Oxylog VE300 Instructions for Use Sw 1.n 5th Edition Dec 2017

This page has been left blank intentionally.

2

Instructions for use

| Oxylog VE300 SW 1.n

Contents

Contents 1

2

3

4

5

6

Information regarding the instructions for use...

6

1.1 1.2 1.3 1.4

Typographical conventions ... Use of terms ... Illustrations... Trademarks...

6 6 6 6

Safety-related information ...

8

2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10

Intended use ... Indications... Contraindications ... Environment of use... Essential performance characteristics ... Target groups ... Information on safety instructions and precautionary statements... Basic safety instructions ... Product-specific safety information... Additional information ...

8 8 8 8 9 9 10 10 15 16

Overview ...

17

3.1 3.2 3.3 3.4 3.5 3.6

Main device... Main device with carrying system ... Breathing circuits ... Range of functions... Abbreviations ... Symbols ...

17 20 21 23 24 25

Operating concept ...

28

4.1 4.2 4.3 4.4

Control elements... Structure of the screen ... Color concept... Selecting and setting ...

28 29 32 32

Assembly and preparation ...

33

5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 5.10

Assembling the main device with carrying system (option) ... Attaching the accessories bag (option)... Internal battery... Connecting the power supply ... External power supply ... Connecting the gas supply ... Connecting the breathing circuit ... Connecting bacteria filters, HME, or catheter mounts ... Connecting the CO2 sensor and the CO2 cuvette (option) ... Attaching the device to rail systems ...

33 35 35 36 36 37 41 45 45 46

Getting started ...

47

6.1 6.2

47 48

Charging the battery ... Determining the approximate pneumatic duration of operation ...

Instructions for use | Oxylog VE300 SW 1.n

3

Contents

6.3 6.4 7

8

9

Performing the system tests ... CO2 zero calibration and CO2 filter test (option)...

49 51

Operation ...

55

7.1 7.2 7.3 7.4 7.5 7.6 7.7

Switching on the device ... Preparing the ventilation mode ... Selecting the ventilation mode... Changing the ventilation mode ... Non-invasive ventilation (NIV) ... O2/air mix... Switching to standby mode and turning off the device ...

55 55 56 63 64 66 67

Alarms...

69

8.1 8.2 8.3 8.4

Safety information... Alarm priorities... Alarm indication ... Setting alarm limits ...

69 69 70 71

Configuration ...

74

9.1 9.2 9.3 9.4 9.5

74 75 75 75

Setting configuration parameters... Adjusting the screen brightness... Setting the breathing circuit ... Setting the HME correction... Setting the ventilation mode for the ventilation category "Ventilation (volume)" Setting the CO2 cuvette type (option) ... Using the Bluetooth function (option)... Activating the screenshot function (option)... Advanced system setup...

75 76 76 77 78

10 Logbook and system information ...

86

9.6 9.7 9.8 9.9

10.1 10.2

Logbook ... System information ...

86 87

11 Troubleshooting... 11.1 Alarm – Cause – Remedy... 11.2 Messages in the alarm message field ... 11.3 Messages in the notification field... 11.4 Error messages during the system test ...

88 88 88 96 97

12 Reprocessing ...

98

12.1 12.2 12.3 12.4 12.5 12.6 12.7 12.8

4

Disassembly ... Information on reprocessing ... Safety information... Classification for reprocessing... Recommendations for reprocessing ... Reprocessing the non-critical components... Reprocessing list ... Assembly ...

98 101 101 101 102 104 104 105

Instructions for use | Oxylog VE300 SW 1.n

Contents

13 Service ... 13.1 13.2 13.3 13.4 13.5 13.6 13.7

106

Safety information... Definition of service terminology... Inspection ... Maintenance ... Repair ... Technical documentation... In the event of a device error or device malfunction ...

106 106 106 107 108 108 108

14 Disposal ...

109

14.1 14.2 14.3

Disposal of the product ... Disposal of the rechargeable battery ... Disposal of the breathing circuit and the CO2 cuvettes ...

109 109 109

15 Technical data ...

110

15.1 Safety information... 15.2 Device specifications ... 15.3 Ambient conditions ... 15.4 Settings... 15.5 Performance data ... 15.6 Displayed measured values... 15.7 Monitoring ... 15.8 Operating data ... 15.9 Materials used ... 15.10 Pneumatic diagram... 15.11 EMC Declaration... 15.12 Emission of high-frequency energy ... 15.13 Connections to IT networks ... 15.14 Open-source software ...

110 110 112 113 114 115 116 118 119 120 121 122 123 124

16 List of accessories...

125

16.1

List of accessories ...

