Oxylog 2000 plus Instructions for Use sw 1.n April 2016

Typographical conventions 1

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

Trademarks

z

Bullet points indicate individual actions or different options for action.

Oxylog®

–

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.

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. 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.

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

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Trademark DrägerService

Trademark owner Dräger ®

Dräger

Neoform MED AF

Dr. Weigert

Neodisher LM2

Dr. Weigert

Sekusept Powder Classic

Ecolab

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 equipment or other property. NOTE A NOTE provides additional information intended to avoid inconvenience during operation.

Instructions for use Oxylog 2000 plus SW 1.n

Definition of target groups For this product, users, service personnel, and experts are defined as target groups.

Service personnel

These target groups must have received instruction in the use of the product and must have the necessary training and knowledge to use, install, reprocess, maintain, or repair the product.

Service personnel are persons who are responsible for the maintenance of the product.

The product must be used, installed, reprocessed, maintained, or repaired exclusively by defined target groups.

Service personnel must be trained in the maintenance of medical devices and install, reprocess, and maintain the product.

Experts

Users

Experts are persons who perform repair or complex maintenance work on the product.

Users are persons who use the product in accordance with its intended use.

Experts must have the necessary knowledge and experience with complex maintenance work on the product.

Abbreviations and symbols Explanations can be found in the sections "Abbreviations" on page 22 and "Symbols" on page 23.

Instructions for use Oxylog 2000 plus SW 1.n

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Instructions for use Oxylog 2000 plus SW 1.n

Contents

Contents For your safety and that of your patients. .

7

Operation...

53

General safety information... Product-specific Safety Information...

8 11

Application...

13

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

14 14 15

System Overview...

17

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

18 21 22 23

Starting operation... Preparing the ventilation mode... VC-CMV, VC-AC... VC-SIMV, VC-SIMV/PS... SpnCPAP, SpnCPAP/PS... NIV – non-invasive ventilation (optional)... O2 AirMix or 100 % O2... Calibration... Screen brightness... Alarm volume... Shutdown...

54 55 56 58 60 63 64 65 65 65 66

Alarms...

67

Operating concept...

25

Switch on or off... Ventilation controls... Display operating controls... Additional function keys... Screen window structure...

26 27 28 29 30

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

68 68 69 71

Monitoring...

73

Assembly...

33

Connecting the reusable breathing circuit . . . Connecting the disposable breathing circuit. . Connecting a bacteria filter or HME... Changing the type of breathing circuit... Internal rechargeable battery... Connecting the power supply... Connecting the gas supply... Attaching the device to standard rail systems

34 36 37 37 38 39 41 43

Displaying the airway pressure... Displaying MVe and VTe... Displaying O2 values... Displaying measured values...

74 74 74 75

Configuration...

77

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

78 80

Problem Solving...

87

Getting Started...

45

88 88

Charging the battery... Determining the approximate pneumatic operating time... Checking readiness for operation... Performing the device check... Preparation for use after system check...

46

Alarm - Cause - Remedy... Messages in the alarm message field... Additional messages in the alarm message field... Messages in the information field... Error messages during device check...

91 92 93

Cleaning, Disinfection and Sterilization . .

95

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

96 98 98 102 102

Instructions for use Oxylog 2000 plus SW 1.n

47 48 48 51

5

Contents

Maintenance... 103 Oxylog 2000 plus maintenance intervals... Inspection... Safety checks... Preventive maintenance... Repair... In case of ventilator failure...

104 105 105 106 106 107

Disposal... 109 Disposing of the medical device... 110 Disposal instructions... 110 Disposing of the breathing circuits... 110 Technical Data... 111 Ambient conditions... Settings... Performance characteristics... Measured values and waveforms display . . . Monitoring... Operating data... Device specifications... Materials used... Technical Documentation for the Oxylog 2000 plus according to EMC standard IEC 60601-1-2 (EN 60601-1-2)...

