D Vapor and D-Vapor 3000 Instructions for Use Edition 9 June 2012

Working with these Instructions for Use The title of the main chapter in the header line helps with orientation and navigation.

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The Instructions for Use combine text and illustrations, providing a comprehensive overview of the system. The information is presented as sequential steps of action, allowing the user to learn directly how to use the device.

A Letters denote elements referred to in the text.

The text provides explanations and instructs the user step-by-step in the practical use of the product, with short, clear instructions in easy-tofollow sequence. 1

Consecutive numbers indicate steps of action, with the numbering restarting with "1" for each new sequence of actions.

Dashes indicate the listing of data, options, or objects.

(A) Letters in parentheses refer to elements in the relevant illustration. The illustrations show the relationship between the text and the device. Elements mentioned in the text are highlighted. Unnecessary details are omitted. These Instructions for Use apply to D-Vapor and D-Vapor 3000 anesthetic vaporizers. If information only applies to one model of Vapor, this is noted in the heading or in the corresponding part of the text.

z Bullet points indicate individual actions or different options for action.

Trademarks –

D-Vapor®

is a trademark of Dräger. –

Selectatec®

is a trademark owned by Datex-Ohmeda. –

Suprane®

is a trademark of Baxter International Inc.

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Instructions for Use D-Vapor/D-Vapor 3000

Safety Information Definitions WARNING A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION A CAUTION statement provides important information about a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or in damage to the medical device or other property. NOTE A NOTE provides additional information intended to avoid inconvenience during operation.

Definitions of the Target Groups For this medical device users, service personnel, and experts are defined as target groups.

Service personnel

These traget groups have been instructed in the use of the medical device and have the necessary knowledge, expertise, and training.

Service personnel can be an individual or a group of persons responsible towards the operating organization.

Dräger emphasizes that the medical device must be used, installed, reprocessed, or maintained exclusively by defined target groups

Service personnel are persons who may instal, reprocess, or maintain the medical device.

Experts Users Users are persons who may use the medical device in accordance with its intended use.

Instructions for Use D-Vapor/D-Vapor 3000

Experts are persons who may carry out complex maintenance work on the medical device.

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Abbreviations and Symbols Please refer to "Abbreviations" on page 22 and "Symbols" on page 23 for explanations.

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Instructions for Use D-Vapor/D-Vapor 3000

Contents

Contents For Your Safety and that of Your Patients . .

7

General Safety Information... 8 Product-specific safety information... 10 Application... 13 Intended use... 14 Environment of Use... 14 System overview... 15 Comparison D-Vapor with D-Vapor 3000... 16 Overview of functions... 17 D-Vapor... 18 D-Vapor 3000... 20 Abbreviations... 22 Symbols... 23 Operating Concept... 25 Operating states... Control dial... Connection and Interlock systems for D-Vapor... Connection and Interlock systems for D-Vapor 3000... Filling systems... Position of the user...

26 27 29 32 33 34

Disconnecting the Vapor... 63 Transport when filled... 65 Shut-down – draining the Vapor... 65 Blowing off the Vapor... 68 Storage... 68 Dispatch... 69 Alarms...

71

Alarm Concept... 72 Secondary Audible Alarm System... 73 Suppressing the Alarm Tone... 73 Problem solving...

75

Problems...

76

Cleaning and disinfection...

85

Safety information for preparation... 86 Preparatory procedure... 87 Before reusing on the patient... 88 Maintenance...

89

Overview... 90 Inspection... 91 Servicing... 92 Repair... 92

Preparation... 35

Disposal...

93

Before first use... 36 Fitting connectors... 37 Filling the Vapor... 40 Connecting the Vapor... 45 Establishing electrical connections... 49

Disposal of a medical device... Battery disposal...

94 94

Technical Data...

