GE Aespire 7100 Technical Reference Manual

...-... product group code, the year of manufacture, and a sequential unit number for _ identification. The serial number can be in one of two formats. ·胃F AAAXllll1 AAAXX ll l1l1AA The X represents an alpha character The XX represents a number indicating indicating the yearthe product was the yearthe product was manufactured; manufactured; H ~ 2004, J ~ 2005, etc. 04 ~ 2004, 05 ~ 2005, etc. I and 0 are not used. Aesplre, ProTlVA, SmartVent, and Unk-25 are registered trademarks of Datex-Ohmeda Inc. • Other brand names or product names used in this manual are trademarks or registered _ trademarks oftheir respective holders. ~ 08/07 Mll10140

Covers the following: Aespire 7100 anesthesia machlne (with non-color or color dlsplay) Aespire 100 anesthesla machine 515 ProTIVA anesthesia machine 50ftware Revisions 1.X and 2.X This document is not to be reproduced in any manner, nor are the contents to be disclosed to anyone, without the express authorization of the product service department, Datex-Ohmeda, Ohmeda Drive, PO Box 7550, Madison, Wisconsin, 53707. @ 2007 Datex-Ohmeda Inc.

models of products which are marketed by Datex-Ohmeda as ofthe effective date of this manual or the latest revision thereof. This Technical Reference manual was prepared for exclusive use by Datex-Ohmeda service personnel in light of their training and experience as well as the availability to them of parts, proper tools and test equipment Consequently, Datex-Ohmeda provides this Technical Reference manual to its customers purely as a business convenience and for the customer' s general information only without warranty of the results with respectto any application of such information. Furthermore, because ofthe wide variety of circumstances underwhich maintenance and repair activities may be performed and the unique nature of each individual's own experience, capacity, and qualifications, the fact that customer has received such information from Datex-Ohmeda does not imply in anyway that Datex- Ohmeda deems said individual to be qualified to perform any such maintenance or repair service. Moreover, it should not be assumed that every acceptable test and safety procedure or method, precaution, tool, equipmentor device is referred to within, or that abnormal or unusual circumstances, may not warrant or suggest different or additional procedures or requirements. This manual is su国ectωperiodic review, update and revision. Customers are cautioned to obtain and consult the latest revision before undertaking any service of the equipment. Comments and suggestions on this manual are invited from our customers. Send your comments and suggestions to the Manager ofTechnical Communications, Datex-Ohmeda, Ohmeda Drive, PO Box 7550, Madison, Wisconsin 53707. Lh. CAUTlON Servicing ofthis product in accordance with this Technical Reference manual should never be undertaken in the absence of proper tools, test equipment and the most recent revision to this service manual which is clearly and thoroughly understood. Technical Competence The procedures described in this Technical Reference manual should be performed by trained and authorized personnel only. Maintenance should only be undertaken by competent individuals who have a general knowledge of and experience with devices of this nature. No repairs should ever be undertaken or a忧empted by anyone not having such qualifications. Datex-Ohmeda strongly recommends using only genuine replacement parts, manufactured or sold by Datex-Ohmeda for all repair parts replacements. Read completely through each step in every procedure before starting the procedure; any exceptions may result in a failure to properly and safely complete the a忧:empted procedure. 08;07 Ml1l0140

Impo此ant..................................................................... .ii Technical Competence . ...................... ............................... .... .ii 1.1 What this manual includes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2 1.2 Standard service procedures . . . . . . . . . . • . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3 1.2.1 User's Reference Manuals . . . . . .. . . .. .•. . . .. .. .. . . . . " . . .. •. .. . . .•. . .. .1-3 1.2.2 Software versions . . . .. . .. . . .. .. . . .. .. . . . . .. .. .. . .. . . . . .. .. .. . . . .. . .. .1-3 1.2.3 Ventilatortests ....................•...............................• .1-3 1.3 Overview .. . . . . . . . . .. .. . . . . . ... . . .. ... . . .. .. . . .. .. .. . . . . .. . . .. . . . . . ... .. .. .1-4 1.3.1 Aespire 100 ....................................................... .1-4 1.3.2 S/5 ProTIVA ....................................................... .1-4 1.4 Configuration options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5 1.4.1 Standard con自guration .............................................. .1-5 1.4.20p回ons ........................................................... .1-5 1.5 Components .••....•.......•.....•••...........•.......•................• .1-5 1.6 Symbols used in the manual oron the equipment. . ..•. .. .. .... . .. . .•. .. .. .••.. 1-10 iii

Iv 2.1 Theoryoverview ................................... ........................ .2-2 2.2 Gas 何owthrough the anesthesia machine ..................................... .2-2 2.2.1 Overview .......................................................... .2-2 2.2.2 Physical connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6 2.2.3 Suction regulators •................................................. .2-7 2.2.4 System switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8 2.2.5 Flow control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9 2.3 Flow through the breathing system .......................................... 2-11 2.3.1 Overview offlow paths .. .... ...................... ....... ...... ..... 2-11 2.3.2 Manual ventilation.. .. . . .. . . . . . . .. . . . . .. . . . . . . .. . . . . .. . . .. .. .. . . . . .. 2-12 2.3.3 Mechanical ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15 2.3.4 Fresh gas and O2 flush flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22 2.4 General Description ...................................................... 2-24 2.5 7100ventilatorfeatures......................... ........ ............. ..... 2-25 2.5.1 Safetyfeatures ............. ....... .................... ....... .... . 2-25 2.67100 ventilator components . . . . . . . . . . . . . . . . • . . . . . . . . . . . . . . • . . . . . . . . . . . . . .. 2-26 2.6.1 Control Module (color display) ....................................... 2-27 2.6.2 Control Module (non-color display) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-28 2.6.3 Monitoring interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29 2.6.4 Serial interface .... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29 2.6.5 The Pneumatic Vent Engine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-30 2.7 Electronic and electrical components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-31 2.7.1 The Aespire 7100 ventilatorfunctional blocks . . . . . . . . . . . . . . . . . . . . . . . . . .. 2-31 2.7.2 Power Supply ..................................................... 2-32 2.7.3 Sealed Lead Acid Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-32 2.7.4 Control Board ..................................................... 2-33 2.7.5 Monitoring interface .. .. . . . . . .. . .. . . . . .. .. . . . . .. .. . . .. .. .. .. . . .. . . .. 2-37 2.7.6 Serial interface .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 08;07 Ml110140

Table of Contents 3.1 Ventilator post-service checkout ............................................. .3-2 3.2lnspect伽e system ........................................................ .3-2 3.3 Pipeline and cylindertests ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3 3.4 Flow control tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4 3.4.1 With O2 monitoring....................... .................... ....... .3-4 3.4.2 Without O2 monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 3-6 3.5 Pressure relieftests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8 3.6 O2 supply alarm test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8 3.7 Flush FlowTest............................................................ .3-8 3.8 Vaporizer back pressure test ............................................... 3-10 3.9 Low-p陪ssure leaktest .................................................... 3-11 3.9.1 Negative low-pressure leak test ...................................... 3-11 3.9.2 ISO or BSI standard low-pressure leak test ............................. 3-12 3.10 Alarm tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 3-14 3.11 Breathingsystemtests................................................... 3-16 3.12 Auxiliary02 t1owmetertests ...............................................3-18 3.13lntegrated Suction Regulatortests ......................................... 3-18 3.14Powerfailuretest ....................................................... 3-19 3.15 Electrical safetytests .................................................... 3-19 4 Self Tests and Servlce Mode Ml110140 08/07 4.1 Selftests ................................................................. 4-3 4.2 Service Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4 4.3 About Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5 4.4 Alarm Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6 4.5 Error Log . . .... . . ... . . . . . .. . . .. .. .. . . ..... . . . . .... . ... . . . . .. .. .. .. .. . . .. .. .4-7 4.6 Language ..... ........ ................................. .............. .... .4-8 4.7 User Settings .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9 4.7.1 Screen Contrast ......... v

4.10.1 Display A/D Channels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25 4.10.2 Display Discrete 1/0 Signals . . .. . . . . .. . . . . . .. . . . . .. . . . . .. . . . . . . . . . . . 4-27 4.10.3 Display Battery Status .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28 4.10.4 Test Panel Switches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29 4.10.5 Valves -Test Tool ................................................. 4-30 4.10.6TestCPU and Memory ............................................. 4-31 4.10. 7Test EEPROM .................................................... 4-32 4.10.8 Test Serial Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33 4.10.9Test5VFaiIAlarm.................................................4-34 4. 10. 10Test InspiratoryValve ............................................. 4-35 4.10.11 Test PEEP Valve ................................................. 4-36 4.10.12TestPEEPSafetyValve ...........................................4-37 4.10.13 BreathingSystem LeakTest ....................................... 4-38 4.10.14 Test Pressure Limit Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-38 4.11 Upgrade Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-40 5.1 Primary Regulators ......................................................... 5-2 5. 1.1 Testsetup ......................................................... .5-2 5. 1.2 Testing Primary Regu lators …........................................ .5-3 5. 1.3 Adjusting Primary Regulators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6 5.2 Secondary Regulators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-7 5.2.1 Testing/ Adjusting Secondary Regulators or Balance Regulators . . . . . . . . . . . . . .5-7 5.3 Flowmeter Needle Valve Calibration .......................................... .5-8 5.3.102 Needle Valve Calibration (Minimum Flow). . . . . . . . . . . . . . . . . . . . . . . . . . . .. 5-8 5.3.2 N20 Needle Valve Calibration (Minimum Flow). . . . . . . . . . . . . . . . . . . . . . . . . .. 5-10 5.3.3 Air Needle Valve Calibration (Minimum Flow). . . . . . . . . . . . . . . . . . . . . . . . . . .. 5-14 5.4 Link system calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 5-17 5.5 O2 Flush Regulator ....................................................... 5-22 5.6Ai阳ay pressure gauge .................................................... 5-23 5.6.1 Zero the pressure gauge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 5-23 5.6.2 Checking the pressure gauge accu阳cy ................................ 5-24 08/07 Mll10140

6 Installatlon and Malntenance 7 Troubleshootlng 850甜ware Installatlon Mlll0140 08/07 6.1 Aespire 7100 Ins姐lIation Checklist. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . • . . . . . .6-2 6.2 Aespire 7100 Planned Maintenance. ... . .. .... . . .. .. . . .. .. .. .. . .•. . .. .. .. . . . . .6-4 6.2.1 Every twelve (12) months . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-4 6.2.2 Every twenty-four (24) months ........................................ .6-5 6.3 Free breathingvalve maintenance . .. .. .. . . .•.. . . . .•. .. . . . . . ., . . • • •• •. . . .. .. . . .6-6 6.4 MOPV pressure reliefvalvetest .............................................. .6-7 6.4.1 Testsetup ......................................................... .6-7 6.4.2 Test procedure ...................................................... 6-7 6.5 Auxiliary 02 四owmetertests . . . .. . . . .•.. .. .. .. . . . . .. . .. . . .. .. . . .. . . . . . . .. .. . . .6-8 6.6lntegrated Suction Regulatortests ........................................... .6-9 7.1 GeneralTroubleshooting. .. . . .. .. . . . . ... . .. .. ... . .. ... . . . . ... . .. .... .. .. . .. . .7-2 7.2 BreathingSystem LeakTest Guide. .. .. .. . . . . . ... . . ..••. . . . . .. . . . . .•. . . . .. ... . .7-4 7.2.1 Breathingsystem leaktest....................... ............... ...... .7-5 7.2.2 BreathingSystem Troubleshooting Flowcharts ............................7-7 7.2.3 Leak lsola甘on Tests ........................•.............•......... 7-12 7.3 Troubleshooting guide ....................................................在28 7.4 Alarm and Error messages ......... . . . .. .. . . .. .. .. . . .. . . . . . . .. .. . ... .. . . . .. 7-30 7.5 Troubleshooting Flowcharts .. .. .... .. .... .. .... . . .. .... .. . . .. . . . . .. . . . .. .., 7-41 7.5.1 Ventilator assessment process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 7-41 7.5.2 No displaytroubleshooting. …………………………………… 7-42 7.5.3Inaccurate volume ventilation troubleshooting. . . .. . . . . . . .. . . . . .. . .. . . .., 7-43 7.5.4 VMB board evaluation .............................................. 7-44 7.5.5 No ventilation troubleshooting. ………………………………… 7-45 7.5.6 High intrinsic PEEP troubleshooting. …………………………….. 7-46 8.1 Before installing new software or replacing the Control Board •...................• .8-2 8. 1.1 KeyjBID label (Key Code) ............................................ .8-3 8.2 After replacingthe Control Board orthe Control Module .......................... .8-4 8.2.1 Calibration and Checkout ............................................ .8-5 8.3So阳are Installation .. . . . . . . . . . . . . . . . . . . • . . . . . . • . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-6 vll

viil 9.1 Howto bleed gas pressure from the machine . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . .. .. .9-4 9.2 Howto remove the rear panels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. .9-4 9.2.1 To remove the rear upper panel . . . .. . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . .. .9-4 9.2.2 To remove the lower access panels.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. .9-4 9.3 Howto remove thetabletop .. . . . . . . . . . .. . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . .. .9-5 9.4 Servicing the pipeline inlet manifold components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-6 9.4.1 Replace pipeline inlet filter ........................................... .9-6 9.4.2 Replace pipeline inletcheckvalve ..................................... .9-6 9.4.3 Replace the inlet manifold . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. .9-7 9.5 Service the cylinder supply modules . . . . .. . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . .. .9-8 9.5.1 Tightening procedure for high-pressure tube 币ttings . . . . . . . . . . . . . . . . . . . . . .. .9-8 9.5.2 Replace primary regulator module (complete replacement) .................9-8 9.5.3 Replace cylinder inlet filter ........................................... .9-9 9.5.4 Replace cylinder check valve. . . . . . . . . .. . . . . . . . . . . . . . . . . . .. . . . . .. . . . . .. .9-9 9.5.5 Replace 3时-gas cylinder supply module .. .. . .. .. . .. .. .. . .. .. . .. .. .. .. . 9-10 9.6 Replace system switch assembly . . . . . . . . . . . . . . . . . .…………………….. 9-11 9.7 Service the flowmeter module .............................................. 9-13 9.7.1 Remove front flowmeter panel shield .................................. 9-13 9.7.2 Remove flowtubes for cleaning or replacement . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13 9.7.3 Remove complete flowmeter head .. .. .. .. . .. . .. .. .. .. .. . .. . . .. .. .. ... 9-15 9.7.4 Replaceflowmetermodules ......................................... 9-16 9.7.5 Replace flowmeterframe . . . . . . . .……………………………… 9-20 9.7.6 Replace O2 supply switch ........................................... 9-21 9.7.7 Checkout procedure for O2 supply switch .............................. 9-21 9.7.8 Replace secondary regulator manifold or balance regulator manifold ....... 9-22 9.7.9 Replace O2 or N20 needle valves (on machines with N20) . . . . . . . . . . . . . . . .. 9-23 9.7.10 Replace an Air needle valve on all machines or an O2 needle valve on machines without N20 ........................................... 9-25 9.8 Service vaporizer manifold parts ........ . 08/07 MI110140