125

17 Password ...

128

17.1

Password protection ...

128

Index...

130

Instructions for use | Oxylog VE300 SW 1.n

5

Information regarding the instructions for use

1

Information regarding the instructions for use

1.1

Typographical conventions Text

Texts printed in bold and italics indicate device labels and screen texts.

1.

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

●

Bullet points indicate individual actions or different options for action.

–

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

(A)

Letters in parentheses refer to elements in the related illustration.

A

Letters in illustrations denote elements referred to in the text.

>

The "greater than" symbol indicates the navigation path in a dialog. This symbol indicates information which makes it easier to use the product.

►

1.2

This triangle is used in safety instructions and precautionary statements to indicate possible ways of avoiding the risk.

Use of terms Dräger uses the term "accessory" not only for accessories in the sense of IEC 60601-1, but also for consumable parts, removable parts and attached parts.

1.3

Illustrations Depending on the configuration, the products and screen content shown in this document may differ from the actual on-site products.

1.4

Trademarks Trademarks owned by Dräger The trademarks are registered in the following countries: Trademark Oxylog® DrägerService® MEDIBUS.X® ClassicStar® NovaStar®

6

Country Germany, EU, USA, Australia Germany, USA EU, USA EU, USA EU, USA

Instructions for use | Oxylog VE300 SW 1.n

Information regarding the instructions for use

Trademarks owned by third-party manufacturers Trademark Dismozon® Korsolex® Neodisher® Buraton® Perform® Mikrozid® acryl-des® Actichlor® Sekusept® Oxycide® Dispatch® Descogen® Virkon® BruTab 6S® Klorsept®

Trademark owner BODE Chemie BODE Chemie Chemische Fabrik Dr. Weigert Schülke & Mayr Schülke & Mayr Schülke & Mayr Schülke & Mayr Ecolab Ecolab Ecolab USA Clorox Antiseptica DuPont Brulin Medentech

Trademark Trademark BIPAP1) 1) Licensed trademark

Instructions for use | Oxylog VE300 SW 1.n

7

Safety-related information

2

Safety-related information

2.1

Intended use Oxylog VE300 is a time-cycled, volume-controlled and pressure-controlled emergency and transport ventilator for patients requiring mandatory or assisted ventilation with a tidal volume from 100 mL upward.

2.2

Indications For patients with a tidal volume of 100 mL upward.

2.3

Contraindications Patients with a tidal volume of 100 mL or less.

2.4

Environment of use Intended environments of use: – Mobile use for emergency patients, for outdoor and indoor environments – During transport in ambulances, airplanes, helicopters, and on board ships – In accident and emergency departments – During intrahospital transport of ventilated patients

WARNING Risk of patient injury The device is not intended for long-term use. ► Do not use the device as an intensive care ventilator.

WARNING Risk of patient injury and device malfunction Do not use the device in hyperbaric chambers. ► This may result in danger to the patient and malfunctioning of the device.

WARNING Risk of patient injury and device malfunction Do not use the device in conjunction with magnetic resonance imaging (MRI). ► This may result in danger to the patient and malfunctioning of the device.

WARNING Risk of explosion and fire The device is not approved for use in areas where oxygen concentrations greater than 25 Vol% and combustible or explosive gas mixtures are likely to occur. ► This may result in risk of explosion and fire.

8

Instructions for use | Oxylog VE300 SW 1.n

Safety-related information

2.5

Essential performance characteristics Provided that the essential performance characteristics are functioning correctly, the product can be used for its intended purpose. The product has the following essential performance characteristics: Provision of controlled and monitored patient ventilation with user-defined pressure limitation for airway pressure or the triggering of a corresponding alarm. If CO2 measurement (option) is active, the product has the following additional essential performance characteristics: – Adherence to the specified CO2 measurement accuracy – Triggering of an alarm if the alarm limit set by the user is exceeded – Triggering of an alarm if the specified CO2 measurement accuracy cannot be maintained In the event of an external power supply failure, the device automatically switches to the internal battery.

2.6

Target groups

2.6.1

Intended users The device is intended for use by and under the supervision of trained healthcare professionals, e.g., doctors, nurses, emergency medical technicians, respiratory therapists, and paramedics.

2.6.2

Definition of target groups The target groups may only carry out the following activities if they meet the necessary requirements.