95

Operation... 51 Checking that the unit is ready for use... 52 Putting into operation... 56 Switching on and self test... 59 Adjusting concentration of anesthetic agent. . . 60 Changing the anesthetic agent... 61 Ending delivery of anesthetic agent... 62 Operation during power failure (battery operation)... 62 End of use... 63 Instructions for Use D-Vapor/D-Vapor 3000

Classifications... 96 Ambient conditions... 96 Performance characteristics... 96 Pneumatic interfaces... 99 Monitoring... 99 Electrical characteristics... 100 Standards... 100 Weight and dimensions D-Vapor... 101 Weight and dimensions D-Vapor 3000... 101 EMC Declaration... 102 Description... 107 5

Contents

Function... 108 D-Vapor 3000... 109 Calibration... 109 Influence of temperature... 109 Influence of flow... 110 Influence of gas type and composition... 111 Influence of atmospheric pressure and altitude... 111 Correction of the flow measurement under the influence of desflurane... 112 List of Accessories... 113 Quality Inspection Certificate... 115 Index... 117

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Instructions for Use D-Vapor/D-Vapor 3000

For Your Safety and that of Your Patients

For Your Safety and that of Your Patients General Safety Information...

8

Strictly follow these Instructions for Use... 8 Maintenance... 8 Safety checks... 8 Accessories... 8 Connected devices... 9 Not for use in areas of explosion hazard... 9 Safe connection with other electrical equipment... 9 Patient safety... 9 Patient monitoring... 9 Keeping the Instructions for Use... 9 Information on Electromagnetic Compatibility... 10 Product-specific safety information... 10 Essential performance... 12 Additional safety information for D-Vapor 3000... 12

Instructions for Use D-Vapor/D-Vapor 3000

7

For Your Safety and that of Your Patients

General Safety Information The following WARNING and CAUTION statements apply to general operation of the medical device. WARNING and CAUTION statements specific to subsystems or particular features of the medical device appear in the respective sections of these Instructions for Use or in the Instructions for Use of another product being used with this device.

Strictly follow these Instructions for Use WARNING Risk of operating error and incorrect use Any use of the medical device requires full understanding and strict observation of all sections of these Instructions for Use. This medical product may only be used for the purpose specified under "Intended use" on page 14. Strictly observe all WARNING and CAUTION statements throughout these Instructions for Useand all statements on medical device labels. Failure to observe these safety information statements constitutes a use of the medical device that is inconsistent with its intended use.

Maintenance WARNING Risk of malfunction of the medical device and risk of patient injury The medical device must be inspected and serviced regularly by service personnel. Repairs and complex maintenance activities on the medical device must be carried out by experts. Dräger recommends taking out a service contract with and having all repairs carried out by DrägerService. Dräger further recommends that only authentic Dräger parts are used for maintenance. If the above are not complied with, the correct functioning of the medical device may be compromised. See chapter "Maintenance".

Safety checks The medical device must be subject to regular safety checks. See chapter "Maintenance".

Accessories WARNING Risk resulting from incorrect accessories Only the accessories indicated on the list of accessories (see page 113) have been tested and approved to be used with the medical device. Therefore, it is strongly recommended that only these accessories are used in conjunction with the medical device. Otherwise, the correct functioning of the medical device may be compromised.

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Instructions for Use D-Vapor/D-Vapor 3000

For Your Safety and that of Your Patients

Connected devices

Patient safety

WARNING Risk of electric shock and of device malfunction

The design of the medical device, the accompanying documentation, and the labeling on the medical device are based on the assumption that the purchase and the use of the medical device are restricted to users, and that certain inherent characteristics of the medical device are known to the user. Instructions and WARNING and CAUTION statements are therefore largely limited to the specifics of the Dräger medical device. These Instructions for Use do not contain references to various hazards which are obvious to professionals who operate this medical device as well as references to the consequences of medical device misuse, and to potentially adverse effects in patients with different underlying diseases. Medical device modification or misuse can be dangerous.

