Oxylog 3000 plus Instructions for Use Sw 1.n 12th Edition Jan 2020

Typographical Conventions 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.

Trademarks Trademark

Trademark owner

Oxylog®

Dräger ®

Dräger

AutoFlow

DrägerService ®

Sekusept

®

Dräger Ecolab

BIPAP1)

A Letters in illustrations denote elements referred to in the text.

1) Trademark used under license

Any text shown on the screen and any labeling on the device are printed in bold and italics, for example, PEEP, Air, or Alarm settings.

Safety information definitions

The "greater than" symbol > indicates the navigation path in a dialog window, for example, System configuration > Monitoring > Basic settings. In this example, System configuration represents the dialog window title, Monitoring represents a horizontally aligned tab, and Basic settings a vertically aligned tab.

WARNING A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury.

Screen reproductions

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 equipment or other property.

The reproductions of screen content in the instructions for use can differ from the content actually shown on the screen.

NOTE A NOTE provides additional information intended to avoid inconvenience during operation.

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Instructions for use Oxylog 3000 plus SW 1.n

Definition of target groups For this medical device, users, maintenance personnel, and experts are defined as target groups. These target groups must have received instruction in the use of the medical device and must have the necessary training and knowledge to use, install, reprocess, maintain, or repair the product. Dräger emphasizes that the medical device must be used, installed, reprocessed, maintained or repaired exclusively by the defined target groups.

Users Users are intended operators as defined on page 14 hereof for the use of the medical device in accordance with its intended use.

Maintenance personnel Maintenance personnel are persons who are responsible to the operating company for the maintenance of the product. Maintenance personnel are persons authorized to install, reprocess or maintain the medical device.

Experts Experts are persons who are authorized to perform repair or complex maintenance work on the medical device.

Abbreviations and symbols For explanations refer to "Abbreviations" on page 23 and "Symbols" on page 24.

Instructions for use Oxylog 3000 plus SW 1.n

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Instructions for use Oxylog 3000 plus SW 1.n

Contents

Contents For Your Safety and that of Your Patients .

7

General safety information... Product-specific safety information...

8 12

Use...

13

Intended use... Indications/Contraindications... Environment of use...

14 14 14

System overview...

17

Basic unit with all options... Range of functions... Abbreviations... Symbols...

18 22 23 24

Operating concept...

27

Switching on and off... Ventilation controls... Display operating controls... Additional function keys... On-screen window structure...

28 29 30 31 32

Assembly...

35

Internal rechargeable battery... 37 Connecting the power supply... 38 External power supply... 39 Connecting the gas supply... 41 Connecting the reusable breathing circuit for adults... 43 Connecting the disposable breathing circuit for adults... 45 Connecting the disposable breathing circuit for pediatric patients... 46 Connecting a bacterial filter or HME... 47 Connecting the CO2 sensor and the cuvette . 48 Attaching the Oxylog 3000 plus to standard rail systems... 49 Preparation...

51

Charging the battery... 52 Determining the approximate pneumatic operating time... 53 Checking readiness for operation... 54 Instructions for use Oxylog 3000 plus SW 1.n

Performing the device check... 54 CO2 zero calibration and filter check before ventilation (optional)... 58 Preparation for use after system check, CO2 zero calibration and CO2 filter check... 60 Operation...

61

Starting operation... Preparing the ventilation mode... VC-CMV, VC-AC... VC-SIMV, VC-SIMV/PS... PC-BIPAP, PC-BIPAP/PS... Spn-CPAP, Spn-CPAP/PS... Non-invasive ventilation (NIV)... Special functions... O2 concentration by "O2 blending"... Setting the HME correction... Calibration... Screen brightness... Alarm volume... Shutdown...

62 64 65 68 70 72 75 76 78 79 80 80 80 81

Alarms...

83

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

84 84 85 87

Monitoring...

89

Displaying curves... Displaying measured values... CO2 measurement (optional)... Data communication (optional)...

90 90 91 94

Configuration...

95

Displaying configuration and information . . . Customer Service Mode... Customer service manual...

96 97 108

Problem solving...

109

Alarm – Cause – Remedy... Messages in the alarm message field...

110 110

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Contents

Additional messages in the alarm message field... 117 Messages in the information field... 118 Error messages during the device check... 120

List of accessories...

165

Index...

167

Accessing Customer Service Mode...