2.6.2.1

Users Task Use of the product in accordance with the intended use

2.6.2.2

Reprocessing personnel Task Reprocessing

2.6.2.3

Requirement Specialist medical knowledge in respiratory care and the use of the medical device

Requirement Specialist knowledge in the reprocessing of medical devices

Service personnel Task Installation Basic service work (inspection, maintenance according to the "Service" chapter)

Instructions for use | Oxylog VE300 SW 1.n

Requirement Specialist knowledge in electrical engineering and mechanics Experience in the servicing of medical devices

9

Safety-related information

2.6.2.4

Specialized service personnel Task Installation Basic and complex service work (inspection, maintenance, repair)

Requirement Specialist knowledge in electrical engineering and mechanics Experience in the servicing of medical devices Experience in complex service work on this product

Dräger recommends arranging a service contract with DrägerService.

2.7

Information on safety instructions and precautionary statements Safety instructions and precautionary statements warn of risks and give instructions for the safe use of the product. Failure to observe them may lead to personal injury or property damage.

2.7.1

Safety instructions This document contains sections with safety instructions which warn of risks. The type of risk and the consequences of non-compliance are described in each safety instruction.

2.7.2

Precautionary statements Precautionary statements relate to action steps and warn of risks that may arise when executing the action steps. Precautionary statements precede the action steps. The following warning signs and signal words indicate precautionary statements and differentiate the possible consequences of non-compliance. Warning sign Signal word WARNING

Consequences of non-compliance May result in death or serious injury.

CAUTION

May result in moderate or minor injury.

NOTICE

May result in property damage.

2.8

Basic safety instructions

2.8.1

Instructions for use Failure to use the product in accordance with the information contained in these instructions for use may result in personal injury and property damage. ► Follow these instructions for use and those for any products used in conjunction with this product. ► Only use this product for the purpose specified in "Intended use". ► Keep these instructions for use close to hand.

10

Instructions for use | Oxylog VE300 SW 1.n

Safety-related information

The instructions for use do not contain any information on the following points: – Risks that are obvious to users – Consequences of obvious improper use of the product – Potentially negative effects on patients with different underlying diseases

2.8.2

Symbols and product labels Failure to observe symbols and product labels may result in personal injury and property damage. ► Observe the symbols and product labels.

2.8.3

Monitoring the patient's condition Monitoring of a patient's condition can range from direct observation to electronic monitoring by means of medical devices. The patient may be put at risk if his or her condition is not adequately monitored. ► Monitor the patient's condition by suitable means and at appropriate intervals.

2.8.4

Duties of the operating organization The tasks described in this document specify the requirements which have to be met by each respective target group. If the respective target group is not appropriately qualified, personal injury and property damage may result. The operating organization of this product must ensure the following: ► The target group has the required qualifications (e.g., has undergone specialist training or acquired specialist knowledge through experience). ► The target group has been trained to perform the task. ► The target group has read the sections of these instructions for use relating to the activity concerned and noted the safety instructions and precautionary statements they contain.

2.8.5

Operation of the device by persons outside the defined target groups The device is not intended for use by non-specialists (persons not defined as target group). Responsibility for use of the device that is inconsistent with its intended use, particularly by non-specialists, lies with the operating organization. If the operating organization nevertheless allows non-specialists to interact with the device, appropriate instruction and supervision must be provided. If non-specialists (e.g., visitors) are given access to the device, the following precautions must be taken: ► Non-specialists must be informed that unauthorized interactions may lead to injury.

2.8.6

Modifications to the product Modifications to the product may lead to malfunctions and unforeseen risks. This may result in injury to the patient or the user or in property damage. ► Do not modify this product.

Instructions for use | Oxylog VE300 SW 1.n

11

Safety-related information

2.8.7

Alarms Failure to notice alarm signals may put the patient at risk. ► Before operation, check that the visual and acoustic alarm signals are working correctly. To do so, generate any alarm, e.g. O2 supply pressure low. ► Set the alarm volume so that alarm signals can be heard. ► The user must stay within hearing range of the acoustic alarm signal. ► Pay additional attention in environments where the surrounding noise interferes with hearing the maximum alarm volume of the device (e.g., in a helicopter). ► Make sure that the alarm system has not been rendered useless by setting the alarm limits to extreme values. ► Check the display regularly for optical alarm signals when the acoustic alarm signals are silenced.

2.8.8

Accessories The use of incompatible accessories may adversely affect the functional integrity of the product. Personal injury and property damage may result. ► Use only compatible accessories. The accessories that are compatible with this product are listed in the list of accessories supplied with the product. ► Do not use any antistatic or electrically conductive breathing circuits.

2.8.9

Connected devices 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 and lead to an electric shock. ► Before operating the medical device, strictly comply with the instructions for use of all connected devices or device combinations. ► 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.