Any connected devices or device combinations not complying with the requirements mentioned in these Instructions for Use may compromise the correct functioning of the medical device. Before operating any combination of devices, refer to and strictly comply with the Instructions for Use for all connected devices and device combinations.

Not for use in areas of explosion hazard WARNING This medical device 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 WARNING Risk of patient injury Electrical connections to equipment not listed in these Instructions for Use or these Assembly Instructions must only be made when approved by each respective manufacturer.

Patient monitoring The user of the medical device is responsible for choosing suitable monitoring that provides appropriate information about medical device performance and the patient's condition. Patient safety may be achieved by a wide variety of means ranging from electronic surveillance of medical device performance and patient condition to simple, direct observation of clinical signs. The responsibility for selecting the best level of patient monitoring lies solely with the user of the medical device.

Keeping the Instructions for Use CAUTION Risk of operating error The Instructions for Use must be kept accessible to the user.

Instructions for Use D-Vapor/D-Vapor 3000

9

For Your Safety and that of Your Patients

Information on Electromagnetic Compatibility

WARNING Risk of device failure

General information on electromagnetic compatibility (EMC) according to international EMC standard IEC 60601-1-2:

Portable and mobile RF communications equipment can affect medical electrical equipment.

Medical electrical equipment is subject to special precautionary measures concerning electromagnetic compatibility (EMC) and must be installed and put into operation in accordance with the EMC information provided on page 102.

Product-specific safety information WARNING Risk of device errors

WARNING Risk of patient injury

Various potentially dangerous situations can arise that require the user's attention.

Damage to the Vapor can cause incorrect output concentrations and serious harm to the patient.

Only use the device under the constant supervision of users in order to provide a prompt remedy in the event of a malfunction. WARNING Not permitted modifications Modifications to the medical device that are not permitted may lead to malfunctions. This medical device may not be modified without the manufacturer's permission.

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Handle the Vapor with care. Be careful not to tilt or drop. Do not carry by the control dial, the control dial caps or the locking lever for the plug-in adapter. Do not use the Vapor if it has been dropped. Check the Vapor that has toppled over, see Checking that the unit is ready for use, page 52. If the check is not possible, do not use the Vapor.

Instructions for Use D-Vapor/D-Vapor 3000

For Your Safety and that of Your Patients

WARNING Risk of patient injury

WARNING Risk of patient injury

Incorrect concentrations of anesthetic agent can harm the patient.

Risk of incorrect output concentration and impeded breathing due to high breathing resistance

Use continuous monitoring of the delivered concentrations of anesthetic agent, conforming to the ISO 21647 standard, with upper and lower alarm limits to detect deviations in concentration. Ensure that the measuring instrument is operational before using it. WARNING Risk of patient injury Incorrect output concentrations will not be detected when operating from the external fresh-gas outlet. An anesthetic gas monitor must be used if the Vapor is used with anesthesia equipment via the external fresh-gas outlet. WARNING Risk of patient injury Device function can be interfered with. Do not use the Vapor with magnetic resonance imaging (MRI). WARNING Risk of patient injury Deviation of the delivered concentration due to filling the Vapor with incorrect anesthetic agent. Only fill the Vapor with desflurane.

The Vapor is not suitable for use in a breathing system. WARNING Risk of patient injury High desflurane settings reduce the O2 concentration in fresh gas. High desflurane concentrations can affect hot wire volume measurement! The indicated volume will appear to be too high. High frequency ventilation or the use of anesthesia equipment with discontinuous fresh-gas flow or repeated use of the O2 flush can cause the Vapor to switch off. Observe the Instructions for Use for the anesthesia equipment. WARNING Risk of patient injury Device functions can be manipulated or switched off via the RS232 interface. The available RS232 interface may only be used for service purposes. WARNING Risk of an equipment fire In the event of a fire at the patient's side, the Vapor may ignite as a result. In the event of a fire, disconnect the oxygen conducting connections from the Vapor. CAUTION Health hazard Take care not to spill anesthetic agent. Do not inhale anesthetic agent vapors.