9.13.1 Servicing the bag support arm ...................................... 9-38 9.13.2 Replace 伽ction pad in lower bag arm assembly . . . . . . . . . . . . . . . . . . . . . . .. 9-39 9.13.3 Replace bag port housing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 9-40 9.14 Replace a以iliary O2 flowmeter ............................ . . . . . . . . . . . . . . .. 9-41 9.15 Replace the suction control module ..................................... . .. 9-42 9.15.1 Front panel method ............................................... 9-42 9.15.2 Rear panel method ............................................... 9-43 9.16 Replace ABS breathing system components .............................. . .. 9-44 9.16.1 Replace Bag,lVentswitch assembly.................................. 9-44 9.16.2 Replace bellows base latch assembly ......... . .. . .. . . .. .. . . . . .. . . . .. 9-45 9.16.3 EZchange Canister spring replacement.………………………… .9-46 9.17 Replace casters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 9-47 9.18 Replace task light and switch ............................................. 9-48 9.18.1 To replace the task-light switch . . . . .. . . .. . .. . .. .. . . . . . . . . .. . . . . .. .. .. 9-48 9.18.2 To replace the task-light circuit board ................................ 9-48 9.19 Replace the display arm or display cables ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-49 9.19.1 Cabletieinstallation .............................................. 9-49 9.19.2 Removingthedisplayarm.......................................... 9-50 9.19.3 Replacing a display cable ...... . . .. . . . . .. .. . . .. .. . .. . .. . .. . .. . .. .. . 9-50 9.19 .4 lnstalling 由e long arm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-51 9.19.5Installing the short arm ............................................ 9-52 9.20 Replace display and cables in ProTIVA machine .............................. 9-53 9.21 Change drive gas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-54 9.22 Control module ............. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-55 9.22.1 Colorcontrol module .............................................. 9-56 9.22.2 Original control module . . .. .. .. . . .. .. . . .. .. . . .. .. . . . . .. . .. . . . . .. .. . 9-61 9.23 Servicing the Vent Engine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 9-67 9.23.1 To remove the Vent En U

x 10.1 Service tools ........................................................... 10-3 10.1.1 Secondary regulator pilot pressure tool ..... . . . . . . . . . . . . . . . . . . . . . . . . .. 10-3 10.1.2 Test Devices ........................... . . . . . . . . . . . . . . . . . . . . . . . . " 10-4 10.1.3 Test Tools ...............................•....................... 10-5 10.2 Extemal components- 骨。ntview... . ... .. . ... . . . . .. . . . . . . .. . . . . ... .. .. ..... 10-6 10.3 Extemal compone阳- front view references ................................. 10-7 10.4 Extemal Components - rear view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 10-8 10.5 Control module mounting for a ProTIVA machine . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 10-9 10.6 Aespire 100 -exclusive components ...................................... 10-10 10.6.1 AC Inlet(Aespire 100) ............................................10-12 10.6.2 Display mount (Aespire 100). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 10-13 10.7 Front panel, gauges and s:如tem switch .................................... 10-14 10.8 Rear panel components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 10-15 10.9 Tabletop components.. .. . . ... . . .. . . . . . .. . . . . " .. . . . . . . . . . . . . .. . . . .. .. .. 10-16 10.10 Right-side Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 10-17 10.11 臼ternal components -Iower assembly ................................... 10-18 10.12ACPowercords................................. ......................10-19 10.13 AC InletjOutlet Components . . . . . . . . . . . . . . . . . . • . . . . . . . . . . . . . . . . . . . . . . . .. 10-20 10.14 Pipeline inlet 自创 ngs................................................... 10-22 10.15 Cylinder Gas Supplies ................................................. 10-23 10.15.1 Cylinder inlet 币四 ngs............................................. 10-24 10.16 Vaporizer manifold . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 10-25 10.17 Flowmeter components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 10-26 10.17.1 Flowtube parts ................................................. 10-28 10.17.2 Secondary regulator components ................................. 10-30 10.18 ABS to machine Interface Components .................... . . . . . . . . . . . . . .. 10-32 10.18.1 Flush Regulator, Flush Valve, and ACGO Selector Switch . . . . . . . . . . . . . .. 10-33 10.19 Auxiliary O2 Flowmeter . . . . . . . ω1/07 Ml110140

10.21.1 APL Valve ..................................................... 10-36 10.21.2 Bag/'VentSwitch .......••...................................... 10-37 10.21.3 Absorbercanister.. .. . . .. .. . . . . .. .. .. .... .. . .. .... . ... .. . . . ... .. 10-38 10.21.4 Row Sensor Module. …………………………………….. 10-39 10.21.5 Breathing Circuit Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 10-40 10.21.6 Exhalation valve . . . ... . .. .. .. . . .. .. .. .. . . .. . . ... . . . .. . . . . . . .. . .. 10-41 10.21. 7 Bellows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 10-42 10.21.8 Bellow base..... ...... ............ ............•.....••... ..•... 10-43 10.21.9 BagArms ..................................................... 10-44 10.21.10 EZchange Canister system (C02 Bypass). . . . . . . . . . . . . . . . . . . . . . . . . .. 10-45 10.21.11 Condenser .......... ............................ ....... ...... 10-46 10.22 Display cables, serial board, AGSS flowtube, and sample return .............. 10-48 10.23 Vent Engine Housing .................................................. 10-49 10.24 Vent Engine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 10-50 10.24.1 Vent Engine - under side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 10-51 10.24.2 Manifold plate. …………………………………………. 10-52 10.25 Display A部embly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 10-53 10.25.1 Display components (Color) .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 10-54 10.25.2 Display Keyboa刚 and LCD assembly (Color) . . . . . . . . . . . . . . . . . . . . . . . .. 10-55 10.25.3 Display components (non-color). ……………………………. 10-56 10.25.4 Display, front cover assembly (non-color) . . . . . . . . . . . . . . . . . . . . . . . . . .. 10-57 s s10.25.5 Display Keyboard and LCD assembly (non-color) ........... . . . . . .. 10-58 10.26 Legris quick-release 币四ngs............................................. 10-59 10.27 Vent Drive and low-pressure tubing ...................................... 10-60 10.28 Tubing for use with Legris 币创 ngs......................................... 10-62 10.29 Cables and harnesses ................................................. 10-64 10.30 Cables and harnesses (Aespire 100) ........... . . . . . . . . . . . . . . . . . . . . . . . . .. 10-66 10.31 Anesthetic Gas Scavenging System - AGSS ... . . . . . . . . . . . . . . . . . . . . . . . . . . .. 10-68 10.31.1 11 Schematlcs and Dlagrams Ml110140ω1/07 国

1his section provides a general overview ofthe Aespire 7100 line of anesthesia machines. M1110140 08/07 1.1 What this manual includes . . . . . . . .. . . . .. . .. . . . .. . .. . .. . . . . . .. . . . . . .. .. . . .. . . .1-2 1.2 Standard service procedures . . . . . . . . . . . .. . . . . . . . .. . . . . .. . . . . .. .. .. . . . . . . .. . . .1-3 1.2.1 User's Reference Manuals ...................... .......... .......... .. .1-3 1.2.2 Software versions . . .. .. . . .. . . . . . . .. . . . . .. . . . . ...…..….... ........ .1-3 1.2.3 Ventilatortests ..................................................... .1-3 1.3 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . • . . . . . . • .1-4 1.3.1 Aespire 100 ....................................................... .1-4 1.3.2 S/5 ProTlVA ....................................................... .1-4 1.4Configur甜 on options ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . • . . . . . . . . . . . . . . . . . . . • .1-5 1.4.1 Standard c。而guration ............................................... 1-5 1.4.20ptions ........................................................... .1-5 1.5 Components ..........................................•.................. .1-5 1.6 Symbols used in the manual oron the equipment .. . . .... . . . . .. . . .. ... . . .. . . ... 1-10 1-1

Anesthesla Machlne 刊 is manual covers the service information for 由eA臼pire 7100 line of anesthesia machines. It covers the following components: • 7100 display components: color and non-color • Vent Engine components • gas delivery components, • breathing system components, • frame component (except those strictly associated with a specific ventilator), • optional suction regulator and auxiliary O2 flowmeter. 5/5 ProTlVA The ProTIVA machine is configured with s'恼 ndard Aespire machine components, with the exception ofthe vaporizer manifold and the Ventilator/ Monitoring Display (7100 Control Module) mounting solution (referto Section 10.5). B Braun equipment is not covered in this manual. Refer to B B 阳 un service documen回tion. Other equlpment Other equipment may be attached to the system on the display mount, the top shelf, or on the side dovetail rails. Consult separate documentation relative ωthese items for details. 1-2 08/07 M1110140

1.2.1 User's Reference Some sections ofthis manual referyouωthe User's Reference Manual forthe Manuals Aespire machine. To expedite repai邸， you must have, and be familiarwith，由e User's Reference Manuals forthis product. Referto the Aespire User's Reference Manual if you need further information about the operation of the system. 1.2.2 Software verslons The revision level is displayed on the ventilator sta阳 p menu. This manual includes test and calibration procedures for Revision 1.X and 2.X software. 1.2.3 Ventllator tests Service calibration functions let Datex-Ohmeda trained users and Datex-Ohmeda service personnel perform ventilator setup functions, tests, calibration and measurements from the front panel display. Normal operational tests, calibration, and troubleshooting can be performed on your 7100 ventilatorwithout removing components from the system. Repair may require removing the ventilator components from the anesthesia machine. &. WARNING Section 4, "SeNice Mode Tests and Calibration" must be performed whenever you access any internal component of the ventilator to verify that all critical parts ofthe ventilator are still operational and within specification. &. WARNING Afterthe ventilator has been serviced, you must perform uposιSeNice Checkout" to verify the entire anesthesia system is properly functioning beforethes归tem can be retumed to clinical use. Ml110140ω~ ~

delivery system. The ventilator portion provides mechanical ventilation to a patient during surgery as well as monitoring and displaying various patient parameters. 刊 e system uses a microprocessor-controlled ventilatorwith internal monitors, electronic PEEP, Volume Mode, and otheroptional features. A serial interface permits communication to cardiovascular and respiratory gas monitoring. Note Configurations available for this product depend on local market and standards requirements. IlIustrations in this manual may not represent all configurations ofthe product. The Aespire machine is not suitable for use in an MRI environment. 1.3.1 Aesplre 100 The Aespire 100 machine is based on the standard Aespire 7100 machine with the following exceptionsωavailable features or options: • does not include the RS232 Seriallnterface • does not include the Bi-Ievel LED light strip • the 2 Vap manifold is standard (does not support 1 Vap manifold) • not available with AC power outlets (area used by AC Inlet) • uses 4-inch casters instead of 5-inch casters 1.3.25/5 ProTIVA The S/5 ProTIVA is a special adaptation ofthe Aespire 7100 machine (does not include vaporizer manifold) for use with B Braun intravenous drug delivery components. 1-4 08/07 M1110140

1.4Con由guration options 1.4.1 Standard conflguratlon 刊e standard configuration includes the following items. Items marked with an asterisk (叮 are not included in the Aespire 100 machine. • 7100 Ventilator (with color or non-color display) • Advanced Breathing System (ABS) • Auxiliary Common Gas Outlet (ACGO) • Seriallnterface - RS232* • Bi-Ievel LED light strip* • Two large drawe陪 1.4.2 Optlons Options include the following items. 1.5 Components Mll10140 08/07 Items marked with an asterisk(叮 are not available in the Aespire 100 machine). • selected software features • vaporizer manifold (1 Vap* or 2 Vap) • pipeline configurations (02/N20, O2/ Air, or 02/N20/ Air) • gas cylinder configurations (two inboard, one outboard) • inboard configuration - 02/N20, 02/Air, or02/02 • outboard configuration - N20 only • manual bag (on SUppo此 arm or on tube) • EZchange Canister (C02 Bypass) and Condenser • gas scavenging (active, adjustable, passive, orventuri) • a suction regulator (pipeline vacuum or venturi vacuum) • an auxiliary O2 flowmeter • localized electrical poweroutlets* (isolated ornon-isolated) • various display mounting solutions The following figures show the front and rear views ofthe machine. There are some differences between models. Figure 1-1 • Aespire machine (frontview -Ieftside) Figure 1-2 • Aespire machine (frontview - rightside) Figure 1-3 • Aespire machine (rear view) Figure 1-4 • S/5 ProTIVA with a typical B Braun fluid manager (fm) system 1町5

2. ACGO 3. Insplratory check valve 4. Insplratory flow sensor or 饵owpo此 adapter 5. Canlster (ca巾on dloxlde abω巾ent) 6. Canlster release 7. Explratory flow sensor or flow port adapter 8. Leak test plug 9. Explratory check valve 10. Breathlngsystem release 11. Manual bag port 12. APl(adJustable pre部ure-lImltlng) valve 13. Bag，tVent 棚Itch 14. Bello嗣 assembly 15. 脚，路ure gauge (allWay) 16. Sample gas retum port 17. Scavenglng flow Indlcator 18. R5-232 Serlal port (not avei灿 lein 由eh即ire 1∞ machlne) Rgure 1-1 • Aespire machine (front view -Ieft side) 1-6 1 2 08/07 M1110140

