk of fire use only hose systems approved for medical purposes and for use with oxygen between the oxygen source and venti lator To reduce the risk of fire do not use a low pres sure oxygen source that delivers a flow greater than 15 l min To reduce the risk of fire ensure adequate ventila tion at the rear of the ventilator To reduce the risk of fire switch off the oxygen source when the ventilator is not in a ventilating mode To prevent possible patient injury when the ventila tor is sourced from an oxygen concentrator never operate the concentrator with a humidifier Any hu midifier system supplied with the concentrator must be drained or removed before using the ventilator The ventilator s Oxygen control is not active when low pressure oxygen is used To prevent possible patient injury use low pressure oxygen only in cases where the low pressure source can provide an adequate level of oxygenation To prevent possible patient injury ensure that an emergency backup oxygen supply for example a cylinder is available in case the low pressure oxy gen source fails To calibrate the O2 cell disconnect all O2 sup plies Calibration is done at 21 E 1 E Low pressur
136. ers a breath during a portion of the breath interval we ll call timy the ventilator immediately delivers a spontaneous breath Figure B 19 If the patient does not trig ger an inspiration during this time the ventilator initiates a mandatory breath at the end of timy P t timv tiny a a _ Pcontrol Psupport a el i aie Sar al aS a PEEP t l Machine triggered Patient triggered mandatory breath breath Figure B 19 Breath timing in PSIMV and NIV ST The control settings active in the PSIMV mode are shown in Figure B 20 through Figure B 22 The control settings active in the NIV ST mode are shown in Figure B 23 through Figure B 25 Both modes require that you set the parameters needed for both mandatory and spontaneous breath types The inspiratory pressure Pinsp setting defines the applied pressure for both mandatory and spontaneous breaths The Rate and TI inspiratory time control settings define the breath timing For spontaneous breaths the expiratory trigger sensi tivity ETS setting defines the percentage of peak flow that cycles the HAMILTON C2 into exhalation Breaths can be trig gered by the ventilator patient or user 624131 04 B 25 B Modes of ventilation nea PIMs Tl PEEP CPAP KE 1 2 0 TE 4 00 s Flowtrigger Controls Alarms Figure B 20 PSIMV basic controls B 26 624131 04 PSIMV Controls Figure B 21 PSIMV more controls 624131 04 B 27 B Mo
137. et alarm limits adjust the alarm loudness and view active alarms through the Alarms windows Limits 1 and Limits 2 Setting alarm limits CAUTION To prevent possible patient injury make sure the alarm limits are appropriately set before you place the patient on the ventilator NOTE If the ventilator is in the ASV S CMV or SIMV mode be sure the Pressure alarm is appropriately set This alarm provides a safety pressure limit for the HAMIL TON C2 to appropriately adjust the inspiratory pressure necessary to achieve the target tidal volume The maxi mum available inspiratory pressure is 10 cmH20 below the Pressure limit indicated by a blue line on the pressure waveform display Set Pressure to a safe value e g 45 cmH20 which limits the pressure target to a maximum of 35 cmH 20 If Pressure is set too low there may not be enough margin for the HAMIL TON C2 to adjust its inspiratory pressure in order to deliver the target tidal volume You can access the Alarms window and change alarm settings at any time without affecting ventilation Table 4 3 is an alphabetical list of the settings and definitions Review and adjust the alarm limits as follows 1 Open the Alarms gt Limits 1 window Figure 4 7 2 Select a parameter and adjust the value Repeat for any other desired parameters Open the Limits 2 window Figure 4 8 and repeat as desired 4 Ventilator settings Low tidal volume Modes PSIMV 1 J 2 4 6 8 1
138. ey apply to the various modes Not listed in the table are operator initiated mandatory man ual breaths which are pressure controlled and time cycled Mandatory breaths have a decelerating flow waveform e Spontaneous breaths Spontaneous breathing is allowed in all modes at any time Additionally in all modes except S CMV PVC and APRV spontaneous breaths are pres sure supported and time cycled if the users set flow trigger threshold is passed In the modes S CMV and PCV a spontaneous effort of the patient activating the flow trig ger results in a pressure controlled and time cycled breath 1 Branson RD Hess DR Chatburn RL Respiratory Care Equipment Philadelphia Lippincott Williams amp Wilkins Publishers 1999 359 93 624131 04 e Triggering Breaths can be patient flow triggered in all modes based on an operator set flow sensitivity All modes permit operator initiated manual breaths e Baseline A positive baseline pressure PEEP CPAP may be set for all breaths in all modes e Pressure rise time An operator set pressure ramp P ramp defines the time required for inspiratory pressure to rise to the set target pressure e Negative pressures There are no negative pressures gen erated during exhalation e FiO FiO can be set in all modes except when oxygen is provided by a low pressure supply Table B 1 Classification of HAMILTON C2 ventilation modes Mandatory breaths Mode Breathing name
139. eypad description 1 11 1 12 Knob press and turn P amp T description 1 13 L Label serial number 1 14 Lamp alarm description 1 11 Language how to configure l 3 Leak leakage percent monitored pa rameter definition 5 12 Leakage percent See Leak Least squares fitting LSF method 5 10 Logs See Event log or Alarm buffer Loops 5 12 Loss of external power alarm 7 14 Loss of PEEP alarm 7 14 Loudness setting definition 4 14 Loudness alarm how to adjust 4 21 Low frequency alarm 7 14 Low minute volume alarm 7 15 Low oxygen alarm 7 15 Low tidal volume alarm 7 15 Low pressure oxygen E 1 E 2 LSF least squares fitting method 5 10 M Main monitoring parameters MMP I 6 how to configure display l 6 location 1 19 Maintenance 9 1 9 14 preventive 9 8 9 14 schedule 9 8 9 9 See also name of specific part Mandatory breath rate See fControl 624131 04 Manual breath function details 8 5 Manual breath key description 1 12 Mask ventilation See Noninvasive venti lation NIV Masks advantages and disadvantages of types in NIV D 6 specifications for compatible 1 10 Maximum inspiratory time See TI max Maximum pressure alarm See Pressure Mean airway pressure See Pmean Messages alarm list 7 9 7 19 Minute volume expiratory alarm set ting or monitored parameter See ExpMinVol Minute volume setting See MinVol MinVol minute volume setting definition 4 14 MMP See Main monitoring parameter
140. for damage Replace as tal policy necessary Every month Air intake dust filters Check for dust and lint If needed or more and fan filter clean or replace Section 9 3 1 often if required 9 8 624131 04 Table 9 2 Preventive maintenance schedule continued Interval Part accessory Procedure Every 6 Batteries Recharge batteries by plugging ven months while tilator into ac power source for at ventilator is in least 4 h storage Yearly or Oxygen cell Replace if depleted Section 9 3 4 every 5000 h NOTE whichever comes first or as neces sary Oxygen cell life specifications are approximate The actual cell life depends on operating environment Operation at higher temperatures or higher oxygen concentrations shortens cell life Ventilator Perform service related preventive maintenance Every Turbine Replace 20 000 h Every 5 years Ventilator Perform service related preventive 30 000 h maintenance 1 Must be done by a HAMILTON MEDICAL authorized service engineer according to instruc tions in the HAMILTON C2 service manual 624131 04 9 9 9 Maintenance 9 3 1 Servicing the air intake and fan filters Service the air intake and fan filters as follows Figure 9 1 1 Remove the filter cover 2 Remove the two air intake dust filters Pull up the retaining clip and pull out the HEPA filter Install a new HEPA filter as required Install new dust filters or wash the existin
141. further details on how apnea backup functions 4 7 4 Ventilator settings TE 4 00 s Figure 4 3 Basic Controls window Control settings applicate to the mode Timing parameters determined from the timing settings if control breaths are permitted in the selected mode el E Ratio of inspiratory time to expiratory time Applies to mandatory breaths eTE Duration of expiratory phase eTl Duration of expiratory phase 4 8 624131 04 PSIMV Alarms Monitoring Figure 4 4 More window 624131 04 4 9 4 Ventilator settings PSIMV Backup mode Backup SIMV Controls Alarms Figure 4 5 Apnea window Apnea backup control settings ghosted to show they cannot be modified 4 4 2 Adjusting and confirming control settings after mode change After you select a different mode the Basic window auto matically opens Figure 4 6 You must review and confirm these proposed settings or the mode change will not be accepted Review and confirm the control settings as follows 4 10 624131 04 1 Select a parameter and adjust the value The change takes effect as soon as you confirm the mode change Repeat for any other desired parameters 2 Open the Controls gt More window Figure 4 4 and select and adjust parameters as desired 3 If applicable open the Controls gt Apnea window Figure 4 5 Select or deselect Backup as desired The backup mode and settings are displayed S
142. g filters in a mild soap solution rinse dry and rein Stall 3 Remove the fan filter Install a new fan filter or wash the existing filter in a mild soap solution rinse dry and rein stall 4 Reinstall the filter cover Figure 9 1 Removing the filter cover Air intake dust filters Fan filter Filter cover 9 10 624131 04 Figure 9 2 Removing the air intake filters Air intake HEPA filter retaining clip Air intake HEPA filter Cooling Fan air intake filter Air intake dust filter 624131 04 9 11 Maintenance 9 3 2 Replacing the batteries 9 12 NOTE e To ensure that the ventilator always has battery backup keep locked battery 1 in the ventilator at all times during ventilator operation Battery 2 may be hot swapped while the ventilator is operating e Because of damage of the battery door lock the bat teries in the correct position Open the battery door To remove battery 1 turn the retaining screw until the battery is released To remove battery 2 press on the tab and slide the battery out of its hous ing Replace with a newly charged battery see Figure 9 3 Figure 9 3 Removing battery 2 Battery 1 Battery 2 Door 624131 04 9 3 3 Charging and calibrating the batteries 624131 04 You can charge and calibrate the HAMILTON C2 s smart bat teries with a HAMILTON MEDICAL supplied charger calibrator PN 369104 Calibrating the batteries al
143. h the patient breathes as much as he is able the remainder being delivered to him via a ventilator Thus the patient is obliged to breathe one way or the other a Mandatory Minute Volume MMV Hewlett 1977 Since then many ventilators have included versions of MMV under different names However all commercially available MMV algorithms have clear limitations which lead to certain risks for the patient Quan 1990 These include rapid shallow breathing inadvertent PEEP creation excessive dead space ventilation and inadvertent wrong user settings due to very complicated use Adaptive support ventilation ASV was designed to minimize those risks and limitations ASV maintains an operator preset minimum minute ventilation independent of the patient s activity The target breathing pattern tidal volume and rate is calculated using Otis equation based on the assumption that if the optimal breath pattern results in the least work of breathing it also results in the least amount of ventilator applied inspiratory pressure when the patient is passive Inspiratory pressure and machine rate are then adjusted to meet the targets A lung protection strategy ensures ASV s safety In contrast to MMV ASV attempts to guide the patient using a favorable breathing pattern and avoids potentially detrimental patterns like rapid shallow breathing excessive dead space ventilation breath stacking inadvertent PEEP and excessively large breaths
144. he present example one iteration step is sufficient i e ftarget 15 b min Finally the target tidal volume is obtained by dividing MinVol by f Vtarget 7000 ml min 15 b min 467 ml C 30 624131 04 C 5 ASV technical data Table C 5 lists technical data related to ASV Underlined parameters are operator set in the ASV mode 624131 04 Table C 5 ASV technical data ASV related operator settings MinVol 25 to 350 Pat height 30 to 250 cm Internal calculations IBW In kg calculated based on Pat height and Gender see Section 4 2 MinVol target In l min target minute volume is calculated as IBW in kg x NormMinVent in I kg min x MinVol 100 where NormMinVent is the normal minute ventilation from Figure C 7 fTotal In b min calculated on the basis of Otis equation VDaw 2 2 ml kg IBW Vt target MinVol f target ASV monitor Target values numerical MinVol Vt fTotal Current achieved values MinVol Vt fTotal numerical Status of patient numerical fSpont fControl Pinsp Graphics display curve f versus Vt target value actual value safety boundaries C 31 C C 32 ASV adaptive support ventilation Table C 5 ASV technical data continued Alarms All HAMILTON C2 alarms are functional except apnea alarms See Section 6 Special ASV Check hi press limit Initialization failed
145. ickly and repeatedly The manual breath uses the mandatory breath settings stan dard or operator set If you try to initiate a manual breath during the early stage of inspiration or the early stage of exhalation the breath will not be delivered 8 5 Special functions To perform an inspiratory hold hold the key down during any breath phase If the ventilator is in exhalation it delivers a mandatory breath then performs a hold maneuver until the key is released up to 15 s additional to the set inspiratory time If the ventilator is in inspiration it performs a hold maneuver at the end of inspiration lasting until the key is released for up to 15 s additional 8 4 Nebulizer 8 6 MN e Do not use an expiratory filter or HME in the patient s breathing circuit during nebulization Nebulization can cause an expiratory side filter to clog substantially increasing flow resistance and impairing ventilation e To prevent the expiratory valve from sticking due to nebulized medications use only medica tions approved for nebulization and regularly check and clean the expiratory valve NOTE e The pneumatic nebulizer is inactive when low pres sure oxygen is used e Delivered ventilation is compensated for the contri bution of the internal nebulizer so that the expected volume and pressure are delivered The HAMILTON C2 s pneumatic nebulization function powers a standard inline nebulizer for delivery of prescribed medi