Instructions for Use D-Vapor/D-Vapor 3000

11

For Your Safety and that of Your Patients

CAUTION Risk of patient injury Observe the instructions for use provided by the manufacturer of the anesthetic agent. Pay particular attention to the described indications, contraindications, side-effects, MAC values, and expiration date of the anesthetic agent used.

Essential performance The essential performance of D-Vapor and D-Vapor 3000 anesthetic vaporizers is the enrichment of medical fresh gases with Desflurane vapor and the generation of alarms in the event of overpressure or underpressure in the internal desflurane vapor supply.

Additional safety information for D-Vapor 3000 WARNING Risk of patient injury The transfer of data to the anesthesia workstation can be erroneous. The indication of the control dial position on the screen of an anesthesia workstation with the Vapor View option is provided only for information. Only rely on the concentration that is set at the Vapor. WARNING Risk of patient injury The transfer of data to the anesthesia workstation can be erroneous. The indication of the filling level on the screen of an anesthesia workstation with Vapor View option serves only as information. Only rely on the filling level at the Vapor. WARNING Risk of patient injury The transfer of data to the anesthesia workstation can be erroneous. The indication of the detected, active Vapor type on the screen of an anesthesia workstation with the Vapor View option is provided only for information. Only rely on the anesthetic agent (color coding, labeling) shown on the vaporizer.

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Instructions for Use D-Vapor/D-Vapor 3000

Application

Application Intended use... 14 Environment of Use... 14

Instructions for Use D-Vapor/D-Vapor 3000

13

Application

Intended use The D-Vapor/D-Vapor 3000 is a heated, calibrated anesthetic vaporizer for enriching dry, medical fresh gas of anesthesia workstations with vapor of the anesthetic agent desflurane for the range of concentrations from 2 to 18 Vol.%.

Environment of Use D-Vapor/D-Vapor 3000 is intended for operation in anesthesia workstations in hospitals and rooms used for medical purposes. Restrictions to the working area D-Vapor/D-Vapor 3000 is not suitable for use in rooms used for magnetic resonance imaging. Installation and/or operation with anesthesia workstations in moving vehicles, airplanes, helicopters or ships is not permitted. If there is a need for such an application, operation is only permitted with the approval of the manufacturer.

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Instructions for Use D-Vapor/D-Vapor 3000

System overview

System overview Comparison D-Vapor with D-Vapor 3000 . . . 16 What is new with the D-Vapor 3000 design . . . 16 What is new with the D-Vapor 3000 functionality... 16 Overview of functions... 17 D-Vapor... 18 Front... 18 Rear... 19 D-Vapor 3000... 20 Front... 20 Rear... 21 Abbreviations... 22 Symbols... 23

Instructions for Use D-Vapor/D-Vapor 3000

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System overview

Comparison D-Vapor with D-Vapor 3000 D-Vapor

D-Vapor 3000

Anesthetic agent

Desflurane (Des.)

Desflurane (Des.)

Connection and Interlock system

Plug-in adapter DW-2000 with Interlock 2 Dräger Auto Exclusion plug-in adapter

Dräger Auto Exclusion plug-in adapter

Plug-in adapter S-2000 with Interlock S Permanent connection Conical connector Filling system

1)

Baxter filling system for Suprane (desflurane)

Baxter filling system for Suprane (desflurane)

Desflurane Piramal Fill / Torane Piramal Fill1)

Desflurane Piramal Fill / Torane Piramal Fill1)

Country-specific name Only the name "Desflurane Piramal Fill" is used in these Instructions for Use. The filling system is not available in every country.

What is new with the D-Vapor 3000 design

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When the refill mark is reached, a filling level message is displayed on the anesthesia workstation screen.

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Ergonomically designed locking bar

–

–

Ergonomically designed control dial

The recognized active Vapor type is displayed on the anesthesia workstation screen.

