Oxylog 1000 Instructions for Use 8th edition Aug 2012

This page is intentionally left blank

2

Contents

Contents For Your Safety and that of Your Patients...5 Precautions...6 Intended Use...6 General description...6 Operating concept...7 Operation...8 Oxylog 1000 Device Check...8 IPPV controlled ventilation...9 Ventilation with PEEP (Special accessory)...11 End-expiratory volume measurement (Special accessory)...12 End of operation...12 Care...13 Dismantling...13 Disinfecting/Cleaning...14 Sterilising...15 Preparation...16 Mounting the ventilation valve...16 Installing the Oxylog 1000...17 Connecting the O2 supply...18

Checking readiness for operation...20 Testing ventilation function...20 Testing the »Paw « alarm...21 Testing the »Paw « alarm...21 Checking the »Psupply« alarm...22 Troubleshooting...23 Maintenance intervals...24 What's what...25 Front view...25 Side view...26 Technical data...27 Abbreviations and symbols...29 Appendix...30 Minute volume and O2 concentration as a function of airway pressure...30 Block circuit diagram...31

Order List...32 Index...33

3

Contents

This page is intentionally left blank

4

For Your Safety and that of Your Patients

For Your Safety and that of Your Patients 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.

Liability for proper function or damage The liability for the proper function of the apparatus is irrevocably transferred to the owner or operator to the extent that the apparatus is improperly serviced or repaired by personnel not employed or authorized by DrägerService or if the apparatus is used in a manner not conforming to its intended use. Dräger cannot be held responsible for damage caused by noncompliance with the recommendations given above. The warranty and liability provisions of the terms of sale and delivery of Dräger are likewise not modified by the recommendations given above. Dräger Medical GmbH, Germany

NOTE:

A NOTE provides additional information intended to avoid inconvenience during operation. Strictly follow these Instructions for Use WARNING!

Strictly follow these Instructions for Use. Any use of the product requires full understanding and strict observation of all portions of these instructions. The device is only to be used for the purpose specified under "Intended Use" on page 6 and in conjunction with appropriate patient monitoring (see page 8). Observe all WARNING and CAUTION statements throughout this manual and all statements on device labels. Maintenance WARNING!

The device must be inspected and serviced regularly by trained service personnel. Repair of the device may also only be carried out by trained service personnel. Dräger recommends that a service contract be obtained with DrägerService and that all repairs also be carried out by them. Dräger recommends that only authentic Dräger repair parts be used for maintenance. Otherwise the correct functioning of the device may be compromised. See chapter "Maintenance Intervals". Accessories Do not use accessory parts other than those in the order list.

5

Precautions

Precautions WARNING!

Standby manual ventilation system If the life-preserving function of the ventilator is no longer guaranteed due to a fault, the patient must immediately be ventilated with an alternative independent ventilating device, e.g. with a self-filling manual breathing bag. WARNING!

Do not use this apparatus in explosion hazard areas. Risk of explosion! WARNING!

Do not use the equipment in conjunction with magnetic resonance imaging (MRI, NMR, NMI). The apparatus may malfunction, causing danger to the patient. CAUTION!

Ventilation monitoring During ventilation, the patient must be constantly monitored by qualified medical personnel.

Intended Use Oxylog 1000 – a time cycled, volume constant transport and emergency ventilator for patients requiring a minute volume ventilation of at least 3 liters per minute.

General description Oxylog 1000 is a purely pneumatic-powered transport and emergency ventilator. With display - of inspiratory airway pressure Paw, with audible and visual alarms for: - airway pressure Paw low - airway pressure Paw high - O2 supply pressure Psupply low with applications in: - mobile use in EMS and primary care of emergency patients - patient transports and transfers by land, sea, or air. - intra-hospital transfers of ventilated patients - secondary transfers between hospitals - the emergency room.