146. ila tion mode intended to adapte with the patient as they progress from full mechanical ventilation to spontaneous breathing ASV graphical data representation an Intelligent Panel ASV numeric patient data an Intelligent Panel Ambient temperature and pressure dry Unintended positive end expiratory pressure a monitored parameter Apnea backup ventilation The buzzer designed to sound for at least 2 min as a back up to the alarm speaker Glossary 1 Glossary base flow b min breathing circuit bronchial tree BTPS C CE cm cmH 20 CMV communications interface COPD CPAP CSA Cstat DC dB A DISS DuoPAP Dynamic Lung Glossary 2 A continuous and constant gas flow from the inspiratory outlet to the expiratory outlet It is essential for flow trig ger Breaths per minute Includes the inspiratory expiratory tubing humidifier filters and water traps A part of the Dynamic Lung that shows resistance Body temperature barometric pressure at sea level satu rated with water vapor Compliance A certification mark that indicates compliance with the Medical Device Directive 93 42 EEC Centimeter a unit of length Centimeters of water a unit of pressure 1 cmH 0 is approximately equal to 1 mbar which equals 1 hPa Controlled mandatory ventilation An option that lets you monitor the patient from a remote workstation Chronic obstructive pulmonary disease Cont
147. ilation in an active patient when the trigger is off Pressure increases when the patient tries to exhale E and pressure decreases when the patient tries to inspire I as valves are closed During the machine determined expiratory phase gas flows only out of the patient Gas flow to the patient is impossible due to the closed inspiratory valve see Flow curve 624131 04 B 7 B Modes of ventilation Figure B 3 shows a partially active patient in the HAMILTON C2 s biphasic PCV mode Note that inspiration and exhalation are possible at any time thereby offering the best synchronization possible between patient and machine PCV acts like an artificial atmosphere to the patient the machine varies the airway pressure to guarantee a minimal ventilation and the patient contributes whatever they can Pressure Time Flow Figure B 3 Biphasic PCV in an active patient when trigger is off The patient can freely inspire and exhale during any phase of ventilation B 8 624131 04 B 3 Mandatory modes The mandatory ventilation modes S CMV and PCV deliver time cycled mandatory breaths B 3 1 S CMV mode or APVcmv The S CMV synchronized controlled mandatory ventilation mode provides volume targeted mandatory breaths using an adaptive volume controller The adaptive volume controller delivers the set target volume Vt at the lowest possible pressure depending on lung conditions The control setti
148. inuous positive airway pressure Canadian Standards Association Static compliance a monitored parameter Direct current Decibel a unit of acoustic power Diameter index safety standard a standard for high pres sure gas inlet fittings Duo Positive Airway Pressure An Intelligent Panel that visualizes tidal volume lung compliance patient triggering and resistance in real time 624131 04 EMC EMI EN ET ETO ETS event log Exp Flow ExpMinVol fControl FiO Flowtrigger fSpont fTotal ft Gender HEPA HME 624131 04 Exhalation Electromagnetic compatibility Electromagnetic interference European Norm a European standard Endotracheal Ethylene oxide Expiratory trigger sensitivity a control setting A record of clinically relevant ventilator occurrences including alarms setting changes calibrations maneu vers and special functions since the ventilator was pow ered on Peak expiratory flow a monitored parameter Expiratory minute volume a monitored parameter and alarm setting In the Vent Status panel ExpMinVol is the percentage of normal minute ventilation based on IBW Respiratory rate Mandatory breath frequency a monitored parameter It is displayed in the ASV target graphics panel and the moni tored data window Fraction of inspired oxygen The patient s inspiratory effort that causes the ventilator to deliver a breath a control setting Spontaneous brea
149. ion provide pressure support ventilation through a mask or other noninvasive inter face Patient triggered breaths are flow triggered Monitoring The HAMILTON C2 offers a variety of monitoring capabilities It displays monitored parameters as numbers You can also see this data graphically as a combination of real time waveforms curves Loops Trends and special Intelligent Pan els These Intelligent Panels include the Dynamic Lung which shows the lung s activity and the Vent Status which indicates the patient s level of ventilator dependency Additionally when the ASV mode is active the ASV target graphics panel and the ASV monitored data window may be displayed The ASV tar get graphics panel shows how the ASV controller moves towards its target while the ASV monitored data window pro vides this information in a numeric form The HAMILTON C2 s monitored data is based on pressure and flow measurements collected by the HAMILTON MEDICAL proximal Flow Sensor between the Y piece and the patient and on FiO measurements by the integral oxygen monitor Alarms The HAMILTON C2 s operator adjustable and nonad justable alarms help ensure your patient s safety 624131 04 User interface The ventilator s ergonomic design including a 10 4 in color touchscreen a press and turn knob and keys lets you easily access the ventilator settings and monitored parameters You can tilt the graphical user interface up to 45 Custom
150. iratory pressure 3 cmH30 below the Pressure alarm limit In ASV changing the Pasvlimit control setting or the Pressure alarm limit automatically changes the other Pressure is always 10 cmH 0 greater than Pasvlimit Low and high expiratory tidal volume for two Off 10 to consecutive breaths If either limit is reached a 3000 ml medium priority alarm is annunciated 4 26 624131 04 624131 04 Monitoring 5 1 5 2 5 3 5 4 5 5 Introduction Values window Viewing numeric patient data Graphics window Selecting second screen graphic About graphic types 5 4 1Waveforms 5 4 2Dynamic Lung 5 4 3Vent Status 5 4 4ASV target graphics panel 5 4 5Trends 5 4 6Loops Table of monitored parameters 5 3 5 7 5 9 5 9 5 9 5 10 5 10 5 10 5 12 5 13 5 1 5 Monitoring 5 1 Introduction CAUTION e To ensure that oxygen monitoring is always fully functional replace an exhausted or missing oxygen cell as soon as possible or use an external monitor that complies with EN ISO 21647 e The ventilator s oxygen monitoring function can be disabled To prevent possible patient injury due to nonfunctional alarms and monitoring however HAMILTON MEDICAL recommends that oxygen monitoring always be enabled e Incase of malfunction of the ventilator s built in monitoring and in order to maintain an adequate level of patient monitoring at all times it is recommended that additional independent monitoring
151. it and may indicate increased patient airway resistance and or increased resistance of the artificial airway if used Always check the patient and confirm adequate ventila tion 624131 04 2 17 2 Preparing for ventilation 2 8 Connecting to primary power source Either ac or dc can supply the primary power to the HAMIL TON C2 2 8 1 Connecting to AC power NOTE e To prevent unintentional disconnection of the power cord make sure it is well seated into the ventilator s socket and secured with the power cord retaining clip Figure 2 10 e The HAMILTON C2 does not require protective earth grounding because it is a class Il device as classified according to IEC 60601 1 Connect the HAMILTON C2 to an outlet that supplies AC power between 100 and 240 V 50 60 Hz Always check the reliability of the ac outlet The ac power symbol in the bottom right hand corner of the screen is displayed with a frame around it Figure 2 10 Power cord retaining clip Power cord retaining clip 2 18 624131 04 2 8 2 Connecting to DC power Connect the HAMILTON C2 to the 12 to 24 V DC on board power circuit of an ambulance vehicle only If the HAMILTON C2 is connected to a DC power source the DC power symbol in the bottom right hand corner of the screen is displayed with a frame around it 2 9 About the batteries 624131 04 NOTE e The backup batteries are intended for short term use only They are not intended to be a
152. it for the set apnea time VERIFY that the Apnea alarm is activated Squeeze the demonstration lung VERIFY that the Apnea alarm resets 624131 04 4 Ventilator settings 624131 04 4 1 4 2 4 3 4 4 4 5 Introduction 4 2 Patient setup 4 3 Modes window Setting the ventilation mode 4 5 Controls windows Setting controls including apnea backup ventilation 4 6 4 4 2 Adjusting and confirming control settings without mode change 4 10 4 4 2 Adjusting and confirming control settings after mode change 4 10 4 4 3 About apnea backup ventilation 4 12 4 4 4 Table of control settings mode additions and ranges 4 16 Alarms windows 4 21 4 5 1 Limits 1 and Limits 2 Setting alarm limits 4 21 4 5 2 Loudness Adjusting alarm loudness 4 24 4 5 3 Buffer Viewing alarm information 4 25 4 5 4 Table of alarm limit settings and ranges 4 25 4 1 4 Ventilator settings 4 1 Introduction CAUTION e To prevent possible patient injury make sure the ventilator is set up for the appropriate patient type with the appropriate breathing circuit parts as described in Section 2 Make sure the Flow Sensor calibration is performed before you use the ventilator e To ensure the ventilator s safe operation always run the preoperational check before using the ventilator on a patient If the ventilator fails any tests remove it from clinical use immediately Do not use the ventilator until necessary repairs are completed and all tests
153. izability You can customize the HAMILTON C2 so that it starts up with institution defined settings Power The HAMILTON C2 uses as its primary power source ac mains 100 to 240 V AC 50 60 Hz or a DC supply 12 to 24 V If the primary power source fails the ventilator power source automatically switches to backup batteries The stan dard battery battery 1 powers the HAMILTON C2 typically for 2 5 h and the optional hot swappable battery battery 2 doubles the running time Mounting variations for the HAMILTON C2 include a stan dard trolley a transport trolley and a shelf mount Both types of trolley have space for oxygen cylinders The transport trolley lets you mount infusion pumps and other devices commonly used at the bedside Nebulization function The nebulization function lets your HAMILTON C2 power a pneumatic nebulizer connected to the nebulizer outlet The communications interface provides an RS 232 port for connection to a remote monitor patient data management system PDMS or other computer system 624131 04 1 3 1 2 1 4 General information 1 2 1 Functional description The following paragraphs describe the operation of the HAM ILTON C2 ventilator from a hardware perspective System overview The HAMILTON C2 is an electronically controlled pneumatic ventilation system with an integrated air compressing system It is powered by ac or dc with battery backup to protect against power failure or un
154. justable alarm ranges and resolutions Operating Parameter range Resolution Default settings ExpMinVol low Off 0 1 to 50 I min NIV NIV ST 0 1 to 50 l min other modes 0 1 l min for lt 1 I min 0 5 min for 1 I min and lt 10 0 5 Rate V min 1 l min for 10 I min ExpMinVol 0 1 min for lt 1 1 1 5 Rate V high min 0 5 l min for 1 I min and lt 10 I min 1 l min for 10 I min lotal 99 b min 624131 04 A 13 A Specifications Table A 9 Adjustable alarm ranges and resolutions continued Operating Parameter range Off 10 to 3000 ml V low Off 10 to 3000 ml 1 The default setting is configurable A 14 Resolution Default settings 5 ml for lt 500 ml 10 ml for 500 to 1000 ml 50 ml for gt 1000 ml 5 ml for lt 500 ml 10 ml for 500 to 1000 ml 50 ml for gt 1000 ml 624131 04 A 8 Configuration specifications Table A 10 lists the configurable parameters ranges and resolutions Table A 10 Configuration specifications General Language English Chinese English Czech Danish Dutch French Ger man Greek Hun garian Indonesian Italian Japanese Korean Norwegian Polish Portuguese Russian Serbian Slovak Spanish Swedish Turkish hPa mbar cmH O cmH 0 HPO mode LPO HPO mode Communications GALILEO interface GALILEO identifier ON HAMILTON C2 iden tifier ON 6241
155. l patient weight can be much greater e g 300 kg or 661 lb A 20 624131 04 A 11 Standards and approvals The HAMILTON C2 was developed in accordance with perti nent international standards The ventilator is manufactured within an ISO 13485 and ISO 9001 Council Directive 93 42 EEC Annex Il Article 1 certified quality management system The ventilator meets the Essential Requirements of Council Directive 93 42 EEC It is a class Ilb device The ventilator meets relevant parts of the following standards e IEC 60601 1 Medical electrical equipment Part 1 General requirements for safety The device classification is Class Il Type B applied part ventilator breathing system VBS ordi nary enclosed equipment without protection against ingress of liquids continuous operation e IEC 60601 1 2 Medical electrical equipment General requirements for safety Collateral standard Electromag netic compatibility Requirements and tests e IEC 60601 2 12 Medical electrical equipment Particular requirements for the safety of lung ventilators Critical care ventilators e CAN CSA C22 2 No 601 1 Medical electrical equipment General requirements for safety e UL60601 1 Medical electrical equipment General require ments for safety 624131 04 A 21 A Specifications A 12 EMC declarations IEC 60601 1 2 The HAMILTON C2 ventilator is intended for use in the electro magnetic environment specified in Table A 13 Table A 14
156. l settings see Figure 4 3 If ASV is active the Basic window also shows calculated MinVol and IBW see Figure 4 6 e If you intend to use the adaptive support ventilation ASV or the noninvasive ventilation modes NIV or NIV ST we recommend that you consult Appendix C or Appendix D for more details You set controls from the three Controls windows Basic More and Apnea You enable the sigh function through the More window You set apnea backup through the Apnea win dow Table 4 2 is an alphabetical list of the control settings with their ranges For control setting ranges and standard set tings see Table A 5 For control settings applicable to the dif ferent ventilation modes see Table A 6 4 6 624131 04 4 4 1 624131 04 Adjusting and confirming control settings without mode change NOTE You can also change PEEP CPAP Oxygen and one addi tional control setting from the basic screen without opening the Controls window Change the control settings at any time as follows 1 Open the Controls gt Basic window Figure 4 3 2 Select a parameter and adjust the value The change takes effect immediately Repeat for any other desired parame ters 3 Open the Controls gt More window Figure 4 4 and select and adjust parameters as desired 4 If applicable open the Controls gt Apnea window Figure 4 5 Select or deselect Backup as desired The backup mode and settings are displayed See Section 4 4 3 for