112 113 114 115 116 117 119 121

122

Principles of Operation... 127 Ventilation modes... 128 Dead space... 130 Functional description... 131 List of accessories... 133 Index... 135 Accessing Customer Service Mode... 137 Accessing Customer Service Mode... 138 Accessing Customer Service Mode Oxylog 2000 plus SW 1.n... 139

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Instructions for use Oxylog 2000 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... Patient safety... Patient monitoring... Information on electromagnetic compatibility . Appropriate Monitoring... Functional safety... Connection to other devices...

8 8 8 9 9 9 9 10 10

Product-specific Safety Information...

11

Installing accessories... Instructions for Use only available once...

11 11

Instructions for use Oxylog 2000 plus SW 1.n

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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.

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Maintenance WARNING Risk of medical device failure and of patient injury The medical device must be inspected and serviced regularly by service 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 Medical recommends that a service contract be obtained with Dräger and that all repairs also be carried out by them. 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 released accessories listed in the current list of accessories.

Instructions for use Oxylog 2000 plus SW 1.n

For your safety and that of your patients

Patient safety 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 persons familiar with the most important inherent characteristics of the medical device. Instructions and WARNING and CAUTION statements are therefore largely limited to the specifics of the Dräger medical device. The instructions for use do not contain any information on the following points: –

Risks that are obvious to users

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Consequences of obvious improper use of the medical device

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Potentially negative effects on patients with different underlying diseases

Medical device modification or misuse can be dangerous. WARNING Risk of patient injury Do not make therapeutic decisions based solely on individual measured values and monitoring parameters.

Patient monitoring The user of the medical device is responsible for choosing a suitable patient monitoring system that provides appropriate information on medical device performance and patient condition. Patient safety can be achieved by a wide variety of means ranging from electronic surveillance of medical device performance and patient condition to direct observation of clinical signs.

Information on electromagnetic compatibility General information on electromagnetic compatibility (EMC) pursuant to international EMC standard IEC 60601-1-2: 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 (see page 154). WARNING Do not use portable and mobile RF telecommunication devices (such as mobile phones) in the immediate vicinity of the medical device.

Appropriate Monitoring The monitoring functionality of the Oxylog 2000 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 RR

Not setting appropriate alarm limits could suppress alarms related to: –

Acute changes in the patient’s condition

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Incorrect settings and faulty handling

–

Device failure

The responsibility for selecting the best level of patient monitoring lies solely with the user of the medical device.

Instructions for use Oxylog 2000 plus SW 1.n

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For your safety and that of your patients

Functional safety The essential performance characteristics of the Oxylog 2000 plus are defined as: Delivery of an appropriate tidal volume to the patient-connection port or generation of an alarm condition.

Connection to other devices Device combinations (Dräger devices + Dräger devices or Dräger devices + third-party devices) approved by Dräger (see instructions for use of individual devices) meet the requirements of the following standards: –

10

–

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 operator must ensure that the device combination meets the applicable standards. Strictly observe instructions for use and assembly instructions of all connected devices.

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

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

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

Instructions for use Oxylog 2000 plus SW 1.n

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 should not rely on the built-in monitoring of the ventilator only and must always assume full responsibility for proper ventilation and patient safety in all situations. WARNING Keep a manual resuscitator at the ready If a failure is detected in the ventilator and its life-support functions can no longer be guaranteed (e.g. in case of a power failure or interruption in the medical gas supply), ventilation must be started without delay with an independent ventilation device (breathing bag) – using PEEP and/or increased inspired O2 concentration as necessary.

Installing accessories CAUTION Installations on the Oxylog 2000 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.

Instructions for Use only available once CAUTION Only one copy of the Instructions for Use is included in the clinical package and should therefore be kept in an accessible location for users.

WARNING Risk of CO2 rebreathing 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. Watch for signs of rebreathing. WARNING Risk of malfunction Unauthorized modifications to the medical device lead to malfunctions. This medical device may not be changed without the permission of Dräger.

