Devapor Desflurane vaporizer Instructions for Use Edition 4 March 2001

Contents

Contents For Your Safety and that of Your Patients ... 3 Strictly follow the Instructions for Use ... 3 Maintenance ... 3 Accessories ... 3 Not for use in areas of explosion hazard ... 3 Safe connection with other electrical equipment ... 3 Liability for proper function or damage ... 3 Intended Use ... 4 Operating principle ... 5 Plug-in system ... 5 Control dial ... 5 Safety filler assembly ... 6 Indicators and alarms ... 6 Preparations for use ... 7 Connecting the mains cable ... 7 Connecting the vaporizer to the plug-in system ... 8 Fitting the equi-potential lead ... 8 Operation ... 9 Switching on and self-test ... 9 Concentration setting ... 10 Filling the vaporizer ... 11 Removing the vaporizer from the plug-in system ... 13 End of operation ... 13 Fault - Cause - Remedy ... 14 Alarm Priority ... 15 User maintenance ... 16 Maintenance intervals ... 16 Disinfection/cleaning ... 16 Changing the battery ... 17 Battery disposal ... 17 Concentration check ... 18 What's What ... 19 Technical Data ... 22 Manufacturer's certificate for interference suppression ... 23 Flow characteristics ... 23 Effects of carrier gas ... 23 Ambient pressure and altitude characteristics ... 24 Effects of back pressure ... 24 Effects of ambient temperature ... 24 Functional Description ... 25 Correction of flow measurement in presence of desflurane ... 26 Order List ... 27 Index ... 28

For Your Safety and that of Your Patients

For Your Safety and that of Your Patients Strictly follow the Instructions for Use

Liability for proper function or damage

Any use of the apparatus requires full understanding and strict observation of these instructions. The apparatus is only to be used for purposes specified here.

The liability for the proper function of the apparatus is irrevocably transferred to the owner or operator to the extent that the apparatus is serviced or repaired by personnel not employed by or authorized by Dräger Service or if the apparatus is used in a manner not conforming to its intended use.

Maintenance The apparatus must be inspected and serviced regularly by trained service personnel at six monthly intervals (and a record kept). Repair and general overhaul of the apparatus may only be carried out by trained service personnel. We recommend that a service contract be obtained with Dräger Service and that all repairs also be carried out by them. Only authentic Dräger spare parts may be used for maintenance.

Dräger cannot be held responsible for damage caused by non-compliance with the recommendations given above. The warranty and liability provisions of the terms of sale and delivery of Dräger are likewise not modified by the recommendations given above. Dräger Medical AG & Co. KGaA

Observe chapter “Maintenance intervals”.

Accessories Do not use accessory parts other than those in the order list.

Not for use in areas of explosion hazard This apparatus is neither approved nor certified for use in areas where combustible or explosive gas mixtures are likely to occur.

Safe connection with other electrical equipment Electrical connections to equipment which is not listed in these Instructions for Use should only be made following consultations with the respective manufacturers or an expert.

3

Intended Use

Intended Use Devapor - anaesthetic agent vaporizer for the addition of desflurane (Suprane®) anaesthetic vapour to medical gases within the concentration range 1% Vol to 18% Vol. It is intended for connection to a Dräger anaesthesia system with the aid of the Dräger plug-in system and is compatible with Dräger Interlock 2. Only fill Devapor vaporizers with desflurane (Suprane®)!

The use of any other anaesthetic agent may result in injury to patients. The Devapor vaporizer must be inserted into the fresh gas line leading to the breathing system of an inhalation anaesthesia machine. Do not connect the Devapor vaporizer downstream of the fresh gas outlet on an anaesthesia machine. Do not use the Devapor vaporizer in the breathing system.

An appropriate anaesthetic gas monitor must be used to monitor the concentration of anaesthetic agent vapour in the inspiratory gas when the vaporizer is in operation, in order to provide protection against hazardous output in the event of a device malfunction. High Desflurane settings reduce the O2 concentration in fresh gas. An oxygen monitor with low oxygen alarm must be used. High Desflurane concentrations may affect a hot wire volumeter! The indicated volume is higher than the actual volume, refer to page 26 for corrective action. High frequency ventilation or discontinuous fresh gas flow delivery of the anaesthesia machine or multiple use of the O2 flush may interrupt the Devapor vaporizer. For corrective action see page 14: Fault - Cause - Remedy. Follow the Instructions for Use of the particular anaesthesia machine used. Handle the Devapor vaporizer with care. Do not drop.