6

Operating concept

Operating concept 9

8

7

6

5

3

1

1 Three rotary control knobs are located in the middle of the front panel for setting the upper alarm limit for airway pressure (»Pmax«), the ventilation rate (»Freq.«) and the minute volume (»MV«). Uniform colour codes are used to identify different scale ranges of the »Freq.« and »MV« knobs to help rapid presetting: with these colour-coded scales, the initial parameters are adapted to the relevant patient group: infants (green) / children (blue) / adults (brown). 2 The main switch 0/I for switching the ventilator on and off is in the bottom right-hand corner of the front panel. 3 With the »Air Mix/No Air Mix« switch, the user can choose between approx. 60 Vol.% O2 and 100 Vol.% O2. 4 The pressure gauge shows the inspiratory airway pressure.

1

1

2

MT-214-99A

4

The flag indicators for the alarms are located above the rotary control knobs for »Freq.«, »MV« and »Pmax«: 5 »Psupply« flag indicator. Green if the supply pressure is sufficient, turns red if the supply pressure is insufficient. 6 Indicator for the upper alarm limit »Paw «. Red if the airway pressure exceeds the maximum limit. 7 Indicator for lower alarm limit »Paw « turns red if lower alarm limit is not reached. 8 » «button to mute the audio alarm for up to 2 minutes. 9 Indicator » « turns yellow when the alarm tone is muted.

NOTE:

The color coded ranges and patient identifications are offered solely for the convenience of the user for selecting initial settings. It is ultimately the responsibility of the user to select the correct settings for each patient.

7

Operation

Operation Oxylog 1000 Device Check The device check must be carried out before each use. Any operation of the device requires thorough knowledge of the Instructions for Use. Type Serial No.

Check the following points before starting up the device: z O2 pressure supply connected z Cylinder pressure at least 100 bar or ventilator connected to the central O2 supply z Ventilation valve and ventilation hose connected Testing correct operation z Fit the test lung to the ventilation valve. z Set the device when using a reusable hose: »MV« approx. 10 L/min »Freq.« approx. 10 bpm »Pmax« approx. 55 mbar Main switch I (ON) Switch »No Air Mix« z Set the device when using a disposable hose to the settings as described in the accompanying leaflet of the disposable hose. Oxylog 1000 must ventilate the test lung After 5 ventilation strokes ventilation is constant, no alarms should occur. z Squeeze the test lung, so that the airway pressure is approx. 60 mbar. The »Paw « indicator turns red, and the audible alarm is sounded. z Remove the test lung: The »Paw « indicator turns red, and the audible alarm is sounded.

8

Operation

In the event of deviations, see "Troubleshooting", page 23. Device check completed Name Date

Use a prepared, operable and disinfected device. Care, page 13. Preparation, page 16. Checking device ready for operation, page 20.

IPPV controlled ventilation For ventilation frequencies of 4 to 54 breaths per minute.

Patient group

Freq. 1/min

MV L/min

Green range for infants

28 to 54

3 to 5

Blue range for children

20 to 28

5 to 9

Brown range for adults

4 to 20

9 to 20

D

Oxylog 1000

1

1 002

For rapid presetting, uniform colour-coded scale ranges can be used for the rotary control knobs for the ventilation rate Freq. and minute volume MV. 1 Presetting the »Freq.« and »MV« control knobs:

NOTE:

The color coded ranges and patient identifications are offered solely for the convenience of the user for selecting initial settings. It is ultimately the responsibility of the user to select the correct settings for each patient.

9

Operation

NOTE:

The tidal volume will be equal to the minute volume setting divided by the rate setting: Minute volume (L/min)

5

3

0.60

Ventilator Rate (1/min) 10 25 35 54 (max) 0.30

0.12

0.09

0.06

7

1.40

0.70

0.28

0.20

0.13

10

2.00

1.00

0.40

0.29

0.13

15

3.00

1.50

0.60

0.43

0.28

20

4.00

2.00

0.80

0.57

0.37

Tidal volume VT (L) The I/E-ratio is fixed to approximately 1:1.5 and changes slightly depending on the setting. The I/E-ratio is within the range considered reasonable for most patients during emergency care and transport. 2 Set the desired O2 concentration with the switch: Air Mix approx. 60 % O2 by volume or No Air Mix = 100 % O2 by volume WARNING!

