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Specifies the DPA02's use in difficult environments and low-resource settings for adult and paediatric patients.
Highlights the need for patient monitoring as the DPA02 does not include built-in monitoring features.
Clarifies that the DPA series is a non-sterile device and not intended for user sterilization.
States the device is intended for use in an oxygen-rich environment.
Details cleaning and disinfection procedures for the reusable breathing circuit and patient valve.
Provides guidance on patient circuit tubing and contact for spares.
Explains product disposal in line with relevant regulations if returned to manufacturer.
Details the dustproof, crushproof, and waterproof IP67 rated carrying case.
Details pressure relief valve, air entry, oxygen port, reservoir bag, vaporiser, connecting block.
Explains vaporisation process, carrier gas, and pressure gradient requirements.
Details the one-way valve, self-inflating bag connection, and other ports.
Describes the expiratory valve and the attachment point for a PEEP valve.
Connects inspiratory and expiratory valves, controlling lung filling.
Describes tubing, Y piece, and test lung for circuit setup and testing.
Instructions for removing the vaporiser from storage and securing it.
Steps for attaching the reservoir bag and connecting the reservoir block.
Attaching the inspiratory valve to the vaporiser outlet ensuring correct flow direction.
Connecting the self-inflating bag and tube to the inspiratory valve port.
Fixing the expiratory valve to the case.
Assembling corrugated tubes to the Y piece and fitting the test lung.
Connecting tubes to the inspiratory and expiratory valve outlets.
Instructions for inserting the oxygen tube onto the barbed connection.
Connecting the other end of the oxygen tube to the regulator or concentrator.
Confirming agent and lever movement, refilling if needed.
Checking oxygen supply and gas scavenging tube connection.
Testing the circuit with a reservoir bag as a test lung.
Removing test bag and affixing patient interface.
Describes the standard Y piece dual limb circuit for adult and paediatric patients above 10kg.
Vaporiser settings are clinical decisions based on patient evaluation and monitoring.
Using Mapleson F circuit with a flowrate of at least 3x the patient's minute volume.
Connecting the PEEP valve to the expiratory valve ensuring correct flow direction.
How to adjust the PEEP valve using the red cap (clockwise for increase, anti-clockwise for decrease).
Lists compatible agents (Halothane, Isoflurane, Sevoflurane) and warns against ether use.
Step-by-step guide for filling the vaporiser with anaesthetic agent.
Methods for completely emptying the vaporiser of anaesthetic agent.
Vaporisers require minimal maintenance; refer to Section 3 for details.
Indicates the medical device manufacturer.
Indicates the authorized representative in the European Community.
Indicates when the medical device was manufactured.
Indicates the date after which the medical device is not to be used.
Indicates the manufacturer's batch code.
Indicates the manufacturer's catalogue number.
Indicates the manufacturer's serial number.
Indicates a medical device that can be broken or damaged.
Indicates a medical device needing protection from moisture.
For single use or single patient use during a single procedure.
User must read instructions before using equipment.
Indicates need for cautionary information or warnings.
Indicates device has not been sterilized.
Indicates Class II equipment.
Indicates Type BF applied part.
Products should not be disposed of in the bin.
Chemical symbol for battery type included beneath.
Indicates absence of natural rubber latex.
Indicates range of atmospheric pressure the device can be exposed to.
Indicates range of humidity the device can be exposed to.
Indicates temperature limits the device can be exposed to.
The Diamedica Portable Anaesthesia System DPA 02 is a medical device designed to facilitate the administration of inhalational anaesthesia and respiratory support, particularly in challenging environments and low-resource settings. It is housed in a protective Peli-case, making it portable for deployment in field operations or humanitarian emergency situations. This device is suitable for use in hospital settings with limited resources, as well as in any field or outreach locations, and can be used for both adult and paediatric patients.
The DPA 02 delivers mixtures of gases and vapours to patients. It can function as a continuous flow machine when connected to an oxygen concentrator or an auxiliary oxygen source. In the event of gas supply failure, the system automatically defaults to a drawover machine, allowing anaesthesia to continue safely using atmospheric air (21% oxygen) as the carrier gas, which can be supplemented with oxygen if available. This drawover capability is a significant advantage, ensuring continued operation even without an external oxygen supply. The system utilizes a vaporiser to convert volatile anaesthetic agents into a gaseous form for administration. The flow capabilities of the drawover vaporiser meet ISO 18835:2015 requirements and can operate consistently up to an intermittent peak inspiratory draw of 35 L/min.
For adult patients and paediatric patients above 10 kg, the standard Y-piece dual limb circuit is used. For paediatric patients weighing less than 10 kg, a continuous flow paediatric circuit (Mapleson F - Ayres T piece) should be used with a minimum fresh gas flow of at least three times the patient's minute volume. The device also supports Positive End Expiratory Pressure (PEEP) functionality, with a PEEP valve that can be adjusted from 0-20 cmH2O.
The DPA 02 is designed for ease of understanding and operation. Its principal components include a protective Peli-case, a reservoir, a vaporiser, and a breathing system. The assembly process involves securing the vaporiser, attaching the reservoir block and bag, and connecting the breathing system components (inspiratory valve, self-inflating bag, expiratory valve, corrugated tubes, and Y-piece). A test lung (1-litre green reservoir bag) is used to confirm correct circuit set-up before attaching the patient interface.
The system allows for oxygen supplementation from an oxygen concentrator, a regulated cylinder, or a regulated central oxygen supply. The vaporisers are agent-specific, with fittings designed to prevent mixing of anaesthetic agents. Users are responsible for ensuring only the specified agent is used and that the vaporiser is neither overfilled nor underfilled.
The anaesthesia machine usage should be logged daily to assist with maintenance and cleaning. The unit and case should be cleaned daily by wiping with a damp cloth, ensuring it is dry and free from moisture afterwards. The ambient air intake grille should be inspected for particulate matter and cleaned if necessary.
Infection control is critical, and the reusable breathing circuit components (patient limb, self-inflating bag, limb to self-inflating bag, patient 'Y' piece) must be cleaned and disinfected according to hospital infection control procedures after each patient use or any contamination event. This typically involves washing in bleach solution, rinsing, and drying. Single-use bacteria filters and other single-use items should be discarded after one use.
Vaporisers are designed for minimal maintenance. If the control lever becomes stiff due to accumulated thymol (in halothane vaporisers), it can be loosened by removing the vaporiser, turning it upside down, shaking it, and moving the lever, then draining and rinsing with fresh agent. The vaporiser does not require recalibration, but any operational calibration should only be performed after consulting the manufacturer. To empty the vaporiser completely, it can be inverted and drained or the agent can be drawn out with a syringe. Residual contents can be removed by turning the dial fully on and blowing gas/air through the chamber for several minutes until no vapour is detected.
The device is Class II equipment and a Type BF applied part. It is not intended to be sterilized by the user. A full list of available spares can be obtained by contacting Diamedica. The manufacturer ensures proper disposal of the device in line with relevant regulations at the end of its life.
| Brand | Diamedica |
|---|---|
| Model | DPA 02 |
| Category | Medical Equipment |
| Language | English |
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