Multigas Analyzer AMG-06

Multigas Analyzer AMG-06 is intended for continuous non-invasive sidestream monitoring of СО2, isoflurane (ISO), sevoflurane (SEV), desflurane (DES) concentration in inspired (FiCO2, FiDES, FiISO, FiSEV) and expired (EtCO2, EtDES, EtISO, EtSEV) gases without automatic identification of anesthetic, and also for determining patient’s respiration rate (RSP) and apnea, MAC index, and measuring atmospheric pressure under the conditions of Operating Rooms, ICUs, and wards when providing anesthetic support.

AMG-06 areas of use – critical care:

· Operating rooms (OR).

· Anesthesiology Departments.

· Intensive Care Units (ICUs) during postoperative period, prolonged sedation, resuscitation, transportation of patients in healthcare facilities.

AMG-06 application can improve patient outcomes due to the following factors:

· Monitored administering of anesthetic gases.

· Confirmation of correct endotracheal tube placement.

· Assisting in the identification of coagulation problems such as emboli.

· Adequacy of ventilation, breathing and gas exchange.

· Early recognition of changes in cardiac output, perfusion and metabolism.

Measuring technology

Based on the infrared method of measuring, enables to measure anesthetics and CO2 concentration, is precise and fast due to a proprietary high-precision sensor.

Measurement accuracy

Complies with ISO 80601-2-55 standard.

Patient’s safety

Manual selection of the anesthetic type, color-coded graphs and numeric data, automatic detection of the incorrect choice. Accurate anesthetic concentration measurement ensures safe anesthesia, especially using low-flow method.

Built-in battery

Turns-on automatically in the absence of power supply, allows the device to continuously work autonomously up to 2 hours.

General-use accessories

All AMG-06 accessories are standard, general-use, and easily accessible for hospitals, thus reducing operating costs and making the device economically efficient.

A set of all needed AMG-06 accessories is supplied with single-use Sedana Medical Sedaconda® ACD (Anesthetic Conserving Device) vaporizer of volatile anesthetics.

Anesthetic gas monitoring

Administering volatile anesthetic agents, such as Sevoflurane, Isoflurane, Desflurane, requires precise control of gas concentration.

Delivery of inhaled volatile agents requires a bedside gas monitoring to provide information on drug dosing.

In particular, COVID-19 patients require delicate therapy, and it is necessary to dose the inhalation anesthetic very precisely.

Bedside end-tidal gas monitoring (correlate of cerebral concentration) can be used to ensure gas delivery, assess concentration of drug needed to achieve a specific clinical sedation endpoint, re-breathing of carbon dioxide and device obstruction.

Angela Jerath, Niall D. Ferguson, Brian Cuthbertson. Inhalational volatile-based sedation for COVID-19 pneumonia and ARDS. Intensive Care Med 2020 Aug;46(8):1563-1566. doi: 10.1007/s00134-020-06154-8. https://pubmed.ncbi.nlm.nih.gov/32588067/

AMG-06 Multigas Analyzer

Multigas Analyzer AMG-06 is intended for continuous non-invasive sidestream monitoring of СО2 and anesthetics concentration in inspired and expired gases. The device also determines RSP, MAC index and measures atmospheric pressure in operating rooms and wards when providing anesthetic support.

Some of the main AMG-06 benefits are.

Design

· Simple design, light weight, compact;

· Portable device, can be used during intrahospital patient transportation;

· Fits into any working environment. AMG-06 can be placed on a hospital pole or on any surface due to its universal mounting system.

Operation

· Intuitive interface, sensitive touchscreen.

· Minimum set of the most necessary functions.

· Can be used with high-frequency electrosurgical devices.

· Works with an external medical information system (MIS), possess Wi-Fi function.

· Maintenance-free.

Patient safety

· Suitable for low-flow anesthesia.

· Automatic detection of installed water trap (adult or neonate version).

· Displaying of the real time gas concentration.

· Extended user-friendly alarm system (visual and audible signals, text messages, vibration).