Use only dry, pure medical gases.

Do not carry by its dial or locking lever.

Do not use the Devapor vaporizer in the presence of combustible media. To avoid fire hazards, flammable anaesthetic agents such as ether or cyclopropane must not be used in the presence of the Devapor vaporizer.

This product contains a small amount of mercury in the tilt switch mechanism and should be disposed of according to local regulations.

Therefore the use of antistatic or electrically conductive breathing tubes and face masks is not necessary. Electrically conductive breathing tubes are unsuitable and therefore not recommended when utilizing high frequency surgery. Before connecting a Devapor vaporizer to other manufacturers' anaesthesia machines or operating it outside the operating conditions specified in the “Technical data” it is essential to consult Dräger to check whether the connection parameters required for it to function properly (for instance geometry, pressure and flow) will be met. Any deviations from the connection parameters may result in incorrect concentration delivered.

Devapor vaporizers must not be used in an MRI environment. Do not use mobile phones within a distance of 10 m to the Devapor vaporizer. Mobile phones may cause malfunction in electromedical equipment.

4

Operating principle

Operating principle

Plug-in system The Devapor is fitted with a locking lever for the rapid, safe connection and removal of the vaporizer.

AB.17.002

To lock the vaporizer onto the plug-in system, turn the locking lever 90° in a clockwise direction until the locked position is reached. Refer to page 8 for “Connecting the vaporizer to the plug-in system”.

Control dial The manually operated dial is used to select the level of agent concentration from 1 Vol.% to 18 Vol.%. The dial release mechanism incorporated in the dial assembly must be operated in order to turn the dial from the q (Standby) position and it must be operated again to turn the dial from 12 Vol.% to a higher Vol.% setting. All other settings can be made without operating the dial release.

AB.17.003

A solenoid interlock mechanism is also incorporated to help to ensure that the dial can be operated only when the green "Operational" light located on the display panel is illuminated.

5

Operating principle

Safety filler assembly

AB.17.004

The filler assembly incorporates a desflurane specific fitting which helps to ensure that only a Suprane® (desflurane) specific bottle equipped with a "Saf-T-Fill™" valve can be inserted in order to fill the vaporizer.

Indicators and alarms Visual indicators and an auditory alarm are used to provide the vaporizer status display and also to indicate an alarm condition, as described on page 14 "Fault Cause - Remedy" The audible alarm mute button can be used to silence the Low Agent alarm for a period of 2 minutes.

AB.19.002

The LCD agent level display indicates the level of agent contained in the vaporizer sump. The range of indication is between a minimum of 60 mL and a maximum of 390 mL. When the indication is below the 240 mL refill mark (-), this indicates that an additional 240 mL of agent can be added.

6

Preparations for use

Preparations for use

●

When carrying the device, hold the main body of the vaporizer securely with both hands and keep upright!

●

Do not support the vaporizer by holding the control dial and/or locking lever as this may cause damage or malfunction!

●

Handle the device with care. Do not drop the device or subject it to a sharp impact!

●

Use only the Dräger Devapor mains cable, 1.5 m or 3.5 m!

●

Turn dial to the q position.

●

Place the vaporizer on its reverse side.

1

Insert the Dräger Devapor (1.5 m or 3.5 m) mains cable firmly in the vaporizer's socket.

2

Carefully remove the retaining plate and feed the mains cable into the mains cable channel.

2

Clip the retaining plate back into place.

●

Return the vaporizer to its upright position.

●

Check whether the voltage information on the type label attached to the reverse side of the vaporizer conforms to the mains voltage: either or

AB.17.006

Connecting the mains cable

220 - 240 V 50/60 Hz 100 - 120 V 50/60 Hz

Use only vaporizers with the correct voltage rating.

7

Preparations for use

Connecting the vaporizer to the plug-in system Use only the Dräger plug-in system! 1

Set the control dial to the q position.