171

Cleaning, Disinfection and Sterilization . . . 121

Accessing Customer Service Mode... Accessing Customer Service Mode Oxylog 3000 plus SW 1.n...

172

Disassembly... Information on reprocessing... Reprocessing procedure... Reprocessing list... Assembling parts...

122 125 125 129 129

173

Maintenance... 131 Maintenance intervals of Oxylog 3000 plus . . Inspection... Safety checks... Preventive maintenance... Repair... In case of ventilator failure...

132 133 133 134 134 135

Disposal... 137 Disposing of the medical device... 138 Disposal instructions... 138 Technical data... 139 Ambient conditions... Settings... Performance characteristics... Measured values and curves display... Monitoring... Operating data... Device specifications... Materials used... EMC declaration...

140 141 142 144 145 146 148 150 151

Description... 155 Ventilation modes... 156 AutoFlow... 160 Dead space... 162 Determining cycle time, inspiratory time and expiratory time... 162 Functional description... 163

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Instructions for use Oxylog 3000 plus SW 1.n

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... Maintenance... Accessories... Connected devices... Safe connection with other electrical equipment... Patient safety... Patient monitoring... Information on Electromagnetic Compatibility Functional safety... Appropriate monitoring... Connection to other devices...

8 8 8 9 9 9 9 9 10 10 10

Product-specific safety information...

12

Installing accessories... Only one copy of instructions for use included

12 12

Instructions for use Oxylog 3000 plus SW 1.n

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 used with this medical device.

Strictly follow these instructions for use WARNING Risk of incorrect operation and of incorrect use Any use of the medical device requires full understanding and strict observation of all sections of these instructions for use. The medical device must only be used for the purpose specified under "Intended use" on page 14. Strictly observe all WARNING and CAUTION statements throughout these instructions for use and 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.

8

Maintenance WARNING Risk of medical device failure and of patient injury The medical device must be inspected and serviced regularly by maintenance personnel. Repair and complex maintenance carried out on the medical device must be performed by experts. If the above is not complied with, medical device failure and patient injury may occur. Observe chapter "Maintenance". Dräger recommends that a service contract is obtained with DrägerService and that all repairs are performed by DrägerService. For maintenance Dräger recommends the use of authentic Dräger repair parts.

Accessories WARNING Risk when using unauthorized accessories If unauthorized accessories are used, patients may be put at risk due to malfunctions of the medical device. Only use the medical device together with authorized accessories listed in the current list of accessories.

Instructions for use Oxylog 3000 plus SW 1.n

For Your Safety and that of Your Patients

Connected devices

Medical device modification or misuse can be dangerous.

WARNING Risk of electric shock and of device malfunction

WARNING Risk of patient injury

Any connected devices or device combination not complying with the requirements set out 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.

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 safety The design of the medical device, the accompanying literature, and the labeling on the medical device are based on the assumption that the use of the equipment is restricted to trained professionals, and that certain inherent characteristics of the medical device are known to the trained user. Instructions, warnings, and caution statements are therefore largely limited to the specifics of the Dräger design. This publication excludes references to various hazards which are obvious to a medical professional and user of this medical device, to the consequences of medical device misuse, and to potentially adverse effects in patients with abnormal conditions.

Instructions for use Oxylog 3000 plus SW 1.n

Do not make therapeutic decisions based solely on individual measured values and monitoring parameters.

Patient monitoring The users of the medical device are responsible for choosing appropriate safety monitoring that provides adequate information on medical device performance and patient condition. Patient safety may be achieved through 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 the selection of the best level of patient monitoring lies solely with the medical device user.

Information on Electromagnetic Compatibility General information on electromagnetic compatibility (EMC) pursuant to international EMC standard IEC 60601-1-2: Electromedical devices are subject to special precautionary measures concerning electromagnetic compatibility (EMC) and must be installed and put into operation in accordance with the EMC information. Refer to section "EMC declaration" on page 151. WARNING Do not use portable and mobile HF communications equipment, e.g., mobile phones, in the vicinity of the medical device.

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For Your Safety and that of Your Patients

Functional safety

Connection to other devices

The essential performance of the Oxylog 3000 plus is defined as:

Device combinations (Dräger devices + Dräger devices or Dräger devices + third-party devices) approved by Dräger (see instructions for use of the individual devices) comply with the following standards:

Appropriate delivery of ventilation to the patientconnection port or generation of an alarm condition.

