Standard Operating Procedure that describes the procedure for operation, and maintenance of Matrix VIP Vaporizer.

1.0 PURPOSE

To design a Standard Operating Procedure that describes the procedure for operation, and maintenance of Matrix VIP Vaporizer.

2.0 SCOPE

This Standard Operating Procedure (SOP) is applicable for the operation, and maintenance of Matrx VIP Vaporizer for Pharmacology studies conducted at the Animal House Facility

3.0 RESPONSIBILITY

3.1 All personnel in the Pharmacology Department shall be responsible for implementation and compliance with the SOP.

3.2 Head/Designees/Study Directors of the Pharmacology department shall be responsible for ensuring the implementation and compliance with the SOP.

4.0 DISTRIBUTION

4.1 The Quality Assurance department is responsible for keeping SOP ‘Master Copy’ approved through the Quality Manager.


5.0 DEFINITION(S) 

5.1 Definition(s)

5.1.1 The Matrix VIP calibrated vaporizer is designed to be used with one anesthetic agent i.e.; isoflurane which provides constant anesthesia to the subject.

6.0 ABBREVIATION(S)

6.1 SOP: Standard Operating Procedure

6.2 AHF: Animal House Facility

6.3 PPEs: Personal Protective Equipment

7.0 PROCEDURE

7.1 Introduction

The Matrix VIP calibrated vaporizer is designed for “out of circuit” uses in continuous flow techniques of inhalation anesthesia and is temperature and flow compensated so that its output remains relatively constant despite cooling due to the vaporization and variations in inlet flow however a single Dial Control with a concentration scale calibrated in % of anesthetic agent to set the desired concentration of the anesthetic agent.

7.2 Principle

The vaporizing chamber is lined with two concentric wicks, which enclose a metal helix so that the space is converted into a long spiral outlet channel. The wicks are in contact with the liquid agent, thereby ensuring that the vapor is maintained at saturation concentration in the gas leaving the vaporizing chamber.

7.3 Instrument description

7.3.1 Resistance to gas flow

The 5 centimeters flow rate gauze is provided.

                                                                  Figure 1: Gas Flow Rate

7.3.2 Liquid capacity

125 ml of anesthetic agent is required to fully charge the vaporizer however 35 ml is retained by the wick system.

7.3.3 Temperature range

The Matrix VIP calibrated vaporizer is designed to operate at temperatures between 59°F (15°C) and 96.8°F (36°C).

7.3.4 Calibration

Matrix VIP calibrated vaporizers are calibrated at 70°F +/- 3°F (21°C +/- 2°C). The variation in output with temperature, flow rate, and duration of use is small, and the variation of output when used with intermittent positive pressure ventilation is negligible.

7.4 Operations

7.4.1 Vaporizer on and off

In order to ON the vaporizer, the dial control release button shall be pressed and turn the dial in a counter-clockwise direction. To avoid inadvertent delivery of small concentrations of agent, the dial control shall be turned to “OFF” when the vaporizer is not in use.

                                                                   Figure 2: Dial Control Button

7.4.2 Filling and draining

7.4.2.1 Filling well

7.4.2.1.1 Ensure that the Dial shall be in the “OFF” position and the screw cap shall be removed.

7.4.2.1.2 The agent to be used shall same as that specified on the front of the vaporizer.

7.4.2.1.3 The agent shall be poured slowly into the filler opening, observing the agent level through the agent level indicator.

Figure 3: Filling the Chamber

7.4.2.1.4 If the vaporizer was dry before filling, the level shall be decreased slightly as the wicks absorb the agent.

7.4.2.1.5 The vaporizer shall be full when the agent level reaches the maximum level mark on the agent level indicator.

7.4.2.1.6 Then the screw cap shall be replaced by turning it clockwise.

7.4.2.1.7 The screw cap shall fully tighten to prevent leakage.

7.4.2.2              Draining well

67.4.2.2.1        Turn the screw cap counter-clockwise, and remove the cap to reveal the drain plug.

Figure 4: Draining of Anesthetic Bottle

7.4.2.2.2 Invert the screw cap and use the slot or hex (depending on the model) in the top to engage the drain plug.

7.4.2.2.3 Turn the inverted screw cap counter-clockwise to loosen the drain plug. Remove the drain plug. Drain the agent into a properly marked recovery bottle for disposal.

7.4.2.2.4 Invert the screw cap and tighten it securely into the fill well.

7.5 Maintenance

7.5.1 Every two weeks

When the level is low, the contents of the Matrix VIP calibrated vaporizer shall be drained into an appropriately marked container. Discard the agent in a locally approved manner and the agents such as Isoflurane and Sevoflurane require less frequent intervals since they do not contain any additives or stabilizing agents.

7.5.2 Annually

The Matrix VIP calibrated vaporizer shall be serviced annually at a Midmark authorized Service Center which includes the following:

7.5.2.1 Complete disassembly of the vaporizer and its components.

7.5.2.2 Thorough cleaning.

7.5.2.3 Inspection for damage and wear.

7.5.2.4 Renewal of wicks, seals, and any damaged worn, or outdated components.

7.5.2.5 Lubrication where necessary.

7.5.2.6 Checking the delivered vapor concentration under closely defined conditions. Re-graduation and adjustment where necessary.

8.0 PRECAUTION

8.1 All PPEs like aprons, gloves, masks, head caps, and shoe covers should be worn before using the instrument.

8.2 Press Keys softly.

8.3 Clean the equipment with a dry piece of robe or a lightly moistened one, do not use organic solutions.

8.4 Never use abrasive products or dissolvents.

8.5 Never pour water or liquids on the equipment.

8.6 Once you have finished using the equipment turn it off by using the main switch, clean, and check the equipment so that it is in optimal condition when you use it again.

8.7 Do not position the unit so that it is difficult to operate the main disconnect device.

8.8 Electrical outlets in the cabinet are restricted to 5 amps maximum current.

8.9 Do not use any detachable power cord that is not adequately rated for the unit.

8.10 Do not fill the vaporizer with any agent other than the one specified on the front label.

8.11 Do not fill the vaporizer unless the dial control is in the “OFF” position.

8.12 Do not turn the dial “ON” during filling, or attempt to fill the vaporizer beyond the full mark.

7.13 Do not drain the agent into any container other than a properly marked container.

7.14 Periodically check the agent level. The Matrix VIP calibrated vaporizer shall be filled at appropriate intervals.

8.15 The Matrix VIP calibrated vaporizer shall be filled and used in an upright position.

8.16 Do not carry the Matrix VIP calibrated vaporizer by holding the dial control.

9.0 REFERENCE & ATTACHMENTS

9.1 Reference

9.1.1 Installation and operation manual Matrix VIP Calibrated Vaporizer, Midmark.

Format – I Format for Log Book Maintenance

Format –II Format for Document History Sheet

10.0 REVISION HISTORY
10.1.1 Maintain the history of SOP or document as per the SOP format. It shall be maintained along with the current version of the SOP.

 

END OF THE DOCUMENT

You may like to read these links: 

1. List of All SOPs and Documents for the In-vivo Laboratory.

2. List of All SOPs and Documents for In-vitro Laboratory

3. List of All SOPs and Documents for the Animal House Facility

4. List of All SOPs and Documents for Clinical Research

5. List of All SOPs and Documents for Laboratory Instruments and Equipment

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