2.8.10

Service If service is not performed regularly, malfunctions may occur, which can result in personal injury and property damage. ► Perform service work as described in "Service".

2.8.11

Electromagnetic compatibility (EMC) Medical electrical equipment is subject to special precautionary measures concerning electromagnetic compatibility. During installation and before initial operation, follow the information in section: "EMC Declaration" (page 121). This device can be affected by other electrical devices.

12

Instructions for use | Oxylog VE300 SW 1.n

Safety-related information

Electromagnetic interferences Wireless communication devices (e.g., cellular phones) and medical electrical equipment (e.g., defibrillators, electrosurgical devices) emit electromagnetic radiation. When such devices are operated too close to this device or its cables, the functional integrity of this device may be compromised by electromagnetic interferences. As a result, the patient could be put at risk. ► Maintain a distance of at least 0.3 m (1.0 ft) between this device and wireless communication devices, to ensure that the essential performance characteristics of this device are fulfilled. ► Maintain an adequate distance between this device and other medical electrical equipment.

2.8.12

Use of oxygen Oxygen enhances combustion of other substances and can intensify fires. ► No smoking or open flames. ► Protect the oxygen cylinder from tipping over, and do not expose it to excessive heat. ► Always provide adequate ventilation in the area where the ventilator is being operated, in order to maintain ambient oxygen concentration below 25 Vol%, to prevent risk of fire. ► Do not use any combustible gases or anesthetic gases with the ventilator. ► Do not use any flammable drugs with the ventilator. Special care must be taken when using oxygen fittings. ► Do not grease or lubricate cylinder valves and pressure reducers or device ports, and do not handle with greasy hands. ► Operate cylinder valves by hand and rotate slowly to prevent the risk of fire or explosion. ► Do not use tools. ► Do not use a control valve or flowmeter in the gas supply line. ► Only use medical oxygen or 93 % oxygen. Special care must be taken when providing gas supply from an oxygen cylinder. ► Always use gas cylinders and pressure reducers that comply with all applicable regulations and have a pressure gauge. ► Always use full oxygen cylinders. ► To protect the patient from hypothermia, do not use oxygen cylinders that are too cold. ► Only use O2 inhalation in conjunction with a pressure reducer for patients with sufficient spontaneous breathing. ► Only use a pressure reducer with a blow-off valve at the outlet to limit the outlet pressure to a maximum of 1000 kPa in the event of a malfunction.

Instructions for use | Oxylog VE300 SW 1.n

13

Safety-related information

2.8.13

Use of the rechargeable battery Observe the following instructions when using the rechargeable battery: ► Remove the battery if the device is not going to be used for an extended period of time. ► In the absence of the rechargeable battery, the integrated clock is powered by a button cell. In the event of permanent storage without the rechargeable battery, replace the button cell after 2 years. ► Fully charge the battery if the device has not been used for an extended period of time. ► Always fit the battery correctly in the device, applying only a small amount of force to do so. ► Before each use, make sure that the battery is sufficiently charged. ► Always keep a fully-charged battery in reserve. ► Do not throw the battery into a fire or try to open by force.

2.8.14

Cleaning and service Disinfectants and cleaning agents Residues of disinfectants or cleaning agents left in the device after reprocessing may put the patient at risk due to irritation to the skin or mucous membranes. ► Observe the instructions relating to disinfectants and cleaning agents. ► Make sure that the device is adequately ventilated after reprocessing. Risk of infection The device must be reprocessed, otherwise there is an increased risk of infection and the function of the device may be impaired. ► Observe the hygiene regulations at the operating location (e.g., hospital or ambulance station), including the reprocessing intervals and reprocessing procedures. ► Have reprocessing personnel perform reprocessing with validated procedures. ► Reprocess reusable products before their first use and after each use. ► Follow the manufacturer's instructions in respect of cleaning agents and disinfectants. ► Reprocess the product before performing service activities or returning it for repair. For further information, see the following chapter: "Reprocessing", page 98. Service This product must be maintained at regular intervals and in the appropriate manner. Failure to perform service activities correctly may result in personal injury and property damage. ► Perform service activities. For further information, see the following chapter: "Service", page 106. ► Service must be performed by those target groups that are assigned to the particular measure. ► Only carry out service activities when there is no patient connected to the device.