· Alarm log and 72-hour trends with intuitive navigation system and alarm filtering, freezing of CO2 and anesthetic graph in the main screen.

· Integrated MAC calculator.

· Safe use of consumables: the device has a special valve which prevents the reverse flow of gas through the sampling tube.

AMG-06 accessories

All AMG-06 accessories are standard, general-use, and easily accessible.  

In Canada, AMG-06 can be used with the following general-use disposable accessories licensed by Health Canada:

1) SAMPLING LINE, ADULT/PEDIATRIC – Licence No. 91789, Device Identifier 115-043017-00, manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Company ID 120691.

2) SAMPLING LINE, NEONATAL – Licence No. 91789, Device Identifier 115-043018-00, manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Company ID 120691.

3) DRYLINE II WATER TRAP, ADULT – Licence No. 96475, Device Identifier 100-000080-00, manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Company ID 120691.

4) DRYLINE II WATER TRAP, NEONATE – Licence No. 96475, Device Identifier 100-000081-00, manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Company ID 120691.

5) OXYGEN TUBE – Licence No. 98782, Device Identifier 1174003, manufactured by Intersurgical Ltd., Company ID 139625.

Main technical parameters and specifications

Detailed characteristics are provided in Table 1 Operating parameters (page 14) of the User Manual available in Downloads.

Device

Standard Set

     * Note: Optional.

**   Note: Determined at order.

The manufacturer guarantees correct performance of the device only with the delivery set specified above.

Accessories

All AMG-06 accessories are standard, general-use, and easily accessible for hospitals in Canada.  

AMG-06 can be used with the following accessories licensed by Health Canada:

1) SAMPLING LINE, ADULT/PEDIATRIC – Licence No. 91789, Device Identifier 115-043017-00, manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Company ID 120691.

2) SAMPLING LINE, NEONATAL – Licence No. 91789, Device Identifier 115-043018-00, manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Company ID 120691.

3) DRYLINE II WATER TRAP, ADULT – Licence No. 96475, Device Identifier 100-000080-00, manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Company ID 120691.

4) DRYLINE II WATER TRAP, NEONATE – Licence No. 96475, Device Identifier 100-000081-00, manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Company ID 120691.

5) OXYGEN TUBE – Licence No. 98782, Device Identifier 1174003, manufactured by Intersurgical Ltd., Company ID 139625.

CAUTION

Warranty service of the device failed because of incorrect operation is not performed.

CAUTION

The warranty does not cover defects or malfunction caused by liquid getting into the measuring cell of the device.

CAUTION

The warranty does not cover cable failure resulting from misuse.

These warranty obligations are general and apply to equipment produced by Triton Electronic Systems Ltd.

Manufacturer guarantees the compliance of the device with the requirements of TESM.943129.002 TR in case of normal, proper and intended transportation, storage and usage according to the User Manual.

The warranty period of the new equipment is 12 months and it can be extended at an extra cost. It is calculated from the commission date (date of putting into operation) by the service center authorized by Triton Electronics Systems Ltd. In the absence of a note of commissioning in the User Manual, the warranty period is calculated from the date of invoice, or, in the absence of an invoice, from the date of equipment manufacture specified on the equipment (see also User Manual, Section 12). In any case, the warranty period of operation cannot exceed 2.5 years from the date of equipment manufacture.

The limited warranty period, which is 12 months, is established for specific components that are subject to natural wear: batteries.

The warranty period for equipment repaired in an authorized service center is 6 months and is calculated from the repair end date specified in Section 13 of the User Manual.

Warranty obligations do not apply to disposable consumables supplied with equipment. Complaints concerning them must be sent to the respective manufacturer. Also, the warranty does not apply to the expiration of disposable consumables from the delivery set.

Warranty service is not provided due to:

· Not following the operating instructions stated in the User Manual.

· Absence of the user manual or serial number on the equipment, as well as incomplete equipment.

· Equipment malfunctions caused by impacts (falls), violation of the rules of packaging, storage and transportation, ingress of foreign objects or liquids, voltage drops or inconsistency with power supply standards and other similar external factors.

