E Caio 00 Service Manual

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DESCRIPTION

The Compact Airway Modules offer a wide range of direct patient ventilation and gas exchange measurements: CO2, O2 concentrations, multigas measurement with anesthetic identification, patient spirometry, CO2 production and O2 consumption.
Module options with anesthetic agent measurement are designed for the use with the Anesthesia Monitor and Compact Anesthesia Monitor. All other modules are designed for both anesthesia and critical care applications.

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1 Reply -finau 4 years ago	4 years agono probleem Do you have any of this on stock Reply
-ryans 6 years ago	6 years agoFailure to I.D. Agent Most of our E-CAiO are giving a 'Failure to I.D. Agent' error when a Tec6 (des) is being used it reads Tec5 and tec7 fine. anyone else having this problem? Reply
0 Replies -Cindy 7 years ago	7 years agoGE gas module cal gas regulator Did you know there is an annual verification process for the regulator? I just found out when I ordered a replacement and it failed the flow test. The procedure is: connect a silicon hose between the regulator and the flow meter. Block the regulator overflow port and open the regulator, check the flow rate from the flow meter, and verify that the flow is between 260-410 ml/min at 2-16 bar. I used my TSI certifier low flow module with it set on O2 and ATP. It only registered 166 ml/min where the two other units we have measured in the 300 ml/min range. Reply

FEATURES

• Airway modules specifically designed for AnesthesiaMonitor and Compact Anesthesia Monitor to measureanesthetic agent with identification, CO2, PatientOxygen™, Patient Spirometry™ and direct gas exchange.• All parameters measured at the patient’s airway• D-fend™ water separation system• Patient Oxygen – Datex-Ohmeda paramagnetictechnology– Inspired and end-tidal values, inspired/expireddifference, waveform• CO2 and N2O – Datex-Ohmeda infrared technology– Inspired and end-tidal values, waveform andrespiration rate• Anesthetic agents – Datex-Ohmeda infrared technology– Measures and identifies all five agents: Halothane,Enflurane, Isoflurane, Sevoflurane and Desflurane– MAC (Minimum Alveolar Concentration)– Agent mixture detection• Balance gas• Patient Spirometry – Datex-Ohmeda patented D-lite+™and Pedi-lite+™ flow sensor and gas sampler– Airway pressures, waveform, minute and tidal volumes,compliance, airway resistance and flow waveforms– Pressure-volume and flow-volume loops– Ability to store and print up to six loops– Recall saved loops to compare to current loop• Gas Exchange – Direct and continuous measurement– Oxygen consumption (VO2) and carbon dioxideproduction (VCO2).– Values for energy expenditure (EE) and respiratoryquotient (RQ).• Full numerical and graphical trends of all measured data

Additional Specifications

General
Module size (WxDxH) 75 x 228 x 112 mm/
3.0 x 9.0 x 4.4 in
Module weight 1.6 kg/3.5 lb
Sampling rate 200 mL/min ±20 mL
Automatic compensation for atmospheric pressure variation
(500 to 800 mmHg), temperature and CO2/N2O and CO2/O2
collision broadening effect. Parameter display update interval
typically breath-by-breath.
Functional alarms for
• Blocked sample line
• D-fend check
• D-fend replacement
Letters in the module name stand for
C = CO2 and N2O, O = patient O2
Ai = Anesthetic agents and agent identification
V = patient spirometry and X = gas exhange
Non-disturbing gases
Ethanol, acetone, methane, nitrogen, nitric oxide, carbon
monoxide, water vapor:
Maximum effect of non-disturbing gases on readings:
CO2 82%
Anesthetic Agent (AA)
Anesthetic agent waveform
MAC value displayed
Agent mixture detection
Halothane, Isoflurane, Enflurane
Measurement range 0 to 6%
Accuracy ±(0.15 vol% + 5% of reading)
Sevoflurane
Measurement range 0 to 8%
Accuracy ±(0.15 vol% + 5% of reading)
Desflurane
Measurement range 0 to 20%
Accuracy ±(0.15 vol% + 5% of reading)
Agent identification
Identification threshold 0.15 vol%*
Adjustable high and low alarm limits for EtAA,