What is new with the D-Vapor 3000 functionality

Vapor View functions are only available for the D-Vapor 3000 anesthetic vaporizer and cannot be fitted to the D-Vapor anesthetic vaporizer.

D-Vapor 3000 has Vapor View functions. Vapor View functions are only active in conjunction with Dräger anesthesia workstations that have the Vapor View option. Vapor View functions: –

The control dial is illuminated.

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The inspection glass dial is illuminated.

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The position of the control dial is transferred to the anesthesia workstation as a setting value.

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Instructions for Use D-Vapor/D-Vapor 3000

System overview

Overview of functions Each Vapor is calibrated for the anesthetic agent specified on the device and is only suitable for that anesthetic agent. The delivered concentration is, for the most part, not influenced by operating and ambient conditions, such as temperature, gas flow and ventilation pressure. See chapter Description, page 109 to page 111. The Vapor is inserted in the fresh-gas line of the anesthesia workstation which typically delivers a continuous fresh-gas flow. The Vapor is connected between the fresh-gas metering unit and the freshgas outlet. Proper functioning of the Vapor is dependent on the direction of flow. The vaporizer must be connected and operated in accordance with the direction of flow specified on the device. The use of the Vapor with different anesthesia workstations is therefore only permissible and safe when it is used with the appropriate special adapter. Simultaneous operation of several Vapors connected in series is not permissible, particularly for different anesthetic agents. The Vapor is not suitable for use with a breathing system due to high pneumatic resistance. D-Vapor/D-Vapor 3000 may only be used with anesthesia equipment which conforms to one of the following standards: – IEC 60601-2-13 – ASTM F 1850 – CSA-Z 168.3

Instructions for Use D-Vapor/D-Vapor 3000

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System overview

D-Vapor

Front

A L K J I H

G

I

Symbol, "Caution! Observe the accompanying documents"

J

Indication of anesthetic agent and Vapor model

K Indication of concentration units

B

L 0 button for locking the control dial in the 0 or T position

C

Display panel

D

A

E

B C

max.

min.

D E

F

A Control dial cap with color coding of the anesthestic agent and Interlock code B Control dial with concentration markings C Sealing plug D Unlocking button for the sealing plug E Sight glass for displaying the filling level F Display panel

053

071

F

A Yellow LED

Audio paused 2 min

B Green LED Operational C Red LED No Output D Red LED Delivery Low E Yellow LED Fill Up F Yellow LED Battery

G Button for suppressing the acoustic alarm for 2 minutes H Protective cap for equipotential equilization pin 18

Instructions for Use D-Vapor/D-Vapor 3000

System overview

Rear

A B C

D

G

E 002

F A Locking lever on plug-in adapter B Opening for Interlock locking device (illustrated: Interlock 2) C Slot for locking lever, so that the Vapor can only be removed from the anesthesia workstation when the control dial is in the T position. D Connector system (Illustration: Plug-in adapter DW-2000) E Cover for RS232 interface F Power cable G Identification plate with manufacturer and model information and Serial Number

Instructions for Use D-Vapor/D-Vapor 3000

19

System overview

D-Vapor 3000

Front H Protective cap for equipotential equilization pin

A M L K J I H

B

I

Symbol, "Caution! Observe the accompanying documents"

J

Indication of anesthetic agent and Vapor model

K Indication of concentration units L Window to allow light to exit for illumination

C

M 0 button for locking the control dial in the 0 or T position

D

Display panel

A

max.

G E

B C

F

min.

D E

003

F

053

A Control dial cap with color coding of the anesthestic agent and Interlock code B Control dial with concentration markings

A Yellow LED

C Sealing plug

B Green LED Operational

D Unlocking button for the sealing plug

C Red LED No Output

E Sight glass for displaying the filling level

D Red LED Delivery Low

F Display panel

E Yellow LED Fill Up

G Button for suppressing the acoustic alarm for 2 minutes

F Yellow LED Battery

20

Audio paused 2 min

Instructions for Use D-Vapor/D-Vapor 3000