Oxylog 3000 Instruction for Use Software 1.n 12th Edition Aug 2010

Working with these Instructions for Use

Working with these Instructions for Use The title of the main chapter in the header line helps with orientation and navigation. 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 systematically learn how to use the device. The text provides explanations and instructs the user step-by-step in the practical use of the product, with short, clear instructions in easy-to-follow sequences. 1

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

z 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 relevant illustration. The illustrations show the relationship between the text and the device. Elements mentioned in the text are highlighted. Unnecessary details are omitted. Schematic renderings of screen images guide the user and allow to reconfirm actions performed. The actual screen images differ in look or in configuration.

Trademarks The Oxylog® name is a registered trademark of Dräger. BIPAP® is a trademark used under license. 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. Abbreviations and Symbols Please refer to "Abbreviations" on page 16 and "Symbols" on page 17 for additional information.

A Letters denote elements referred to in the text. Typing conventions 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.

2

Instructions for Use Oxylog 3000 SW 1.n

Contents

Contents For Your Safety and that of Your Patients .

5

General WARNINGS and CAUTIONS...

7

Application...

9

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

10 10 10

System Overview...

11

Front panel with all options... Available ventilation modes... Special modes... For O2 inhalation... With monitoring... Abbreviations... Symbols...

12 14 15 15 15 16 17

Operating Concept...

19

Switch ON or OFF... Ventilation controls... Display operating controls... Screen window structure...

20 21 22 23

Assembly...

27

Dead space... Assemble the reusable hose system... Connect the disposable hose system... Connecting the power supply... Internal supply with rechargeable battery... Connecting the gas supply... Hanging Oxylog 3000 on standard rail systems...

28 29 31 32 32 34

Getting Started...

37

Charging the battery... Determining the approximate pneumatic operating time for the Oxylog 3000... Checking readiness for operation... Perform device check... Preparation for use after system check...

38 39 40 41 43

Operation...

45

Instructions for Use Oxylog 3000 SW 1.n

36

Starting operation... Preparing ventilation mode... IPPV (CMV), IPPVAssist (CMVAssist)... SIMV, SIMV/ASB (SIMV/PS)... BIPAP® (PCV+), BIPAP®/ASB (PCV+/PS) . . CPAP, CPAP/ASB (CPAP/PS)... O2 concentration with "O2 blending"... Calibration... Screen brightness... Volume loudness... Shutdown...

46 47 48 51 53 55 59 61 61 61 62

Alarms...

63

Types of alarms... In the event of an alarm... Setting alarm limits...

64 65 67

Monitoring...

69

Displaying curves... Displaying other measured values... Special functions...

70 70 71

Configuration...

75

Set configuration parameters / display information... Displaying configuration and information . . . Customer Service Mode...

76 77 79

Problem Solving...

87

Alarm - Cause - Remedy... Messages in the alarm window... Messages in the information window... Error messages during the device check . . .

88 88 93 94

Cleaning, Disinfection and Sterilization . .

95

Disassembly... Reprocessing procedure...

96 99

Maintenance...

103

Maintenance intervals...

104

Disposal...

107

Safety information...

108 3

Contents

Disposal of batteries... 108 Disposal of the medical device... 108 Disposal of the disposable hose system... 109 Technical Data... 111 Ambient conditions... 112 Settings... 113 Performance data... 114 Measured value display... 115 Monitoring... 116 Operating data... 117 Device specifications... 119 Materials used... 120 Technical Documentation for the Oxylog 3000 according to EMC standard IEC/EN 606011-2... 121 Principles of Operation... 125 Ventilation modes... 126 BIPAP® (PCV+)... 129 Functional description... 131 List of Accessories... 133 Index... 135

4

Instructions for Use Oxylog 3000 SW 1.n

For Your Safety and that of Your Patients

For Your Safety and that of Your Patients

Strictly follow these Instructions for Use

Accessories

WARNING Any use of the medical device requires full understanding and strict observation of all portions of these Instructions for Use. The medical device is only to be used for the purpose specified under "Intended use" on page 10 and in conjunction with appropriate patient monitoring.

WARNING Only the accessories indicated on the list of accessories (page 133) have been tested and approved to be used with the medical device. Accordingly, it is strongly recommended that only these accessories be used in conjunction with the specific medical device. Otherwise, the correct functioning of the medical device may be compromised.