510(k)

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Registration & Listing

Adverse Events

Recalls

PMA

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Classification

Standards

CFR Title 21

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Class 2 Device Recall CARESCAPE Respiratory Modules, EsCO, EsCOV, EsCAiO and EsCAiOV and accessories

Z-2617-2014
Date Initiated by Firm	August 08, 2014
Date Posted	September 09, 2014
Recall Status¹	Terminated ³ on September 08, 2015
Recall Event ID	68877
Analyzer, gas, oxygen, gaseous-phase - Product CodeCCL
Product	CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units. The affected modules could be in use with any of the following GE host devices: -CARESCAPE respiratory modules with CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Avance CS2 and Aisys CS2 Anesthesia Carestations, B40 Patient Monitor -Airway Gas Option N-CAiO modules with B40 Patient Monitor
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M1184207 SGV14224438HA M1184207 SGV14224439HA M1184207 SGV14224466HA M1184207 SGV14224473HA M1184207 SGV14224476HA M1184207 SGV14160350HA M1226039 SGV14203396HA M1184844 SGV14203397HA M1184844 SGV14203398HA M1184844 SGV14203403HA M1184844 SGV14203406HA M1184844 SGV14203407HA M1184844 SGV14203411HA M1184844 SGV14203412HA M1184844 SGV14203414HA M1184844 SGV14160256HA 2070616-001 SGV14171153HA 2070616-001 SGV14182022HA 2065638-001 SGV14192247HA 2070616-001 SGV14192248HA 2070616-001 SGV14192249HA 2070616-001 SGV14192251HA 2070616-001 SGV14192253HA 2070616-001 SGV14192254HA 2070616-001 SGV14192256HA 2070616-001 SGV14192257HA 2070616-001 SGV14159967HA 2065628-001 SGV14150176HA M1184207 SGV14159975HA M1184207 SGV14148744HA M1179136-X SGV14150040HA M1184207 SGV14150046HA M1179136-X SGV14150048HA M1179136-X SGV14150058HA M1179136-X SGV14150036HA M1184207 SGV14150038HA M1184207 SGV14150061HA M1184207 SGV14159403HA M1217240 SGV14159478HA M1184207 SGV14159500HA M1184207 SGV14159690HA M1184207 SGV14159696HA M1184207 SGV14159701HA M1184207 SGV14159974HA M1184207 SGV14159980HA M1184207 SGV14159992HA M1184207 SGV14159996HA M1184207 SGV14159998HA M1184207 SGV14160343HA M1217240 SGV14160518HA M1184207 SGV14181892HA M1217240 SGV14181893HA M1217240 SGV14181894HA M1217240 SGV14181896HA M1217240 SGV14181899HA M1217240 SGV14181900HA M1217240 SGV14181901HA M1217240 SGV14181903HA M1217240 SGV14181906HA M1217240 SGV14181908HA M1217240 SGV14181909HA M1217240 SGV14181910HA M1217240 SGV14181911HA M1217240 SGV14182030HA M1184207 SGV14192277HA M1217240 SGV14192279HA M1217240 SGV14192280HA M1217240 SGV14192287HA M1217240 SGV14192291HA M1217240 SGV14192292HA M1217240 SGV14192293HA M1217240 SGV14192294HA M1217240 SGV14224446HA 2065636-001 SGV14224452HA M1184207 SGV14224456HA M1184207 SGV14224474HA M1184207 SGV14224480HA M1184207 SGV14150181HA 2065628-001 SGV14150063HA M1184207 SGV14150055HA 2065635-001 SGV14160530HA 2065635-001 SGV14160531HA 2065635-001 SGV14224449HA 2065635-001 SGV14150187HA 2065628-001 SGV14150196HA 2065628-001 SGV14160548HA 2065628-001 SGV14160223HA M1226032 SGV14160236HA M1226032 SGV14170902HA M1226032 SGV14170904HA M1226032 SGV14170906HA M1226032 SGV14170907HA M1226032 SGV14170924HA M1226032 SGV14170926HA M1226032 SGV14170927HA M1226032 SGV14170928HA M1226032 