2. Row contrals 3. Ve耐 lator Dlsplay/Co睛olMωule (color or non-color) 4. Dovetall ralls 5. Vaporlzer 6. 阴 pellne pressure gauge(s) (upper row) 7. System sw\tch 8. 句Ilnder pressure gauge(s) 刷刷rro呐 9. 02 阴山h 10. AuxlllalJ O2 匍跚meter 11. 5uc制，四 relÞllator Figure 1.2 • Aespire machine (阳ntview -right side) M1110140 08/07 4 s e y llntroduction 1-7

1 2 3 匠。，。啼， 1. Clrcult Breaker for Electrlcal Outlets. 2. 目ectrlcalOutlets. 3. 阴 pellne Connectlon(s) 4. Cyllnder 5uppllω 5. S归lem Clrcult Breaker (AC Inlat fus笛 forA键plre 1∞ mac刷刷 6. Malns Inlet 7. Equlpotentlal 5tud 事 Items marked w灿 an asteñsk 俨) are not available in the Aespire 100 machine. Rgure 1-3 • Aespire machine (rearview) 1-8 08/07 Mll10140

2. 句rlnge pumps (3) 3. fmωn阳11.， 4. fm 创IIRputer 5. 阳 segment 1 Figure 1-4 • 5/5 Pro TIVA with a typi，臼I B Braun fluid manager(i加I)system Mll10140 08/07 llntroduction 5 1-9

O 。 O 。 O ~ ④ -L l 专 1-10 On (power) 0仔 (power) Standby Symbols replace words on the equipment, on the display, or in Datex-Ohmeda manuals. No one device or manual uses all of the symbols. Warnings and Cautions tell you about dangerous conditions that can occur if you do notfollow all instructions in this manual: • Warnings tell about a condition that can cause injury to the operator or the patient. • Cautions tell about a condition that can cause damage to the equipment. Read and follow all warnings and cautions. 因 Alarm silence 三只 Alarm silence 安 Type B equipment Standby or preparatory state for part of 囚 Type BF equipment the equipment "ON" only for part ofthe equipment 圃 Type CF equipment "OFF" only for part ofthe equipment A Caution, ISO 7000-0434 Direct current &A Attention, refer to product instructions, IEC 60601-1 Alternating current Dangerous voltage Protective earth ground G• Electrical input Earth ground 。争 Electrical output Frame or chassis ground E Pneumatic input Equipotential 曰争 Pneumatic output 08/07 M1110140

~ Movement in one direction Minus, negative polarity 等--击' Movement in 000 directions 4ζ二1 Variability U Read top offloat ..c::It3口 Variability in steps e Read to center offloat -:C艾- Lamp, lighting, illumination 。+ Vacuum inlet II Thiswayup E Suction bottle outlet 矿ICIÞ Pipeline Cylinder 自 Lock ]II[ Isolation transformer 自 Unlock Jt'r Linkage system ,. Close drain ⑧ Risk of Explosion. ,. Drain (remove condensate) ~~已 L川… l叫 • ⑧ Not autoclavable 因 Mechanical ventilation 1340 C Autoclavable ~ Bag position/ manual ventilation '&=cmH20 APL settings are approximate 02+ O2 Flush button M1110140 08/07 1-11

:• Bain/Mapleson D breathing circuit module 俨h The primary regulator is set to pressure 俨 The primary regulaωr is setto pressure less than 345 kPa (50 psi) less than 414 kPa (60 psi) 9+ Absorberon A CO2 Bypass Option C02 。毕 雷鸣2 EZchange Canister (C02 bypass) Absorber off (C02 Bypass active) 00 No battery/ba忧:ery failure -l Ba忧ery in use. Bar indicates amount of ba忧:ery power remaining. REF Stock Number MAX Maximum SN Serial Number |政 ONLyl Caution: federallaw prohibits dispensing without prescription. ~叫 Authorized representa回ve in the European CE Systems with this mark agree with the Community European Council Directive (93/42/EEC) E皿Z for Medical Devices when they are used as specified in their User's Reference d Date of Manufactur manuals. The 以xx is the certification number ofthe Noti币ed Body used by Datex-Ohmeda's Quality Systems. " Manufacturer e GOST R Russian certification 1-12 08/07 MI110140

In this section 2.1 Theoryoverview ........................................................... .2-2 M1110140ω:/07 2.2 Gas flowthrough the anesthesia machine ..................................... .2-2 2.2.1 Overview .......................................................... .2-2 2.2.2 Physical connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6 2.2.3 Suction regulators .................................................. .2-7 2.2.4 System switch ................... .................. ............... .. .2-8 2.2.5 Flow control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9 2.3 Flowthrough the breathingsystem .......................................... 2-11 2.3.1 Overviewofflowpaths .............................................. 2-11 2.3.2 Manual ventilation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 2-12 2.3.3 Mechanical ventilation . . . . . . . . • . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . " 2-15 2.3.4 Fresh gas and O2 flush flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 2-22 2.4 General Description ...................................................... 2-24 2.5 7100 ventilator features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . • . . . " 2-25 2.5.1 Safety features .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 2-25 2.6 7100ventilatorcomponents ............................................... 2-26 2.6.1 Control Module (color display) ....................................... 2-27 2.6.2 Control Module (non-color display) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 2-28 2.6.3 Monitoring interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 2-29 2.6.4 Serial interface ................ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29 2.6.5 The Pneumatic Vent Engine . . . . • . . . . . . . . . . . • • . . . . . . . . . . . . . . . . . . . . . . " 2-30 2.7 Electronic and electrical components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-31 2.7.1 刊e Aespire 7100 ventilatorfunctional blocks . . . . . . . . . . . . . . . . . . . . . . . . . .. 2-31 2.7.2 Power Supply ........•............................................ 2-32 2.7.3 Sealed Lead Acid Ba阳 ry. . .. .. .. . . .. . . . . .. . . . . . . .. . . . . . .. . . . . ... . '" 2-32 2.7.4 Control Boa时..................................................... 2-33 2.7.5 Monitoring interface .. . .. . . . .. .. . . .. . . . . .. . . . . . . .. . . . . . . .. . . .. . . . ... 2-37 2.7.6 Serial interface .......... . . . . . . . . . . . . . . . . . . . . . 2-1

刊 is section describes: • The f10w of gas through the anesthesia machine. • The f10w of gas through the breathing system. • Electrical signals between the anesthesia machine, includingthe breathingsystem, and the ventilator. • Ventilator mechanical subsystems 2.2 Gas flow through the anesthesia machine 2-2 2.2.1 Overvlew Refer to Figu re 2-1. Gas supplles Gas comes into the system through a pipeline (2) or cylinder (4) connection. AII connections have indexed fittings, filters, and check valves (one-way valves). Gauges show the pipeline (1) and cylinder (3) pre臼ures. A primary regulator (5) decreases the cylinder pressuresωapproximately pipeline levels. A pressure relief valve (6) helps protect the system from high pressures. To help prevent problems with the gas supplies: • Install yoke plugs on all empty cylinder connections. • When a pipeline supply is adequate, keep the cylinder valve closed. O2 flow Pipeline or regulated cylinder pre臼ure supplies O2 directly to the ventilator (7a for O2 drive gas) and the venturi suction (21a for O2 drive gas) supply connection. An additional regulator(13) decreases the pressure forthe flush valve (14a) and the auxiliary flowmeter (25). The flush valve supplies high flows of O2 to the fresh gas outlet (26 or 27) when you push the flush button. The flush pressure switch (14b) monitors activation of the flush valve. When the system switch (8) is On, O2 flows to the rest ofthe system. A secondary regulator (10) supplies a constant O2 pressureωthe O2 flow control valve (11). There is a minimum flow of 25 to 75 mLjmin (for dual-tube flowmeters) or 175 to 225 mL/min (for single-tube flowmeters) through the O2 flowmeter (12). The O2 pressure switch (9) monitors the O2 supply pressu陀. Ifthe pressure is too low, an alarm appears on the ventilator display. 08/07 MI110140

Note: Original production machines include a secondary regu lator (18) atthe inputto the Airflow control valve (19). Mlxedgas MI110140 08/07 2 Theory of Qperation Pipeline or regulated cylinder pressure supplies Air directly to the ventilator (7b for Air drive gas) and the venturi suction (21b for Air drive gas) supply connection. When the system switch (8) is On, airflows to the Airflow control valve (19). Because there is no balance regulator, airflow continues at the set rate during an O2 supply failure. A balance regulator (15) controls the N20 supply pressureωthe N20 flow control valve(16). The O2 secondary regulator pressure at a pilot port controls the output ofthe balance regulator. The N20 output pressure drops with decreasing O2 supply pre臼ure and shuts off hypoxic gas flow before the O2 supply pressure reaches zero. A chain link system (Unk-25) on the N20 and O2 flow controls (16, 11) helps keep the O2 concentration higherthan 21 % (approximate value) at the common gas outlet The mixed gas goes from the flowmeter outlet, through the vaporizer manifold and vaporizer (23) that is On ， ωthe ACGO selector switch (曰. A pressure reliefvalve (24) limits the maximum outlet pressure. The ACGO selector switch directs the mixed gas to the selected circuit - to the breathi ng system (26) orωthe ACGO (27). 2-3

Components Note: Current production machines do not include a secondary regulator (18) in the Air flowhead module. Key to Symbols 2-4 1. Pipeline pressure gauge 2. Pipeline inlet 3. Cylinder pressure gauge 4. Cylinder inlet (maximum of 3 cylinders) 5. Primary regulator (cylinder pressure) 6. High-pre臼ure reliefvalve (758 kPa j 110 psi)* 7. Supply connections forthe ventilator a. O2 drive gas b. Air drive gas 8. System switch 9. Switch for low O2 supply pressure alarm (used with the ventilator) 10. O2 secondary regulaωr(207 kPa j 30 psi)* 11. O2 flow control valve 12. O2 flow tube(s) 13. O2 flush and auxiliary flowmeter 陀gulator(241 kPa j 35 psi)* 14. O2 Flush a. Flush valve b. Pressure switch (used with the ventilator) 15. N20 balance regulator 16. N20 flow control valve 17. N20 flow tube(s) 18. Air secondary regulator (207 kPa j 30 psi)* 19. Airflow control valve 20. Air flow tube(s) 21. Supply connection forVenturi suction a. O2 drive gas b. Air drive gas 22. Vaporizer port valve 23. Vaporizer 24. Low-pre臼ure reliefvalve (38 kPa j 5.5 psi)* 25. Auxiliary flowmeter (optional) 26. ToABS 27. ToACGO 28. Test port (primary regulator) 29. Test port (secondaryjbalance regulator) * Approximate values t唾)+( Pneumatic Connection obAV Rlter Direction of Flow CheckValve 08/07 M1l10140

26 27 。2 4 IO()1 L旦」 148 日再「 1 l 1 W[D--τL i)(| 02 4 2 Alr 4 28 2 N20 4 28 nu=ZE 守hdd ‘ -m -Ul-- -n 主 -nrp • 2 • 2 -2 啕，. 「|t|- A. Cyllnder Supplles B. 阳eumatlc Manlfold C. 目øwmeter Head D.Vaporlzer 翩翩lfold E. ACGO Select SWltch 2-5 Figure 2-1 • Pneumatic circuit 08/07 Mll10140

connectlons 口问口守 h内田，吨 ABS Rgure 2-2 • Typical tubing connections -picωrial 2-6 08/07 Ml110140

2.2.3 Suctlon Plpellne vacuum regulators 1he suction regulator (shown in Figure 2-2) uses an external vacuum source. Venturl Drlve Gas Alror02 Rgure 2-3 • Venturi suct;on Mll10140ω1/07 Venturl Drlve vacuum 1he suction regulator (shown in Figure 2-3) uses an internal, venturi derived vacuum source. Drive gas (internally plumbed Alr or O2) enters the Venturi Module 阳M) atthe drive po同 (A). As the drive gas passes through the venturi module, a vacuum is created at po同 B. 1he drive gas exits the venturi module at port C and is exhausted outside the machine through the muffler (D). 1he control port (E) on the venturi module r，臼ponds to pneumatic signals from the front panel switch on the Suction Control Module (SCM) to turn the venturi vacuum drive gas on or off. The check valve (CV) helps prevent pressur国tion ofthe suction circuitry ifthe exhaust is occluded or the venturi unit fails. E - c 圃 E 仁=:lIJ国 Suctlon - --1 I D E t 2-7

栅Itch In the Standby posltlon 1he switch: • Tums off the ventilator (electrical). • Stops O2 and Air to the flowhead (pneumatic). • Without O2 pressure，由e N20 balance regulaωrstops N20. In the On posltlon 1he switch: • Turns on the ventilator (electrical). • Supplies O2 and Air to the flowhead. • With adequate O2 pressure, the N20 balance regulator supplies N20. 2-8 句stem Swltch ( electrlcal) tt::国D (Rear阴阳} 句悦em S1回tch (pneumatlc) 佣:;07 Ml110140