Instructions for use Oxylog 2000 plus SW 1.n

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Instructions for use Oxylog 2000 plus SW 1.n

Application

Application Intended use...

14

Indications/Contraindications...

14

Environment of use...

15

Instructions for use Oxylog 2000 plus SW 1.n

13

Application

Intended use The Oxylog 2000 plus is a time-controlled, volumecontrolled emergency and transport ventilator with pressure support for patients requiring mandatory or assisted ventilation with a tidal volume of 100 mL upwards. For use by and under the supervision of trained health care professionals.

Indications/Contraindications For patients with tidal volume of 100 mL upwards. WARNING The Oxylog 2000 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.

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Instructions for use Oxylog 2000 plus SW 1.n

Application

Environment of use Intended environment of use: –

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

–

During transport in ambulances, aircraft, and helicopters.

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In accident and emergency departments.

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When moving ventilated patients around the hospital.

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In the recovery room.

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.

WARNING The medical device may not be used in hyperbaric chambers The medical device may malfunction, causing danger to the patient. WARNING Do not use the medical device in conjunction with magnetic resonance imaging (MRT, NMR, NMI). The device may malfunction, causing danger to the patient. WARNING Risk of explosion and fire The medical device is not approved for use in areas where oxygen concentrations of over 25 Vol%, combustible or explosive gas mixtures are likely to occur. WARNING In toxic surroundings: – The patient must be ventilated with 100 % O2 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. Instructions for use Oxylog 2000 plus SW 1.n

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Instructions for use Oxylog 2000 plus SW 1.n

System Overview

System Overview Basic unit with all options...

18

Side view, right... Rear view... Reusable breathing circuit... Disposable breathing circuit...

19 19 20 20

Range of functions...

21

Ventilation functions of the Oxylog 2000 plus.

21

Abbreviations...

22

Symbols...

23

Instructions for use Oxylog 2000 plus SW 1.n

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System Overview

043

Basic unit with all options

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

for setting and displaying

J

Start / Standby key

K Display symbols for the power supply Charge status of the internal battery External power supply

C Settings key for setting additional ventilation parameters

L Rotary knob for making selections, changing and confirming settings

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

M Control knob for setting O2 AirMix or 100 % O2

E Key for setting the ventilation mode VC-SIMV (PS)*

N Control knob for setting the maximum inspiratory pressure Pmax O Control knob for setting the respiratory rate RR

F Key for setting the ventilation mode SpnCPAP (PS)*

P Control knob for setting the tidal volume VT

G Red and yellow LEDs as alarm indicators

Q Key Values to select the displayed measured values

H

key for silencing acoustic alarm signals for 2 minutes

I

Key Alarm Reset for acknowledging alarm messages

*

VC-SIMV/PS and SpnCPAP/PS are optional features.

18

R Key Values to select the displayed measured MVe or VTe values

Instructions for use Oxylog 2000 plus SW 1.n

System Overview

042

Rear view

041

Side view, right

A Emergency air inlet

A Atmospheric air inlet

CAUTION Do not block the emergency air inlet

CAUTION Do not block the atmospheric air inlet

This may result in ventilator malfunction.

This may result in ventilator malfunction.

B Screw to secure the battery compartment cover

B Rating plate

C Connectors for the flow measuring lines D Breathing hose connector E Connector for medical gas hose F Connector for DC supply G Window for Infrared Data Association (IrDA) interface

Instructions for use Oxylog 2000 plus SW 1.n

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System Overview

Reusable breathing circuit

A

Disposable breathing circuit

C

B D

E C

A 002

E 001

D

B

A Breathing valve

A Breathing valve

B Breathing hose

B Breathing hose

C Flow and pressure measuring lines

C Flow and pressure measuring lines

D Angled connector

D Flow sensor

E Flow sensor

E Angled connector

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Instructions for use Oxylog 2000 plus SW 1.n