157. larm 7 11 Battery low alarm 7 10 Biphasic ventilation concept descrip tion B 5 B 8 Breath hold function 8 5 Breathing circuit how to install 2 6 2 13 ordering information G 2 specifications A 15 specifications for compatible 1 10 Buffer alarm 7 6 7 7 C Calibrations See Tests calibrations and utilities or name of specific calibration Cell oxygen See Oxygen cell Check Flow Sensor alarm 7 11 Check Flow Sensor tubing alarm 7 11 Chemical disinfection general guide lines 9 7 Circuit breathing See Breathing circuit Cleaning disinfection and sterilization 9 2 9 5 Cleaning general guidelines 9 6 Clinical application of noninvasive venti lation D 1 D 11 Communications interface option H 1 H 7 RS232 connector location 1 14 RS 232 interface H 1 H 5 Compliance static See Cstat Configuration l 1 l 1 1 how to access l 2 how to enable communications in terface l 5 how to establish start up settings for new patient l 7 l 9 how to select default language l 3 how to select low or high pressure oxygen source l 5 Index 2 how to select main monitoring pa rameter MMP display l 6 how to set units of measure l 4 how to set weaning zone ranges for Vent Status panel l 10 l 1 1 specifications A 13 A 14 Connectors electrical power location 1 14 gas supply location 1 14 RS232 location 1 14 USB location 1 17 Connectors specifications A 3 Control settings definitions 4 13 4 17 how to adjust and confirm 4 7 4 11 See
158. lation This is not typically critical because significant there is also generally significant leakage in noninvasive ventilation CO3 rebreathing may occur because there is not the usual dead space reduction from an endotracheal tube or tracheostomy and because the mask or other noninvasive interface creates additional dead space Consider this additional dead space when prescribing a specific type of noninvasive patient interface Despite the use of a noninvasive interface the dead space ventilation per minute may decrease if the therapy results in an increase in tidal volume and decrease in respiratory rate D 11 References e Hess DR The evidence for noninvasive positive pressure ventilation in the care of patients in acute respiratory failure a systematic review of the literature Respir Care 2004 Jul 49 7 810 25 e Mehta S et al Noninvasive ventilation Am J Respir Crit Care Med 2001 Feb 163 2 540 77 e Arroliga AC Noninvasive positive pressure ventilation in acute respiratory failure does it improve outcome Cleveland Clin J Med 2001 Aug 68 8 677 80 e Hill NS Noninvasive ventilation in chronic obstructive pulmonary disease Clin Chest Med 2000 Dec 21 4 783 97 624131 04 624131 04 AARC Consensus statement Noninvasive positive pressure ventilation Respir Care 1997 42 4 365 9 Evans TW et al Noninvasive positive pressure ventilation in acute respiratory failure Report of an international consensus conf
159. le materials 624131 04 1 21 1 General information 1 22 624131 04 624131 04 Preparing for ventilation 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8 2 9 2 10 2 11 2 12 2 13 2 14 Introduction Installing the patient tubing support arm Installing the humidifier Installing the patient breathing circuit Installing a pneumatic nebulizer 2 2 2 4 2 5 2 6 2 14 Installing the optional Aeroneb Pro nebulizer 2 16 Using an expiratory filter Connecting to primary power source 2 8 1 Connecting to AC power 2 8 2 Connecting to DC power About the batteries Connecting the oxygen supply Connecting to an external patient monitor or other device Starting up the ventilator Shutting down the ventilator Display navigation guidelines 2 17 2 18 2 18 2 19 2 19 2 21 2 23 2 23 2 24 2 24 2 1 2 Preparing for ventilation 2 1 Introduction CAUTION e Additional equipment connected to medical elec trical equipment must comply with the respective IEC or ISO standards Furthermore all configura tions shall comply with the requirements for medi cal electrical systems see IEC 60601 1 1 or clause 16 of edition 3 of IEC 60601 1 respectively Any body connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible that the system com plies with the requirements for medical electrical systems Also be aware that local laws take prior ity over the abo
160. les are successfully transferred you must reinitialize the USB port by powering the ventilator off and on again e The USB device must be USB 1 1 compatible 624131 04 Configuration Data transfer Data transfer to USB failed Figure 3 6 Data transfer window 624131 04 3 15 3 Tests calibrations and utilities 3 5 Alarm tests The HAMILTON C2 performs a self check during start up and continuously during operation Alarm functionality is verified by this self check You may also want to run alarm tests which demonstrate the alarms operation 3 5 1 Before performing the alarm tests set the HAMILTON C2 up as for normal ventilation complete with breathing circuit and 2 demonstration lung assembly with ET tube High pressure 1 Make sure a 2 demonstration lung assembly is connected to the ventilator Put the ventilator into the PCV mode Set the Pressure alarm limit to 15 cmH 0 above the mea sured Ppeak Squeeze the demonstration lung hard during inspiration 5 VERIFY that the High pressure alarm is activated the ventilator cycles into exhalation and pressure falls to the PEEP CPAP level 3 5 2 Low minute volume Let the ventilator deliver 10 breaths with no alarms Adjust the minimum ExpMinVol alarm limit so it is higher than the measured value VERIFY that the Low minute volume alarm is activated 3 5 3 Low oxygen alarm 3 16 1 Set the Oxygen control to 50
161. lity and performance of the patient interface largely determine the effectiveness of noninvasive ventilation Either a face oronasal mask that covers the mouth and nose a nasal mask that covers the nose only a mouthpiece or a helmet type interface may be used with noninvasive ventilation In general a face mask is more efficient than a nasal mask but a nasal mask is better tolerated Consider the following additional advantages and disadvantages when selecting a patient interface Advantage Disadvantage Face mask Nasal mask D 6 e Little patient e Verbal communication cooperation required not possible e Little leakage e Gastric distension e Ability to sleep e Greater dead space e Comfort e Patient cooperation e Verbal communication required possible e Oral leakage e Little dead space Mouthpiece e Simple to use e Nasal air leakage e Inexpensive e Greater dead space In general a mask used with the noninvasive modes should meet these requirements e It must be of the non vented non ported design e Gas leakage should be controllable at low mask application pressures e The material in contact with the face should be soft biocompatible and nonallergenic e t should be easy to install and remove e It should remain properly positioned when the patient moves their head If you try using a nasal mask but there is significant gas leakage through the open mouth switch to a face mask 624131 04 D 7 Cont
162. lows spontaneous breathing at any time during the respiratory cycle V for APRV breath depends on lung compliance respiratory resistance the magnitude and duration of the pressure release and the magnitude of the patient s spontaneous breathing efforts Figure B 31 shows the breath timing and pressure settings in APRV 624131 04 Pressure B 8 2 624131 04 Figure B 31 APRV breath timing Initialization of APRV NOTE When applying long Thigh phases without patient activity you may adjust the apnea time alarm setting to avoid switching to apnea backup ventilation When switching to APRV the first time timing and pressure settings proposed are based on Table B 2 Settings for Phigh Thigh and Tlow will be stored when switching back to another mode but recalled when returning to APRV again The initialization occurs as in Table B 2 shown or last set value in APRV Table B 2 Control parameters for initialization of APRV 20 20 0 B Modes of ventilation Table B 2 Control parameters for initialization of APRV 014 1 When switching to APRV a second time repeatedly the former settings are kept B 8 3 Sustained high pressure recruitment manoeuvres One approach to lung recruitment has been that of sustained high pressure recruitment manoeuvres APRV can be set to apply elevated pressures for up to 40 seconds B 38 624131 04 B 8 4 Controls of APRV T low KE 9 0 1 Rate 1
163. lows the ventilator to accurately read the remaining battery charge Charge and calibrate the batteries following the instructions supplied with the charger calibrator MON The charger calibrator item is not a Medical device It has to be used outside of the patient room 9 13 9 Maintenance 9 3 4 Replacing the oxygen cell NOTE e Replace the oxygen cell with genuine HAMILTON MEDICAL parts only otherwise oxygen measure ment will not function e To prevent leakage within the ventilator make sure an oxygen cell is installed at all times even if you use an external monitor or disable oxygen monitoring e To prevent a permanent alarm use special HAMILTON MEDICAL oxygen cells only To remove the oxygen cell pull off its cover then disconnect and remove the cell see Figure 9 4 Install the new cell then apply the oxygen cell cover Run the oxygen cell calibration see Section 3 3 2 4 CAUTION To reduce the risk of explosion do not burn the oxygen cell or force the cell open 9 14 624131 04 Figure 9 4 Replacing the oxygen cell Oxygen cell Cover 9 4 Storage To maintain the battery charge and to prolong the life of the batteries keep the ventilator connected to its primary power source Have the batteries recharged every 6 months depend ing on storage conditions see specifications in Appendix A 9 5 Repacking and shipping If you must ship the ventilator use the original packing materi
164. lzer CF Chiol ro R Chassot PG Mueller XM Revelly JP Adaptive Support Ventilation for fast tracheal extubation after cardiac surgery Anesthesiology 2001 Dec 95 6 1339 45 Tassaux D Dalmas E Gratadour P Jolliet P Patient ventilator interactions during partial ventilatory support A preliminary study comparing the effects of adaptive support ventilation with synchronized intermittent mandatory ventilation plus inspiratory pressure support Crit Care Med 2002 30 4 801 7 624131 04 APPENDIX Clinical application of noninvasive ventilation D 1 Introduction D 2 D 2 Benefits of noninvasive ventilation D 3 D 3 Required conditions for use D 4 D 4 Contraindications D 5 D 5 Potential adverse reactions D 5 D 6 Selecting a patient interface D 6 D 7 Control settings D 7 D 8 Alarms D 8 D 9 Monitored parameters D 8 D 10 Additional notes about using noninvasive ventilation D 9 D 11 References D 10 624131 04 D 1 D D 1 Clinical application of noninvasive ventilation Introduction NOTE e Noninvasive ventilation in critically ill patients should only be used by properly trained and experienced personnel e As a precaution you must be prepared to intubate the patient and start invasive ventilation at any time while noninvasive ventilation is in use e The use of a mask may increase dead space Always heed the mask manufacturer s instructions when using noninvasive ventilation The noninvasive ventilation mode NI
165. m is reset Notes See Figure 2 2 through Figure 2 5 The buzzer sounds only briefly in the beginning For details on running these tests and calibrations refer to Section 3 3 2 See Section 3 3 2 4 During standby patient alarms are suppressed Corrective action If the ventilator does not pass the preoper ational check have it serviced 3 4 624131 04 3 3 System functions You can run tests and calibrations view device specific infor mation and perform other ventilator system functions from the System window NOTE The audible alarm is silenced during the calibration func tions and for 30 s thereafter 3 3 1 Info Viewing device specific information Open the System gt Info window Figure 3 1 to view device specific information PSIMV Serial number 1003 Version 1 1 0 Model Hamilton C2 B2009_03_09_20 00 Operating hours 1262h Time to service 4835h Hours since start up Oh Battery 1 91 Installed options Monitoring Figure 3 1 Info window 624131 04 3 5 3 Tests calibrations and utilities 3 3 2 Tests amp calib Running sensor calibrations and the tightness test Open the System gt Tests amp calib window Figure 3 2 to access the tests and calibrations E PSM Il O2 cel A 2008 06 19 16 40 Monitoring Figure 3 2 Tests amp calib window 624131 04 3 3 2 1 Tightness test with the LiteCircuit 624131 04 NOTE e Make sure another
166. mode and to the spontaneous mode B 20 624131 04 B 5 1 Patient triggered SIMV mode or APVsimv The SIMV mode combines attributes of the S CMV and SPONT modes delivering volume targeted time cycled mandatory breaths and pressure supported flow cycled spontaneous breaths As with the S CMV mode the SIMV mode ensures that the set target volume is delivered during the mandatory breaths Each SIMV breath interval timy can be thought of as having a trigger window ttrigger during which the ventilator waits for a patient trigger Figure B 15 If the patient triggers a breath during this time the ventilator immediately delivers a mandatory breath with the target volume If the patient does not trigger a breath then the ventilator automatically delivers a mandatory breath at the end of trigger After the mandatory breath is delivered the patient is free to take any number of spontaneous breaths for the remainder of timy Flow timv timv a ere AA Ms mandatory breath T oa a ve af mandatory tial breath breath 624131 04 a ttrigger A pe trigge aq Figure B 15 Breath timing in SIMV The control settings active in the SIMV mode are shown in Figure B 16 through Figure B 18 The SIMV mode requires that you set the parameters needed for both mandatory and spontaneous breath types As for S CMV breaths the tidal volume Vt setting defines the delivered volume of mandatory breaths The Rate
167. n off function 3 10 Service See Maintenance Settings See Ventilator settings Con trol settings or name of specific set ting Setup ventilator 2 1 2 24 Shipping 9 14 Sigh setting definition 4 17 Silence alarm key description 1 12 SIMV mode description B 20 B 24 Software DataLogger using to com municate with a computer H 5 Special functions 8 1 8 6 Specifications A 1 A 27 alarms settings and ranges adjust able A 11 A 12 ASV C 31 C 32 audible alarm A 18 backup batteries A 4 base flow A 16 breathing circuit A 15 configuration A 13 A 14 connectors A 3 dimensions ventilator A 2 electrical A 4 environmental A 3 gas mixing system A 3 inspiratory filter particle size and ef ficiency A 15 monitored parameters accuracies A 8 A 10 ranges and resolutions A 8 A 10 pneumatic A 3 standards and approvals A 19 624131 04 ventilator settings ranges and reso lutions A 5 A 6 ventilator weight A 2 SPONT mode description B 14 B 17 Spontaneous breath frequency See fS pont Spontaneous minute volume See MV Spont Standards and approvals A 19 Standby details 8 2 Startup ventilator 2 22 Static compliance See Cstat Steam autoclaving general guidelines 9 7 Sterilization steam autoclave general guidelines 9 7 Storage requirements 9 14 Support arm how to install 2 4 Switch power description 1 16 Switched to PCV alarm 7 18 Symbols definitions 1 20 1 21 Synchronized controlled mandatory ventilation mode