2.2.5 Flow control Needle valves (one for each gas) adjust gas flows. Clockwise rotation decreases flow. Countercloc阳ise increases flow. Mechanical stops set minimum flows for all gases. The link system sets the maximum ratio of N20 to O2, &. WARNING The Link 25 Proportioning System sets a minimum O2 concentration in the fresh gas stream when only O2 and N20 are used. Use of an absorber or another gas can still cause a hypoxic mixture to be delivered to the patient, especially at low O2 flow rates. Mlnlmum flows At minimum flow, two tabs prevent clockwise rotation of the valve stem. One tab is on the stop collar; the other is on the valve body. ValveStem Stop Collar ValveBody Llnk system The chain link system helps assure an approximate minimum 1 to 3 ratio of flow Mll10140 08/07 between O2 and N20. When engaged (minimum O2 concentration), a tab on the O2 knob is in contact with a tab on the O2 sprocket so that the O2 and N20 knobs tum together: • an increase in N20 flow causes an increase in O2 flow, • a decrease in O2 flow causes a decrease in N20 flow. UnkageTabs O2 恼10b 2-9

reducing the N20 flow below the point of engagement or by increasing O2 flow above the point of engagement When the N20 flow is below the point of engagement, increasing the N20 flow turns the O2 sprocket without changing the O2 flow. At the point of engagement, the tab on the O2 sprocket makes contact with the tab on the O2 knob. Once the linkage is engaged, turning the N20 flow control counterclockwise (increase in N20 flow) also turns the O2 knob counterclocl例ise (increase in O2 flow) to maintain a nominal25% minimum O2 concentration. Decreasing the N20 flow from the engagement point rotates the tab on the O2 sprocket away from the tab on the O2 knob. Increasing the O2 flow rotates the knob tab away from the sprocket tab. Either action increases the O2 concentration above 21 %. Sufficiently decreasing O2 flow or increasingthe N20 flow brings the two tabs back into contact and engages the linkage. The kick-in point is defined as the N20 flow at which the N20 valve becomes engaged with the O2 valve flowing at 200 mLjmin. This engagement point is an arbitrary benchmark that assists in calibrating the proportioning system. The position of the kick-in is set in the factory. During field calibration, you set the O2 flow to 200 mLjmin and the N20 flow to the kick-in flow (usually in the range of 400 to 700 mLjmin) and then install the sprockets with the O2 knobjsprocket engaged. Maxlmum flows When the Aespire machine was first produced, all gas flows in Canada required maximum flow stops. Early production Aespire machines shipped to Canada include a maximum stop collar on the body ofthe needle valve to set the maximum flow. Canada no longer requires maximum flow stops forthe gasses that the Aespire machine is designed to deliver. Current production Aespire machines do not include the maximum stop collar. Maxlmum StopCollar ValveStem Valve Body Mlnlmum Stop Collar 08;07 M1110140

2.3 Flow through the breathing system 2.3.1 Overvlewof ßowpaths Ml110140 佣1/07 1his section looks at four types of flow paths. • Ventllatlon paths: How gas flows from the drive source (bag or bellows)ωandfrom the patient. • Fresh gas paths: Fresh gas can flow from the machine interface directly to the patient through the inspiratory check valve, orthrough 由e absorber into the expiratory flow, or directly to an extemal circuit through the optional auxiliary common gas outlet. • Scavenged gas paths: APL or Pop-off. • Flow 伽rough 伽e optlonal EZ抽ange Canlster and Condenser: EZchange ON and EZchange OFF (C02 bypa臼). 2-11

Manuallnsplratlon The Bag,lVent switch closes the ventilator path (8). AP B FG 1 2 3 Gas flows from the bag (町， through the absorber (2), into the breathing circuit module, and through a unidirectional valve (inspiraωry check valve)ωthe patient (3). During inspiration, fresh gas (FG) flows from the machine into the inspiratory limb, upstream of the inspiratory check valve. 得礼 ~~ayPressure BagNent switch to Bag FreshGas Flow to absorber Flow from absorber Inspiratory flow Figure 2-4 • Gas flow during manual inspiration 2-12 ω:/01 M1110140

Manual 饵plratlon The Bag,lVent switch keeps the ventilator path closed (8). Gas f10ws from 由e patient (4), through a unidirectional valve (expiratory check valve), and into the bag (5). During exhalation, fresh gas flows bac阳ards through the absorber (FG) into 由e expiratory limb, downstream of the expiratory check valve. For machines that are plumbed to return sample gas to the breathing system, the retumed gas (SGR) enters the breathing system after the expiratory check valve. 费礼 AP Airway Pressure B BagNent switch to Bag FG FreshGas SGR Sample Gas Retum 4 Expiratory flow 5 Flow to bag Rgure 2-5 • Row during manual expiration M1110140 08/07 2-13

⑦ As you turn the APL knob, it puts more or less force on the APL disc and seat (D/S). If the circuit pressure is too high (6), the disc and seat inside the diaphragm opens and vents gas to the scavenging system (7). D/S APL disc and seat 6 APLflow 7 To scavenging Rgure 2-6 • Row through the APL Valve 2-14 08/07 M1110140

2.3.3 Mechanlcal ventllatlon Mechanlcallnsplratlon The Bag/Vent switch closes the manual path (V). Pilot pressure (P) closes the exhalation valve. Drive gas (0) pushes down on the bellows. Gas flows from the bellows (1), through the abso巾er(2), and through a unidirectional valve (inspiratory check valve) to the patient (3). During inspiration, fresh gas flows into the inspiratory limb, upstream of the inspirato叩 check valve. AP Airway Pressure D Drive gas FG Fresh Gas P Pi10t pressure v BagNent switch to Vent 1 Flow to absorber 2 Flow from absorber 3 Inspiratory ftow Rgure 2-7 • Mechanical inspiration M1110140 08;07 2-15

⑤ AP Airway Pressure D Drive gas FG FreshGas patient (4), through a unidirectional valve (expiratory check valve) and into the bellows (5). Residual drive gas (0) flows out of the bellows to the scavenging system (6). If PEEP is selected, static pressure on the pilot port ofthe exhalation valve sets the PEEPlevel. During exhalation, fresh gas flows backwards through the absorber (FG) into the expiratory limb, downstream of the expiratory check valve. For machines that are plumbed to return sample gas to the breathing system, the returned gas (SGR) enters the breathing system after the expiraωry check valve. SGR Sample Gas Retum 4 Expiratory flow 5 Flow to bellows 6 To scavenging Rgure 2-8 • Mechanical expiration 2-16 08/07 Mll10140

⑨ AP Airway Pressure D Drive gas FG Fresh Gas P Pilot pressure 2lheory of Operation The Bag,'Vent switch closes the manual path (V). Pilot pressure (P) closes the exhalation valve. Drive gas (0) pushes down on the bellows. Gas flows from the bellows (白， through the abso巾er(28), Condenser (2b), and through a unidirectional valve (inspiratory check valve) to the patient (3). During inspiration, fr，臼h gas flows into the inspiratory limb, upstream ofthe inspiratory check valve. v BagIVent switch to Vent 1 Flow to absorber 2a Flow 仕omabsorber 2b Flow 仕om condenser 3 Inspiratory flow Rgure 2-9 • Mechanical inspiration 伪rough Condenser with EZchange Canister and Condenser ON Ml110140 08/07 2-17

D Drive gas FG FreshGas Drive-gas f10w sωpsandthe 创lalation valve opens. Exhaled gas f10ws from the patient(剑， through a unidirectional valve (expiratory check valve) and into the bellows (5). Residual drive gas (0) flows out of the bellows to the scavenging system (6). If PEEP is selected, static pressure on the pilot po同时 the exhalation valve sets the PEEPlevel. During exhalation, fresh gas flows backwards through the Condenser and absorber (FG) into the expiratory limb, downstream of the expiratory check valve. For machines that are plumbed to return sample gas to the breathing system, the returned gas (SGR) enters 由e breathingsystem afterthe expiraωry check valve. SGR Sample Gas Retum ~II I 4 Expiratory flow 5 Flow to bellows 6 To scavenging Figure 2-10 • Mechanical expiration through Condenser with EZchange 臼nisterand Condenser ON 2-18 ω107 M1110140

⑨ AP D FG P Airway Pressure Drive gas Fresh Gas Pilot pressure 2 Theory of Operation The Bag,lVent switch closes the manual path (V). Pilot pressure (P) closes the exhalation valve. Drive gas (0) pushes down on the bellows. Gas flows from the b创 lows (1), through 由e EZchange module bypassing the abso巾er (2), and through a unidirectional valve (inspiratory check valve) to the patient (3). During inspiration, fresh gas flows into the inspiratory limb, upstream ofthe inspiratory check valve. s a 理 v ' BagIVent switch to Vent F10w to absorber 2 Bypass flow 3 Inspiratory ftow Rgure 2-11 • Mechanical inspiration with EZchange Canister and Condenser OFF M1110140 08/07 2-19

patient (4), through a unidirectional valve (expiratory check valve) and into the bellows (5). Residual drive gas (0) flows out of the bellows to the scavenging system (6). Aespire 7100 Mechanlcal explraUon (EZchange and condenser 。仔} If PEEP is selected, static pressure on the pilot port ofthe exhalation valve sets the PEEPlevel. During exhalation, fresh gas flows backwards thrOUgh the EZchange module (阳) into the expiratory limb, downstream ofthe expiratory checkvalve. For machines that are plumbed to return sample gas to the breathing system, the returned gas (SGR) enters the breathing system after the expiratory check valve. g g !:rì AP D FG SGR Sample Gas Retum Expiratory flow Flow to bellows VA e u ca gu 阳部二 m vdgbE WH@h mvuvc ‘u z·n 晦 ADR 4 5 6 To scavenging 08/07 Mll10140 Rgure 2-12 • Mechanical expiration with EZchange Canister and Condenser OFF 2-20

Pop-o何 valve 1he pop-offvalve limits the pressure inside 由e bellows to 2.5 cm H20 above the drive gas pressure. 1his normally occurs when the bellows reaches the top of the housing at the end of exhalation (5). ⑦ 5 F10w to bellows 6 Pop-off flow 7 To scavenging b归路 gas (6) ventsωthe scavenging system (7) through the pop-off valve and the exhalation valve. Figure2-13. Rowthroughthepop-offvalve Mll10140 08/07 2-21

To ABS breathlng 叼stem Fresh gas (1) flows from the vaporizer manifold outlet to the ACGO Selector Switch. With the ACGO Selector Switch in the ABS position, fresh gas flow is channeled to the breathingsystem through port3. The output of the O2 Rush regulator (2) is channeled to the O2 Rush valve. When activated, O2 flush flow joins the fresh gas flow in the ACGO Selector Switch. l 翩 t翩翩 Absorber 一 ._._.1~ |2 SEer l From OzSupply InspFlow PawTrans Rgure2-14 • 丹田hgas and O2 flush flow (to ABS) 2-22 08/07 Ml110140

Outlet 2 Theory of Operation Fresh gas (1) flows from the vaporizer manifold outlet to the ACGO Selector Switch. With the ACGO Selector Switch in the ACGO position, fresh gas flow is channeled to the ACGO outlet. At the ACGO outlet, a small sample is dive民:ed to the O2 Sensor in the ABS for O2 monitoring. The outputofthe O2 Aush regulator(2) is channeled to the O2 Aush valve. When activated, O2 flush flow joins the fresh gas flow in the ACGO Selector Switch. Absorber i~ i~ nsar l From 02 SUPP/Y f-H Insp Flow PawTrans Rgure 2-15 • Fresh gas and O2 flush flow (to ACGO) Mll10140 ω:;07 2-23

、 ?……、 ; 队刷 卜-:嗣蛐n " lkIt I~b由....， r-. ---------一， 二‘….' 1田ideMac如lne 刊 e 7100 ventilaωr is a microprocessor based, electronically-controlled, pneumaticall沪driven ventilaωr with a built-in monitoring system for inspired oxygen, airway pre臼ure and exhaled volume. The ventilator is an integral component of the Aespire anesthesia machine. 阳翩翩-国嗣 Note: For non-color displays, the backlight is powered through the control board, as shown. For color displays, the control module includes a separate circuit board to power the backlight. : 爱 Figure 2-16 -1100 ventilator functional block diagram 2-24 08/07 Ml110140

2.5 7100 ventllator features • Sensors in the breathing circuit are used to control and monitor patient ventilation and measure inspired oxygen concentration. This lets 由e ventilator compensate for compression losses, fresh gas contribution, valve and regulator drift and smallleakages in the breathing absorber, bellows andsystem. • Positive End Expiratory Pressure (PEEP) is generated electronically. PEEP is not active when mechanical ventilation is 0何. • User settings and microprocessor calculations control breathing pa忧ems. User interface se创 ngs are kept in non-volatile memory. • Mechanical ventilation is started with the Bag/Vent switch on the breathing sys恒m. • The 7100 ventilator has minimum monitoring and alarms managed on the ventilator panel (there is no other panel for safety relevant alarm management, etc.). • Ventilator hardware is regularly monitored by software tests. • An RS在32 serial digi恼 I communications port connects to and communicates with extemal devices. • An exhalation valve modulates flow in the pressure mode. • Pressure and volume modes are selectable by the operator. • AII pneumatic components are located on one manifold. • Exhausted drive gas and bellows pressure reliefvalve gases are mixed and go through the ventilator exhalation valve. • The exhalation valve block is autoclavable. • Excess fresh gas released from the bellows and ventilator drive gas are transferred from the exhalation valve to the Anesthesia Gas Scavenging System (AGSS). • Optimized for service with a low number of components. 2.5.1 Safety features • Dual redundant airway overpressure protection, linked to Plimit setting. • Volume over-delivery limits and protection. • Proprietary hose connections and fixed manifolds. • Proven mechanical components used. • 10 VA electrical power limiting to potential oxygen enriched environment. • 150 psi burstoverpressure protection. Mll10140 08/07 2-25

Major components of the 7100 ventilator are found in different locations of the anesthesia machine. The ventilator package consists of: 1. a Control Module (CM) - (color or non-color display) - the CM includes: • a Control Board (CB) • an LCD Display • a Keyboard (wi由 rotary encoder switch) • a Power Supply • a backup battery 2. a Ventilator Monitoring Board (VMB). 3. a Seriallsolation Connector Board (SICB). 4. a Vent Engine (VE) with a Vent Engine Board (VEB). 3 1 2 4 Rgure 2-17 • Location of 71 00 ventilator components 2-26 08/07 Ml110140