–

Appropriate monitoring CAUTION Always use a separate SpO2 monitor for patients who are dependent on an exact O2 concentration. The monitoring functionality of the Oxylog 3000 plus ensures appropriate monitoring of ventilation therapy. To ensure appropriate monitoring during ventilation, always set alarm limits for the following parameters: –

Airway pressure, Paw

–

Expiratory minute volume, MVe

–

Respiratory rate (if applicable), RR

–

etCO2 (if applicable)

If appropriate alarm limits are not set, alarms may not be triggered in the following cases: –

Acute changes in the patient’s condition

–

Incorrect settings and faulty handling

–

Hose system leakage

10

–

IEC 60601-1 (3rd edition) Medical electrical equipment Part 1-1: General requirements for safety and essential performance –

IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for safety and essential performance Collateral standard: Electromagnetic compatibility – Requirements and tests

–

IEC 60601-1-8 Medical electrical equipment Part 1-8: General requirements for safety Collateral standard: General requirements, tests, and guidance for alarm systems in medical equipment and medical electrical systems

IEC 60601-1 (2nd edition) Medical electrical equipment Part 1: General requirements for safety –

IEC 60601-1-1 Medical electrical equipment Part 1-1: General requirements for safety Collateral standard: Safety requirements for medical electrical systems

–

IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility; Requirements and tests

–

IEC 60601-1-4 Medical electrical equipment Part 1-4: General requirements for safety Collateral standard: Programmable electrical medical systems

Instructions for use Oxylog 3000 plus SW 1.n

For Your Safety and that of Your Patients

–

IEC 60601-1-8 Medical electrical equipment Part 1-8: General requirements for safety Collateral standard: General requirements, tests, and guidance for alarm systems in medical electrical equipment and medical electrical systems

If a device combination is not approved by Dräger, proper operation of the devices can be compromised. The user must ensure that the device combination meets the applicable standards. Strictly observe instructions for use and assembly instructions of all connected devices.

Instructions for use Oxylog 3000 plus SW 1.n

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For Your Safety and that of Your Patients

Product-specific safety information WARNING 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 case of a malfunction. The user must not solely rely on the built-in monitoring of the ventilator and must always assume full responsibility for proper ventilation and patient safety in all situations. WARNING Keep an manual resuscitator at the ready If a malfunction is detected in the ventilator and its life-support functions can no longer be guaranteed (such as in case of a power supply failure or interruption in the compressed gas supply), ventilation must be started without delay with an independent ventilator (manual resuscitator) – using PEEP and/or increased inspired O2 concentration as necessary. WARNING Risk of CO2 rebreathing

CAUTION An etCO2 value by itself is insufficient as a basis for medical decisions.

Installing accessories CAUTION Installations on the Oxylog 3000 plus must be done in accordance with these instructions for use. Make sure that the connections are securely fitted onto the basic unit system. Strictly follow the assembly instructions and instructions for use.

Only one copy of instructions for use included CAUTION Only one copy of the instructions for use is included per device, and it must therefore be kept in an accessible location for users.

To ensure proper ventilation when setting the ventilation parameters, the total dead space volume of the breathing circuit must be considered. This applies particularly when using low tidal volumes. Observe for signs of rebreathing. WARNING Risk of malfunction Unauthorized modification of the medical device will result in malfunction. This medical device must not be modified without the permission of Dräger.

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Instructions for use Oxylog 3000 plus SW 1.n

Use

Use Intended use...

14

Indications/Contraindications...

14

Environment of use...

14

Instructions for use Oxylog 3000 plus SW 1.n

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Use

Intended use The Oxylog 3000 plus is a time-cycled, volumecontrolled and pressure-controlled emergency and transport ventilator for patients requiring mandatory or assisted ventilation with a tidal volume from 50 mL upwards. Intended user: 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.

Indications/Contraindications For patients with tidal volume of 50 mL upwards. WARNING The Oxylog 3000 plus ventilator must only be used under the supervision of qualified medical personnel in order to provide immediate corrective action in case of a malfunction.

Environment of use Intended environment of use: –

Mobile use for emergency patients, in both outdoor and indoor environments.

–

During transport in ambulances or aircraft, including helicopters.

–

In accident and emergency departments.

–

When moving ventilated patients around the hospital.