D

2

In Air Mix mode, the applied tidal volume VT is reduced at high airway pressures due to the physical characteristics of the injector used for the mixing and the O2 concentration increases due to the smaller amount of air intake. (See also page 30 in the appendix). WARNING!

Set »Pmax« When the patient is connected: 1 Check the »MV« setting and adjust according to the patient. 2 Check the airway pressure on the pressure gauge. 3 Set desired upper alarm limit »Pmax«. When the desired upper alarm limit set »Pmax« is reached, the machine limits the airway pressure increase by blowing off part of the inspiratory flow. Inspiration is continued by the machine. WARNING!

D

Oxylog 1000

2

3

1

004

Watch the pressure gauge and take note of alarm conditions in order to recognise incorrect ventilation at an early stage and prevent danger to the patient.

003

In toxic surroundings: - The patient must be ventilated in No Air mix mode in order to ensure that toxic constituents are not entrained into the breathing gas. - The patient must immediately be transferred to a breathable atmosphere in order to prevent inhalation of toxic air when spontaneous breathing resumes.

10

Operation

For heart-lung resuscitation For resuscitation of adults using the "two helper method": 4 Set the »Freq.« knob to the heart symbol , 5 Set the »Pmax« knob to the heart symbol , approx. 55 mbar. NOTE:

D

Airway pressure limiting is now activated. When the peak pressure limit is reached, tidal volume may not be fully applied under certain conditions.

Oxylog 1000

4

006

5

028

Ventilation with a mask z Connect mask to patient connection on breathing valve. z Position mask over the face to cover the bridge of the nose and the chin, to ensure a tight fit.

Ventilation with PEEP (Special accessory) 1 Set the PEEP valve to 0 mbar = turn the knob anti-clockwise as far as it will go and fit it to the expiration connector of the ventilation valve. Set PEEP = turn knob. The end-expiratory pressure is increased by the set PEEP value.

D

Oxylog 1000

NOTE:

The PEEP pressure is not displayed on the pressure gauge!

028

1

11

Operation

Only for stationary use!

End-expiratory volume measurement (Special accessory) To measure the end-expiratory tidal volume and end-expiratory minute volume. Cannot be combined with the PEEP valve.

D

Oxylog 1000

NOTE:

Strictly follow the Instructions for Use of the Volumeter 3000. 2 3 4 5 6

Clamp the Volumeter 3000 holder to the wall rail. Screw the Volumeter 3000 to the holder. Screw the elbow connector to the Volumeter 3000. Fit adapter to expiration connector of the ventilation valve. Connect the ventilation valve and Volumeter 3000 with 1.5 m long ventilation hose.

5

6 4

3

009

2

End of operation After disconnecting the patient: 1 Switch the main switch to 0.

D

Oxylog 1000

If the Oxylog is supplied by O2 cylinder: z Fully close the cylinder valve. If the Oxylog is supplied by the central gas supply: z Remove the gas supply connector.

12

010

1

Care

Care z After each operational use of the ventilator, dismantle and disinfect the reusable ventilation valve and ventilation hose, the volume metering parts and the reusable PEEP valve. z The ventilator and compressed gas hoses must also be cleaned/disinfected if severely soiled. z Use the single-use system, consisting of the ventilation valve, the ventilation hose and the single-use PEEP valve, only once. These parts are marked: For single use only! z Dispose of the single-use components in accordance with local regulations.

Dismantling

2

1

011

z Remove Oxylog 1000 from its holder. 1 Unscrew the O2 compressed gas hose from the Oxylog 1000. 2 Remove the ventilation hose from the connector on the side of the ventilator.

CAUTION!

To remove the ventilation hose, always grip it by the sleeve and not the spiral stiffening ridges. Otherwise the spiral ridges may be torn, e.g. at the sleeve, or the hose may be ripped out of the sleeve.

012

z Remove the ventilation valve from the ventilation hose. z Pull the PEEP valve out of the ventilation valve, or z remove and dismantle the volume metering parts.

13

Care

Dismantling the ventilation valve Turn the cover about 45o anti-clockwise = unlock, and remove the cover. 3 Remove the diaphragm. Do not dismantle any further.