168. ng to alarms 0 129 F x Limits 1 o s Controls 6 33 Technical event 232030 Alarms Monitoring Utilities Events Figure 7 5 Alarm buffer with inactive alarms Indicates there is information about inactive alarms in the alarm buffer High priority alarm red background Low or medium priority alarm yellow background Press Reset button to clear information about inactive alarms Box with right angle corners 7 8 624131 04 7 4 Events window Reviewing the event log The Events window shows the event log or data about clini cally relevant ventilator occurrences since the HAMILTON C2 was powered on including alarms setting changes calibra tions maneuvers and special functions The date time and description are included NOTE A more extensive log including technical and configura tion information is available to service engineers ues PSIMV Perea k es 14 12 07 18 16 12 Alarm Vt low 650 gt 235 ml 07 18 16 12 Alarm Vt low 80 gt 650 ml 07 18 16 12 Control Oxygen 36 gt 21 7 18 16 12 Il Oxygen supply failed 07 18 16 12 Control Oxygen 21 gt 36 07 18 16 12 Control Pinsp 5 gt 15 cmH20 07 18 16 11 Control ETS gt 25 07 18 16 11 Control P ramp gt 50 ms Mic 1toring Figure 7 6 Events window 624131 04 7 9 7 Responding to alarms 7 5 Alarm troubleshooting table Table 7 2 is an alphabetical list of the alarm messages displaye
169. ngs active in the S CMV mode are shown in Figure B 4 through Figure B 5 The tidal volume Vt setting defines the delivered volume The Rate and I E control settings determine the breath timing Breaths can be triggered by the ventilator patient or user b min Rate 473 ml Ha Th 2 005 TE 4 00 5 Flowtrigger Figure B 4 S CMV basic controls 624131 04 B 9 B Modes of ventilation Figure B 5 S CMV more controls The adaptive volume controller works by comparing the user set tidal volume with the average of delivered and exhaled tidal volumes The controller in turn adjusts the inspiratory pressure that will be applied during the next breath in order to obtain the target volume The inspiratory pressure is adjusted in steps to a maximum of 2 cmH gt 0 per breath The controller adjusts the total inspiratory pressure applied including PEEP so it is between PEEP 5 cmH gt 0 and Pressure 10 cmH 0 to a maximum of 60 cmH O Figure B 6 The ventilator recalculates the minimal inspiratory pressure needed to achieve the target volume as lung characteristics change This continuous reassessment of the patient s dynamic lung status helps guarantee the required ventilation while pre venting hypoventilation or barotrauma B 10 624131 04 Volume Trigger Target window Flow Rate TE min dependent on Rate Time y Pressure Pressure 4 pressure 10 cmH2Q i Pressure limit
170. not be achieved Step 6 Monitoring ASV ASV interacts with the patient continuously Whenever the patient s respiratory mechanics change ASV adapts to this change Whenever the patient s breathing activity changes ASV adapts To let you view the current status the HAMILTON C2 provides the ASV target graphics panel Figure C 5 and the ASV monitored data window target graphics panel Table C 2 through Table C 4 give an overview of typical ventilatory patterns and their possible interpretation from a technical point of view Figure C 1 is a flow chart to guide you through the ASV adjustment weaning process 624131 04 i Oteleline ta b min 11 fSpont b min Current measured point formed by intersection of measured tidal volume and rate Target point formed by intersection of target tidal volume and target rate Numerical value of target minute volume Safety frame in which target point may move Pinsp inspiratory pressure set by ventilator Control machine rate fSpont spontaneous breath rate Horizontal axis for rate f Vertical axis for tidal volume V Minute volume curve Figure C 5 ASV target graphics panel 624131 04 C 13 C ASV adaptive support ventilation Values Graphics Target Current a Minvol ExpMin ol fg Vmin 5 oe 434 464 1 amp fTotal fTotal 16 vain 1 S Monitoring Figure C 6 ASV monitored data window Table C 2 Interpretation of breathing pa
171. not supplied by HAMILTON MEDICAL follow the manu facturers guidelines Do not attempt cleaning procedures unless specified by HAMILTON MEDICAL or the original manu facturer After cleaning and decontaminating parts perform any required tests and calibrations described in Section 3 9 3 9 Maintenance Table 9 1 Decontamination methods for HAMILTON C2 parts Part material Ventilator exte rior including housing gas sup ply hoses and power cord Touchscreen Flow Sensor reus able Expiratory valve membrane sili cone rubber 9 4 How to decontaminate Wipe with an appropriate bacte ricidal agent after each patient use Dampen a soft cloth with isopro pyl alcohol or a nonabrasive glass cleaner and wipe the screen Chemically disin fect or gas ETO or plasma sterilize Steam autoclave Do not use alcohol as a disinfectant It does not harm the ventilator but it has not been proven to be an effective bactericidal or bacterio static Do not clean the ventilator interior This can damage internal parts Avoid using cleaners other than glass cleaners Do not use any vine gar based solutions Avoid using gritty cloths Handle the touch screen with care To facilitate cleaning the touch screen during ventilation use the screen lock key Mild alkaline agents can be used for cleaning Hard brushes or other materials may damage the flap or connector and must not be used Use
172. nstant RCexp Marini 1989 Brunner 1995 In order to achieve a nearly complete exhalation to the equilibrium point of the respiratory system 90 of the maximum potential volume change an expiratory time of at least 2 x RCexp is C 21 G ASV adaptive support ventilation C 3 4 C 22 theoretically required For this reason ASV calculates the maximum rate based on the principle of giving a minimum inspiratory time equal to 1 x RCexp and a minimum expiratory time equal to 2 x RCexp which results in the following equations fmax 60 3 x RCexp 20 RCexp fmax lt 60 b min 3 For example the 70 kg patient with a respiratory system compliance of 50 ml cmH 0 equal to 0 05 I cmH gt 0 an airway resistance including endotracheal tube of 5 cmH gt O l s and a resistance of the expiratory hose and valve of another 5 cMH gt O l s would have an RCexp of 0 05 I cmH20 x 5 5 cmH20 l s 0 5 s and thus a maximum rate of 40 b min Since this value is higher than the one calculated above the lower of the two values is in effect i e 22 b min D Low rate limit The lowest target rate see D in Figure C 9 is between 5 and 15 b min depending on IBW This low rate in turn limits the maximum tidal volume to 1400 ml in the example of the 70 kg patient above when MinVol is set to 100 Optimal breath pattern Although the lung protective rules strategy limits possible combinations of Vt and f ASV prescribes an explicit
173. nt when the trigger is off Pressure increases when the patient tries to exhale E and pressure decreases when the patient tries to inspire I as valves are closed 0 0 00 0008 B 7 Biphasic PCV in an active patient when trigger is off The patient can freely inspire and exhale during any phase of VENIGON EE aeon thats stn tole e aA an Sate dt ade as B 8 S CMV basic Control Sie essorer eo ee B 9 SXCMV more controls 0 0 0 eee B 10 Breath delivery by the adaptive volume controller B 11 624131 04 B 7 B 8 B 9 B 10 B 11 B 12 B 13 B 14 B 15 B 16 B 17 B 18 B 19 B 20 B 21 B 22 B 23 B 24 B 25 B 26 B 27 B 28 B 29 B 30 B 31 B 32 B 33 B 34 B 35 C 1 C 2 C 3 C 5 PCV basic controls 000000000000 cee B 12 PCV4 MOre COMMONS a erel nera Pda eh Ba bebe an B 13 SPON T Basic CONTOS teyra eb ne ete hw ea oe beetle ha B 15 SPONT THOTE CONTAS erir eu ae AROR ne Saeed dade ew wale eee B 16 SPONT apnea controls 0 0000 cece eee B 17 NIV basic controls aarre eee B 18 NIVmOre COntrOlS Sec tiv eas ehh geen ee wees B 19 NIV apnea controls 2 0 0 0 cc eee B 20 Breath timing in SIMV 0 200000000 cee eee eee B 21 SIMV basic controls 2 ee B 22 SIMV4 MOre controles ose oo hee the ee oe ee B 23 SIMV apnea controls 0 0 0000 eee B 24 Breath timing in PSIMV and NIV ST 2 0 5 B 25 PSIMV basic controls 2 0 eee B 26 PSIMMV2E MOreCORTIO
174. nt Status panel 6 6 6 7 list of parameters 6 7 Ventilator settings 4 1 4 23 ranges and resolutions A 5 A 6 See also name of specific setting Volume alarm how to adjust 4 21 Index 8 expiratory minute See ExpMinVol expiratory tidal monitored parame ter See VTE inspiratory tidal monitored parame ter See VTI leakage See VLeak spontaneous minute monitored pa rameter See MVSpont tidal See Vt Volume limit reached alarm 7 19 Volume ventilation modes See S CMV or SIMV Vt tidal volume alarm setting defini tion 4 23 Vt tidal volume setting definition 4 17 VTE expiratory tidal volume monitored parameter definition 5 15 VTI inspiratory tidal volume monitored parameter definition 5 15 W Warranty A 24 A 27 Waveforms description 5 9 Weight ventilator A 2 Window See name of specific window 624131 04
175. nt monitors Using the HAMILTON C2 with a patient monitor requires the hardware shown in Figure H 1 Interfacing hardware specific to the manufacturers monitors is listed in Table H 1 Order this interfacing hardware directly from the monitor manufacturer 624131 04 H 3 H Communications interface Monitor RS 232 cable shielded Monitor module and grounded on HAMILTON MEDICAL monitor side only ventilators Figure H 1 HAMILTON C2 connected to a patient monitor Table H 1 Interfacing hardware for patient monitors required Spacelabs Medical Flexport converter and cable for GE Medical HAMILTON MEDICAL ventilators Systems GE Marquette Octanet and cable for Tram net is not Medical Systems HAMILTON MEDICAL ventilators compatible Schiller Cable for HAMILTON MEDICAL ventilators Drager Medical MIB II Protocol Converter or MIB For use with Infinity Il Duo Protocol Converter and Modular Monitors GALILEO MIB interface cable formerly Siemens Medical Nihon Kohden QI 407P interface BSM 4100 5100 series bedside monitor H 4 624131 04 H 3 Patient data management system PDMS or other computer system The computer connected to the HAMILTON C2 should be for medical use and meet the require ments of IEC 60601 1 Alternatively a battery pow ered laptop computer may be used Do not connect other types of personal computer because such computers do not fulfill the requirements of the standard Consult a
176. nute ventilation The MinVol for a normal patient might be 100 100 ml min kg body weight for adults and 300 ml min kg body weight for pediatric patients for a COPD patient 90 for an ARDS patient 120 and for other patients 110 Add 20 if body temperature gt 38 5 C 101 3 F and 5 per 500 m 1640 ft above sea level Applies in ASV see Appendix C Oxygen Oxygen concentration to be delivered 21 to 100 Applies to all breaths Not active when low pressure oxygen is used Pasvlimit Maximum pressure to be applied 5 to For the ASV controller to function correctly 60 cmH30 Pasvlimit must be at least 15 cmH 0 above PEEP CPAP Changing Pasvlimit or the Pressure alarm limit automatically changes the other Pressure is always 10 cmH 0 greater than Pasv limit Applies only in ASV mode Pat height Patient height It determines the ideal body 30 to weight IBW which is used in calculations for 250 cm 12 ASV and start up settings to 100 in 624131 04 4 17 4 Ventilator settings Table 4 3 Control settings mode additions and ranges continued Pcontrol Pressure additional to PEEP CPAP to be 5 to applied during the inspiratory phase 60 cmH 0 Applies in PCV above PEEP CPAP PEEP CPAP PEEP positive end expiratory pressure and 0 to CPAP continuous positive airway pressure 35 cmH20 baseline pressures applied during the expiratory phase Applies to all breaths Applies in DuoPAP and APRV
177. o exhalation peak flow Increasing the ETS setting results in a shorter inspiratory time which may be beneficial in patients with obstructive lung disease The ETS setting lets you match the inspiratory time of pressure supported breaths to the patient s neural timing Applies to spontaneous breaths Flowtrigger The patient s inspiratory flow that triggers the Off 1 to ventilator to deliver a breath The HAMILTON 10 l min C2 generates a continuous and constant base S CMV flow from the inspiratory outlet to the expira and PCV tory outlet during the later part of exhalation modes Base flow is essential for flow trigger This base 1 to flow ranges from 4 to 20 l min as follows 10 l min e For Flowtrigger values lt 2 l min 4 I min other e For Flowtrigger values gt 2 l min 2 x modes Flowtrigger setting Applies to all breaths NOTE If autotriggering occurs first check the patient breathing circuit and other set tings as possible causes before decreas ing the trigger sensitivity 4 16 624131 04 Table 4 3 Control settings mode additions and ranges continued Gender Sex of patient Used to compute ideal body Male weight IBW Female Ratio of inspiratory time to expiratory time Applies to mandatory breaths Applies in S CMV and PCV MinVol Percentage of minute volume to be delivered 25 to 350 The HAMILTON C2 uses the MinVol Pat height and Gender settings to calculate the target mi
178. o poene Low minute volume Message bar Alarm lamp Alarm silence key Figure 7 1 Visual alarm indications Safety ventilation 385002 SAFETY Figure 7 2 Safety ventilation screen 7 4 624131 04 Technical fault 446012 Ambient Figure 7 3 Technical fault screen 7 2 How to respond to an alarm CAUTION e To prevent possible patient injury when alarms are active check the patient for adequate ventilation Identify and remove the cause of the alarms Readjust the alarm limits only when they are inappropriately set for the current conditions e To prevent possible patient injury arising from an equipment malfunction HAMILTON MEDICAL recommends that you immediately remove any ventilator with a technical fault from use record the technical fault code and have the ventilator serviced 624131 04 7 5 7 Responding to alarms NOTE e Be aware that an alarm may result from either a clin ical condition or an equipment problem e Be aware that one alarm condition can induce multi ple alarms Normally only one or two indicate the root cause of the alarm the rest are resultant Your search for the causes of the alarm condition should be assisted by but not limited to the alarm mes sages displayed Respond to an alarm as follows 1 Approach the patient immediately Secure sufficient and effective ventilation for the patient You may silence the alarm if possible Correct the al
179. oe 5 2 5 2 Values window Viewing numeric patient data 5 3 5 3 Graphics window Selecting second screen graphic 5 7 5 4 About graphic types s 2 eae es See bee edd 5 9 54T Waveforms itech ia eaietuety ia dire eek gee dd 5 9 5 4 2 DYNAMIC LUNG pissin te acetic nae 5 9 343 MANE STATUS inak iaaa a ae atone AAA 5 10 5 4 4 ASV target graphics panel 5 10 BAe PROMS Sau y r A EE athe Se unten apa a Geta 5 10 5 A OLOODS ccs wuts pena wa oA Ma inate Bh ae a ae 5 12 5 5 Table of monitored parameters 5 13 Intelligent Panels cv it cies ete ede vie tiw eeden Se 6 1 6 1 IATOOUGHION El e a bad aia keOade fe den Biba a 6 2 6 2 Dynamic Lung panel 0020 000 eee eee 6 3 6 2 1 Tidal VOlWMeW De iaaa in dented vo ke was aoe 6 3 6 2 2 Compliance Cstat 0 0 00 ee eee 6 4 6 2 3 Patient triggering Muscle 6 4 6 2 4 Resistance Bronchial tree 0 6 5 6 3 Vent Status panel 0 000000 ee eee 6 6 6 4 ASV target graphics panel 2 0 0 00 6 8 Responding to alarms 22 005 7 1 Flee 4 DUO OUCUION a5 ties n8 hoes pete ein hataehe tus chee somes a 7 2 7 2 How to respond to an alarm 7 5 7 3 Alan DUE Pnn t e rA AAA hee A ORE 7 6 7 4 Events window Reviewing the eventlog 7 8 7 5 Alarm troubleshooting table 7 9 Special functions 00 c cee eee 8