●

Remove protective plugs from vaporizer's ports.

2

Install the enclosed 'O' rings, if necessary, as described in the relevant anaesthesia system Operation and Maintenance manual.

3

The locking lever must be set to the "unlocked" position.

●

With both hands, hold the main body of the vaporizer in an upright position and lower it on to the plug-in system, ensuring that the vaporizer ports correctly engage with the plug-in system port valves.

●

To lock the vaporizer, turn the locking lever 90° in a clockwise direction.

AB.17.007

On commissioning only:

The vaporizer should lie positioned horizontally on the plug-in system.

AB.17.008

If the vaporizer does not fit horizontally on the plug-in system, remove the vaporizer as described on page 13 "Removing the vaporizer from the plug-in system" and repeat the procedures as described above.

Fitting the equi-potential lead e.g. for intracardiac or intracranial surgery. Fit one end of the lead to the equi-potential stud on the Devapor.

●

Route and connect the other end of the lead to a central ground stud, as described in the relevant anaesthesia system Operation and Maintenance Manual.

AB.17.009

●

8

Operation

Operation

Switching on and self-test Use vaporizers that are in a serviceable condition only! Do not use the vaporizer if, during the alarm and display test, any one of the 5 lights does not illuminate, the indicator bars on the agent level display do not flash or if the audible alarm fails to operate! ●

Connect the mains cable to the mains socket. This will activate the self-test.

●

All 5 lights and all the indicator bars of the agent level display will flash for approximately 4 seconds. The audible alarm is activated for approximately 4 seconds.

●

4 lights will then be extinguished, and the amber "Warm-up" light together with the agent level display will illuminate continuously .

An alarm and display test may be carried out at any time during operation without affecting the operation of the vaporizer: 1

Press the mute button for a minimum of 3 seconds to activate the test.

After a warm-up period of up to 10 minutes, the "Operational" light will be illuminated. The vaporizer is now ready for use.

●

If the "Low Agent" light is illuminated after the test, fill the vaporizer as described on page 11.

●

If the "Operational" light does not illuminate within 10 minutes, refer to page 14 "Fault - Cause - Remedy".

AB.19.003

Only now, after pressing the dial release button, the control dial can be rotated.

9

Operation

Concentration setting Dräger strongly recommends the use of the agent monitor and O2 monitor and set the agent monitor to Desflurane! High desflurane concentrations may reduce the O 2 concentration in the fresh gas. Use the O2 monitor! The vaporizer has not been calibrated at any dial position between q and 1 Vol.%. Do not use the vaporizer at dial settings between q and 1 Vol.%! It is a requirement of the European Standard EN 740 - Anaesthetic Workstation and Their Modules, that the gas monitoring referred to in the ‘Intended Purpose’ Section of this manual is in operating condition, by being enabled and functioning prior to use of the vaporizer. On the anaesthesia system: ●

Adjust fresh gas flow.

To adjust the concentration level on the Devapor: 1

Press the dial release button and turn the dial in a counter-clockwise direction from q.

2

Release the dial release button then adjust the dial to the required concentration level. Do not use settings between q and 1 Vol.%!

●

For settings higher than 12 Vol.%, press the dial release button and set the concentration by using the control dial.

If concentration levels higher than 12 Vol.% are reduced to levels lower than 12 Vol.%, the dial release button need not be operated.

10

AB.17.011

If the dial setting exceeds 12 Vol.%, the dial release mechanism comes into operation once more.

Operation

Filling the vaporizer Fill vaporizer with only Suprane® (desflurane)! If any other substance is used, patient injury could occur! A Devapor filled with any agent other than Desflurane must be returned to DrägerService! Fill the vaporizer using only the Suprane® (desflurane) specific bottle equipped with a "Saf-T-Fill"® valve! The vaporizer must only be filled in an upright position! Do not fill the vaporizer when it is disconnected. If the agent level display is not operating, overfilling may occur! AB.19.012

If the agent level display reaches the refill mark (–), the whole content of a desflurane bottle (approx. 240 mL) can be added to the vaporizer. If the amber "Low agent" light flashes and the audible alarm (see “Alarm Priority”, page 15) is activated, the agent level in the vaporizer is below 60 mL and the vaporizer must be replenished. The vaporizer may be filled: during the warm-up period, or during operation (which entails a longer filling time).