1

WARNING!

Protect the diaphragm from damage. WARNING!

2

Do not allow any foreign matter to enter the housing of the ventilation valve. The red non return valve in the diaphragm should not be removed, damaged or bent. Otherwise, impaired valve operation will occur, putting the patient at risk.

Disinfecting/Cleaning Use only preparations classified as »surface disinfectants« for disinfecting. For material compatibility, we recommend preparations based on - aldehydes, - alcohols, - quaternary ammonium compounds. Due to possible damage to materials, the following preparations are unsuitable: - compounds containing alkylamine - compounds containing phenol - halogen-releasing compounds - strong organic acids - oxygen-releasing compounds. For users in the Federal Republic of Germany, we recommend the use of disinfectants listed in the current DGHM list (DGHM = German Society for Hygiene and Microbiology). The DGHM list (published by mhp Verlag GmbH, Wiesbaden) also specifies the active basis of each disinfectant. For countries where the DGHM list is unavailable, we recommend products based on the above active bases.

14

013

WARNING!

Care

Wipe disinfecting Ventilator, O2 compressed gas hose: z Wipe disinfect with e.g. Buraton 10 F or Terralin. Strictly follow the Instructions for Use of the disinfectant manufacturer. Coarse impurities must first be removed with a disposable cloth. CAUTION!

Do not allow any liquids to penetrate inside the ventilator or O2 compressed gas hose. Liquid inside the system can impair ventilation.

Immersion disinfecting Dismantled components of the ventilation valve, ventilation hose, volume metering parts, not the Volumeter 3000: z Disinfect in disinfectant bath with e.g. Gigasept FF = formaldehyde-free. Strictly follow the Instructions for Use of the disinfectant manufacturer. Thoroughly stir the parts in the solution. Do not clean with hard brushes. Do not allow any foreign object to enter the inside of the ventilation valve. z Rinse thoroughly with Aquadest. CAUTION!

Allow the parts to dry fully. If any water remains in the ventilation valve, the ventilation function may be impaired.

Sterilising Sterilise as follows if necessary: Disassembled parts of the breathing valve, ventilation hose and mask: z Sterilise in hot steam at 134 oC. Exposure time in accordance with EN 285: at least 3 minutes. NOTE:

Do not expose the plastic parts to the hot steam for more than 10 minutes, since this can accelerate the ageing of the materials.

PEEP valve and Volumeter 3000 z treat as specified in their specific Instructions for use.

After care z Preparation, page 16. z Connect the O2 supply, page 18. z Betriebsbereitschaft prüfen, page 20.

15

Preparation

Preparation The reusable ventilation hose and the ventilation valve are supplied with the ventilator. Alternatively, the optional, pre-assembled singe-use system, consisting of a ventilation hose and ventilation valve, can be used. These parts are marked: For single use only!

Mounting the ventilation valve 1 Check that the red non-return valve is securely seated in the diaphragm and lies flat on the diaphragm. WARNING!

The red non return valve in the diaphragm should not be removed, damaged or bent. Otherwise, impaired valve operation will occur, putting the patient at risk.

1 2

2 Insert the diaphragm in the valve housing, with the red nonreturn valve facing the housing. 3 The bead of the diaphragm must lie flat and flush on the edge of the housing. 4 Fit the cover as shown, press down and turn 45° clockwise to lock. The inspiration connector and the expiration connector should be facing one another. The diaphragm should fit into the housing without creasing.

4

014

3

5

015

5 Fit the ventilation hose to the inspiration connector of the ventilation valve.

6

016

6 Fit the ventilation hose to the connector on the ventilator.

16

Preparation

029

Mounting the PEEP valve (option) Both a reusable PEEP valve and a single-use PEEP valve are available. The single-use PEEP valve is marked: For single use only! z Mount the PEEP valve on the expiration connector of the ventilation valve. Measurement of the expiratory volume is not possible when the PEEP valve is used.

Installing the Oxylog 1000 For stationary use z Place firmly on a level, non-slip surface, ensuring unit cannot fall, or: z Suspend at the head of the bed, or: z Suspend on a wall rail, as illustrated.