Strictly observe all WARNING and CAUTION statements throughout these Instructions for Use and all statements on medical device labels.

Maintenance WARNING The medical device must be inspected and serviced regularly by properly trained service personnel.

WARNING Any connected devices, or combination of devices, not complying with the requirements mentioned in these Instructions for Use may compromise the correct functioning of the medical device. Prior to operating the medical device, consult the respective documentation and Instructions for Use of all connected devices or combination of devices.

Repair of the device must be carried out by properly trained service personnel.

Not for use in explosion hazard areas

Dräger Medical recommends that a service contract be obtained with DrägerService and that all repairs also be carried out by them. Dräger Medical recommends that only authentic Dräger Medical repair parts be used for maintenance. Otherwise, the proper functioning of the medical device may be compromised.

WARNING This medical device is neither approved nor certified for use in areas where combustible or explosive gas mixtures are likely to occur.

Refer to the chapter "Maintenance" on page 103 for additional information.

Instructions for Use Oxylog 3000 SW 1.n

5

For Your Safety and that of Your Patients

Patient safety

Functional safety

The design of the medical device, the accompanying literature, and the labeling on the medical device are based on the assumption that the purchase and use of the equipment are restricted to trained professionals, and that certain inherent characteristics of the medical device are known to the trained operator. Instructions, warnings, and caution statements are limited, therefore, largely to the specifics of the Dräger design.

The essential performance of the Oxylog 3000 is defined as:

This publication excludes references to various hazards which are obvious to a medical professional and operator of this medical device, to the consequences of medical device misuse, and to potentially adverse effects in patients with abnormal conditions. Medical device modification or misuse can be dangerous. CAUTION Have a supply of extra batteries available.

Patient monitoring

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

Appropriate monitoring WARNING The monitoring functionality of the Oxylog 3000 ensures appropriate monitoring of ventilation therapy. To ensure appropriate monitoring during ventilation always set the following alarm limits: – airway pressure, Paw – expiratory minute volume, MV – breathing frequency. Not setting appropriate alarm limits could suppress alarms related to: –

acute changes in the patient’s condition

–

incorrect settings and faulty handling

–

equipment malfunctions.

The operators of the medical device are responsible for choosing appropriate safety monitoring that supplies 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 operator.

6

Instructions for Use Oxylog 3000 SW 1.n

For Your Safety and that of Your Patients

General WARNINGS and CAUTIONS The following WARNINGS and CAUTIONS apply to general operation of the device. WARNINGS and CAUTIONS specific to subsystems or particular features appear with those topics in later sections of the manual.

Note on EMC/ESD risk for the device function 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 "Technical Documentation for the Oxylog 3000 according to EMC standard IEC/EN 60601-1-2" on page 121. Portable and mobile RF communications equipment can affect medical electrical equipment. 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.

WARNING Keep a manual resuscitation bag available! 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 (resuscitation bag) – using PEEP and/or increased inspired O2 concentration as necessary. WARNING Always use officially approved gas cylinders and pressure regulators that comply with all applicable regulations. WARNING To ensure proper ventilation, always consider the dead space of the total ventilation circuit when setting ventilation parameters, especially when applying small tidal volumes. When using tidal volume settings below 100 mL Dräger Medical recommends constant monitoring of etCO2 and SpO2.

The operator shall 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.

Instructions for Use Oxylog 3000 SW 1.n

7

For Your Safety and that of Your Patients

Installing accessories CAUTION Installations to the basic device must be done in accordance with the Instructions for Use of the basic device. Make sure that the connection is securely fitted onto the basic device 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.

8

Instructions for Use Oxylog 3000 SW 1.n

Application

Application Intended use...

10

Indications/Contraindications...

10

Environment of use...

10

Instructions for Use Oxylog 3000 SW 1.n

9

Application

Intended use The Oxylog ® 3000 is a time-cycled, volume-constant and pressure-controlled emergency and transport ventilator for patients with a tidal volume from 50 mL upwards.

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

Environment of use Mobile use for emergency medical care or primary care of emergency patients: –

During transport in emergency rescue vehicles or aircraft including helicopters.

–

In accident and emergency departments, in the recovery room.

WARNING Do not use the equipment in hyperbaric chambers! The device may malfunction, causing danger to the patient.

–

During transfer by road or air.

WARNING Do not use the equipment in conjunction with magnetic resonance imaging (MRI, NMR, NMI).