SGV14171160HA M1226032 SGV14224434HA M1184207 SGV14224472HA M1184207 SGV14181852HA 2065605-001 SGV14224440HA 2067394-001 SGV14224459HA 2067394-001 SGV14150053HA 2065628-001 SGV14150057HA M1184207 SGV14150078HA M1184207 SGV14150190HA M1184207 SGV14160327HA M1184207 SGV14192282HA M1217240 SGV14182006HA 2067395-001 SGV14192762HA 2067395-001 SGV14192994HA 2067395-001 SGV14193002HA 2067395-001 SGV14193003HA 2067395-001 SGV14224451HA 2067395-001 SGV14224478HA 2067395-001 SGV14224460HA M1184207 SGV14224470HA M1184207 SGV14150002HA 2065633-001 SGV14150174HA 2065633-001 SGV14159705HA 2065633-001 SGV14160246HA 2070611-001 SGV14160251HA 2070611-001 SGV14160253HA 2070611-001 SGV14170900HA 2070611-001 SGV14224467HA 2065633-001 SGV14150171HA 2065632-001 SGV14150186HA 2065632-001 SGV14150198HA 2065632-001 SGV14159710HA 2065632-001 SGV14170914HA 2070610-001 SGV14192731HA 2065632-001 SGV14192738HA M1184207 SGV14192977HA M1184207 SGV14149258HA M1184207 SGV14150003HA M1184207 SGV14150050HA M1184207 SGV14150052HA M1184207 SGV14150076HA M1184207 SGV14150167HA M1184207 SGV14150168HA M1184207 SGV14150172HA M1184207 SGV14150173HA M1184207 SGV14150175HA M1184207 SGV14150177HA M1184207 SGV14150178HA M1184207 SGV14150183HA M1184207 SGV14150188HA M1184207 SGV14150200HA M1184207 SGV14150202HA M1184207 SGV14159503HA M1184207 SGV14159700HA M1184207 SGV14159981HA M1184207 SGV14159986HA M1184207 SGV14160535HA M1184207 SGV14160549HA M1184207 SGV14182004HA M1184207 SGV14182014HA M1184207 SGV14182016HA M1184207 SGV14182018HA M1184207 SGV14182019HA M1184207 SGV14182020HA M1184207 SGV14182021HA M1184207 SGV14182023HA M1184207 SGV14182024HA M1184207 SGV14182026HA M1184207 SGV14182027HA M1184207 SGV14182031HA 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Recalling Firm/ Manufacturer	GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
For Additional Information Contact	Technical Support or local service Rep. 800-558-7044
GE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sensor component associated with the CARESCAPE respiratory modules, the Airway Gas Option and their respective service exchange units.
Nonconforming Material/Component
Consignees were sent on 8/8/2014 a GE Healthcare 'Urgent Medical Device Correction' letter Ref# 36106 dated August 8, 2014. The letter was addressed to Healthcare Administrator / Risk Manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions you can contact Technical Support at 1-800-558-7044 or your local Service Representative.
748 (307 units US, 441 units OUS)
US: CA, CO, FL, GA, IN, KY, LA, MD,MI, NY,NC,OH, PA, SC, TN, TX, VA,WI. OUS: UNITED KINGDOM, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, PHILIPPINES, PANAMA, PAKISTAN, NORWAY, NICARAGUA, NEW ZEALAND, NETHERLANDS, MEXICO, LEBANON, KUWAIT, REPUBLIC OF KOREA, JAPAN, ITALY, INDONESIA, INDIA, GERMANY, FRANCE, FINLAND, EGYPT, CZECH REPUBLIC, COLOMBIA, CHILE, BULGARIA, BELGIUM, AZERBAIJAN, AUSTRALIA.
TPLC Device Report
¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. ² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. ³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database	510(K)s with Product Code = CCL and Original Applicant = GE HEALTHCARE FINLAND OY 510(K)s with Product Code = CCL and Original Applicant = GE MEDICAL SYSTEMS CHINA CO., LTD.