· Faults caused by the use of non-recommended or low-quality spare parts and consumables.

· No mandatory periodic maintenance.

· Detection of attempted repairs by persons and organizations not authorized by the manufacturer;

· Normal wear and tear of accessories, spare parts and consumables.

Keep the transport packaging and User Manual for the entire warranty period.

Make sure that the commissioning and maintenance repair data are correct.

For consultations concerning maintenance please contact the importer and distributor in Canada, Neuronix Inc.

In the event that the manufacturer receives the warranty equipment that does not contain defects declared by the customer, the distributor and manufacturer reserve the right to charge for delivery, testing and after-sales service of the equipment.

Multigas Analyzer AMG-06 Brochure

Multigas Analyzer AMG-06 User Manual

Inhalational (inhalative) sedation is administered with vaporized volatile anesthetics delivered through the breathing circuit to the patient’s lungs while the patient is on mechanical ventilation.

Inhalational (inhalative) sedation has advantages over intravenous medications.  It provides excellent controllability compared to intravenous (IV) sedation with propofol, midazolam, etc., and a low metabolic rate.

It may be a method of choice for sedation in patients with heart, liver, and kidney problems.

Volatile anesthetics ensure controlled use of a sedative and minimize the risk of developing such reactions as prolonged awakening, delirium, impaired cognitive functions after awakening.  They may be also suitable in cases when intravenous sedation is contraindicated due to intolerance to intravenous drugs.

Application of inhalative sedation in COVID-19 patients was particularly shown by Canadian researchers and clinicians lead by Dr. Angela Jerath, MSC FRCPC FANZCA MD BSC at Sunnybrook Health Science Centre: Sunnybrook researchers are trialing an alternative method of sedation for critically ill COVID-19 patients. http://health.sunnybrook.ca/research/practice-change-icu-sedative-pandemic/ 

If the patient is transferred to extended ventilation, it is necessary to synchronize the patient with the ventilator.  In order to make the adaptation to mechanical ventilation as comfortable and physiological as possible, it is possible to use inhalational anesthetics.

Recent clinical studies show that the use of inhalational anesthetic drugs for ventilated COVID-19 patients improves patient outcomes, reduces the time of mechanical ventilation, and reduces expenses of ICUs on sedating intubated mechanically ventilated patients.

Inhaled volatile anesthetic agents are a readily implementable solution for providing ICU sedation. Inhaled volatile agents may also provide important pulmonary benefits for COVID-19 patients with ARDS that could improve gas exchange and reduce time spent on a ventilator.

Angela Jerath, Niall D. Ferguson, Brian Cuthbertson. Inhalational volatile-based sedation for COVID-19 pneumonia and ARDS. Intensive Care Med 2020 Aug;46(8):1563-1566. doi: 10.1007/s00134-020-06154-8. https://pubmed.ncbi.nlm.nih.gov/32588067/

Inhalational agents may mitigate the progression of the disease through many mechanisms: near-balanced immunosuppression, antiviral properties, antithrombotic effects, preservation of membranous and cellular integrity, improvement of tissue oxygenation and bronchodilation.

Aiman Suleiman, Abdallah Barjas Qaswal, Mazen Alnouti, et. al. Sedating Mechanically Ventilated COVID-19 Patients with Volatile Anesthetics: Insights on the Last-Minute Potential Weapons. Sci. Pharm. 2021, 89(1), 6: doi.org/10.3390/scipharm89010006 https://www.mdpi.com/2218-0532/89/1/6

The severity of lung injury in COVID-19 patients correlates with levels of cytokines and viral load. Convincing preclinical data from others and us have shown that inhalational anesthetic drugs attenuate lung inflammation and dilate airways.

Beverley A. Orsera, Dian-Shi Wangb, Wei-Yang Lud. Sedating ventilated COVID-19 patients with inhalational anesthetic drugs: EBioMedicine . 2020 May;55:102770. doi: 10.1016/j.ebiom.2020.102770 https://pubmed.ncbi.nlm.nih.gov/32344199/

Bedside end-tidal gas monitoring is very important, especially in the treatment of patients with COVID-19.