–

When moving ventilated patients around the hospital.

The device may malfunction, causing danger to the patient.

Mobile use for secondary transfers:

10

Instructions for Use Oxylog 3000 SW 1.n

System Overview

System Overview Front panel with all options...

12

Side view, right... Rear view... Reusable hose system... Disposable hose system...

13 13 14 14

Available ventilation modes...

14

Special modes...

15

For O2 inhalation...

15

With monitoring...

15

Abbreviations...

16

Symbols...

17

Instructions for Use Oxylog 3000 SW 1.n

11

System Overview

Front panel with all options A

B C D E

F G

H I J

U T

K L

S

R

Q

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

for setting and displaying

P

O

MT-799-2000

M

N

M Key O Start/Standby N Display symbols for the power supply Charge status of the internal battery N Mains power supply connected

C Key Settings for setting other ventilation parameters on the screen

O Central rotary knob for making selections / settings and for confirming these

D Key for ventilation mode CPAP, CPAP/ ASB (CPAP/PS)

P Control knob for setting the O2 concentration O2 from 40 % up to 100 %

E Key for ventilation mode IPPV (CMV), IPPVAssist (CMVAssist)

Q Control knob for setting the maximum inspiratory pressure Pmax

F Key for ventilation mode SIMV, SIMV/ASB (SIMV/PS)

R Control knob for setting the ventilation frequency Freq.

G Key for ventilation modes BIPAP® (PCV+), BIPAP®/ASB (PCV+/PS) H Red and yellow lights as alarm indicators I

Key to suppress the audible alarm for 2 minutes

J

Key Alarm Reset for acknowledging alarm messages

S Control knob for setting the tidal volume VT Curves

T Key Curves for zooming the curve display and changing over between displayed "Flow" and "Paw" curves U Key Values values

for displaying measured

K Key O2-Inhalat. for changing over to O2 inhalation or key 100 % O2 for oxygenation L Key Insp. hold for manual inspiration 12

Instructions for Use Oxylog 3000 SW 1.n

System Overview

Side view, right

Rear view

A B C D F

B

A Emergency air intake

A Filter cartridge for intake of ambient air

WARNING Do not block the emergency air intake. This may result in ventilator malfunction.

CAUTION Do not block the air intake. This may result in ventilator malfunction.

B Screw to secure the battery compartment cover

B Rating plate

C Connectors for flow measuring hoses D Gas outlet for ventilation hose E Connector for medical gas hose F Connector for DC supply G Window for Infrared Data Association (IrDA) interface

Instructions for Use Oxylog 3000 SW 1.n

13

MT-158-2006

E MT-156-2006

G

A

System Overview

Reusable hose system

A

Disposable hose system

C

B D

E C

A 002

E 001

D

B

A Breathing valve

A Breathing valve

B Ventilation hose

B Ventilation hose

C Flow and pressure measuring hoses

C Flow and pressure measuring hoses

D Angled connector

D Flow sensor

E Flow sensor

E Angled connector

Available ventilation modes –

IPPV/IPPVAssist (CMV/CMVAssist*) Intermittent Positive Pressure Ventilation with PEEP. Intermittent Positive Pressure Ventilation with Assist Control with PEEP.

–

SIMV/ASB (SIMV/PS) Synchronized Intermittent Mandatory Ventilation. Mode for weaning patients off the ventilator after they have started spontaneous breathing, with adjustable pressure assist during spontaneous breathing.

*

14

CMV Controlled Mandatory Ventilation

–

BIPAP®/ASB (PCV+/PS)** Biphasic Positive Airway Pressure. Pressurecontrolled ventilation combined with free spontaneous breathing during the complete breathing cycle, and adjustable pressure assist on CPAP level.

–

CPAP/ASB (CPAP/PS) Continuous Positive Airway Pressure. Spontaneous breathing with positive airway pressure and adjustable pressure assist.

**

PCV+ Pressure Controlled Ventilation plus PS Pressure Support

Instructions for Use Oxylog 3000 SW 1.n

System Overview

Special modes In the ventilation mode CPAP, two special modes are available.

–

Apnoea Ventilation To automatically switch to volume-controlled mandatory ventilation if spontaneous breathing stops.

–

NIV For mask ventilation to support non-invasive ventilation of spontaneously breathing patients with leakage compensation.