2.6.1 Control Module The control module with a color display consists oftwo enclosures. 7 {ωlor dlsplay) The rear enclosure Includ阳 8 ' 1. inline fuses 2. a powersupply 3. a cooling fan 4. a backup ba忧:ery 刊e power supply receives AC power from the anesthesia machine. AII the power necessary to operate the ventilator comes from the power supply. The front enclosure Includes: 5. a control board (controls operation ofthe ventilator) 6. a backlight inve由r 7. anLCDdisplay 8. a keyboard front panel 9. a rotary encoder 10.a speaker 2 ' 10 3 4 5 6 Rgure 2-18 • 7100 ventilatorcontrol module Ml110140 08/07 2-27

The control module with a non-color display consists oftwo enclosures. (non-color dlsplay) The rear enclosure Includes: 1 8 ' 1. inline fuses 2. a powersupply 3. a cooling fan 4. a backup battery The power supply receives AC power from the anesthesia machine. AII the power necessary to operate the ventilator comes from the power supply. The 伽ont enclosure Includes: 5. a control board (controls operation ofthe ventilator) 6. a front panel assembly The front panel assembly includes four submodules: 7. an LCD display 8. a keyboard front panel 9. a rotary encoder 10.a speaker 1 2 3 4 5 6 Figure 2-19 • 7100 ventilatorcontrol module 2-28 08/07 Ml110140

The Ventilator Monitoring Board (VMB) serves as the interface between 由e ventilator's control board and the breathing system sensors and switches: • the inspiratory and expiratory flow senso附 • the O2 sensor • the BaglVent switch • the VMB is hardwired to indicate a Circle module • the canister release switch • machines that include the canister release switch are hardwired to show so伽are the presence of an EZchange (C02 Bypa臼) canister assembly • the "control panel switch" signal in an Aespire machine indicates whether the ABS breathing system is engaged or disengaged • the Auxiliary Common Gas Outlet (ACGO) switch • task light power The VMB is located under the tabletop (below the worksurface). Machines that do not include monitoring use a depopulated board (Task Light Interface Board - TLlB) to power the task light and to interface the breathing system switches. 2.6.4 Serial interface The Seriallnterface and Connection Board (SICB) provides two functions.lt Ml110140ω1/07 serves as the inte巾ce between the ventilator's control board and additional switches located in the machine and channels serial communications signals from the controller board to the RS232 connector. The machine switches include: • the System On/Standby switch • the O2 supply pressure switch • the O2 flush switch The SICB also provides an on/off signal from the system switch ωa remote monitorthrough the RS232 connector. 2-29

Englne 2-30 1he pneumatic engine enclosure is located in the back chamber of the breathing system and is shielded to contain EMI emissions. 1he enclosure includes the pneumatic Vent Engine (VE) and a pneumatic Vent Engine control Board (VEB). 1he pneumatic Vent Engine consists of the hardware that drives the ventilator bellows. It includes: • a 2-micron inlet filter • a pressure regulator • a proportional inspiratory valve • a mechanical overpressure reliefvalve • a free-breathing check valve • a PEEP safety valve • a supply pressure sense switch • a proportional PEEP valve • a 200 mL reservoir • a calibrated bleed orifice 1he pneumatic Vent Engine Board is an interface between the engine components and the control board and includes: • an ai阳ay pressure transducer VE VEB 08/07 Ml110140

2.7 Electronic and electrical components The Aespire 7100 Ventilator electronicj electrical subassemblies or modules include: 2.7.1 百1e Aesplre 7100 ventllator functlonal blocks • a Power Supply for operation under line power and a backup ba忧ery for limited operation in case of powerfailure; • a Control Board with digital, analog and power circuits to manage all operations of the ventilaωr; • a Front Panel Assembly that includes an LCD dlsplay for display of all ventilation and monitoring parameters and a k，叼board for operator input; • a Ventllator Monltorlng Board to preprocess patientcircuit parameters and to channel 由e breathing system switch states; • a Serlallsolatlon Connectlon Board to channel machine switch states and to provide a RS232 serial output for extemal communication. 面HD.- 守性.一田，‘ Control Board MCF62060 COIdFlre Prac副嗣『 Møn盼ryer回 VO IleoodIr啕 FIa脯， 8陆M&EEPROM SCR Clrcωtry AIO- 口IA ConvM町 W曲白伺 S回m 阳晒阳"叩VOJve C刷刷 (tOVAllmltod) PEEP Valve eontr剧 (tO VA linMod) t2VDC8町>PIY (tOVA ImMod) DC 阳PPIY-咱 剧团町Managemer鸭 r---------_____________________ τ Insi由 Machlne I Note: For non-color displays, the backlight is powered through the control board, as shown. For color displays, the control module includes a separate circuit boardωpower the backlight ' BnI帽曲曲唱Sys幅m 2-31 Rgure2-20 • 日ectronic 仙nctionalblock diagram as usecl in an Aespire machine ω1/07 Mll10140

power supply is a universal40 watt switching supply that outputs two DC voltages. The DC voltages are routed to the Control Board where they are further regulated to produce the power requirements for the 7100 ventilator system. Aespire 7100 2.7.2 Power Supply • Input: Universal85-264 VAC 47 -63 Hz • OutputVl: 6.0 VDC (:1:0.5%) at 0-5 A • OutputV2: 9.0VDC(士5%) at 0-0.5 A symbol. High voltage in area of 与 &WARNING 6V return w 9Vreturn 9V O ···Eo 0000 。 口 E二3 Llne Neutral -o 一 A sealed lead acid battery supplies battery backup for the 7100 ventilator. Since it only provides power in case of a powerfailure, the battery is in a float charge state most of the time. Figure 2-21 • 7100 Ventilator power supply 2.7.3 Sealed Lead Acld Batte叩 The battery meets the following: • capacity to operate ventilator system for 30 minutes (fully charged); • long 目oat charge life; • the ba忧ery is intemallyfused (auto-rese忧able). Input: Nominally 6.8 VDC at 250C during float charge. 08/07 Ml110140 Output: +0.6ω+6 Amps during discharge 2-32

The Control Board contains all of the major circuit functions nece臼aryto control ventilator operation. Note: The functions supported by the color and non-color control boards are identical. The circuit descriptions that follow apply to both control boards, except where differences are noted to support the color display. The Control Board comprises three functional circuit types: • power circuits, • analog circui恼， • di国恼 I circuits. These circuits are detailed individually in the following sections. Overall, the Control Board's functions include: • Bus access control signals for all memory and peripheral devices • Interrupt handling • Clocks and timers for the system • RS232C serial l/O • Baud rate generator for serial po此 • Hard (power-up) and soft (watchdog error) reset generation • Data bus buffers • Memory and 1/0 decoding • program memory with "memory stick" so仕ware upgrade • Safety Relevant Computing (SRC) • Watchdog system • Data acquisition • Aow valve control • PEEP valve drive and PEEP safety valve drive • Front panel interface • Audio alarm Cω忧rol Board - non-color dlspl8J co四IroIBoard-ωlordlspl町 Mll10140 佣;/07 2-33

outputs from the power supply. Control Board Power Clrcults Aespire 7100 刊 e 9 VDC supply is used to charge the backup ba忧ery. The 6 VDC supply is processed further to supply various power requirement throughout the 7100 ventilator. In case of power failure, the battery is switched in to supply power. • powerωdrive the fan (5V) • 5V supply for digital circuits • 3.3V supply forthe CPU • 5V supply for the LCD display backlight • supply for the LCD display contrast adjustment • -24V adjustable (non-color display) • 1.3Vto 2.3V adjustable (color display) • 1.5A supply for control of the Inspiratory and PEEP valves • + 12V supply for analog circuits • + 12V supply for the Monitoring Interface Assembly • -12V supply for analog circuits 5V lDO (MIC2刷刷 5.0BU) SUPPlY MONITOR 晶 SEl.E CTION P.CH MOSFET SWITCHES ON I STBY SWITCH 5V lDO (MIC2915 D-5.0町} SHdz ‘ 08/07 Ml110140 VOlTAGE 晶 CURRENT MONITOR 日;gure 2-22 • Control board block d，阳gram -Power circuits 2-34 9.0 V 0 500mA MAX BATTERY CIWIGER uω906

The analog section of the controller board processes inputs from the Monitoring Interface Board and the Pneumatic Engine Board. It multiplexes 由e inputs fordisplay bythe digital section. • Inspiratory flow • Expiratory flow • Airway 02 • Airway pressure Under the control of the digital section, the analog section includes drivers for the pneumatic engine components: • flow valve (inspira协 ry valve) • PEEPvalve • PEEP safety valve The switch signals from the Monitoring Interface Board and the supply pressure signal from the Pneumatic Engine Board are passed on as inputs to the digital section. HLPRESS FLDW DAC 院EP_DAC Figure 2-23. Control board block diagram -Analog circuits Ml110140 08/07 2-35

microcontroller. The Aespire 7100 operatingsoftware isstored in 2MB of8-bit (lMx16) Rash ROM. The board includes: Control Board Dlgltal Clrcults Aespire 7100 • 1MB of 8-bit (512Kx16) static RAM (SRAM) for operation, • and (*32Kx8 for non-color) or{* *64Kx16 forcolor) CMOS static RAM for processing video information The controller receives switch inputs from the front panel keyboard and the system inputs from the Vent Monitoring Board, the Seriallsolation Connector Board and the Vent Engine Board. The patient circuit parameters are multiplexed through the analog section. The LCD Display is driven through the Video Controller. It displays the processed patient circuit paramete附 along with the derived alarm and system condition messages. :… r Additional outputs include an audio amplifier to drive the speaker and a RS232 driver for external communication through the Seriallsolation Connector Board. l··················el-- •••••••••••••• , 飞咽 a「饵'''气，， -dEEd 晕目zib--iwE-mu--······JJ Elz 囊J固dRE‘"圃， d··- •• , •• … 11Eli-…叫 EdE 二 it … !! hh 口刊HMM二，， EtdE 二 d"hH… Hl 配川剧自丁噩「 -s二『 EU HE--RB …… ZEda2·tEM--2. 而叫旨-t·· 吨wa--d 凰dz-ER目··…‘「盈 2·· -ad 温哥dgIE--aHEERgu-MIHE P ‘2雹6··a!·建理hr-gaa 画画'da·-PSB」22 tpl' -,fE···EBBEE--J''E· ,. iiiij;;;; ..Ooseplra恤 bo.rd 阳coIord崎l町 -----_...…". 刷刷峭IIo8rd conn幢幢 , ……………… ，……..……………·、 SerlaIMI阳阳阳 ‘ ' '.…..……---------_ .. 08/07 MI110140 Rgure 2-24 • Control board block diagram - Digi臼I circuits 2-36

The Vent Monitoring Board (VMB) is the interface between the patient circuit sensors (the inspiratory and expiratory flow sensor, the O2 sensor) and the ventilator control module. It also passes different switch functions through to the ventilator control module and provides power to the task light Respiratory gas flow, to and from the patient, is monitored by measuring the differential pressure across a variable orifice in each flow sensor. The pressure transducers for measuring the differential pressure are on the VMB. Conditioning circuitry is supplied for these transducers and for the 伽ygen sensor used in the breathing circuit 2.7.5 Monltorlng Interface Pre臼ure sense tubing and signal wiring is routed from the sensors and switches in the breathingsystem to the VMB. A separate cable transfers power and signals to and from the Control Board in the display module. 啤国」【 -m 吨圃，‘ 撞a····0····za--u 吨却 目嗣 1-帽副d ESD 缸... 回回归 B 酬 BEE-a .. ,a'a". ‘ ••• EzzaHe 2.37 Rgure 2.25 • Breathing Circuit Vent Monitoring Board (VMB) 08/07 Ml110140

• It serves as an interface between the control board and switches that are located in the machine itself (not in the breathing system). • It processes serial communications signals from the control board to the RS-232 Serial po此 on 由e breathing system side of the Aespire machine. • Itprovides remote monitorOnjOffthrough an isolated relay. 2.7.6 Serlallnterface The machine switches include: • the System OnjStandby switch • the O2 supply pressure switch • the O2 flush switch Machlne Swltches The serial inte巾ce provides isolated RS232 serial communications. The lXD (transmit) and RXD (receive) signals between the SICB and the control board are at RS-232 levels. Serlal Communlcatlons Circuits on the board change the signals to digital5V levels; isolate them through optocouplers; then, change them back to RS-232 levels before sending them to the outside world. • The extemal communications signals conform to standard RS-232C signal standards. • The extemal connector is a 15-pin female D connector. • It is configured for Data Communications Equipment (DCE) • Pin 6 - Receive da恒 • Pin 13 -Transmit data • Pin 5 - Signal ground • Pin 1 - Monitor OnjStandby • Pin 9 - Monitor OnjStandby retum 』〔回回.向守.田，‘ Ea--··a···aa-- ••• ,za 08/07 Ml110140 Rgure 2-26 • Seriallsolation Connector Board (SICB) 2-38

有le Vent Engine Board (VEB) provides two functions: • Itserves as an interface between the control board and the pneumatic engine. • Itprocess臼 the output from the airway pressure transducer. 2.7.7 Vent Englne Board The board provides a direct connection for the drive and retum lines for the control valves on the pneumatic engine: Pneumatlc 画191ne Interface • Inspiraωry Flow Valve • PEEPValve • PEEP Safety Valve The board routes the Supply Pressure Switch signals to 由 e control board. 刊e VEB includes a +5VA regulator to powerthe airway pressure transducer circuitry. The circuits provide EMI filtering, signal amplification, and buffering. Alrway Pressure Transducer FLOW OR FLOW_RET EO-u 国zzau az--adaz--EU--FH PEEPVALVE SAFETYVAl旺 LOW SUPPLY PRESSURE SWITCH CONNECTOR 旦旦旦L四E SUPPLY _LOW_RET PEEP OR 丽#踹 SAFETY_VLV_R盯 2-39 g g g +5VA Rgure 2-27 • Vent Engine Board (VEB) ω:/07 Ml110140

