Zeus Infinity Empowered Supplement to Instructions for Use Sw 2.n Edition 1 Feb 2015

English Supplement

Zeus Infinity Empowered

en

English

Supplement to the instructions for use Instructions for use

Part number

Edition

Zeus IE SW 2.n

9054908

1 – 2015-02 and higher

 Keep this supplement with the instructions for use. This supplement updates the information on reprocessing the anesthesia machine in the following chapters of all instructions for use and all supplements for Zeus IE.

NOTE The names of the chapters in the referenced documents may differ.

Information about this document

Trademarks The following trademarks have been added or replace existing trademarks.

Trademarks owned by Dräger

Trademark

Trademark owner

acryl-des®

Schülke & Mayr

Mikrozid

®

Perform®

Trademark

Actichlor®

WaterLock®

Ecolab USA

®

Incidin The following web page provides a list of the countries in which the trademarks are registered: www.draeger.com/trademarks Trademarks owned by third-party manufacturers Trademark Dismozon

®

Trademark owner BODE Chemie

2

BruTab 6S®

Brulin

Dispatch®

Clorox

Klorsept

®

Descogen

Medentech ®

Antiseptica

®

Oxygenon SteriMax®

Cleanisept

Mikrobac® Neodisher Mediclean®

Oxycide®

Aseptix ®

Dr. Schumacher

Dr. Weigert

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Reprocessing

Safety information

Appropriate reprocessing WARNING Risk due to inappropriately reprocessed products

SpiroLife flow sensor

Reusable products must be reprocessed, otherwise there is an increased risk of infection. – Follow the infection prevention policies and reprocessing regulations of the health-care facility. – Follow the national infection prevention policies and reprocessing regulations. – Use validated procedures for reprocessing. – Reprocess reusable products after every use. – Follow the manufacturer's instructions for cleaning agents, disinfectants, and reprocessing devices.

Improper reprocessing and soiling, such as deposits or particles, may damage the flow sensor: – No machine cleaning or disinfection of the sensor insert – No plasma sterilization or radiation sterilization – No water jets, compressed air, brushes, or similar to be used on the sensor insert – No ultrasonic bath – Clean and disinfect the flow sensor in accordance with the corresponding instructions for use. – For disinfecting the flow sensor use only clean disinfectant solutions.

WARNING Risk due to faulty products

WARNING Risk of fire

Signs of wear, e.g., cracks, deformation, discoloration, or peeling, may occur with reprocessed products.

Residual vapors of highly flammable disinfectants (e.g., alcohols) and deposits that were not removed during reprocessing may ignite when the flow sensor is in use. – Ensure particle-free cleaning and disinfection. – After disinfection, allow the flow sensor to air for at least 30 minutes. – Before inserting the flow sensor check for visible damage and soiling, such as residual mucus, medication aerosols, and particles. – Replace flow sensors when damaged, soiled, or not particlefree.

Check the products for signs of wear. Replace them if necessary.

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CAUTION Risk of failure of flow measurement

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WARNING Risk of injury to patients due to failure of accessories Disposable products have been designed, tested, and manufactured exclusively for single use. Reuse, reprocessing or sterilization can result in failure of the accessory and injury to the patient. Do not reuse, reprocess, or sterilize disposable products.

Information on reprocessing Follow the national infection prevention policies and reprocessing regulations. Follow the infection prevention policies and reprocessing regulations of the health-care facility (e.g., concerning the reprocessing cycles).

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Classifications for reprocessing

Classification of medical devices The classification depends on the intended use of the medical device. The risk of infection transmission through the application of the product to the patient without proper reprocessing is the basis of the Spaulding classification. Classification

Explanation

Non-critical

Components that come into contact only with skin that is intact

Semi-critical

Components that carry breathing gas or come into contact with mucous membranes or pathologically altered skin

Critical

Components that penetrate skin or mucous membranes or come into contact with blood

Classification of device-specific components Follow the instructions for use for the components.

Critical

The following classification is a recommendation from Dräger.

The device does not contain any components classified as critical.

Non-critical – – – –

Device surface including screen Trolley and holders Removable parts of the main device Breathing system mount

Semi-critical –

– – –

Breathing system – Housing (upper part and lower part) – Expiratory port, inspiratory port – APL valve – Additional air valve Flexible breathing bag arm (option) TurboVent 2 blower module Absorber container and absorber insert

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Before reprocessing Observe before disassembly 1

Switch off the device and all devices connected to it.