Administering inhalational sedation typically requires an anesthesia machine or an ICU ventilator, a vaporizer of volatile anesthetic agents, such as isoflurane, sevoflurane, desflurane, anesthetic gas monitor, and disposable accessories.

An example of inhalational sedation set-up is shown in the diagram:

Anesthetic gas monitor

AMG-06 Multigas Analyzer serves for monitoring anesthetic gases.

Vaporizer of volatile anesthetics

Sedaconda^® ACD – available in Canada from BOMImed

Sedaconda^® ACD (Anesthetic Conserving Device) is a disposable medical device which enables the administration of volatile anesthetics (isoflurane or sevoflurane) and is inserted between the Y-piece and ET-tube. The device has no electrical components and is MRI & CT-scan compatible.  It also acts as an efficient Heat and Moisture Exchanger (HME) and contains an electro-static bacterial/viral filter.

Sedaconda^® ACD-L has a dead space of 100 ml and can function with tidal volumes as low as 350 ml.

Sedaconda^® ACD-S has a dead space of 50ml and can function with tidal volumes as low as 200 ml.

Formerly named AnaConDa.

Sedaconda^® ACD main features:

· Disposable medical device which enables the administration of volatile anesthetics (isoflurane or sevoflurane)

· Ability to easily control the level of patient sedation

· Sedaconda^® ACD-L has a dead space of 100ml and can function with tidal volumes as low as 350ml

· Sedaconda^® ACD-S has a lower dead space of 50ml and can function with tidal volumes as low as 200ml

· Simple setup

· Unique design

· Single patient use

ICU Ventilators

It can be used in conjunction with the following ICU ventilators authorized and available for sale in Canada, Health Canada COVID-19 Medical Device Authorization for Importation or Sale. Authorization Reference Number: 326828.  Issue Date: 2021-05-19:

• Intensive Care Ventilator Zisline MV200
• Intensive Care Ventilator Zisline MV300
• Hamilton-G5 – available in Canada from BOMImed
• Other ICU-level ventilators licensed by Health Canada, such as Evita 4 – Device Licence No. 12749, Device Identifiers 8412980, 84 14 467, 84 14 469, 84 14 474, 84 14 476, 84 14 478, manufactured by Draegerwerk Ag & Co. Kgaa, Company ID: 103279.

The method of inhalational sedation is described in many papers, particularly in the following.

Jerath A, Ferguson ND, Steel A, Wijeysundera D, Macdonald J, Wasowicz M. The use of volatile anesthetic agents for long-term critical care sedation (VALTS): study protocol for a pilot randomized controlled trial. Trials. 2015 Dec 9;16:560. doi: 10.1186/s13063-015-1083-5. PMID: 26646404; PMCID: PMC4673781.  Available from: https://pubmed.ncbi.nlm.nih.gov/26646404/

Jerath A, Parotto M, Wasowicz M, Ferguson ND. Volatile Anesthetics. Is a New Player Emerging in Critical Care Sedation? Am J Respir Crit Care Med. 2016 Jun 1;193(11):1202-12. doi: 10.1164/rccm.201512-2435CP. PMID: 27002466.  Available from:  https://pubmed.ncbi.nlm.nih.gov/27002466/

Jerath A, Panckhurst J, Parotto M, Lightfoot N, Wasowicz M, Ferguson ND, Steel A, Beattie WS. Safety and Efficacy of Volatile Anesthetic Agents Compared With Standard Intravenous Midazolam/Propofol Sedation in Ventilated Critical Care Patients: A Meta-analysis and Systematic Review of Prospective Trials. Anesth Analg. 2017 Apr;124(4):1190-1199. doi: 10.1213/ANE.0000000000001634. PMID: 27828800.  Available from: https://journals.lww.com/anesthesia-analgesia/Fulltext/2017/04000/Safety_and_Efficacy_of_Volatile_Anesthetic_Agents.27.aspx