180. ollows 1 Dn oO A W 9 6 Disassemble parts Breathing circuits must be disassembled completely Wash parts in warm water and soap or mild detergent solu tion Rinse parts thoroughly with clean warm water Air dry Inspect all parts and replace if damaged If you will sterilize or disinfect the part continue with the appropriate sterilization disinfection procedure Section 9 2 2 or Section 9 2 3 If you will not sterilize or disinfect the part reassemble and reinstall parts and perform any required tests 624131 04 9 2 2 General guidelines for chemical disinfection 9 2 3 624131 04 NOTE Table 9 1 lists materials of construction for the HAMIL TON C2 parts To prevent premature deterioration of parts make sure the disinfecting chemical is compatible with the part material Disinfect the HAMILTON C2 parts as follows 1 2 3 Disassemble Clean Section 9 2 1 Disinfect with a mild bactericidal chemical solution compat ible with the part s materials of construction Specific disin fectants given in Section 9 1 have been tested according to the manufacturers guidelines Other brand names with similar active ingredients may also be suitable Reassemble and reinstall parts and perform any required tests General guidelines for autoclave ETO or plasma sterilization Autoclave ETO or plasma sterilize the HAMILTON C2 parts as follows 1 2 3 Clean Section 9 2
181. ollows 1 Select the correct breathing circuit parts for your patient from Table 2 1 Table 2 1 Breathing circuit parts according to Pat height Pat IBW Breathing 5 circuit tube height kg OD mm 3to7 15 Pediatric adult 2 Assemble the patient breathing circuit Figure 2 2 through Figure 2 5 show four typical circuit configurations for ordering information contact your HAMILTON MEDICAL representative Follow the specific guidelines for the differ ent parts 3 Properly position the breathing circuit after assembly Make sure the hoses will not be pushed pulled or kinked during patient s movement nebulization or other procedures 624131 04 2 7 2 Preparing for ventilation 000000 o To patient TH Gy From patien Nebulizer outlet Expiratory valve membrane Flow Sensor Expiratory valve cover connectors Inspiratory filter Expiratory limb Flow Sensor g Water trap f ee ch i Inspiratory limb Y piece Heater wire lt gt T Humidifier In place of the flex tube shown a 15 x 22 adapter may be used to attach the Flow Sensor to the ET tube Figure 2 2 Patient breathing circuit for use with inspiratory heater wire 2 8 624131
182. on on the screen Repeat for the remaining parameters Figure l 4 MMP configuration window Parameters selected for display Select from these parameters 1 6 624131 04 I 5 Settings window Through the Settings window you define the default startup settings for a new patient 1 5 1 Use settings Selecting the default startup settings Open the Settings gt Use settings window Figure l 5 and make the desired settings from the Modes Controls and Alarms windows You can view these settings in the Mode Ctrls Figure l 6 and Alarms Figure l 7 configuration windows Open the Use settings window and select Use current settings The next time you ventilate a New patient the configured settings will be used by default Monitoring Figure l 5 Use settings configuration window 624131 04 l 7 Configuration S JCMV Configuration Mode Ctrls Alarms S CMV Graphics PEEP CPAP cmH20 5 Flowtrigger Yimin 50 P ramp ms Pat height 9 30 cm i V B Figure l 6 Mode Ctrls configuration window Fs 624131 04 Configuration Pressure ExpMinVol 40 1 0 0 5 Apnea time Oxygen 97 20 18 5 Loudness Figure l 7 Alarms configuration window 624131 04 l 9 Configuration 1 6 Vent Status Configuring the Vent Status panel The Vent Status window Figure I 8 lets you configure the weaning zone ranges of the Vent Status intelligent panel Figure l 9
183. or the operator set concentration If low pressure oxygen is supplied the delivered oxygen concentration is determined by the flow of the source oxygen Gas is supplied to the patient via the inspiratory valve The microprocessor controls the size of the inspiratory valve open ing and the length of time it is open to meet the user settings The HAMILTON C2 delivers gas to the patient through the inspiratory limb breathing circuit parts which may include an inspiratory filter flex tubes the humidification system water traps the Y piece and the Flow Sensor An internal pneumatic nebulizer supplies the nebulizer flow Gas exhaled by the patient passes through the expiratory limb breathing circuit parts including flex tubes the Flow Sensor the Y piece a water trap and an expiratory valve cover and membrane Gas is vented through the expiratory valve cover such that no exhaled gas comes into contact with any internal components of the HAMILTON C2 Measurements taken at the Flow Sensor are used in the pressure flow and volume mea surements An oxygen cell sensor monitors the oxygen concentration of the gas to be delivered to the patient This galvanic cell gener ates a voltage proportional to the partial pressure of oxygen in the delivered gas This oxygen measurement is compensated for changes in pressure The operations of the inspiratory and expiratory valves are coordinated to maintain system pressure levels 624131 04
184. orted with the set pressure support When pressure support is set to zero the ventilator functions like a conventional CPAP system The control settings active in the SPONT mode are shown in Figure B 9 through Figure B 11 The control settings active in the NIV mode are shown in Figure B 12 through Figure B 14 The pressure support Psupport setting defines the applied pressure The patient determines the breath timing Breaths can be triggered by the patient or user B 14 624131 04 Psupport PEEP CPAP Flowtrigger Figure B 9 SPONT basic controls 624131 04 B 15 B Modes of ventilation Figure B 10 SPONT more controls B 16 624131 04 Backup mode SIMV Monitoring Figure B 11 SPONT apnea controls 624131 04 B 17 B Modes of ventilation Flowtrigger Oxygen Figure B 12 NIV basic controls B 18 624131 04 Figure B 13 NIV more controls 624131 04 B 19 B Modes of ventilation Backup mode tora fa v EST PCV b min Figure B 14 NIV apnea controls B 5 SIMV modes The HAMILTON C2 s SIMV synchronized intermittent mandatory ventilation modes SIMV PSIMV and NIV ST guarantee breath delivery at the user set Rate Both mandatory and spontaneous breaths may be delivered in the SIMV modes Because the SIMV modes are mixed modes with attributes of both a mandatory and a spontaneous pressure support mode the user sets the parameters specific to the applicable mandatory
185. ou must switch off ventilator power to exit the ambient state 7 2 624131 04 Jeq abessatw ay u ayeuJaye sabessaww wieje payeldosse au aie SI WUe e aU UeY BOW jI PadIMas JO E I UIA au BACH JO E IUBA BY JO UINL UOHe U A A1 EUI e SPIAOIg a e s JuaIquue y a e UAA Ajayes JoUUeD 4I 4I VO apou Ajajes y S1 U JO JE UAA Y 1 panbas SI SsouUdJeEMe Joye1ado uoue ydwojd spaau jualjed ayL uo ua e ze p wwu spaau wajqoid au pasiWoJdwod s Ajayes sjuaijed ayL pauinbas uopy padualis aq JouUeD J8ZZNq y 8UO J8ZZNG snonuly UOD e WNWIUILW y y ajqissod Ajjediu Yyda 4 wueye uond ypiy 104 se awes pajeada 0u SI SIU sdaaq Jo s 2u nb s OM spunos osje J8ZZNq uo snonuuo gt y A NUIWW S114 Y HULNP paduals you s Wee ajqipne au 4 Ajjed1po d pajyeadas sdaaq g 4o aduaNnbas y spunos osje J8ZZNG uo snNonu uo y apnulw 4S1 84 HBULIND Paduais zou SI weje aqipne ay 4 Jase S WUe e ay IJUN payeadas sdaaq g Jo aduaNnbas y MO 2A MO 2A dwe wey ZO NOLTINVH U suonepu wely L Z 3 qeL Z anD XXXXXX 3 Ney TeotuyooL Jo Z 4 ain6I4 XXXXXX UOT ETT3 U A 3 78S YIM pay abessaw WEE YUM MOJA abessaw wieje YUM Moja L 4 n abessaw WEE ULM pay jJeq abessoyy yne je gt UY22L wueje Aywoud WNI paN L 7 3 624131 04 7 Responding to alarms
186. over the last 8 total breaths An increased fSpont may indicate that the patient is compen sating for a low compliance This may indicate ventilatory fatigue due to imposed work of breathing Total breathing frequency The moving average of the patient s total breathing frequency over the last 8 breaths including both mandatory and spontaneous breaths When the patient triggers or the user initiates a breath fTotal may be higher than the Rate setting NOTE Respiratory rate monitoring on the HAMILTON C2 requires breath delivery followed by detection of expi ratory flow at the proximal Flow Sensor Inspiratory expiratory ratio Ratio of the patient s inspiratory time to expiratory time for every breath cycle This includes both mandatory and spontaneous breaths I E may differ from the set I E ratio if the patient breathes spontaneously Insp Flow Peak inspiratory flow spontaneous or mandatory l min Leak Leakage percent The percentage of the delivered inspiratory volume VTI that is not returned during exhalation averaged over the past 8 breaths Leak can indicate leaks on the patient side of the Flow Sensor endotracheal tube chest tube mask It does not include leakage between the ventilator and Flow Sensor 624131 04 5 15 5 Monitoring Table 5 1 Monitored parameters continued Parameter Definition unit MVSpont l min PEEP CPAP cmH 70 5 16 Spontaneous expiratory minute volume The m
187. oving average of the monitored expiratory volume per minute for spontane ous breaths over the last 8 mandatory and spontaneous breaths Oxygen concentration of the delivered gas It is measured by the oxygen cell in the inspiratory pneumatics This parameter is not displayed if the oxygen supply is not connected if the oxygen cell is not installed is defective or is not a genuine HAMILTON MEDICAL part or if oxygen moni toring is disabled Monitored PEEP positive end expiratory pressure CPAP con tinuous positive airway pressure The airway pressure at the end of exhalation Measured PEEP CPAP may differ slightly from set PEEP CPAP especially in actively breathing patients Inspiratory pressure the automatically calculated target pres sure additional to PEEP CPAP applied during the inspiratory phase Available in ASV and in the Vent Status panel Pinsp is as follows ASV S CMV SIMV Automatically calculated target pres sure Pressure controlled mode PCV Pcontrol setting PSIMV NIV ST Pinsp setting SPONT NIV Psupport setting APRV DuoPAP Phigh setting Mean airway pressure The absolute pressure averaged over the breath cycle Pmean is an important indicator of the possible impact of applied positive pressure on hemodynamics and surrounding organs Peak airway pressure The highest pressure during the previ ous breath cycle It is influenced by airway resistance and compliance It may differ notice
188. position Technically speaking RCexp has increased and this increase requires a longer expiratory time For a given minute ventilation this calls for an increase in Vt and a decrease in rate longer expiratory time Otis equation yields the following new targets f 11 b min and Vt 636 ml Figure C 13 shows the change Note also that the increase in resistance results in a decrease in the volume pressure ratio V P The changes in RCexp and dynamic compliance affect the safety limits accordingly and with each breath see previous subsection C 27 C ASV adaptive support ventilation 2000 1500 1000 Vt ml 500 0 20 40 60 f b min Figure C 13 Changes of target values in broncho constriction For clarity the safety limits are omitted For clinical examples see Belliato 2000 C 28 624131 04 C 4 Minimum work of breathing Otis equation 624131 04 Otis basic question was how do mammals choose their breathing pattern and on what parameters does it depend Otis 1950 The same question was investigated years before by Rohrer and a very similar result was obtained Rohrer 1925 The hypothesis was that the breath pattern with the least work of breathing WOB is chosen by mammals Figure C 14 below shows the relationship between rate and WOB graphically for resistive load elastic load and total load to breathing an ul oO OB Voule s W O a O 0 20 40 60 f b min
189. ramp setting defini tion 4 16 Preoperational check 3 3 3 4 Preparing for ventilation 2 1 2 24 Press and turn P amp T knob description 1 13 Pressure control setting See Pcontrol Pressure limit has changed alarm 7 17 Pressure limitation alarm 7 17 Pressure not released alarm 7 17 Pressure ramp See P ramp Pressure support setting See Psupport Pressure See names of specific pressure Pressure controlled ventilation modes See PCV or PSIMV Preventive maintenance 9 8 9 15 schedule 9 8 9 9 Preventive maintenance required alarm 7 17 PSIMV mode description B 20 B 24 B 28 Psupport pressure support setting function and range 4 16 R Rate mandatory breath See fControl spontaneous breath See fSpont total respiratory See fTotal Rate setting definition 4 17 RCexp expiratory time constant moni tored parameter definition 5 14 Repacking and shipping 9 14 Replace HEPA filter alarm 7 17 Resistance inspiratory flow See Rinsp Responding to alarms 7 1 7 18 Rinsp inspiratory flow resistance mon itored parameter definition 5 14 RS 232 interface H 1 H 5 connector pin assignments H 7 RSB Vent Status parameter definition 6 7 624131 04 S SAFETY mode and ambient state B 40 Safety ventilation alarm 7 18 Safety ventilation mode description 7 2 Schedule of preventive maintenance 9 8 9 9 S CMV mode description B 9 B 11 Screen See name of specific screen Sensor Flow See Flow Sensor Sensors o
190. rauma might develop In active patients AUtoPEEP may present an extra workload to the patient AutoPEEP or air trapping may result from an expiratory phase that is too short which may be observed under these condi tions Delivered tidal volume too large Expiratory time too short or respiratory rate too high Circuit impedance too high or expiratory airway obstruc tion Peak expiratory flow too low Cstat Static compliance of the respiratory system including lung ml cmH20 and chest wall compliances It is calculated using the LSF method Cstat can help diagnose changes in elastic charac teristics of the patient s lungs NOTE Actively breathing patients can create artifact or noise which can affect the accuracy of these measurements however To minimize patient participation during these measurements you may want to increase Psup port by 10 cmH 0 After completion return this con trol to its former setting Exp Flow Peak expiratory flow l min 5 14 624131 04 Table 5 1 Monitored parameters continued Parameter Definition unit ExpMinVol Expiratory minute volume The moving average of the moni l min tored expiratory volume per minute over the last 8 breaths fControl Mandatory breath frequency in ASV The moving average of b min machine delivered breaths per minute over the last 8 total breaths fSpont Spontaneous breath frequency The moving average of spon b min taneous breaths per minute