2

Disconnect all power plugs.

Patient-specific accessories and consumables The patient-specific accessories and consumables must be removed from the device and, if necessary, disassembled.

C

Reusable products:

C

 If the reusable product has its own instructions for use, perform reprocessing in accordance with the separate instructions for use.

A

B

046

 If no separate instructions for use are available for the reusable product, perform reprocessing in accordance with the instructions in this supplement. Disposable products:  Dispose of the disposable products. Removing patient-specific accessories and consumables Remove the following accessories: – – – –

6

Breathing hoses Breathing bag Filters Water traps

Removing the filter  Remove the filter (A) from the nozzle on the Ypiece, inspiratory port, or expiratory port. Removing the breathing bag Remove the breathing bag and hose (B).

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Removing the breathing hoses

 Disconnect the sample line (D) from the CO2 water trap (E) and from the filter on the Y-piece.  Remove the internal sample line (G) on the Protect water trap (F).

016

WARNING Risk of infection

 Remove the breathing hoses (C) from the ports on the breathing system. NOTE Do not damage the breathing hoses. When attaching or removing the breathing hoses always hold them at the connection sleeve and not at the spiral ribbing. Otherwise the spiral ribbing can become detached from the sleeve. Breathing hoses with damaged spiral ribbing can get kinked and interrupt ventilation.

Breathing gas, in which there may be infectious agent, flows through the sample line. – If there is no bacterial filter used between the sample line and the patient, the sample lines must not be reused and must be replaced after each patient. – Observe the replacement intervals of the water traps. – Replace the bacterial filter in the sample gas return line in accordance with the intervals listed in the information in the "Maintenance" chapter. WARNING Material damage due to disinfectants When the sample line is disinfected and residues of the disinfectant remain in the sample line, these residues can get into the water trap and the patient-gas measurement module later. This may result in faulty measurements.

Removing the sample lines

Sample lines are disposable products. Disposable products must not be disinfected.

F E

G

157

D

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Removing the water traps  Follow the instructions for use for the water traps. Zeus IE is equipped with 2 water traps to protect the device monitoring system: Protect: Water trap for the internal sample line CO2: Water trap for the patient sample line

1

Pull off the CO2 water trap (E) towards the front.

2

Pull off the Protect water trap (F) towards the front.

106

– –

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Device-specific components Reusable absorber

The device-specific components must be removed from the device and, if necessary, disassembled. Removing the CO2 absorber 1

Remove the CO2 absorber: – –

CLIC absorber (disposable) Or Reusable CO2 absorber

B A

CLIC absorber (disposable absorber)

018

 Follow the instructions for use for the CLIC absorber.

A B

1

Unscrew the CO2 absorber (A) from the breathing system.

2

Remove and dispose of the optional disposable dust filter (B).

3

Empty the used soda lime. Dispose of according to the instructions for use for the soda lime.

C

068

C

Press the release button (A). The CLIC adapter flips open.

2

Pull the CLIC absorber (C) upwards out of the holder (B).

3

D 013

1

4

Remove the absorber insert (C) from the absorber container. The sealing ring (D) remains on the absorber insert.

5

Prepare the CO2 absorber for cleaning and disinfection in the washer-disinfector.

Flip the holder back until it clicks into place.

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Removing the flow sensors

Removing the breathing system

B

019

A

Release the two lateral twist locks (A).

2

Pull the breathing system out upwards by the handle (B).

3

Unscrew the CLIC adapter (optional).

B

A 030

1

 Follow the instructions for use for the flow sensors.

NOTE To prevent accidental penetration of soda lime into the breathing system, do not transport the breathing system with a filled reusable CO2 absorber.

1

Loosen the knurled nut on the expiratory port (A). Remove the port.

2

Loosen the knurled nut on the inspiratory port (B). Remove the port.

Removing the CLIC adapter (optional)

C (2x)

177

 Follow the instructions for use for the CLIC adapter.

Remove the two flow sensors (C).

107

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Disassembling the breathing system

Removing the APL valve WARNING Risk of damage to breathing system

A (5x)

If the APL valve is not disassembled before the breathing system is reprocessed, this can lead to leakages in the breathing system. Always remove the APL valve prior to reprocessing.