D

017

Oxylog 1000

For mobile use in vehicles z Use the vehicle mount 1 Suspend Oxylog 1000 by its bracket on the rod of the holder. 2 Swivel the ventilator up into the holder until it clicks into place.

1

3

To pull out the ventilator: 3 Press the release catch from underneath.

018

2

17

Preparation

Connecting the O2 supply Take care when handling oxygen. WARNING!

O2 is highly flammable and intensively propagates any source of fire. Do not smoke or allow any naked flame in the vicinity of the O2 supply. Protect O2 cylinders against falling, and do not expose them to intense heat. WARNING!

Do not oil or grease O2 fittings, such as cylinder valves and pressure-reducing valves, and do not handle these parts with greasy hands. Fire risk. WARNING!

Only open/close cylinder valves by hand, turning evenly. Never use a tool to open/close the valves.

For supply by O2 cylinder WARNING!

Use only compressed gas cylinders that conform to national safety standards and have been duly approved. Use full cylinders with 200 bar cylinder pressure. z Screw a pressure-reducing valve onto the O2 cylinder (for supply pressure 2.7 to 6.0 bar). WARNING!

Use only pressure-reducing valves with an outlet exhaust valve that limits the outlet pressure to approx. 5 bar in the event of failure. z Connect the Oxylog 1000 to the pressure-reducing valve with the compressed gas hose. z Open the cylinder valve by turning slowly as far as it will go.

O2

Do not insert metering valves or flow meters in the O2 supply of the Oxylog 1000. Risk of impaired function of the ventilator with consequent danger to the patient.

18

019

CAUTION!

Preparation

Determining the gas content of the O2 cylinder Example: Cylinder pressure measured at the pressure gauge of the pressure-reducing valve: 200 bar O2 cylinder capacity: 2.5 L Compressed gas content: 2.5 L x 200 bar = approx. 500 L Estimated operating time of the Oxylog 1000 Example: Freq. 10 bpm, VT = 1 L, MV = 10 L/min Operating time = Compressed gas content [L] (MV +1*) [L/min] Operating time =

500 11

= approx. 45 min

If Oxylog 1000 is switched to »Air Mix«, the gas consumption is reduced by about 50 %, thereby increasing the operating time to about 90 minutes.

For supply from a central O2 supply z Screw the compressed gas hose to the Oxylog 1000 and insert the gas connector in the O2 supply socket.

020

In exceptional cases, the Oxylog 1000 may also be supplied with compressed air, in which case the O2 concentration is always 21 % by volume.

For use with the Dräger Oxator z Screw the O2 compressed gas hose to the Oxylog 1000. z Insert the gas connector securely into one of the two O2 ports until it clicks into place. NOTE:

Strictly follow the Instructions for Use of the Oxator.

_________ 021

* Intrinsic consumption of the device: approx. 1 L/min

19

Checking readiness for operation

Checking readiness for operation - - - z

after changing the ventilation valve, after each care and reassembly procedure, at the latest every 6 months. ocument testing in the medical products book.

022

Connecting the test lung The test lung consists of the mask elbow for connecting to the ventilation valve, the Ø7 catheter connector for simulating the resistance of the airways and a 2 L breathing bag to simulate lung compliance. z Insert the mask elbow of the test lung onto the patient connector of the ventilation valve.

Switch on the O2 supply z Open the O2 cylinder supply by turning slowly as far as it will go or z insert the O2 compressed gas connector in the supply socket until it clicks into place = tapping position.

Testing ventilation function Set the ventilator when using a reusable hose: »MV« knob approx. 10 L/min »Freq.« knob approx. 10 bpm »Pmax« knob approx. 55 mbar Main switch I (On) Switch »No Air Mix«

z Set the device when using a disposable hose to the settings as described in the accompanying leaflet of the disposable hose. z Oxylog 1000 ventilates the test lung. After 5 ventilation strokes ventilation is constant, no alarms should occur.

20

D

Oxylog 1000

5 3

2

1

4 023

z 1 2 3 4 5