Jerath A, Ferguson ND, Cuthbertson B. Inhalational volatile-based sedation for COVID-19 pneumonia and ARDS. Intensive Care Med. 2020 Aug;46(8):1563-1566. doi: 10.1007/s00134-020-06154-8. Epub 2020 Jun 25. PMID: 32588067; PMCID: PMC7315695.  Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7315695/

Gorsky K, Cuninghame S, Chen J, Jayaraj K, Withington D, Francoeur C, Slessarev M, Jerath A. Use of inhalational anaesthetic agents in paediatric and adult patients for status asthmaticus, status epilepticus and difficult sedation scenarios: a protocol for a systematic review. BMJ Open. 2021 Nov 10;11(11):e051745. doi: 10.1136/bmjopen-2021-051745. PMID: 34758996; PMCID: PMC8587357.  Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8587357/

Cuninghame S, Gorsky K, Francoeur C, Withington D, Burry L, Jerath A, Slessarev M. Effect of sedation with inhaled anaesthetics on cognitive and psychiatric outcomes in critically ill adults: a systematic review protocol. BMJ Open. 2022 Feb 7;12(2):e052893. doi: 10.1136/bmjopen-2021-052893. PMID: 35131825; PMCID: PMC8822506.  Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8822506/

Flinspach AN, Herrmann E, Raimann FJ, Zacharowski K, Adam EH. Evaluation of volatile sedation in the postoperative intensive care of patients recovering from heart valve surgery: protocol for a randomised, controlled, monocentre trial. BMJ Open. 2022 Feb 23;12(2):e057804. doi: 10.1136/bmjopen-2021-057804. PMID: 35197356; PMCID: PMC8867344.  Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8867344/

Jessica Spence, Sean Donald, Kan Ma, Sarah Hussain, Emily Belley-Côté, Nazari Dvirnik, Richard Whitlock, PJ Devereaux. Efficacy and safety of inhaled anesthetic for postoperative sedation during mechanical ventilation in adult cardiac surgery patients: protocol for a systematic review and meta-analysis. PROSPERO 2016 CRD42016033874.  Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42016033874

Orser BA, Wang DS, Lu WY. Sedating ventilated COVID-19 patients with inhalational anesthetic drugs. EBioMedicine. 2020 May;55:102770. doi: 10.1016/j.ebiom.2020.102770. Epub 2020 Apr 21. PMID: 32344199; PMCID: PMC7172604.  Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7172604/

ASA/APSF Guidance for Use of Volatile Anesthesic for Sedation of ICU Patients. Emergency Use for the COVID-19 Pandemic.  Available from: https://www.bing.com/ck/a?!&&p=0151f93255dbf529JmltdHM9MTY2NTUzMjgwMCZpZ3VpZD0xZjE5ZWQwMy04ODc0LTY1NjUtMTU2My1mY2RjODk0ZjY0ZmEmaW5zaWQ9NTI5NA&ptn=3&hsh=3&fclid=1f19ed03-8874-6565-1563-fcdc894f64fa&psq=The+Use+of+Volatile+Anesthesia+Agents+as+an+Alternative+For+Critical+Care+Sedation+During+COVID-19&u=a1aHR0cHM6Ly93d3cuYXNhaHEub3JnLy0vbWVkaWEvZmlsZXMvc3BvdGxpZ2h0L2d1aWRhbmNlLWZvci11c2Utb2Ytdm9sYXRpbGUtYW5lc3RoZXRpYy1mb3Itc2VkYXRpb24tb2YtaWN1LXBhdGllbnRzLnBkZg&ntb=1

Flinspach AN, Zacharowski K, Ioanna D, Adam EH. Volatile Isoflurane in Critically Ill Coronavirus Disease 2019 Patients-A Case Series and Systematic Review. Crit Care Explor. 2020 Oct 21;2(10):e0256. doi: 10.1097/CCE.0000000000000256. PMID: 33134946; PMCID: PMC7587445.  Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7587445/

APSF-Endorsed Statement on Revising Recommendations for Patient Monitoring During Anesthesia.  Available from:  https://www.apsf.org/wp-content/uploads/newsletters/2022/3701/APSF3701-2022-02-a03-StatementPatientMonitoring.pdf