ReferωFigure 11-1, .System connection block diagram," in Section 11 forthe complete pneumaticjmechanical subsystem. The mechanical subsystem includes: Pneumatic Vent Engine • Drive gas inlet filter • Supply gas pressure regulaω『 • Inspiratory flow control valve • PEEP valve; PEEP safety valve; Pressure sense switch • Mechanical Overpressure Valve (MOPV) • Bleed resistor • Free breathing valve Exhalation valve Bellows assembly Breathing circuit flow sensors 2.8.1 Drlve gas Drive gas (can be selected from O2 or Air) enters the Vent Engine (1) at a pressure of 241ω690 kPa(35ω100 psi) through a 2-micron filter (2) that is located under the gas inlet fitting. Smooth side up (undør platø) Rgure 2-28 • Inlet filter 2-40 ω:/07 Ml110140

2.8.2 Pre钝ure Regulator 1he pressure regulator (3) is a non-relieving pressure regulator that regulates high pressure filtered supply gas down ω172 kPa (25 psi). Figure 2-29 • Pressure regulator 2.8.3 Insplratory flow control valve Figure 2-30 • Row control va伽e Mll10140 08/07 1he inspiratory flow control valve (4) is cycled by the control board to supply drive gas to the outer chamber of the bellows assembly at a rate determined by ventilator set目ngs and sensor signals. 1he control valve modulates the incoming 172 kPa (25 psi) drive gases to an output from 0 ω70 liters per minute at pressures ranging from 0 to 100 cm H20. 2-41

pre臼ures in the breathing circuit The exhalation valve includes two male ports on the bottom for: • Bellows drive gas (5) • Exhalation valve pilot (6) - (manifold pressure) The exhalation valve includes three ports on top that connect to the bellows base manifold: • Drive gas pass through (7) • Drive gas return and pop-off valve flow (8) • APL exhaust flow to scavenging (9) A port at the back ofthe exhalation valve (10) connects to the down tube that directs all the exhaust flows to the scavenging receiver. The exhalation valve is normally open. When the exhalation port is open, gas flows from the bellows housing to the scavenging port. Approximately 2 cm H20 of pilot pre臼ure is nece臼ary to close the valve. Pilot control ofthe exhalation valve is done with PEEP Control Valve (A), Supply Pressure Switch (8), and the PEEP Safety Valve (C). Rgure 2-31 • Exhalation (PEE月阳Ive 2-42 08/07 MI110140

2.8.5 Reservolr and bleed 1he reservoir (11) is a 200 ml chamber that dampens the manifold (pilot) Mll10140 08;07 reslstor pressure pulses to the exhalation valve. lE 1he bleed resistor(12) is a .controlled leak" from 0ω10 L/min in responseto circuit pressures from 0 ω100 cm H20. 1he small quantity of pneumatic flow exhaustingthrough the bleed resistor permits control ofthe exhalation valve' s pilot pressure by modulation of the valve output 1he bleed resistor exhausts only clean drive gas and must not be connectedωa waste gas scavenging circuit 1he output is routed away from the electrical components to make sure thatsystems usingoxygen drive gas meetthe 10VA limitation requirement for oxygen enrichment. @ Rgure 2-32 • ReseNoir and bleed resistor 2-43

breathingsystem. The pre臼ure reliefvalve (or pop-offvalve) in the bellows assembly (13) limits pre臼ure in the patient circuit. Excess fresh gas is discharged through the exhalation valve into the gas scavenging system. The pre臼ure relief valve is normally closed, maintaining approximately 1.5 cm H20 in the breathing circuit in a no flow condition, enough to keep the bellows inflated. It is piloted closed during inspiration and remains closed until the bellows is refilled during exhalation. Ifthe pressure in the patient circuit exceeds 4 cm H20, the pop-off valve opens to exhaust excess fresh gas flow at a rate up to 4 Lfmin. lathlng Val晴 Figure 2-33 • Bellows pressure reJiefvalve 2.8.7 Mechanlcal Overpressure Valve The Mechanical Overpressure Valve (MOPV) is a mechanical valve (14) that operates regardless of electrical power. It functions as a third level of redundancy to the ventilator's pressure limit control functions, supplying pressure relief at approximately 110 cm H20. Rgure 2-34 • Mechanical overpressure valve 2-44 08/07 Mll10140

Ml110140 08107 2 Theory of Operation The free breathing valve (15) helps assure the patient can spontaneously breathe. The ventilator is programmed to supply a specified number of breaths per minute to the patient If, in between one ofthese programmed cycles，由e patient needs a breath (spontaneous), the free breathing valve permits the patient to inhale. The free breathing valve is closed on mechanical inspiration. 2-45

inspiratory flow sensor is downstream ofthe gas system inspiratory check valve. Feedback from the inspiratory transducer is used to supply tidal volumes that make allowances forthe e仔ects offresh gas flow and circuit compressibility. The expiratory flow sensor is located at the input to the gas system expiratory check valve. Feedback from the expiratory flow sensor is used to supply signals for expiratory tidal volume monitoring and the breath rate. Airway Pressure (p Gauge Rgure 2-36 • Row sensors 2-46 08/07 Mll10140

In 由Issec目。n 3.1 Ventilator post-service checko川............................................. .3-2 3.2lnspectthesystem ........................................................ .3-2 3.3 Pipeline and cylindertests ...................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3 3.4 Flow control tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4 3.4.1 With O2 monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4 3.4.2Witho川 O2 monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 3-6 3.5 Pressure relieftests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8 3.6 O2 supply alarm test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8 3.7 Flush FlowTest... . . . . .. . . . ... . . . . .. .. . . .. .. . . . . .. . . . . .. .. . .. .. .. . . ... . .. .. .3-8 3.8 Vaporizer back pressure test ............................................... 3-10 3.9 Low-pressure leak test .................................................... 3-11 3.9.1 Negative low-pressure leaktest ...................................... 3-11 3.9.2IS0 or BSI standard low-pressure leaktest ............................. 3-12 3.10 Alarm tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14 3.11 Breathing system tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16 3.12 Auxiliary 02 f10wmetertests .. . .. . . .... .. . '" .. . .. ... . .. . . .. . . .. . . . . .. . ... . 3-18 3.13lntegrated Suction Regulatortests ......................................... 3-18 3.14Powerfailuretest ...... .................................................3-19 3.15 日 ectrical safetyte筑s .................................................... 3-19 .&. WARNINGS Afterany repairorservice ofthe Aespire system, complete all tests in thissection. Mll10140ω:/07 Before you do the tests in 由 issection: • Complete all necessary calibrations and subassembly tests. Refer to the individual procedures for a list of nece部ary calibrations. • Completely reassemble the system. If a test failure occurs, make appropriate repairs and test for correct operation. 3-1

After servicing the 7100 ventilator, perfonn the following service mode Calibrations: • O2 Calibration • Zero Flow and Ai附ay Sensors • Adjust Drive Gas Regulator • Airway Sensor Span • PEEP Valve Calibration • Inspiratory Valve Calibration • Pressure Sensitivity Then, complete the checkout procedure forthe entire machine in the following sections. 3.2 Inspect the system 3-2 .&. CAunON The upper shelfweight limit is 34 kg (75Ib) • .&. WARNING Do not leave gas cylinder valves open ifthe pipeline supply is in use. Cylinder supplies could be depleted, leaving an insufficient reserve supply in case of pipeline failure. Before testing the system, ensure that: • The equipment is not damaged. • Components are correctly attached. • The breathing circuit is correctly connected, not damaged. • Pipeline gas supplies are connected. • Cylindervalves are closed. • Models with cylinder supplies have a cylinder wrench attached to 由e system. • Models with cylinder supplies have a reserve supply of O2 connected to the machine during system checkout. • The casters are not loose and the brakes are set and prevent movement. ·刊e power cord is connected to a wall outlet. The mains indicator comes on when AC Power is connected. ω1/07 Ml110140

3.3 Pipeline and cylinder tests Mll10140 08/07 .&. CAunON To prevent damage: • Open the cylinder valves slowly. • 00 not force the flow controls. If your system does not use cylinder supplies, do not do steps 2 and 3. 1. Disconnect the pipeline supplies and close all cylinder valves (if equipped).lfthe pipeline and the cylinder pressure gauges are not atzero, bleed all gasses from the sys'恒m. a. Connect an 02supply. b. Set the system switch to On. c. Set the flow controls to mid range. d. Make sure that all gauges but O2 are at zero. e. Disconnect the O2 supply. f. Make sure that the O2 gauge goes to zero. As pressure decreases, alarms for low O2 supply pressure should occur. 2. Make sure thatthe cylinde隐 are full: a. Open each cylindervalve. b. Make sure that each cylinder has sufficient pressure. If not, close the applicable cylindervalve and install a full cylinder. 3. Test one cylinder at a time for high pressure leaks: a. Set the system switch to Standby, which stops 由e02flow. b. If equipped, turn the auxiliary O2 flow cont刚 fullycloc阳ise (no flow). c. If equipped, turn offventuri derived suction. d. Open the cylinder. e. Record the cylinder pressure. f. Close the cylindervalve. g. Record 由e cylinder pressure after one minute. If the pressure decreases more than indicated below, there is a leak. 5000 kPa (725 pslg) forventilatordrive gas. 690 kPa (100 pslg) for non ventilator drive gas. Install a new cylinder gasket and do this step again. h. Repeat step 3 for all cylinde隐• .&. WARNING 00 not leave gas cylinder valves open ifthe pipeline supply is in use. Cylinder supplies could be depleted, leaving an insufficient reserve supply in case of pipeline failure. 4. Connect the pipeline supplies one at a time and ensure that the corresponding gauge indicates pipeline pre臼ure. 3-3

3-4 3.4.1 Wlth O2 monltorlng Ifthe system Includes O2 monltorl晤， complete the flow control tests in Section 3.4.1, "With O2 monitoring". Ifthe 甸事，tem does not Include O2 monltorlng, complete the flow control tests in Section 3.4.2, "Without O2 moniωring飞 &. WARNING Nitrous oxide (N20) f10ws through the system duringthis test. Use a safe and approved procedure to collect and remove it. 1. Set up the gas scavenging system. a. Connect the AGSS to a gas scavenging system. b. Attach a patient circuit and plug the patient po比 c. At回ch a bagωthe bag port (or plug 由e bagpo民:). d. Setthe Bag/VentswitchωBag. e. Adjust the APL valve to minimum. 2. Connect the pipeline supplies or slowly open the cylinder valves. 3. Turn all flow controls fully clockwise (minimum flow). 4. Set the ACGO selector switch to ABS. 5. Turn on the system. 6. Confirm that the O2 sensor measures 21 % in room air and 100% in pure O2, If not, calibrate the O2 sensor. 7. Make sure that: • For a dual-tube O2 flowmeter, the O2 flowtube shows 0.025ω0.075νmin. • For a single-tube O2 flowmeter, the O2 flowtube shows 0.175 to 0.225 Lfmin. • The otherflowtubes show no gas flow. 8. Set the flow controls to mid range of each flowtube and make sure that the flowtube floats rotate and move smoothly. Note Ifthe system does not include N20, skip steps 9 and 10. 9. Check the Link proportioningsystem concentration (increasing N 20 刊ow). Observe the following precautions: a. Start with all valves at the minimum se忧ing. b. Adjust only the N20 flow control. c. Increase the N20 flow as specified in the following table and make sure the O2 concentration is in range. 08/07 Ml110140

Note: Allow the O2 monitorto stabilize. Atthe lowerflows, the O2 monitor may take up to 90 seconds to stabilize. d. If you overshoot a setting, turn the O2 f10w control clockwise until the N20 f10w decreases to the previous setting before continuing the test. Set 甜le N20 f10w (Ljmln) Measured02 0.15 (dual flowtubes only) 21%minimum 0.5 (dual flowtubes only) 21%minimum 0.8 21%t030% 1.0 21%t030% 2.0 21%t030% 6.0 21%t030% 9.0 21%t030% 10.Check the proportioning system concentration (decreasing O2 f1ow). Observe the following precautions: a. Start with N20 valve at the maximum setting. b. Adjust only the O2 flow control. c. Decrease the O2 f10w as specified in the table and make sure the O2 concentration is in the allowed range. Note: Allow the O2 monitor to stabilize. At the lower f1ows, the O2 monitor may take up to 90 seconds to stabilize. d. If you overshoot a setting, turn the N20 f10w control counterclockwise until the O2 flow increases to the previous setting before continuingthe test. Set the O2 f10w (Ljmln) Measured O2 3.0 21%t030% 2.0 21%t030% 1.0 21%t030% 0.3 21%t030% 11. Check the linearity ofthe Airflow control. • Turn the N20 f10w control fully clockwise to minimum stop. Set the O2 f10w Set 伽e A1r flow (Ljmln) O2 monltor range {νmln) 4.0 3.0 61%to 71% 3.5 6.0 45%t055% 1.5 8.0 28%t038% 3-5

