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Diamedica DPA 02 - User Manual

Diamedica DPA 02
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DPA 02 MANUAL ENGLISH © Copyright Diamedica (UK) Ltd 2022 Page 1 of 25
DPA 02
TM
Diamedica Portable Anaesthesia System
INSTRUCTIONS FOR USE MANUAL
ENG
Diamedica (UK) Ltd
Grange Hill Industrial Estate
Bratton Fleming, Barnstaple,
Devon, EX31 4UH, United Kingdom
Tel: +44 (0)1598 710066
WhatsApp: +44 (0) 7716 503156
Email: support@diamedica.co.uk
Web: www.diamedica.co.uk
Alphamed Consulting Ltd, Knock, Barnaderg, Tuam,
Co. Galway, H54 W220
Revision D 17/02/2022 DCN-0142
1639
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Summary

Intended Use and Warnings

Intended Use of the DPA02

Specifies the DPA02's use in difficult environments and low-resource settings for adult and paediatric patients.

Patient Monitoring Warning

Highlights the need for patient monitoring as the DPA02 does not include built-in monitoring features.

Operational Considerations

Sterilization Methods

Clarifies that the DPA series is a non-sterile device and not intended for user sterilization.

Suitability for Oxygen Rich Environment

States the device is intended for use in an oxygen-rich environment.

Introduction to the DPA Series

Specifications of the DPA 02

Cleaning, Maintenance, and Disposal

Breathing Circuit Cleaning and Disinfection

Details cleaning and disinfection procedures for the reusable breathing circuit and patient valve.

Vaporiser Maintenance and Troubleshooting

Accessories, Spares, and Disposal

Accessories and Spares Information

Provides guidance on patient circuit tubing and contact for spares.

Device Disposal Method

Explains product disposal in line with relevant regulations if returned to manufacturer.

Component Parts of the DPA 02

Protective Peli Case Features

Details the dustproof, crushproof, and waterproof IP67 rated carrying case.

Reservoir Components and Function

Details pressure relief valve, air entry, oxygen port, reservoir bag, vaporiser, connecting block.

Vaporiser Operation and Pressure Gradient

Explains vaporisation process, carrier gas, and pressure gradient requirements.

Draw Over Vaporiser Functionality

The Breathing System

Inspiratory Valve Description and Connections

Details the one-way valve, self-inflating bag connection, and other ports.

Expiratory Valve and PEEP Connection

Describes the expiratory valve and the attachment point for a PEEP valve.

Pressure Stabilization Tube Function

Connects inspiratory and expiratory valves, controlling lung filling.

Silicon Respiratory Tubing and Test Lung Setup

Describes tubing, Y piece, and test lung for circuit setup and testing.

Control and Operation

Vaporiser Positioning and Securing

Instructions for removing the vaporiser from storage and securing it.

Reservoir Block Assembly and Connection

Steps for attaching the reservoir bag and connecting the reservoir block.

Breathing System Assembly and Testing

Inspiratory Valve Attachment to Vaporiser

Attaching the inspiratory valve to the vaporiser outlet ensuring correct flow direction.

Self-Inflating Bag and Tube Connection

Connecting the self-inflating bag and tube to the inspiratory valve port.

Expiratory Valve Fixing

Fixing the expiratory valve to the case.

Corrugated Tubes and Test Lung Assembly

Assembling corrugated tubes to the Y piece and fitting the test lung.

Tube Connection to Inspiratory and Expiratory Valves

Connecting tubes to the inspiratory and expiratory valve outlets.

Test Assembly Procedure

Vaporiser Agent Compatibility and Filling

Supplementary Oxygen Sources

Oxygen Tube Connection to Barbed Fitting

Instructions for inserting the oxygen tube onto the barbed connection.

Oxygen Tube Connection to Regulator;Concentrator

Connecting the other end of the oxygen tube to the regulator or concentrator.

Test Procedure Before Use

Vaporiser Check and Refill Procedure

Confirming agent and lever movement, refilling if needed.

Oxygen Supply and Scavenging Tube Check

Checking oxygen supply and gas scavenging tube connection.

Anaesthetic Circuit Test Procedure

Testing the circuit with a reservoir bag as a test lung.

Final Readiness Check Before Use

Removing test bag and affixing patient interface.

Use of the DPA 02

Use on Adult Patients

Describes the standard Y piece dual limb circuit for adult and paediatric patients above 10kg.