–

14

In the recovery room.

WARNING Only use the device under the permissible ambient conditions and supply conditions. Otherwise, the device may not be functional and may fail. WARNING Do not use the device in hyperbaric chambers. The medical device may malfunction, causing danger to the patient.

Instructions for use Oxylog 3000 plus SW 1.n

Use

WARNING Do not use the device in conjunction with magnetic resonance imaging (MRI, NMR, NMI). The medical device may malfunction, causing danger to the patient. WARNING Risk of explosion and fire This device is neither approved nor certified for use in areas where oxygen concentrations above 25 Vol% or combustible or explosive gas mixtures are likely to occur. WARNING In toxic surroundings: – The patient must be ventilated with 100 % medical grade oxygen so that toxic constituents do not enter into the breathing gas. – The patient must be immediately transferred to a breathable atmosphere in order to prevent inhalation of toxic air when spontaneous breathing resumes. WARNING In infectious environments: – The patient must be ventilated with 100 % medical grade oxygen so that bacteria, viruses, fungi or spores do not enter the breathing gas. – The patient must be immediately transferred to a breathable atmosphere in order to prevent inhalation of infectious air when spontaneous breathing resumes.

Instructions for use Oxylog 3000 plus SW 1.n

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Instructions for use Oxylog 3000 plus SW 1.n

System overview

System overview Basic unit with all options...

18

Side view, right... Rear view... Reusable breathing circuit for adults... Disposable breathing circuit for adults... Disposable breathing circuit for pediatric patients...

19 19 20 20 21

Range of functions...

22

Ventilation functions of the Oxylog 3000 plus.

22

Abbreviations...

23

Symbols...

24

Instructions for use Oxylog 3000 plus SW 1.n

17

System overview

Basic unit with all options A

BC D E FG

T

S

R

Q

A Screen with screen pages for the specific application B Alarms alarm limits

key for setting and displaying

C Settings key for setting additional ventilation parameters

P

O

N

N Power supply symbols Charge status of the internal battery External mains power supply O Rotary knob for making selections, changing and confirming settings

D Key for setting the ventilation mode Spn-CPAP

P Control knob for setting the O2 concentration FiO2

E Key for setting the ventilation mode VC-CMV / VC-AC

Q Control knob for setting the maximum inspiratory pressure Pmax

F Key for setting the ventilation mode VC-SIMV

R Control knob for setting the respiratory rate RR

G Key for setting the ventilation mode PC-BIPAP

S Control knob for setting the tidal volume VT

H Red and yellow LEDs as alarm indicators

T Explanation of color codes for quick pre-setting of RR and VT

I

key for silencing acoustic alarm signals for 2 minutes

J

Key Alarm Reset for acknowledging alarm messages

K O2 inhalation key for O2 inhalation or 100 % O2 key for 100 % O2 application (factory set)

Curves

U Curves key for switching between the pressure, flow, and CO2 (optional) curves in small and large view V Values key for switching between screen pages in the measured values window

L Insp. Hold key for initiating a manual inspiration or for extending the current inspiratory time M Start/Standby key

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Instructions for use Oxylog 3000 plus SW 1.n

Front

H I J K L M

V U

System overview

Side view, right

Rear view

A H

G

B

C

C

A B

D

Side

Rear

E F

A Emergency air inlet CAUTION Do not block the emergency air inlet This may result in ventilator malfunction. B Battery compartment cover fixing screw

A Ambient air inlet B Ambient air inlet, with filter element CAUTION Do not block the ambient air inlet This may result in ventilator malfunction.

C Connectors for the flow measuring lines

C Protection bracket

D Connector for the breathing hose

CAUTION Do not use the protection bracket as a handle

E Connector for the compressed gas hose F Connector for the DC power supply G Connector for the CO2 sensor

Tilting the device to a vertical position may lead to airway pressure oscillation.

H Connector for data communication cable

Instructions for use Oxylog 3000 plus SW 1.n

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System overview

Reusable breathing circuit for adults

C

Disposable breathing circuit for adults

C

D

D

E

B

B E

002

A 001

A

A Angled connector

A Angled connector

B Flow sensor

B Flow sensor

C Breathing valve

C Breathing valve

D Breathing hose

D Breathing hose

E Flow and pressure measuring lines

E Flow and pressure measuring lines

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Instructions for use Oxylog 3000 plus SW 1.n