3-6 & WARNING 1he following procedure will test for any significant malfunction ofthe Link system but itwill notconfirm proper calibration. Periodic calibration procedures using an accurate and properly calibrated O2 monitor must be performed as recommended in the User's Reference Manual, Pa眈 2 ， section 3 User Maintenance. & Nitrous oxide (N20) flows through the system during this test. Use a safe and approved procedure to collect and remove it. 1. Set up the gas scavenging system. a. Connect the AGSS to a gas scavenging system. b. A'忧ach a patient circuit and plug the patient port. c. Attach a bag to the bag po民 (or plug the bag po 此). d. Setthe Bag，lVentswitchωBag. e. Adjust 由e APL valve to minimum. 2. Connect the pipeline supplies or slowly open the cylinder valves. 3. Turn all flow controls fully clockwise (minimum flow). 4. Set the ACGO selector switch to ABS. 5. Turn on the system. 6. Make sure that: • For a dual-tube O2 flowmeter, the O2 flowtube shows 0.025ω0.075 Ljmin. • For a single-tube O2 flowmeter, the O2 flowtube shows 0.175ω0.225υmin. .而e other flowtubes show no gas flow. 7. Set the flow controls to mid range of each flowtube and make sure that the flowtube floats rotate and move smoothly. Note Ifthe system does not include N20, skip steps 8 and 9. 8. Check the Link proportioning system (increasing N20 flow). Observe 由e following precautions: a. Start with all valves at the minimum se忧ing. b. Adjust only the N20 flow control. c. Increase the N20 flow as specified in the following table and make sure 伽e O2 flow is as specified. 08/07 Ml110140

d. If you overshoot a se剧唱， turn 由e O2 flow control clockwise until 由e N20 flow decreases to the previous setting before continuing the test SettheN20 帽owω阴阳I 协 The O2 flow must be (L/mln) greater 由an (L/mln): 0.8 0.2 2 0.5 4 1.0 10 2.5 9. Check the Link proportioning system (decreasing O2 flow). Observe the following precautions: a. Setthe N20 flow to 9.0 Ljmin. b. Setthe O2 flow to 3νmin or higher. c. While reducing the 02 flow, set the N20 flow to the rates shown in the table. The O2 flow must be greater than the minimum limits. d. If you overshoot a setting, tum the N20 flow control counterclockwise until the N20 flow increases to the previous setting before continuing 由etest Set the N20 fl跚 The02 匍侧 mustbe (using 伽e02 饵owcontrol) greater 伽an to(L/mln) {νmln) 8.0 2.0 4.0 1.0 0.8 0.2 3-7

tests 3.6 O2 supply alarm test 3.7 Flush FlowTest To check the pressure reliefvalve (vaporizer manifold outlet). 1. Turn all flow controls fully clockwise (minimum 币ow). 2. Setthe ACGO selectorswitch to ACGO. 3. Connect a gauge or a digital manometer to the ACGO outlet using the positive pre臼ure leak test adapter. 4. Adjust the O2 flow to 0.5 Lfmin. 5. Verify that the test device reading stabilizes within the following range: 31-60 kPa, 230-450 mm Hg, 4.5-8.5 psl. 6. Remove the test device and the adapter. 1. Set all flow controlsω3νmin. Test Adapter 2. Stop the O2 supply. (Disconnect the pipeline supply or close the cylinder valve.) 3. Make sure that: a. The low O2 supply alarm occurs. b. The N20 (if equipped) and O2 flows stop. The O2 flow stopslast. c. Air (if equipped) flow continues. d. Gas supply alarms occur on the ventilator ifthe ventilator uses O2 as the drive gas. 4. Turn all of the flow controls fully clockwise (minimum flow). 5. Reconnectthe pipeline supplies. Wlth Ventllator 1. Setthe BagjVentswitch to Vent. 3-8 2. Set the system switch to Standby. 3. Attach a patient circuit and plug the patient po比 4. Setthe ACGO selectorswitch to ABS (Circle). 5. Ensure that the bellows is completely collapsed. 6. Measure the amount of time it takes to fill the bellows when the O2 Flush button is fully and continuously depressed. 7. Repeat the above measurement two more times (deflate bellows by removing the plug from the patient port). • The bellows should fill in 1.8 to 2.3 seconds. 08/07 Ml110140

WlthoutVentllator: 1. Setthe Bag/VentswitchωBag. 2. Set the system switch to Standby. 3. At阳ch a patientcircuitand plugthe patientpo此. 4. At恼ch a 3-liter rebreathing bag on the bag arm or manual bag port (if a 3-liter bag is notavailable, use the time specified for a 1-liter bagtimes the volume of the bag used). 5. Set the ACGO selector switch to ABS (Circle). 6. Ensure that the rebreathing bag is completely collapsed. 7. Adjust 由e APL valve to maximum. 8. Measure the amount oftime ittakes to fill the rebreathing bagwhen the O2 Aush button is fully and continuously depre部ed. Note: When the airway pressure gauge exceeds 10 cm H20, the rebreathing bag is full. 9. Repeat the above step two more times (deflate 伽e rebreathing bag by removingthe plugfrom 由 epa甘entpo 民). • A 3-liter bag should fill in 3.6 to 5.1 seconds. • A 1-literbagshouldfill in 1.2ω 1. 7 seconds. Posslble Causes of Fallure • Large leak (if long filling time). Ml110140ω;07 • Flush regulator se四ing (Section 5.5). • Aush regulator cross-connection (if long filling time). • ACGO selectorvalve inlet cross-connection (if short filling time). From ~ To F1ushValYe (and optlonal Awdllary O2 F10wmete。 O2 F1ush Output From ACGO S剑ector 剑IItch Vaporlzer 翩翩Ifold 3-9

3-10 &. WARNING Anesthetic agent vapor comes out ofthe common gas outJet during this test Use a safe, approved procedure to remove and collect the agent 1. Set up the gas scavenging system. a. Connect the AGSS to a gas scavenging system. b. Attach a patient circuit and plug the patient port. c. Attach a bag to the bag port (or plug the bag port). d. Set the Bag!Vent switchωBag. e. Adjust the APL valve to minimum. 2. Set the ACGO selector switch to ABS. 3. Set the system switch to On. 4. Setthe O2 flow to 6 Ljmin. 5. Make sure that the O2 flow stays constant and the float moves freely. 6. Adjust the vaporizer concentration from 0 to 1% one click at a time. The O2 flow must not decrease more than 1 Ljmin through the full range. If the O2 flow decreases more than 1νmm: a. Install a ditferent vaporizer and try this step again. b. Ifthe O2 flow decreases less than 1 Ljmin with a ditferentvaporizer, the malfunction is in the first vaporizer. c. Ifthe O2 flow also decreases more than 1 Ljmin with a ditferent vaporizer, the malfunction is in the Aespire system. Do not use the system until it is serviced (repair vaporizer manifold po民 valve). 7. Complete steps 3 through 5 for each vaporizer and vaporizer position. 8. Setthe system switch to Standby. 08;07 Mll10140

3.9 Low-pressure leak test Note .&. WARNING 3.9.1 Negatlve low- pressure leak test Perform either the MNega回ve low-pressure leak test" or 由eMISOorBSI standard low-pressure leak test. It is not nece臼ary to perform both tests. 00 not use a system with a low-pressure leak. Anesthetic gas will go into the atmosphere, not into the breathing circuit. 1. Test the leak test device: a. Put your hand on the inlet of the leak test device. Push hard for a good seal. b. Squeeze the bulb to remove all air from the bulb. c. Ifthe bulb completely inflates in less than 60 seconds, replace the leak test device. 2. Setthe system switch to S恼 ndby. 3. Set the ACGO selector switch to ACGO. 4. Turn off all vaporize附. 5. Test the anesthesia machine for low-pressure lea悔: a. Open the flow controls one and a half turns counterclockwise. b. Con nect the test device to the ACGO outlet. c. Compress and release the bulb until it is empty. d. The vacuum causes the floats to move. This is usual. Ifthe bulb completely inflates in 30 seconds or less, there is a leak in the low- prl臼sure circuit. 6. Testeach vaporizerfor low-pressure leaks: a. Setthevaporizerto 1%. b. Repeat step 5. c. Setthe vaporizerto OFF. d. Test the remaining vaporizers. 7. Oisconnect the test device. 8. Turn all flow controls fully clockwise (minimum flow). 00 not over tighten. & WARNING Agent mixtures from the low仰ssure leak test stay in the system. Mll10140 08/07 Always flush the system with O2 afterthe low-pressure leak test (1νmin forone minute). Tumo何 all vaporizers at the end of the low-pressure leak test 9. F1ush the system wi由 O2 : a. Setthe system switchωOn. b. Set the O2 flow to 1νmin. c. Continue 世le O2 flow for one minute. d. Tum the O2 flow control fully cloc阳ise (minimum flow). e. Setthes归tem switch to Standby. 3-11

low-pressure leak test 3-12 & CAunON Do the positive pre臼ure leak test at the ACGO outlet only. 1. Set the ACGO selector switch to ACGO. 2. Tum all flow controls fully clockwise (minimum flow). 3. Using 由e positive prl臼sure leak test adapter, connect the ISO or BSI specific leak test device to 由e ACGO outlet. Push the adapter into the ACGO outlet throughout the test to get a good seal. T创t Devlce σ'op Vl棚} |咿| Tωt Devlce (FrontVlew) 4. Keep flowmeter of the test device vertical for accurate results. 5. Fully open the needle valve on the test device (counterclockwise). & CAunON If the needle valve is not fully open, this test can damage the pressure gauge on the test device. 6. Setthe system switch to On. ω/07 M1110140

7. Open the O2 f10w control and set a to臼 1 f10w ofO.4 νminthrough 由e f10wmeter on the test device. 8. Makesure 由at 由e pressu陪 gauge on the test device reads zero and that all other f10w controls are fully closed. 9. CIose the needle valve on the 饱stdevice until 由 etestga咽.e reads: I505358 3kPa BSI4272.3 20 kPa 10.lfthe f10w through 由e test device is less than 。.35 L/mln (150) or 0.3νmln(B51) ， there is a low pressure leak in the anesthesia machine. 11. Fully open the needle valve on the test device to decrease the back pressure. 12. Test each vaporizer for low-pressu re lea阳: a. Setthe vaporizer to 1%. b. Repeat steps 7 由rough 10. c. Turn the vaporizer OFF. d. Test the remaining vaporizers. 13. Remove test tool and adapter. & WARNING Agent mixtures from the low-pressure leak test stay in the system. Always 11 ush the system with 02 after the low-pressure lea k test ( 1νmin for one minute). Turn all vaporizers OFF atthe end ofthe low-pressure leak test. 14. Flush the system with O2: a. Setthe system switch to On. b. Set the O2 flowω1νmin. c. Continue the O2 f10w for one minute. d. Turn the O2 f10w control fully clockwise (minimum f10W). e. Set the system switch to Standby. 3-13

3-14 1. Connect a test lung to the patient connection. 2. Setthe Bag,lVentswitch to Vent. 3. Set the system switch to On. 4. Setthe controls: • Ventilation Mode: Volume control (select from main menu) • Ventilator. - 1idal Vol: 400 ml - Rate: 12 - I:E Ratio:1:2 - Plimit:40 cm H20 - PEEP:O阵 • Anesthesia Machine: - O2 flow: minimum flow - AII other gases: OFF - ACGO selector switch to ABS 5. Push O2 Flush ωfill the bellows. 6. Set the Bag,lVent switch to Bag and back to Vent. 7. Make sure that: a. Mechanical ventilation starts. b. A subatmospheric pre臼ure alarrn does not occur. Note: With active gas scavenging, too much scavenging flow can cause subatmospheric alarrn. c. The ventilator displays the correct data. d. The bellows inflate and deflate during mechanical ventilation. 8. Set the O2 flow control ω5 lfmin. 9. Make sure that: a. The end expiratory pressure is approximately 0 cm H20. Note: Positive end expiratory pressure when PEEP is 0仔 may indicate that the scavenging system is not removing enough gas. b. The ventilator displays the correct data. c. The bellows inflate and deflate during mechanical ventilation. 10. Test the low minute volume alarm: a. Go to the alarrns menu. b. Set the alarrn limit for low minute volume to 6.0νmin. c. Make sure that a low minute volume alarrn occurs. d. Go to the alarrns menu. e. Set the low minute volume alarm ωOFF. ω:/07 M1110140

11. Testthe high ai附aypre臼urealarm: a. Set Plimit to less than the peak airway pressure. b. Make sure that 由ehigh ai附'aypre臼ure alarm occurs. c. Set Plimit to correct level. 12. Testthe apnea and lowai阳aypre臼ure alarms: a. Turn all flow controls fully cloc阳 ise. b. Remove the test lung from the patient connection. c. Other alarms such as low minute volume can occur. d. Make sure that the low airway pressure and apnea alarms occur. The apnea alarm occurs after 30 seconds. 13. Test the sustained airway pressure alarm: a. Set the controls: • APL valve - Closed (70) • Bag,lVent switch - Bag b. Mechanical ventilation stops when the Bag,lVent switch is set to Bag. c. Occlude the bag port connector with a test plug. d. Close the patient connection using the test plug located on the side of the ABS and push the O2 Rush button. e. Make sure that the sustained pressure alarm occurs after approximately 15 seconds at the sustained pressure limit (6-30 cm H20 varies with pressure limit). 14.Testthe O2 monitor and alarms: a. Remove the O2 sensorfrom the circuit module. b. Make surethe sensor measures approximately 21 % O2 in room air. c. Set the low O2 alarm ω50%. Make sure a low O2 alarm occu附. d. Set the low O2 alarm back to 21 % and make sure that alarm cancels. e. Put the O2 sensor back in 由e circuit. f. Remove the test lung from the patient connection. g. Set the High O2 alarm to 50%. h. Push the flush butωn to fill the breathingsystem. i. Set the O2 flow control to 2υmin. j. Make sure the high O2 alarm comes On. k. Setthe high O2 alarm backto 100% and make sure that alarm cancels. 1. After 2 minutes in pure O2 • 由e O2 display reads approximately 100%. m. Tum the O2 flow control fully clockwise (minimum flow). 15. Set the system switch to S恼 ndby. 3-15

3-16 ..&.. WARNING Objects in the breathingsystem can stop gas f10w to the patient. This can cause injury or death: • 00 not use a test plug that is small enough to fall into the breathing system. 1. Verify thatAGSS is operating. For systems that have a flow indicator on the side, make sure that the flow indicator shows a flow in 由e green (norrnal) region. 2. Zero the pressure gauge (Section 5.6.1). Check Valves 3. Make sure 由atthe check valves on the breathing circuit module work correctly: a. The Inspira协 ry check valve rises during inspiration and falls at the start of expiration. b. The Expiratory check valve rises during expiration and 旬 IIsatthes恼眈 of inspiration. Ventlla协r Bellows 4. Ventilator bellows test: a. Set the system switch to Standby. b. Setthe Bag,tVentswitch to Ventilator. c. Set all flow controls to minimum. d. Close the breathing circuit at the patient connection. Use the test plug located on the side of the ABS. e. Push the O2 flush butωn to fill the bellows. f. The pre臼ure must not increaseωmore than 15 cm H20 on the pressure gauge. g. Ifthe bellows falls more than 100 mLjmin (ωp of indicator), it has a leak. Servlce Mode Tests 5. Enterthe Service Mode: Push and hold the adjustment knob on the ventilator's display and set由 e system switch to On. a. Selectand confirrn .Service Modes." b. Follow the menu structure outline belowto reach the adjustment for由e inspiratory flow valve. Select and confirrn at each step. • "Diagnostics TestsjTools" • "Breathing System Leak Test" c. Follow the instructions on the screen. d. The leak rate should be less than 200 mLjmin. For machines with a single-tube O2 flowmeter, the pressure reading should reach 30 cm H20 atminimum flows greaterthan 200 mLjmin. Note: If test fails, see Section 7.2, "Breathing System Leak Test Guide". 08/07 M1110140