191. rcuits from all poles of the supply mains simultaneously disconnect the mains plug 624131 04 2 3 2 Preparing for ventilation Installing the patient tubing support arm CAUTION To prevent possible patient injury due to acciden tal extubation check the support arm joints and secure as necessary 2 2 Install the patient tubing support arm on either side of the HAMILTON C2 trolley Figure 2 1 The arm snaps into place Vi ca i i i ii nt i Figure 2 1 Installing the patient tubing support arm and humidifier Support arm mount Humidifier slide bracket 624131 04 2 4 2 3 Installing the humidifier CAUTION e To prevent possible patient injury and possible water damage to the ventilator make sure the humidifier is set to appropriate temperature and humidification settings e To prevent possible patient injury and equipment damage do not turn the humidifier on until the gas flow has started and is regulated Starting the heater or leaving it on without gas flow for pro longed periods may result in heat build up caus ing a bolus of hot air to be delivered to the patient Circuit tubing may melt under these condi tions Turn the heater power switch off before stopping gas flow Install a humidifier to the HAMILTON C2 using the slide bracket on the trolley column Figure 2 1 Prepare the humidi fier as described in the manufacturer s operation manual 624131 04 2 5 2 Preparing for
192. recom mended separation distance in meters m Field strengths from fixed RF transmitters as determined by an elec tromagnetic site sur vey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equip ment marked with the symbol Q 1 Uy is the ac mains voltage prior to app ication of the test level 2 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz 3 The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges 624131 04 A 25 A Specifications 4 Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in
193. rm troubleshooting table 7 5 7 6 7 9 7 10 7 1 7 Responding to alarms 7 1 Introduction The HAMILTON C2 s alarms notify the operator of problems These alarm types including their audiovisual characteristics and required actions are summarized in Table 7 1 You can view active or inactive alarms as applicable in the alarm buffer Figure 7 4 Information about the alarm is also stored in an event log see Section 7 4 When a low medium or high priority alarm occurs ventila tion typically continues When the condition that caused the alarm is corrected the HAMILTON C2 automatically resets the alarm By contrast a technical fault alarm indicates a potentially more serious equipment problem In less serious cases the ventilator enters the safety ventilation mode which ensures a basic min ute ventilation while giving the user time for corrective actions A constant blower speed helps maintain the default inspiratory pressure The expiratory valve opens as needed to switch sys tem pressure levels between PEEP and inspiratory pressure Patient sensing is nonfunctional during safety ventilation You must switch off ventilator power to exit safety ventilation If the technical fault alarm is serious enough to possibly com promise safe ventilation the ventilator enters the ambient state The inspiratory valve is closed and the ambient and expi ratory valves are opened letting the patient breathe room air unassisted Y
194. rol settings 624131 04 When ventilating with a mask avoid high airway pressures High pressures may cause gastric distension Peak pressures exceeding 33 cmH20 may increase the risk of aspiration due to gastric insufflation When ventilating with such pressures consider using an invasive mode In case of a significant leak the inspiratory flow may never fall below ETS thus not allowing the ventilator to cycle into exhalation and resulting in endless inspiration For this reason the Tl max setting was added providing an alternative way to cycle into exhalation When inspiration lasts longer than TI max the HAMILTON C2 cycles into exhalation It is the most comfortable for the patient when the ventilator cycles based on the ETS setting rather than TI max however Make sure the TI max setting is sufficiently long to give ETS the chance to cycle the ventilator Adjusting the TI max setting increases or decreases the allowable inspiratory time Increasing ETS above the default 25 allows the ventilator to cycle to terminate inspiration at a higher flow in order to accommodate larger leaks Other controls require special attention Carefully observe the patient ventilator interaction The leakage in these mode may reduce the actual applied PEEP CPAP and give rise to autotriggering Adjust Psupport or Pinsp to obtain appropriate tidal volumes Adjust PEEP CPAP further considering oxygenation and AutoPEEP 1 Bach JR Alba AS
195. roximately 1 9 ml cmH 20 Coaxial circuit Approximately 0 64 ml cmH 0 Volume Adult circuit 19 mm ID Approximately 2 4 Pediatric circuit 15 mm ID Approximately 1 8 Flow Sensor 9 ml single use or 11 ml reusable Bacteria filter Particle size Captures particles of 0 3 um micron with gt 99 99 efficiency Resistance lt 4 cmH30 at 60 l min Flow Sensor lt 9ml dead space 1 The inspiratory limb includes ambient valve Flow Sensor inspiratory filter inspiratory tubes and humidifier It does not include the heating wire The expiratory limb includes expiratory tubes water trap expiratory valve and Flow Sensor 624131 04 A 17 A Specifications A 10 Other technical data Table A 12 lists other ventilator technical data Table A 12 Other technical data Patient ideal body weight deter mined from Pat height setting Maximum working pressure 0 to 60 cmH 0 a combination of PEEP CPAP and Pinsp Ensured through pres sure limiting Maximum inspiratory flow 240 l min 150 min with 100 O3 Tidal volume target tidal volume 20 to 2000 ml Minute volume capability Up to 60 I min Inspiratory time spontaneous 0 2 to3s breaths Minimum expiratory time 20 of cycle time 0 2 s to 0 8 s Automatic expiratory base flow 4 to 20 l min For Flowtrigger lt 2 l min 4 l min For Flowtrigger gt 2 l min 2 x Flowtrigger Means of inspiratory triggering Flow Flowtrigger control setting Oxygen mixer accuracy
196. ry ventilation mode Breaths delivered to deliberately increase tidal volume at a regular interval If enabled a sigh breath is delivered every 50 breaths with an additional 10 cmH20 Synchronized intermittent mandatory ventilation mode Spontaneous pressure support mode of ventilation A breath for which both the timing and size are con trolled by the patient That is the patient both triggers and cycles the breath Glossary 7 Glossary standby STPD TE technical fault TF Thigh TI TI max timv ttrigger Tlow Trends V VA VDaw ventilator breath ing system VBS Vent Status panel Vt Glossary 8 The ventilator is in a waiting state during which time there is no breath delivery Standard temperature and pressure dry Defined as gas at 0 C 273 K barometric pressure at sea level and dry Expiratory time a monitored parameter A type of alarm resulting because HAMILTON C2 s ability to ventilate safely is questionable Technical fault Maximum time in APRV and DuoPAP mode Inspiratory time a control setting and monitored parame ter Maximum inspiratory time a control setting in NIV and NIV ST modes SIMV breath interval Trigger window in SIMV modes Minimum time in APRV mode Special graphic type Volt a unit of electric potential or volume Volt ampere a unit of electric power Airway dead space A breathing system bounded by the low pressure gas input port s
197. s A 6 Monitored parameters Table A 7 is an alphabetical list of monitored parameter ranges resolutions and accuracies including those of the Vent Status panel Table A 8 lists the ranges of the real time curves and loops Pressure flow and volume measurements are based on readings from the Flow Sensor and they are expressed in BTPS body temperature and pressure saturated You can choose to show all monitored parameters as 1 6 12 or 24 hour trends Table A 7 Monitored parameter ranges resolutions and accuracies Ppeak Pmean 0 to 80 cmH 0 0 1 cmH 0 for lt 2 of full PEEP CPAP 10 cmH 0 scale reading 1 cmH 0 for gt 4 of actual 10 cmH 0 reading AutoPEEP 0 to 80 cmH 0 0 1 cmH 0 for lt 10 cmH20 1 cmH 0 for gt 10 cmH 20 Insp Flow 0 to 999 I min 0 1 l min for lt 10 of actual 100 l min reading or 1 l min for gt 20 ml s which 100 l min ever is greater Exp Flow 0 to 999 I min 0 1 l min for lt 10 of actual 100 l min reading or 1 Imin for gt 20 ml s which 100 l min ever is greater Volume A 9 624131 04 A Specifications Table A 7 Monitored parameter ranges resolutions and accuracies continued VTE VTI 0 to 9000 ml 1 ml 10 of actual reading or 10ml which ever is greater ExpMinVol 0 0 to 99 9 I min 0 01 l min for lt 10 of actual MvVSpont 3 0 l min reading or 0 1 l min for gt 0 3 l min 3 0 l min whichever is greater Leak O to 100 1
198. s Modes of ventilation B 1 D 9 control settings active in all modes A 7 how to set 4 5 See also name of specific mode Monitored parameters accuracies A 8 A 10 definitions 5 11 5 15 ranges and resolutions A 8 A 10 See also name of specific parameter Monitoring 5 1 5 15 Monitoring windows how to access 5 2 Mouthpiece advantages and disadvan tages for NIV D 6 MvVSpont spontaneous minute volume monitored parameter definition 5 13 N Nebulization function details 8 6 Nebulizer Aeroneb Pro how to install 2 15 pneumatic how to install 2 14 specifications for compatible 1 10 624131 04 Nebulizer on off key description 1 12 1 13 NIV mode description B 14 B 18 B 20 NIV See Noninvasive ventilation NIV ST mode description B 20 B 24 B 29 B 31 No battery alarm 7 15 Noninvasive ventilation NIV adverse reactions D 5 alarms D 8 benefits of D 3 checking mask fit and position D 9 CO rebreathing D 10 contraindications D 5 control settings D 7 maintaining PEEP and preventing autotriggering D 9 monitored parameters D 8 required conditions for use D 4 selecting a patient interface D 6 Numeric patient data how to view 5 3 5 6 O O2 cell cal needed alarm 7 15 O2 cell defective alarm 7 16 O2 cell missing alarm 7 16 O2 cell not system compatible alarm 7 16 Operating hours versions options and versions how to view 3 5 Otis equation C 29 C 30 Oxygen alarm setting definition 4 22 Oxygen cell calibration
199. s Have the ventilator serviced XXXXXX detected The ventilator switches to the safety mode CAUTION To prevent possible patient injury arising from an equipment malfunction HAMILTON MEDICAL recom mends that you immediately remove any ventilator with a technical fault from use record the code and have the ventilator serviced Technical Low medium or high priority Have the ventilator serviced event A hardware or software mal XXXXXX function was detected A technical alarm cannot typi cally be corrected by the oper ator Ventilation continues 624131 04 7 19 7 Responding to alarms Table 7 2 Alarms and other messages continued Technical Technical fault A hardware or Provide alternative ventilation fault software malfunction was Have the ventilator serviced XXXXXX detected The ventilator switches to the ambient state CAUTION To prevent possible patient injury arising from an equipment malfunction HAMILTON MEDICAL recom mends that you immediately remove any ventilator with a technical fault from use record the code and have the ventilator serviced Turn Flow Low priority The Flow Sensor Reverse the ends of the Flow Sensor connections are reversed Ven Sensor The blue sensing line is tilation continues but the ven close to the patient and must tilator corrects for the reversed be attached to the blue con signal nector The colorless sensing line is close to the ventilator and mus
200. s over to PCV mode and displays ventilator pres sure Pvent instead of Paw The ventilator automatically returns to its previous mode when the measurements are within the expected range High priority The Flow Sensor sensing lines are disconnected or occluded The ventilator switches over to PCV mode and displays ventilator pres sure Pvent instead of Paw The ventilator automatically returns to its previous mode when the measurements are within the expected range High priority The internal tem perature of the ventilator is higher than expected High priority Peak pressure lower than expected in NIV or NIV ST mode Change the battery Use a HAMILTON C2 Li lon battery Change the battery Use a HAMILTON C2 Li lon battery Check the Flow Sensor and the sensing lines Try to calibrate the Flow Sen sor Install a new Flow Sensor Check the Flow Sensor and the sensing lines Try to calibrate the Flow Sen sor Install a new Flow Sensor Remove the ventilator from the sun or other heat source Check the cooling fan filter and fan Have the ventilator serviced Troubleshoot as per Discon nection on patient side or Disconnection on ventilator side alarm 624131 04 Table 7 2 Alarms and other messages continued Disconnec tion on patient side Disconnec tion on ventilator side Exhalation obstructed 624131 04 High priority VTE lt 1 8 deliv ered VTI and delivered VTI
201. s time an alarm is annunci ated Apnea backup ventilation will begin if enabled Low and high expiratory minute volume If either limit is reached a high priority alarm is annunciated Low and high monitored total breath rate fTo tal including both spontaneous and manda tory breaths If either limit is reached a medium priority alarm is annunciated Low and high monitored oxygen concentration Oxygen If either limit is reached a high prior ity alarm is annunciated Applies only when low pressure oxygen is used 15 to 60s Low Off 0 1 to 50 l min NIV NIV ST 0 1 to 50 l min other modes High 0 1 to 50 l min 0 to 99 b min Low 18 to 97 High 18 to 103 4 25 4 Ventilator settings Table 4 4 Alarm limit settings and ranges continued Pressure High monitored pressure at the patient airway 15 to Ppeak If Pressure is reached a high priority 70 cmH 3 0 alarm is annunciated In addition when pressure reaches Pressure mi nus 10 cmH 0 pressure is limited no further pressure is applied If Pressure is reached the ventilator immediately stops gas flow to the patient and opens the expiratory valve to re duce pressure to the PEEP CPAP level The ven tilator is designed to limit patient airway pressure to 60 cmH 0 but if pressure climbs to 75 cmH30 the ambient valve opens releasing pressure to the ambient level An exception is sigh breaths when the ventila tor may apply insp
202. stable power and to facilitate intrahospital transport The HAMILTON C2 s pneumatics deliver gas and its electrical systems control pneumatics monitor alarms and dis tribute power The user provides inputs to the HAMILTON C2 microprocessor system through a touchscreen keys and a press and turn knob These inputs become instructions for the HAMILTON C2 s pneumatics to deliver a precisely controlled gas mixture to the patient The HAMILTON C2 receives inputs from the proxi mal Flow Sensor and other sensors within the ventilator Based on this monitored data the HAMILTON C2 adjusts gas delivery to the patient Monitored data is also displayed by the graphic user interface The HAMILTON C2 s microprocessor system controls gas deliv ery and monitors the patient The gas delivery and monitoring functions are cross checked by an alarm controller This cross checking helps prevent simultaneous failure of these two main functions and minimizes the possible hazards of software fail ure A comprehensive system of visual and audible alarms helps ensure the patient s safety Clinical alarms can indicate an abnormal physiological condition Technical alarms triggered by the ventilator s self tests including ongoing background checks can indicate a hardware or software failure In the case of some technical alarms a special safety mode ensures a basic minute ventilation while giving the user time for corrective 624131 04 actions When