Vaporiser Settings for Induction and Maintenance

Vaporiser settings are clinical decisions based on patient evaluation and monitoring.

Use on Paediatric Patients

Ayres T Piece Paediatric Circuit Usage

Using Mapleson F circuit with a flowrate of at least 3x the patient's minute volume.

PEEP (Positive End Expiratory Pressure)

PEEP Valve Fitting to Expiratory Valve

Connecting the PEEP valve to the expiratory valve ensuring correct flow direction.

PEEP Valve Adjustment Procedure

How to adjust the PEEP valve using the red cap (clockwise for increase, anti-clockwise for decrease).

Frequently Asked Questions

Compatible Volatile Agents for Vaporiser

Lists compatible agents (Halothane, Isoflurane, Sevoflurane) and warns against ether use.

Vaporiser Filling Procedure

Step-by-step guide for filling the vaporiser with anaesthetic agent.

Vaporiser Emptying Procedure

Methods for completely emptying the vaporiser of anaesthetic agent.

Vaporiser Regular Maintenance Requirements

Vaporisers require minimal maintenance; refer to Section 3 for details.

Symbols Glossary

Manufacturer Symbol Explanation

Indicates the medical device manufacturer.

Authorized Representative Symbol Explanation

Indicates the authorized representative in the European Community.

Date of Manufacture Symbol Explanation

Indicates when the medical device was manufactured.

Use-by Date Symbol Explanation

Indicates the date after which the medical device is not to be used.

Batch Code Symbol Explanation

Indicates the manufacturer's batch code.

Catalogue Number Symbol Explanation

Indicates the manufacturer's catalogue number.

Serial Number Symbol Explanation

Indicates the manufacturer's serial number.

Fragile, Handle with Care Symbol Explanation

Indicates a medical device that can be broken or damaged.

Keep Dry Symbol Explanation

Indicates a medical device needing protection from moisture.

Do Not Re-use Symbol Explanation

For single use or single patient use during a single procedure.

Refer to Instruction Manual Symbol Explanation

User must read instructions before using equipment.

Caution Symbol Explanation

Indicates need for cautionary information or warnings.

Non-sterile Symbol Explanation

Indicates device has not been sterilized.

Class II Equipment Symbol Explanation

Indicates Class II equipment.

Type BF Applied Part Symbol Explanation

Indicates Type BF applied part.

Recycling Symbol Explanation

Products should not be disposed of in the bin.

Battery Recycling Symbol Explanation

Chemical symbol for battery type included beneath.

Latex-free Symbol Explanation

Indicates absence of natural rubber latex.

Atmospheric Pressure Limitation Symbol Explanation

Indicates range of atmospheric pressure the device can be exposed to.

Humidity Limitation Symbol Explanation

Indicates range of humidity the device can be exposed to.

Temperature Limit Symbol Explanation

Indicates temperature limits the device can be exposed to.

Overview

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.

Function Description:

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.

Important Technical Specifications:

  • Dimensions (Closed case): Height 17cm, Width 47cm, Depth 35cm.
  • Weight: 9.8kg.
  • Operating Environment: Temperature 5-40°C, Humidity 35%-90% H, Altitude 79-106 kPa.
  • Storage Environment: Temperature -10-+45°C, Humidity 15%-93% H, Altitude 79-106 kPa.
  • Maximum Operational Altitude: < 2000m.
  • Oxygen Concentrator Input: 0.5 Bar Min.
  • Regulated External Gas Supply (Cylinder or wall) Input: 5 Bar Max.
  • PEEP Range: 0-20 cm H2O (circuit dependent).
  • Vaporiser Low Inspiration Resistance: <0.6 kPa.
  • Vaporiser Suitability: Suitable for Drawover and continuous flow.
  • Anaesthetic Agents: Isoflurane/Halothane or Sevoflurane.
  • Vaporiser Capacity: 150ml.
  • Agent Concentration Range: ISO/HAL 0-5%, SEV 0-8%. Delivered concentration is accurate within ±20% of set value for concentrations greater than 1% and ±50% of set value for concentrations of 1% or below.
  • Patient Circuit Tubing: Non-conducting (Applied Part).
  • Safety: The Peli-case is dustproof, crushproof, and waterproof, rated IP67 when latched shut for transportation.

Usage Features:

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.

Maintenance Features:

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.

Diamedica DPA 02 Specifications

General IconGeneral
BrandDiamedica
ModelDPA 02
CategoryMedical Equipment
LanguageEnglish