14

Instructions for use | Oxylog VE300 SW 1.n

Safety-related information

Checks prior to use of the device Reprocessing, wear and tear, and improper storage may damage parts of the device such that they no longer function correctly. This puts the patient at risk. Make sure that the following preconditions are met before operating the device: ► There are no cracks or sharp edges on the device. ► All hoses are undamaged and correctly connected. ► The touchscreen and the rotary knob are working correctly. ► The visual and acoustic alarm signals are working correctly. Undetected damage to the device Reprocessing, wear and tear, and improper storage may damage the device such that it no longer functions correctly. The patient is put at risk. ► If a device is behaving suspiciously or is clearly malfunctioning, replace it with a device in proper working order.

2.9

Product-specific safety information Patient monitoring Ventilation monitoring is mandatory at all times. Whenever a patient is connected to the ventilator, constant attention by qualified medical staff is required in order to provide immediate corrective action in the event of a malfunction. ► The user must not rely solely on the built-in ventilation monitoring. ► The user bears full responsibility for proper ventilation, and for the patient's safety, in all situations. ► Do not make therapeutic decisions based solely on individual measured values and monitoring parameters. ► An etCO2 value is insufficient as a basis for medical decisions. Always consider multiple values as part of the decision-making process. Settings on the device To ensure proper ventilation, the total dead space of the breathing circuit must be considered when setting the ventilation parameters. This applies particularly when using low tidal volumes. ► Observe for signs of CO2 rebreathing. ► The factory presettings of the device must be compared with standard procedures and the valid guidelines, e.g., of the American Heart Association or the European Resuscitation Council. ► The device settings must be checked for each patient and adjusted to the patient’s condition as necessary. Device malfunction If a malfunction is detected in the ventilator, and its life-preserving function can no longer be ensured (e.g., in the event of a power failure or an interruption of the gas supply), ventilation with an independent ventilation device (breathing bag) must be started immediately. ► Keep a manual resuscitator at the ready. ► Ventilate with PEEP and/or increased inspiratory O2 concentration if necessary.

Instructions for use | Oxylog VE300 SW 1.n

15

Safety-related information

Transporting the device If the device is operated during transport, there is a risk of selecting undesired settings or the device falling down. ► Transport the device safely and in a stable manner. ► Place the device on a flat and stable surface for operation.

2.10

Additional information

2.10.1

Training User training is offered by the responsible Dräger organization, see www.draeger.com.

16

Instructions for use | Oxylog VE300 SW 1.n

Overview

3

Overview

3.1

Main device A

B

C

28169

Upper side

D

E F

K

J

No. A B

Designation Carrying handle Start/standby key

C

Rotary knob

D

LED

E

Start dialog key

F

Screen rotation key

G

Screen

H

Alarm silence key

I J

Color LEDs USB port

K

Battery compartment cover

Instructions for use | Oxylog VE300 SW 1.n

I

H

G

Description To transport the device To switch the device on and off and to switch to standby mode To select, change and confirm settings To display the state of charge of the battery and the power supply To return from any dialog to the start dialog To rotate the screen orientation by 180° To display and operate the application-specific dialog pages To suppress the acoustic alarm signal for 2 minutes To visually indicate alarms To export data. Compatible with USB 2.0

17

Overview

28170

Rear

A

B C

No. A B C

18

Designation Description Carrying handle To transport the device Compressed gas port with standard To connect an O2 compressed gas hose connector Connector for the DC power supply To connect to an external power supply

Instructions for use | Oxylog VE300 SW 1.n

Overview

28171

Front

A No. A B C D E

B

C D E

Designation Breathing circuit port

Description To connect a disposable or reusable breathing circuit Measuring line ports To connect the measuring lines of the breathing circuit To connect the CO2 sensor cable CO2 sensor port Emergency air and ambient air inlet To suction ambient air Additional quick-coupling port For additional gas supply from the wall terminal unit, to swap the gas supply without interrupting ventilation.

CAUTION Ventilator malfunction Do not block the emergency air inlet. ► A blocked emergency air inlet may result in ventilator malfunction. Devices with the Plus option are indicated by labels on the sides of the device.

Instructions for use | Oxylog VE300 SW 1.n

19

Overview

3.2

Main device with carrying system 33377

Side view, right

A

20

B

C

D

E

No. A

Designation Protection bar

B

Strap brackets (on front and rear)

C

Closure

D

Hinge (when the closure is raised)

E

Pins

A Description To protect the compressed gas cylinder and the pressure reducer. For diagonal fixing of the carrying strap (option). To open the carrying system. Height-adjustable. For further information, see the following chapter: "Assembling the main device with carrying system (option)", page 33. To open the carrying system. Height-adjustable. For further information, see the following chapter: "Assembling the main device with carrying system (option)", page 33. To attach the accessories bag (option)

Instructions for use | Oxylog VE300 SW 1.n