Bag Clrcult 6. Testthe Bag circuitfor lea悔: a. Setthe system switch to On. b. Set the Bag,tVentilator switch to Bag. c. Plug the Bag port (use your hand or the approved test plug). d. Close the APL valve (70 cm H20). e. Set the O2 flow to 0.25νmin. f. Close 世le patientconnection (usinga hand ortest plugon the side of the breathingsystem) and pressurize 由 e bag circuit with the O2 flush bu忱。n to approximately 30 cm H20. g. Release the flush button. The pressure must not decrease. A pressure decrease la唱.e enough to see on the gauge indicates an unaccep切 ble leak. Note: Iftestfails, see Section 7.2, "Breathing System Leak Test Guide". APL Valve 7. Testthe APL valve: a. Fully close the APL valve (70 cm H20). b. Set the total fresh gas flow to approximately 3 Ljmin and make sure thatthe value on the inspiraωry pressure gauge does not exceed 85 cm H20. Some pressure fluctuation is normal. c. Fully open the APL valve (to 由 e MIN position). d. Set O2 flow to 3 Ljmin. Tum any other gases 0仔. e. Make sure thatthe value on the inspiratory pressure gauge is less than approximately 5 cm H20. f. Push the O2 flush button. Make sure that the value on the inspiratory pressure gauge stays less than 10 cm H20. g. Set the O2 flow to minimum and make sure that the value on the inspiratory pressure gauge does notdecrease below 0 cm H20. 8. Remove your hand or the test plug from 由e patient connection. 9. Setthe System switch ωS恼 ndby. .&. WARNING Make sure that there are no 恒st plugs or other obje也 caughtin the breathing system. Ml110140ωvm ~U

1. Open the O2 cylindervalve or connect an O2 pipeline. 2. Rotate the flow cont刚 clockwise (decrease)ωshut off the flow. The ball should rest at the bottom of the flow tube and not move. 3. Rotate the flow control counterclockwise (i ncrease)凰The ball should rise immediately after rotation is begun. Itshould rise smoothly and steadily with continued counterclockwise rotation. When a desired flow is set, the ball should maintain in a steady position. 4. Occlude the auxiliary O2 outlet. The ball should rest at the bottom of the flow tube and not move. A ball that does not rest at the bottom of the flow tube indicates a leak and requires service. 5. Rotate the flow control clockwise to shut offthe flow. 3.13 Integrated Suction Regulator tests 3-18 The gauge needle should come to rest within the zero range bracket when no suction is beingsupplied. Gauges which do notcomply may be outof calibra甘 on. 1. Adjustthe regulator setting to minimum. 2. Turn the mode selectorto I (On). 3. Ensure the gauge remains less than 200 mmHg (26 kPa, 0.26 Bar). 4. Occlude the inlet. 5. Ensure the gauge remains less than 200 mmHg (26 kPa, 0.26 Bar). 6. Adjust the regulator in an increasing vacuum level. 7. The gauge should rise after rotation has begun. The gauge should rise with continued rotation ofthe regulator adjustment. 8. Adjust the regulator setting to minimum. 9. Turn the Mode selectorto 0 (0的. 08/07 Mll10140

3 Checkout Procedure 1. Connect the power cord to a mains outlet. The mains indicator on the display comes on when AC Power is connected. If the indicator is not on, the display assembly is not receiving AC power. • Verify AC powerωthe machine (reset circuit breaker). • Check fuses in display assembly's inlet module. • Check fuses in machine's AC inlet assembly. 2. Setthe system switch to On. 3. Unplugthe powerco时 with 由 e system turned on. 4. Make sure that the power failure alarm comes on. 5. Make sure the following message is on the ventilator display: • .On Ba忧ery - Power OK?" 6. Connectthe powercable again. 7. Make sure the alarm cancels. 3.15 Electrical safety tests Mll10140 08/07 Make sure the system is completely assembled and all accessory devices are connected to electrical ou甘ets. 1. Connectan approved testdevice (e.g. UL, CSA, or AAMI) and verifythatthe leakage current isless than: Voltage 120jl00Vac 220j240Vac Max. Leakage Current 300μAmps 500μAmps 2. Make sure thatthe resistance to ground isless than O.2Q between an exposed metalsurface and the ground pin on the power cord. 3-19

.&. WARNING: Post-Service Checkout is required after you complete 由 is 扭曲ion. You must perform Section 3.1 Post-service checkoutafter performing any maintenance, service or repair. Failure to do so may result in patient injury. In this section To ensure proper operation, the Aespire 7100 Ventilator includes several tests that run automatically (selftests) and a series of menu pages that a qualified service person can use to test, calibrate, or troubleshoot ventilator related components in the Aespire anesthesia machine (Service Mode). Mll10140 08/07 4.1 Selftests ................................................................ .4-3 4.2 Service Mode .. .. . . .. . . . . . .. . .. . . ... . .. . ... . . . ... . . . . . .. . . .. . ... . .. . .. .. . . .4-4 4.3 About Ventilator .. . .. . . . . . . .. . .. . . .. . . .. . .. . . . . . .. . . .. .. .. . . .. . . . . .. . .. .. . . .4-5 4.4 Alarrn Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6 4.5 Error Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7 4.6 Language . .. .. .. . . . . .. .. .. .. . . . . .. ... . ... . . . . . .. .. . .. . . . . . . .. . . . . . . .. .. .. .4-8 4.7 User Settings .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9 4.7.1ScreenContrast .....................................................4-9 4.8 System Con币guration ..................................................... 4-10 4.9 Calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 4-12 4.9.1 02 Calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . " 4-13 4.9.2 Zero Flow and Airway Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . " 4-14 4.9.3 Adjust Drive Gas Regulator .......................................... 4-15 4.9.4AirwaySensorSpan ................................................4-16 4.9.5 PEEP Valve Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 4-18 4.9.6 Inspiratory Valve Calibration ......................................... 4-19 4.9.7 Pressure Sensitivity ................................................ 4-21 4.9.8 Service Calibrations Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . " 4-23 4-1

4.10.1 Display A/D Channels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25 4.10.2 Display Discrete 1/0 Signals . . .. . . . . .. . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . 4-27 4.10.3 Display Battery Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28 4.10.4 Test Panel Switches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29 4.10.5 Valves -Test Tool ................................…………… ..4-30 4.10.6 Test CPU and Memory ……………………………………… 4-31 4.10.7TestEEPROM .................................................... 4-32 4.10.8TestSeriaIPort ................................................... 4-33 4.10.9 Test 5V Fail Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34 4.10.10 Test Inspiratory Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-35 4.10.11 Test PEEP Valve ................................................. 4-36 4.10.12TestPEEPSafetyValve ...........................................4-37 4.10.13 BreathingSystem LeakTest ................................… ....4-38 4.10.14 Test Pressure Limit Circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-38 4.11 Upgrade Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-40 08/07 Ml110140

4 Tests and Calibration The Aespire 7100 Ventilator software includes self tests that determine whether or not 由e operating software is functioning properly and whether or not the electronic circuits on the circuit boards are functional. The self tests include: • powerup tests • continuous tests • periodic tests Powerup tests The following list of the tests run at powerup: • Sequential watchdog • Logical watchdog • Data RAM walking pa忧emtest • FLASH ROM CRC verification • PEEP Valve test • PEEP Safety Valve test If one or more of these tests fail, the display provides a readout of the problem. Contlnuous tests These tests are run continuously during normal operation and alarms are associated with each test. A failure causes an alarm ωdisplay on the screen in the alarm display area. • Supply voltage chec恼 • Battery voltage checks • Inspiratory control valve DAC and voltage feedback • PEEP control valve DAC and voltage feedback Perlodlc tests These tests are run every 30 seconds during normal operation. Alarms are associated with each test. A failure causes an alarm to display on the screen in the alarm display area. • CPUTest • Display RAM walking pattem test • Da恼 RAM walking pa忧.emtest • FLASH ROM CRC verification Mll10140 08/07 4-3

刊e Servlce Mode is used to test, calibrate, or troubleshoot ventilator related components in the anesthesia machine. 1here are two ways to enter the service mode: • Ifthe machine is tumed off, push and hold in the adjustment knob while setting the system switch to On. Hold the adjustment knob pushed in until the .Service Confirmation" menu appears. Use the adjustment knob to highlight .Service Mode", then push the adjustment knob to confirm the selection. • Ifthe machine is already in normal operation, setthe Bag/Ventswitch to Bag. 1hen, press the VT/Pinsp, the PEEP, and the menu switches at the same time to reset the so伽are (powerup). Push and hold the adjustment knob until the .Service Confirmation" menu appears. Note: Volume alarms must be in standby. ..- Language Speclflc From this menu you can: • Go to the Service Modes • Return to Normal Operations Servlce Modes Menu The Servlce Modes main menu displays the servi四 te也 you can select. 4-4 SelVice Modes 圃'回-回..... ……… AI部mLog Error Log Lang崎ge User Settlngs Systell Contiguration Calibrations Diagn国际 Test矿Tools Upgr~ Optlons Go toN田旧 I ~rations 1he selectable service tests are displayed in categorical order. But you can select the service test from this menu in any order. 1he following sections in this manual are sequenced in the order that they appear on the screen. 08/07 Ml110140

4.3 About Ventilator Ml110140ω1/07 The About Ventllator menu identifies the current software loaded into the ventilator's Rash-ROM memory and displays the total .on time" of the system. • Software Verslon • S。伽'areDate • Hardware ID • Total 句stemOn Tlme • Current Bootup Count - The bootup count is incremented each time the machine is tumed on. The bootup count is not overwritten when new software is loaded. However, if a new control board is installed, the bootup count will reflect the value stored in the EEPROM of the new boar吼 旬flwi!le V阳 ion: 缸躏NareDate: Har刷刷 ID: About Ventilator . . . 1.1 A咽篇 2删节 :31:43 Total 句~阳伽Ti.e: 0 Vear( s] 0 阳~(s] 0 Hour( s] 0 MirUe(s] CUrrent 勘ot叩 E咽d: 4-5

The Alarm Log displays up to 20 of the most current alarrn messages that have been logged. Each log entry shows: • Bootup Count number (the bootup count is incremented each time the machine is turned on). • Time (ms) - the time in milliseconds since bootup when the latest alarm condition occurred. • Alann message associated wi伽由 e particular alarm condition. • # Times - the number of times that the specific alarm condition has occurred during the noted bootup count. The bottom-Ieft comer ofthe screen displays additional information: • Bootup Count Last Cleared • Current Bootup Count Clear Alarm Log Bootup Count Last CI回red 1 Current Bootup Count: 55 Go 10 Service Mode$ Menu Scroll Data To view all the log entries, select "Scroll Data." Then, use the control knob to scroll through the entries. To exit Scroll Data, press the control knob. Clear Alarm Log To clearthe alarrn log, select "Clear Alarm Log." The system asks you to confirm thatyou want to clearthe alarm log. Remarks Afteryou clearthe alarrn log: • the "Bootup Count Last Cleared" number will be reset to the "Current Bootup Count" number. • the menu will show the message "No entries in log! ". 4-6 08/07 Ml110140

4 Tests and Calibration There are two special types of alarms: • Minimum monitoringalarms thatstop mechanical ventilation • Minimum shutdown alarms that stop mechanical ventilation and monitoring. An alarm message that results from these special types of alarms is considered an error alarm. The Errol Log displays up to 20 ofthe most current Error messages that have been logged. Each log entry shows: • Bootup Count number (the bootup count is incremented each time the machine is turned on). • T1me (ms) - the time in milliseconds since bootup when the latest alarm condition occurred. • Error message associated with the particular alarm condition. • Address - the place in the software sequence where the last occurrence ofthe errorωokplace. The error address and software revision are important pieces of information to note if technical suppo此 is required. The bo忱。m-Ieft comer of the screen displays additional information: • Bootup Count Last Cleared • Current Bootup Count 口幅rEπOIL吨 自lOIUP C四ntL甜 CI剧创 1 0町田11 Boot叩 E国mt: 55 Go to SelVlce Modes M酬』 Scroll Data To view all the log entries, select "Scroll Data." Then, use the control knob ωscroll through the entries. To exit Scroll Data, press the control knob. Clear Error Log To clearthe error log, select "Clear Error Log." 而esystem as陆 youωconfirm thatyou want to clear the error log. Ml110140 08/07 Remarks Afteryou clearthe alarm log: • the "Boot Count Last Cleared" numberwill be resetto the "Current Boot Count" number. • the menu will showthe message "No entries in log!". 4-7

Service Confinnation menu (except for text MNonnal Operation") and all the Service Modes menus are shown only in English. 刊e Language menu is used to set the specific language for nonnal operation. Go to SelVlce Modea M回四 1he 7100 ventilator supports the following languages. 1he language selections appear in language specific text. . .. English Español . . . . . . Spanish Deutsch . . . . . . German Polski. . . . . . . . Polish p。此uguês . . . . portugue曾 Français . . . . . Fren由 Itallano. . . . . . . Italian Ce剖na ...... Czech Magyar . . . . . . Hungarian Nederlands . . . Dutch .. Greek ...... Russian . . . Japanese .. Chinese 1he following additionallanguages are available in Software revisions 1.4 and greater. Suomi . . . . . . . Finnish Tilrkçe. . . . . . . Turkish Norsk. . . . . . . . Norweglan 1he language se创ng is stored in EEPROM with the default setting as English. 08/07 Ml110140