B

043

B

Open the 5 quick-release screws (A) by turning them 90° counterclockwise. To do so, use a 6 mm hexagon socket screwdriver (included in the scope of delivery).

2

Remove the housing upper part (B).

A 007

1

1

Loosen the knurled nut (A).

2

Pull off valve (B).

Removing the flexible arm and breathing bag (optional)

A

3

Unscrew the additional air valve (C).

4

Prepare the housing parts for cleaning and disinfection in the washer-disinfector.

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C

1

Loosen the knurled screws (A) on the connector on the arm.

2

Pull the arm off the breathing system.

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Removing the TurboVent 2 blower module

Removing the anesthetic gas receiving system  Follow the instructions for use for the anesthetic gas receiving system.

A (2x) B B

C

C A

1

2

12

Using a suitable aid (e.g., a coin), release the 2 quick-release screws (A) by turning them 90° counterclockwise. Remove the blower module (B) from the breathing system mount (C).

022

092

B

1

Disconnect the suction hose (A) from the receiving system on the back of Zeus IE.

2

Remove the transfer hose (B).

3

Remove the anesthetic gas receiving system (C).

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Validated reprocessing procedures

Overview of the reprocessing procedures of the components Components –

Surface disinfection with cleaning

Machine cleaning with Description of the prothermal disinfection cedure

Device surface including screen Trolley and holders Removable parts of the main device

Yes

No

See page 14

–

Breathing system mount

Yes

No

See page 15

–

Breathing system – Housing (upper part and lower part) – Expiratory port, inspiratory port – APL valve – Additional air valve

– –

See page 16

No

Yes

–

Flexible breathing bag arm (optional)

See pages 17 and 17

–

TurboVent 2 blower module

See pages 17 and 18

–

Absorber container and absorber insert

See pages 17 and 18

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Surface disinfection with cleaning Components: – Device surface including screen – Trolley and holders – Removable parts of the main device – Breathing system mount Components – – –

Surface disinfectant

Device surface includ- Dismozon ing screen Trolley and holders Removable parts of the main device

Breathing system mount

Mikrobac Tissues

Prerequisites: – The surface disinfectant has been prepared in accordance with the manufacturer's instructions. – The manufacturer's instructions, e.g., regarding shelf life or application conditions, are observed. – An almost sterile lint-free cloth soaked in surface disinfectant is used for the cleaning surface disinfection. WARNING Risk due to penetrating liquid Penetrating liquid may cause the following: – Damage to the device – Electric shock – Device malfunctions

Manufacturer

Concentration

Contact time

Bode Chemie

1.6 %

15 min

Bode Chemie

–

–

Surface disinfection 3

Wipe cleaned surfaces again to visibly wet all surfaces to be disinfected with surface disinfectant.

4

Wait for the surface disinfectant contact time.

5

At the end of the contact time, moisten a new almost sterile lint-free cloth with water (at least drinking water quality).

6

Wipe all surfaces until no remains of the surface disinfectant, such as foam residues or streaks, are visible.

7

Wait until the surfaces are dry.

8

Check the surfaces for visible damage and, if necessary, replace the product.

Ensure that no liquid penetrates the device. Cleaning 1

Wipe off obvious soiling using a disposable cloth (or a similar cloth) soaked in surface disinfectant and dispose of this.

2

Wipe all surfaces. After that, there must no longer be any soiling visible.

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Supplementary information Breathing system mount Perform the following steps:

A (6x)

1

Use a cloth dampened with disinfectant or a disposable cloth that is ready for use.

2

Perform the surface disinfection of the breathing system mount by wiping it back and forth at least 3 times. In particular, disinfect the optically highlighted connections (A).

073

Repeat steps 1 and 2 four times respectively. Use a new cloth for each repetition of steps 1 and 2.

NOTE – Do not use any alcohol-based disinfectants. – Remove deposits. – Ensure lint-free cleaning and disinfection. – Do not allow fluid to get inside. Prerequisite: –

The breathing system has been removed.

WARNING Risk due to penetrating liquid Penetrating liquid may cause the following: – Damage to the device – Electric shock – Device malfunctions Ensure that no liquid penetrates the device.