203. t and AutoPEEP breath by breath during mandatory and spontaneous breaths in all modes without interruption in ventilation To obtain these measurements the HAMILTON C2 uses a statistical technique called the least squares fitting LSF method This method is applied on a breath by breath basis without the need for special inspiratory flow patterns and occlusion maneuvers provided that the patient is relaxed or nearly relaxed Actively breathing patients can create artifact or noise which can affect the accuracy of these measurements however The more active the patient the less accurate the measurements To minimize patient participation during these measurements you may want to increase Psupport by 10 cmH20 After completion return this control to its former setting Table 5 1 is an alphabetical list of the HAMILTON C2 s monitored parameters These can be viewed in the Values windows Figure 5 2 through Figure 5 4 The display of monitored parameters is updated every breath 624131 04 5 13 5 Monitoring Table 5 1 Monitored parameters Parameter Definition unit AutoPEEP The difference between the set PEEP and the calculated total cmH 70 PEEP within the lungs AutoPEEP is the abnormal pressure generated by air trapped in the alveoli due to inadequate lung emptying Ideally it should be zero AutoPEEP is calcu lated using the LSF method applied to the entire breath When AutoPEEP is present volutrauma or barot
204. t be attached to the white connector 7 20 624131 04 624131 04 Special functions 8 1 8 2 8 3 8 4 Standby 100 O2 Manual breath inspiratory hold Nebulizer 8 2 8 5 8 5 8 6 8 1 8 Special functions 8 1 Standby CAUTION e To prevent possible patient injury due to lack of ventilatory support secure alternative ventila tion for the patient before entering the standby mode You must confirm that no patient is attached before entering standby e To prevent possible patient injury or damage to breathing circuit from overheated gas after reconnection from standby turn off the humid ifier when entering the standby mode NOTE e To keep the batteries fully charged make sure the ventilator is connected to ac power while in standby mode e When in standby the HAMILTON C2 does not auto matically resume ventilation when the patient is reconnected Instead you must manually restart ven tilation e Patient alarms are suppressed during standby Standby is a waiting mode that lets you maintain ventilator set tings while the HAMILTON C2 is not performing any ventila tory functions To put the ventilator into standby press and quickly release the power standby switch Figure 8 1 while the ventilator is pow ered on The Activate standby window Figure 8 2 opens Select Activate standby 8 2 624131 04 Power standby switch 100 0 Manual breath inspiratory hold Nebulizer on off
205. t is shown as a red line When the ventilator is in the ASV S CMV or SIMV mode it uses Pressure as a Safety boundary for its inspiratory pressure adjustment The ventilator does not apply inspiratory pressures higher than this pressure limitation value An exception is sigh breaths when the ventilator may apply inspiratory pressures 3 cmH gt 0 below the Pressure alarm limit Figure 5 6 Pressure waveform display Red Pressure alarm line Blue Pressure limitation line Dynamic Lung The Dynamic Lung panel visualizes tidal volume lung compliance patient triggering and resistance in real time For more information see Section 6 5 9 5 Monitoring 5 4 3 5 4 4 5 4 5 Vent Status The Vent Status panel visualizes parameters related to oxygenation CO elimination and patient activity and it indicates the patient s level of ventilator dependency and when discontinuing ventilation should be considered For more information see Section 6 ASV target graphics panel The ASV target graphics panel Figure C 5 which is accessible only in the ASV mode shows how the adaptive lung controller moves toward its targets It shows both the target and actual parameters for tidal volume frequency pressure and minute ventilation See Appendix C for detailed information on ASV including how to interpret the data in the target graphics panel Trends You can choose to show monitored parameters as 1 6 12 or
206. t pressure additional to PEEP CPAP applied during the inspiratory phase see Table 5 1 Rapid shallow breathing index The total breathing frequency fTotal divided by the exhaled tidal volume VTE Because a patient with dyspnea typically takes faster shallower breaths than a nondyspneic patient RSB is high in the dyspneic patient and low in the nondyspneic patient RSB is often used clinically as an indicator to judge whether a ventilated patient is ready for weaning RSB has significance for spontaneously breathing patients only and is shown only if 80 of the last 25 breaths are spontaneous Spontaneous breath percentage The moving average of the percentage of spontaneous breaths over the last 8 total breaths 1 Weaning zone defaults are based on a normal of lt 100 l min for adult patients 624131 04 6 Intelligent Panels 6 4 ASV target graphics panel 6 8 The ASV target graphics panel Figure C 5 which is accessible only in the ASV mode shows how the adaptive lung controller moves toward its targets It shows both the target and actual parameters for tidal volume frequency pressure and minute ventilation See Appendix D for detailed information on ASV including how to interpret the data in the target graphics panel 624131 04 624131 04 Responding to alarms 7 1 7 2 7 3 7 4 7 5 Introduction How to respond to an alarm Alarm buffer Events window Reviewing the event log Ala
207. the HAMILTON C2 Attach it to the mounting bracket Figure 2 9 Consult the operating instructions sup plied with the nebulizer for further installation and operating information Figure 2 9 Installing the Aeroneb Pro nebulizer 2 16 624131 04 2 7 Using an expiratory filter MOT The use of an expiratory filter may lead to a signif icant increase in expiratory circuit resistance Excessive expiratory circuit resistance may com promise ventilation and increased patient work of breathing and or AutoPEEP An expiratory filter is not required on the HAMILTON C2 but you may use one according to your institution s protocol An expiratory filter is not required because the expiratory valve design prevents internal ventilator components from contact with the patient s exhaled gas If you do use an expiratory filter place it on the patient side of the expiratory valve cover Remove any expiratory filter or HME during nebulization Monitor closely for increased expiratory circuit resistance An Exhalation obstruction alarm may also indicate excessive expiratory circuit resistance If the Exhalation obstruction alarm occurs repeatedly remove the expiratory filter immediately If you otherwise suspect increased expiratory circuit resistance remove the expiratory filter or install a new filter to eliminate it as a potential cause NOTE Monitored parameters for increased expiratory resis tance are not specific to the breathing circu
208. the intended use Humidi fiers must comply with ISO 8185 Heat and moisture exchanger HME HMEs must comply with ISO 9360 HAMILTON MEDICAL parts only marked with the HAMIL TON H Expiratory valve HAMILTON MEDICAL parts only membrane and cover Nebulizer e Internal nebulizer Pneumatic nebulizer specified for 8 l min e External nebulizer Pneumatic small volume nebulizer powered by an external gas source or a standalone ultra sonic or electronic piezo micropump nebulizer such as the Aerogen Aeroneb Pro nebulizer system Oxygen cell HAMILTON MEDICAL parts only 1 10 624131 04 1 3 2 Ventilator unit Figure 1 4 through Figure 1 6 show the controls indicators and other important parts of the ventilator unit When a key is pressed and the selected function is active the LED beside the key is lit Standby 00 6600060 Figure 1 4 Front view ously lit when alarm silence is active This red LED flashes when an alarm silence is inactive but an alarm is active Alarm lamp Entire lamp lights when an alarm is active red high priority alarm yellow medium or low prior ity alarm In addition a red LED in the middle is continu 624131 04 1 11 1 General information O 100 Qo Q 6 2 MIN 1 12 Battery charge indicator Lights to show that the batter ies can be charged It is lit whenever the ventilator is con nected to ac power or to gt 20 V dc whether or not power is switch
209. thing frequency a monitored parame ter Total breathing frequency a monitored parameter and alarm setting Foot a unit of length Sex of patient a control setting High efficiency particle air filter Heat and moisture exchanger artificial nose Glossary 3 Glossary hPa HPO Hz gt sp Flow nspiratory hold ntelligent Panel IntelliTrig IRV ISO kg kPa l min Glossary 4 Hectopascal a unit of pressure 1 hPa is equal to 1 mbar which is approximately equal to 1 cmH 0 High pressure oxygen Hertz or cycles per second a unit of frequency nspiration Ideal bodyweight ntensive care unit nner diameter nternational Electrotechnical Commission nspiratory expiratory ratio a setting timing parameter and monitored parameter Ratio of inspiratory time to expiratory time Inch a unit of length Peak inspiratory flow a monitored parameter A respiratory maneuver in which gas is retained in the patient s airways often for X raying purposes A type of graphic display on the HAMILTON C2 The Intelligent Panels include the Dynamic Lung Vent Status ASV target graphics panel and ASV monitored data window panels Intelligent trigger a feature that ensures that the set trigger sensitivity can trigger a breath independent from leakage and breath pattern Inverse ratio ventilation International Organization for Standardization a world wide federation of nation
210. tically voids all warranties and liabilities The preventive maintenance program requires a general service every 5000 hours or yearly whichever comes first 624131 04 e To ensure the ventilator s safe operation always run the tests and calibrations prescribed in Section 3 before using the ventilator on a patient If the ventilator fails any tests remove it from clinical use immediately Do not use the ven tilator until necessary repairs are completed and all tests have passed e The manufacturer considers itself responsible for the safety reliability and performance of the ventilator only if appropriately trained personnel carry out assembly operations extensions readjustments modifications or repairs the electrical installation of the relevant room complies with the appropriate requirements and the ventilator system is used in accordance with the operator s manual Electromagnetic susceptibility The HAMILTON C2 complies with the IEC 60601 1 2 EMC Electro Magnetic Compatibility Collateral Standard It is intended for use in the electromagnetic environment described in Table A 13 through Table A 15 Do not use the HAMILTON C2 in an environment with magnetic resonance imaging MRI equipment Units of measure Pressures are indicated on the HAMILTON C2 in cmH30 or mbar Hectopascals hPa are used by some institutions instead Since 1 mbar equals 1 hPa which equals 1 016 cmH30 the units may be use
211. ting definition 4 14 General information 1 1 1 21 Glossary Glossary 1 Glossary 8 Index 3 Index Graphics how to select second screen graphic 5 7 5 8 types 5 9 5 10 High frequency alarm 7 13 High minute volume alarm 7 13 High oxygen alarm 7 13 High pressure alarm 7 13 High pressure during sigh alarm 7 13 High tidal volume alarm 7 14 High pressure oxygen supply how to connect 2 20 2 21 Hold inspiratory how to perform 8 5 Humidifier how to install 2 5 specifications for compatible 1 10 l LE inspiratory expiratory ratio moni tored parameter definition 5 12 LE inspiratory expiratory ratio setting definition 4 14 Insp Flow peak inspiratory flow moni tored parameter definition 5 12 Inspiratory filter See Filter inspiratory Inspiratory flow resistance See Rinsp Inspiratory tidal volume See VTI Inspiratory time monitored parameter See TI Inspiratory time setting See TI Installation Aeroneb Pro nebulizer 2 15 breathing circuit 2 6 2 13 expiratory valve cover and mem brane 2 12 first time notes 2 3 Flow Sensor 2 13 humidifier 2 5 pneumatic nebulizer 2 14 support arm 2 4 to electrical supply 2 17 2 18 to oxygen supply 2 20 2 21 Intelligent Panels 6 1 6 8 Index 4 Dynamic Lung 6 3 6 5 Vent Status 6 6 6 7 IntelliTrig intelligent trigger function D 9 Interface communications connector location 1 14 Internal battery See Batteries backup Intrinsic PEEP See AutoPEEP IRV alarm 7 14 K K
212. to access standby then press the switch again for gt 3 s or if there is a technical fault press and hold the switch for gt 10 s NOTE The ventilator remains connected to power when the power switch is switched off This permits the batteries to charge To totally disconnect the ventilator from power unplug it from the mains power outlet or discon nect it from the dc supply 2 14 Display navigation guidelines Use the touchscreen and the press and turn knob to access the HAMILTON C2 ventilation parameters and monitored data You typically use a select activate or select activate adjust activate procedure 2 24 624131 04 To open a window touch the window tab p to select and activate it or turn the knob to Controls select the window tab it is framed in yellow and then press the knob to activate your selection Activated To close a window touch the window tab r or the X in the upper left hand corner to select and activate it or turn the knob to select the X it is framed in yellow and then press the knob to activate your selection To adjust a control touch the control to select and activate it or turn the knob to a select the control it is framed in yellow and then press the knob to activate your selec ees tion The activated control turns red Turn Selected the knob to increment or decrement the value Press the knob or touch the control to confirm the adjustment and deactivate
213. tory trigger sensitivity See ETS Expiratory valve cover and membrane how to install 2 12 location 1 13 maintenance 9 5 ExpMinVol expiratory minute volume alarm setting definition 4 22 ExpMinVol expiratory minute volume monitored parameter definition 5 12 ExpMinVol Vent Status parameter definition 6 7 F Fan failure alarm 7 13 Fan filter See Filter fan 624131 04 fControl mandatory breath rate moni tored parameter definition 5 12 Filter air intake dust and HEPA how to clean or replace 9 10 9 11 expiratory using with the HAMIL TON G5 2 16 fan how to clean or replace 9 10 9 11 inspiratory particle size and efficiency A 15 specifications for compatible 1 10 Flex arm See Support arm Flow Sensor calibration 3 8 description 1 7 how to install 2 13 location of connection 1 13 maintenace 9 4 part numbers G 2 Flowtrigger setting definition 4 14 Frequency mandatory breath See fControl spontaneous breath See fSpont total breath See fTotal Frequency See also Rate From patient port location 1 13 fSpont spontaneous breath frequency monitored parameter definition 5 12 fSpont Vent Status parameter defi nition 6 7 fTotal total respiratory rate alarm set ting definition 4 22 fTotal total respiratory rate monitored parameter definition 5 12 Function test See Preoperational check G Gas mixing system specifications A 3 Gas supply or Gas fitting See Oxygen supply or fitting Gender set