●

Set control dial to settings lower than 12 Vol.% to avoid activating the "No output" alarm.

●

Unscrew bottle cap and ensure that the 'O' ring is correctly fitted to the bottle probe.

●

Insert bottle probe into the filler port. Push the bottle against the spring pressure until it is fully engaged in the filler port. Do not twist bottle to insert.

AB.17.013

For filling during operation:

11

Operation

Ensure that the bottle probe is fully engaged into the filler port before attempting to lift the bottle!

Lift the bottle upwards to lock the bottle into the filler port. When the bottle reaches the upper stop, bubbling of agent in the bottle will occur for a period of up to 45 seconds before the agent flows into the vaporizer.

●

Hold the bottle in position at the upper stop and fill until the bottle is empty or the agent level display indicates that the sump is full.

AB.17.014

●

●

Grip the bottle firmly and lower it to the lower stop position. This interrupts the filling operation.

●

When the bottle reaches the lower stop position, hold the bottle briefly in the filler port until the small amount of desflurane in the filler system has drained back into the bottle. Do not twist bottle to remove.

●

Do not drop the bottle when it is automatically unlocked from the filler port!

The valve on the bottle automatically closes to avoid any loss of desflurane. ●

12

Replace the bottle cap.

AB.17.015

Once the bottle is empty or agent level display indicates that the vaporizer is full:

Operation

End of operation Turn the dial in a clockwise direction until the release button is automatically arrested.

●

The vaporizer will remain in q ready for further use until the mains supply is disconnected.

AB.19.011

●

1

Ensure that the dial is set to the q position.

●

Remove the mains cable from the mains socket.

2

Release the locking lever by turning 90° in a counter-clockwise direction.

3

Using both hands, carefully lift the vaporizer from the plug-in system.

AB.17.016

Removing the vaporizer from the plug-in system

13

Fault - Cause - Remedy

Fault - Cause - Remedy The following table indicates alarm conditions and their possible causes, together with the corrective action to be performed by the operator.

Possible Cause

Remedy

Desflurane level less than 20 mL. (Low Agent also alarming)

Turn dial to q setting. If the “Low agent” alarm has been activated, replenish with desflurane as shown on page 11

Prior power failure?

Turn dial to q position. Check electrical connection.

Vaporizer was tilted or jerky moved during operation.

Turn dial to q position. After 10 to 15 seconds the auditory alarm and flashing “No Output” light disappears. The vaporizer will be ready for use and the dial can again be set to the desired concentration.

Internal malfunction.

Use an alternative vaporizer. Contact DrägerService for assistance.

Desflurane level less than 60 mL. If this condition persists until the level is less than 20 mL, the “No output” alarm is activated and no further desflurane is supplied.

Replenish with desflurane as shown on page 11.

If the “Warm-up” light does not extinguish within 10 minutes after the vaporizer is connected to the mains supply, there may be an internal malfunction.

Do not attempt to use the vaporizer!

Used battery.

Change battery at next available opportunity (see page 17).

AB.19.005

AB.19.004

Alarm indication

AB.19.007

AB.19.006

Contact DrägerService for assistance.

If the vaporizer fails to function correctly after the appropriate action has been taken to rectify the fault, contact DrägerService for assistance! 14

Fault - Cause - Remedy

Alarm Priority The Devapor Vaporizer has three distinct alarm priorities. For each priority there is a different set of visual and auditory signals:

Alarm Priority

Visual Signal

Auditory Signal

High

Rapid red flashing light

Two sets of five audio beeps every 10 seconds

Medium

Amber flashing light

One set of three audio beeps every 25 seconds.

Low

Continuous amber light One audio beep only

An internal processor failure may also present an intermittent red No Output LED and alarm tone.