For O2 inhalation –

with inhalation mask

With monitoring –

Airway pressure Paw.

–

Expiratory minute volume MV.

–

Apnoea.

–

Rapid shallow breathing: High frequency alarm.

Instructions for Use Oxylog 3000 SW 1.n

15

System Overview

Abbreviations

Abbreviation Explanation

Abbreviation Explanation Paw

Airway pressure

PCV+

Pressure Controlled Ventilation plus

PEEP

Positive end expiratory pressure

ΔASB (ΔPS) Set value for pressure support ASB ΔASB over PEEP

Pinsp

Set value of the upper pressure level in BIPAP®

bpm

Breaths per minute

Pmax

Maximum airway pressure

BTPS

Body Temperature, Pressure Saturated Measured values referred to the conditions of the patient's lung, body temperature 37 oC, airway pressure, water-vapor-saturated gas

Pmean

Mean airway pressure

ASB (PS)

Assisted Spontaneous Breathing Pressure-assisted spontaneous breathing

C

Lung compliance

CMV

Controlled Mandatory Ventilation

CPAP

Continuous Positive Airway Pressure Spontaneous breathing with continuous positive pressure

Pplat

Plateau pressure

R

Resistance

Ramp

Set value for the rise in pressure over time for pressure assistance with ASB

SIMV

Synchronized Intermittent Mandatory Ventilation

TApnoea

Time for apnoea alarm

Te

Expiratory time

Tinsp

Set inspiratory time

ESD

Electrostatic discharge

Tplat

Plateau time

f

Ventilation frequency

VTApnoea

fApnoea

Frequency of apnoea ventilation

Tidal volume during apnoea ventilation

FiO2

Fraction of inspiratory oxygen

VT

Set tidal volume

Freq.

Ventilation frequency

VTe

Expiratory tidal volume

fspn

Spontaneous breathing rate

100 % O2

100 % O2 flow

I:E

Relation inspiratory time to expiratory time

IrDA

Infrared Data Association

MV

Minute volume

MVe

Total expiratory minute volume

MVspn

Spontaneous minute volume

NIV

Non-invasive ventilation – mask ventilation

O2

Set value for the inspiratory O2 concentration

O2-Inhalat.

O2 Inhalation

16

Instructions for Use Oxylog 3000 SW 1.n

System Overview

Symbols

Symbol

Explanation

,

Start inspiration or hold manually

Symbol

Charge status of the internal battery

N Settings

Display screen window "Settings"

Alarms

Display screen window "Alarms"

Values

Display screen window measured "Values"

Curves

Change between flow/pressure curves

Mains power supply connected Battery charge (example: three quarters full)

E4

10 R-02 XXXX

IPX4

The device complies with UN Regulation no. 10, revision 2 with respect to EMC for use in motor vehicles. Device protected from water sprayed from all directions, limited entrance allowed.

Acknowledge alarms

Class II equipment, device protected against electric shock with additional safety precautions such as double or reinforced insulations, without protective earthing.

Start / Standby key

Do not dispose of the device as municipal waste.

Suppress audible alarm for 2 minutes Alarm Reset

Explanation

Manufacturing date Upper alarm limit only Manufacturer Lower alarm limit only DC input !

Advisory message Consult the instructions for use.

!!

Caution message Indoor use only

!!!

Warning message Caution, hot surface!

!

Attention! Consult accompanying documents!

Warning, dangerous voltage!

Type BF applied part (body floating)

Instructions for Use Oxylog 3000 SW 1.n

17

System Overview

Symbol

Explanation Do not open! Temperature limitations Latex free Do not reuse Handle oil and grease free Non-sterile Keep away from sunlight

18

Instructions for Use Oxylog 3000 SW 1.n

Operating Concept

Operating Concept Switch ON or OFF...

20

Switch ON... Switch OFF...

20 20

Ventilation controls...

21

Display operating controls...

22

Changing screen pages in the windows...

23

Screen window structure...

23

Instructions for Use Oxylog 3000 SW 1.n

19

Operating Concept

Switch ON or OFF

B

A

00337170

Oxylog 3000

Switch ON z To switch ON, briefly press the O key (A).

Switch OFF 1

To switch OFF, hold down the O key (A) for approximately 3 seconds.

2

Press the rotary knob (B) to confirm the switch OFF process.

20

Instructions for Use Oxylog 3000 SW 1.n