214. ttern at 100 MinVol setting Pinsp fControl fSpont Interpretation Fully controlled mechanical ventilation To start weaning consider reducing MinVol Accept Supported spontaneous breathing Consider able reducing MinVol lt 8 Accept Unsupported breathing Consider able extubation D High Dyspnea Consider increasing Y MinVol and other clinical treatments Check for autotriggering C 14 624131 04 Table C 3 Interpretation of breathing pattern at much higher than 100 MinVol setting fControl fSpont Interpretation gt 10 Fully controlled mechanical ventilation Check arterial blood gases To start weaning consider reducing MinvVol Accept Supported spontaneous breathing Check able reason for increased ventilation requirement Consider reducing MinVol Accept Unsupported breathing Check reason for able increased ventilation requirement Consider reducing MinVol and extubation High Dyspnea Check reason for increased ventilation requirement Consider other mode of ventilation and clinical treatment Check for autotriggering Table C 4 Interpretation of breathing pattern at much lower than 100 MinVol setting Pinsp fControl fSpont Interpretation gt 10 gt 10 0 Danger of hypoventilation Check arterial blood gases and consider increasing MinVol a gt 10 0 Accept Enforced weaning pattern Monitor arterial able blood gases and patient respiratory effort Consider
215. ty The delivered Vt gt 1 5 the set Vt high alarm limit Pressure is reduced by 3 mbar for next breath Check the patient Check the breathing circuit for leaks Replace the breathing circuit if necessary Check the patient Adjust the low fTotal alarm limit If the ventilator is in ASV check the MinVol and Pat height settings Consider suctioning check for a kinked ET tube or consider the possi bility of acute asthma Check the patient Check the breathing circuit Check and adjust the ventila tor settings including alarms If the ventilator is in ASV check the MinVol and Pat height settings Consider suctioning check for a kinked ET tube or consider the possi bility of acute asthma Check the patient Check the oxygen supply Pro vide an alternative source of oxygen if necessary Calibrate the oxygen cell Install a new oxygen cell Reduce the Psupport setting Adjust the high Vt high alarm limit 624131 04 Table 7 2 Alarms and other messages continued O2 cell cal needed O2 cell defective O2 cell missing 624131 04 Medium priority Measured VTE lt the set limit for 2 con secutive breaths Low priority Oxygen cell cali bration data is not within expected range or cell is new and requires calibration High priority The oxygen cell is depleted Check the patient Check and adjust the ventila tor settings including alarm limits Check for l
216. ty at first then low priority after silenced Inspiratory pressure including PEEP CPAP is 10 cmH 70 below Pressure The ventilator limits applied pressure so the target pressure or volume may not be achieved Install an oxygen cell intended for the HAMILTON C2 PN 396200 Check the patient Check the oxygen supply Pro vide an alternative source of oxygen if necessary Make sure the pressure limit is high enough so that sufficient pressure can be applied for adequate breath delivery Check the patient for ade quate ventilation Check ventilator settings and alarm limits 624131 04 Table 7 2 Alarms and other messages continued Pressure High priority Airway pressure Provide alternative ventilation not has exceeded the Pressure Check expiratory valve and released limit and the pressure was not breathing circuit released via the expiratory valve after 5 s The ventilator enters the ambient state Have the ventilator serviced Preventive Low priority According to its Have the ventilator serviced mainte operating hours the ventilator nance requires preventive mainte required nance Replace Low priority The air inlet HEPA Replace the HEPA filter HEPA filter filter shows increased resis tance Real time Low priority Date and time Set date and time clock failure not set Safety ven Technical fault A hardware or Provide alternative ventilation tilation software malfunction wa
217. ve mentioned requirements If in doubt consult your local representative or Techni cal Support e To prevent possible patient injury do not block the holes at the back of the ventilator These holes are vents for the fresh air intake and the cooling fan e To prevent back pressure and possible patient injury do not attach a spirometer tube or other device to the exhaust port of the exhalation valve housing e To prevent interrupted operation of the ventilator or any accessories use only accessories or cables that are expressly stated in this manual e To prevent interrupted operation of the ventilator due to electromagnetic interference avoid using it adjacent to or stacking other devices on it If adja cent or stacked use is necessary verify the ventila tor s normal operation in the configuration in which it will be used e To prevent possible personal injury and equipment damage make sure the ventilator is secured to the trolley or shelf with the quick locking mechanism 2 2 624131 04 CAUTION e To prevent possible equipment damage avoid tipping over the ventilator when crossing thresholds e To prevent possible equipment damage lock the trolley s wheels when parking the ventilator e Before using the ven tilator for the first time HAMILTON MEDICAL recom mends that you clean its exterior and sterilize its components as described in Section 8 e To electrically isolate the ventilator ci
218. ventilation 2 4 Installing the patient breathing circuit CAUTION e To minimize the risk of bacterial contamination or physical damage handle bacteria filters with care e To prevent patient or ventilator contamination always use a bacteria filter between the ventilator and the inspiratory limb of the patient breathing circuit e To reduce the risk of fire use only breathing cir cuits intended for use in oxygen enriched environ ments Do not use antistatic or electrically conductive tubing NOTE e For optimal ventilator operation use HAMILTON MEDICAL breathing circuits or other circuits that meet the specifications given in Appendix A When altering the HAMILTON MEDICAL breathing circuit configurations for example when adding accesso ries or components make sure not to exceed these inspiratory and expiratory resistance values of the ventilator breathing system as required by IEC 60601 2 12 adult 6 cmH 30 at 60 I min and pediatric 6 cmH gt 0 at 30 l min e Any bacteria filter HME or additional accessories in the expiratory limb may substantially increase flow resistance and impair ventilation e To ensure that all breathing circuit connections are leak tight perform the tightness test every time you install a circuit or change a circuit part e Regularly check the water traps and the breathing circuit hoses for water accumulation Empty as required 2 6 624131 04 Install the breathing circuit as f
219. ventilation Only if Pinsp and fControl are at their minimal values can weaning be assumed to be complete C 16 624131 04 C 3 Detailed functional description of ASV C 3 1 Definition of normal minute ventilation ASV defines normal minute ventilation according to the graph in Figure C 7 min kg 3 kg 03 z T g 0 2 oO E 0 1 S 3 15 30 kg IBW Figure C 7 Normal minute ventilation as a function of IBW For patients between 3 and 5 kg minute ventilation is 0 3 min kg For patients above 30 kg minute ventilation is calculated as 0 1 I min kg For patients with IBW between these points the values indicated by the dotted line are used Minute ventilation for a 15 kg patient thus is calculated as 0 2 min x 15 kg 3 l min For example for an IBW of 70 kg normal minute ventilation corresponds to 7 l min C 3 2 Targeted minute ventilation When selecting ASV it is necessary to select an appropriate minute ventilation for the patient Minute ventilation is set with the MinVol control which together with the Pat height control determines the total minute ventilation in liters per minute 624131 04 C 17 C ASV adaptive support ventilation A MinVol setting of 100 corresponds to a normal minute ventilation as defined above A setting less than 100 or higher than 100 corresponds to a minute ventilation lower or higher than normal From the MinvVol the target minute ventilation in l min is
220. which the HAMILTON C2 ventilator is used exceeds the applicable RF compliance level above the HAMILTON C2 ventilator should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the HAMILTON C2 ventilator 5 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m A 26 624131 04 Table A 15 Recommended separation distances between portable and mobile RF communications equipment and the HAMILTON C2 ventilator Rated maximum output power Separation distance according to frequency of of transmitter transmitter m 2245 w 150 kHz to 150 kHz to 80 MHz to 80 MHz to 80 MHz 80 MHz 800 MHz 2 5 GHz outside ISM in ISM d 0 6 P d 1 15 P bands bands d 0 35 P d 1 2 P 0 01 0 035 0 12 0 06 0 12 0 1 0 11 0 38 0 19 0 37 1 0 35 1 2 0 6 1 15 10 1 1 3 8 1 9 3 65 100 3 5 12 6 11 5 1 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 2 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer 3 At 80 MHz and 800
221. window 2 5 5 5 Monitoring 1 PE Z O Tam Ie e Monitoring Figure 5 4 Values window 3 5 6 624131 04 5 3 Graphics window Selecting second screen 624131 04 graphic The HAMILTON C2 displays a pressure time waveform by default but through the Graphics window you can select the second graphic to be displayed at the bottom of the screen Section 5 4 describes the graphic types 1 Open the Monitoring gt Graphics window Figure 5 5 either with the window tab or by touching the graphic at the bottom of the screen 2 Select the desired type of graphic Flow Flow time waveform Volume Volume time waveform Dynamic Lung shown in Figure 6 2 Vent Status shown in Figure 6 6 ASV target graphics panel if the ventilator is in the ASV mode shown in Figure C 5 Trends shown in Figure 5 7 Loops shown in Figure 5 8 5 7 5 5 8 Monitoring Figure 5 5 Graphics window Controls 624131 04 5 4 About graphic types 5 4 1 5 4 2 624131 04 Waveforms NOTE The ventilator uses an autoscaling function so the scales of individual waveforms may differ based on the range of values to be displayed For example the flow scale may vary from one flow time waveform to another The HAMILTON C2 plots pressure volume and flow against time A blue pressure limitation line shows the maximum safe pressure which is 10 cmH20O below the set Pressure alarm limit The Pressure limi
222. wing settings If the original the HAMILTON C2 support mode enters this land ventilates using is backup mode these settings SIMV SIMV Increased rate SPONT PSIMV SIMV Startup control settings DuoPAP APRV SIMV NIV NIV ST PCV see Table 4 1 1 The start up setting is the default for a new patient for the first application of that specific control If the control setting is later changed the new set ting overrides the standard setting 624131 04 624131 04 If the patient triggers two consecutive breaths the HAMILTON C2 reverts to ventilation in the original support mode and at the original settings and it displays Apnea ventilation ended Once apnea backup ventilation is enabled or disabled it retains this status in all applicable modes Apnea backup ventilation requires no clinician intervention although you can freely change the mode during apnea backup ventilation either switching to a new mode or accepting the backup mode as the new mode When apnea backup ventilation is disabled the high pri ority Apnea alarm is annunciated when apnea occurs 4 13 4 4 14 Ventilator settings Table 4 1 Settings during backup mode PCV IBW kg fans Acari I E 3 to 5 15 30 1 2 6 to8 15 25 1 2 9 to 11 15 20 1 2 12 to 14 15 20 1 2 15 to 20 15 20 1 2 21 to 23 15 5 1 2 24 to 29 15 5 1 2 30 to 39 15 4 1 2 40 to 59 15 2 1 2
223. xvii List of figures C 6 C 7 C 8 G 1 G 2 G 3 H 1 H 2 H 3 H 4 l 1 l 2 l 3 l 4 xviii ASV monitored data window 0 0000 e eee C 14 Normal minute ventilation as a function of IBW For patients between 3 and 5 kg minute ventilation is 0 3 I min kg For patients above 30 kg minute ventilation is calculated as 0 1 I min kg For patients with IBW between these points the values indicated by the dotted line are used Minute ventilation for a 15 kg patient thus is calculated as 0 2 l min x 15 kg SB AAI Noes ty eters gcse nen go arte a oe ater eh al a cada ea Oe Si C 17 MinVol 7 l min All possible combinations of Vt and f which result in a minute ventilation of 7 l min lie on the bold line C 18 Lung protective rules strategy to avoid high tidal volumes and pressures A low alveolar ventilation B dynamic hyper inflation or breath stacking C and apnea D C 20 Anatomy of the ASV target graphics panel The rectangle shows the safety limits the circle shows the target breath patterM scat few rt GAN A ora Laren Mien eee EN C 23 Example of a situation after the three initial breaths The cross marks the actual measured values for Vt and rate C 25 Lung protective limits are changed dynamically and according to the respiratory system mechanics However the limits derived from the operator input are never violated C 26 Changes of target values in broncho
224. y limits the circle shows the target breath pattern 624131 04 C 23 C ASV adaptive support ventilation C 3 4 1 Initial breaths How ASV starts C 24 The question is how to achieve the target values in a given patient if it is not known whether or not the patient can breathe spontaneously For this purpose ASV employs a synchronized intermittent mandatory pressure ventilation mode Every breath triggered by the patient is pressure supported and flow cycled i e the transition to exhalation is made based on flow In contrast if the patient does not trigger the breath the delivery of the breath is pressure preset and time cycled The following controls can be set by the operator e Pat height e MinVol e PEEP CPAP e Oxygen e P ramp e ETS e Flowtrigger The following controls are adjusted automatically by ASV and thus cannot be adjusted by the operator e SIMV rate to change total respiratory rate e Inspiratory pressure level to change inspiratory volume e Inspiratory time to allow gas flow into the lungs e Startup breath pattern To safely start ASV the operator inputs the Pat height setting which is used to calculate the IBW Three initial test breaths are delivered The resulting rate and tidal volume are measured and compared with the target values ASV then responds according to the differences between the actual and target Vt as well as the actual and target rates 624131 04 C 3 4 2 Appro

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