Devapor Condition

Low Battery

Low Agent

No Output

Dial ON

Medium Priority

Medium Priority

High Priority

Dial ON, Alarm Silence Pressed

Low Priority

Audio silenced for 120 seconds, then audio active

High Priority (pressing Silence has no effect)

Dial turned to n

Low Priority

Low Priority (dial locked until condition corrected)

Low Priority (dial locked until condition corrected)

15

User maintenance

User maintenance

Maintenance intervals Prior to performing any maintenance procedures or returning to service center for repairs, clean and disinfect the vaporizer.

Every six months

Planned safety inspections together with the anesthesia system by qualified personnel. Inspect and perform Output Concentration check as outlined on page 18 of manual.

Annually

Battery replacement.

Disinfection/cleaning For disinfection purposes, cleaning agents of a surface germicide type should be used. In terms of material compatibility, cleaning agents which contain the following active ingredients are suitable for use: –

aldehydes,

–

alcohol,

–

quaternary ammonium compounds.

Owing to possible damage to materials, the following compounds are not suitable for use: –

halogen hydrolysing compounds,

–

strong organic acids,

–

oxygen hydrolysing compounds.

Do not immerse the Devapor in any liquid, do not sterilise and do not disinfect in an Aseptor! Do not allow cleaning agents or germicides to accumulate in the filler, the gas inlet and outlet ports, or around the control dial! ●

Wipe any heavy soiling with a disposable tissue.

●

To clean external surfaces, use a moist cloth and neutral detergent (pH 7 to 10.5).

16

User maintenance

Changing the battery The battery, which supports the power failure alarm, must be changed: Annually. and When the amber "Alarm battery low" light is illuminated at the next available opportunity.

●

Turn the dial to the q position and remove the mains cable from the mains supply.

●

Remove the vaporizer from the plug-in system as described on page 13 and place the vaporizer carefully on its reverse side.

●

Unscrew the battery cover slotted screw with the aid of a coin or a screwdriver and remove the cover.

●

Remove the battery and disconnect the terminals. Dispose of the battery with care.

●

Clip the terminals firmly on to the new battery and insert the battery into the vaporizer. Replace the battery cover and tighten the slotted screw.

AB.17.021

Use a 9 Volt battery according to IEC 6LR61: Duracell - Alkaline MN/1604 or VARTA - Alkaline or VARTA - Electric Power 8022. The installation of any other battery may damage the vaporizer and/or injure the operator!

Battery disposal Do not throw batteries into a fire! - Batteries may explode! Do not open batteries with force! - Risk of causticization! Do not recharge! - Risk of explosion! ●

Batteries should be treated as special waste and disposed of according to local regulations regarding waste disposal!

Information may be obtained from local environmental or regulatory offices and relevant waste disposal companies.

17

User maintenance

Concentration check Connect the Devapor to the plug-in system of the anaesthesia machine, as described on page 8. ●

Set the oxygen output of the anaesthesia machine to a flow of 5 ± 0.5 L/min.

●

Ensure that the fresh gas output is connected to a gas scavenging system.

●

Measure the concentration at the fresh gas outlet, using an agent monitor which is calibrated to measure desflurane.

●

Allow the readings to stabilise and check that the readings are within the specified tolerances.

●

Document and maintain the test results, including the date, person performing the test, and serial number of the unit tested.

The accuracy of the measuring equipment must be considered when obtaining the readings!

Dial Setting 1 6 12 18

●

18

Min Vol. % .5 5.10 10.20 15.30

Max Vol. % 1.50 6.90 13.80 20.70

If the Devapor does not meet the calibration tolerances, do not use the Devapor. Contact DrägerService!

What’s what

What's What

Devapor

2

3 4

1

8

AB.17.001

5

6 7

1 2 3 4 5

Release button for the control dial Locking lever for the plug-in system Equi-potential stud Control dial Audible alarm mute button and self-test during operation 6 Display panel 7 Filler port for desflurane bottle 8 Port for interlock system

19

What’s what

Display panel

6.1

6.2 6.3

6.6

6.4

AB.19.008

6.5

6.1 Operational green light 6.2 No Output red/amber light 6.3 Low Agent amber light 6.4 Warm-Up amber light 6.5 Alarm Battery Low amber light 6.6 Agent level display = 390 mL ± 25 mL = Refill mark indicating the ability to fill vaporizer with a desflurane bottle approx. 240 mL in size

= 60 mL

20