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Machine cleaning with thermal disinfection Use a washer-disinfector that meets the requirements of the standard ISO 15883. Dräger recommends the use of a load carrier for anesthesia accessories and ventilation accessories. Follow the manufacturer's instructions for the washer-disinfector. Components: – Breathing system – Housing (upper part and lower part) – Expiratory port, inspiratory port – APL valve – Additional air valve – Absorber container – Absorber insert – TurboVent 2 blower module – Flexible breathing bag arm (optional) Step

Agent

Manufacturer Concentration

Temperature

Contact time

Cleaning

Neodisher MediClean Forte

Dr. Weigert

According to the manufacturer's instructions

Min. 55 °C (131 °F)

Min. 10 min

Disinfecting

–

–

–

Min. 90 °C (194 °F)

Min. 5 min

Drying

–

–

–

–

Drying time depends on the load

Prerequisites: – The washer-disinfector has been prepared in accordance with the manufacturer's instructions.

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Positioning the components in the load carrier Flexible breathing bag arm (optional)

Depending on the equipment level of the device, not all components may be present.

Required aids: – Hose (diameter: 12 mm (0.47 in), length: max. 50 cm (19.7 in)) for connecting the breathing bag arm

All components must be positioned firmly in the load carrier. Ensure the following: – –

All surfaces and interiors can be completely rinsed. The water can drain off freely.

C

The following illustrations are non-binding recommendations for individual components. Depending on the washer-disinfector devices used, other positions can be used.

B

The connections shown are binding.

A

Breathing system

A 035

B

Connect the flexible breathing bag arm (A) to the hose (B).

2

Place both of them in the load carrier.

3

Connect the other end of the hose to a suitable nozzle (C) on the load carrier.

114

1

 Position the breathing system (A) and the housing cover (B) slightly tilted.

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Absorber insert

TurboVent 2 blower module

Required aids: – Hose (diameter: 12 mm (0.47 in), length: max. 50 cm (19.7 in)) for connecting the absorber insert

Required aids: – Adapter A special holder is needed for the TurboVent 2 blower module. This holder must be mounted on a suitable flushing nozzle on the load carrier.

C B A

096

A 1

Connect the absorber insert (A) to the hose (B).

2

Place both of them in the load carrier.

3

Connect the other end of the hose to a suitable nozzle (C) on the load carrier.

B

041

Absorber container

Fit the TurboVent 2 blower module (A) in the holder (B). Make sure the lock snaps audibly into place.

098

1

 Place the absorber container with the opening facing downwards on an injector nozzle.

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Drying the TurboVent 2 blower module The TurboVent 2 blower module can be dried using the following methods:

C

1

Remove the remaining liquid from the TurboVent 2 blower module.

D

072

F

2

–

105

2

Position the TurboVent 2 blower module (F) with the openings facing downwards until no liquid is left.

Put on cap (C).

At the end of the cycle, proceed as follows:

–

Place the TurboVent 2 blower module in a drying cabinet for 3 hours at 60 °C (140 °F). Or Dry the TurboVent 2 blower module on a grid for 24 hours at room temperature. The grid allows air circulation.

1

Remove the cap (C) from the TurboVent 2 blower module.

2

Release the lock (D). Remove the TurboVent 2 blower module.

At least 30 reprocessing cycles are possible.

3

Check all components for visible soiling.

Performing reprocessing

4

Repeat the cycle, if necessary.

1

Select a cycle.

2

When the cycle has ended, check the components for visible soiling and repeat the cycle if necessary.

3

Check the components for visible damage and replace if necessary.

C

070

E

5

If necessary, fix the cap (C) on the holder (E)

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Storage and transport After reprocessing, there are no special requirements for the storage and transport of the product. All other information in the instructions for use regarding storage and transport continues to apply. In addition, the requirements that prevent contamination or damage to the product must be met. These include, for example, dry and dust-free storage and avoiding damage during transport to the operating location.

Other agents and reprocessing procedures

Disinfectants Use disinfectants that are nationally approved and are suitable for the particular reprocessing procedure. Surface disinfectant The manufacturers of the surface disinfectants have verified at least the following spectra of activity: – Bactericidal – Yeasticidal – Virucidal or virucidal against enveloped viruses Follow the manufacturer's instructions for surface disinfectants.

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