user and service manual - hyvan

HYVAN Compact Anaesthesia Machine November 2020

User & Service Manual Revision 1 of 35

USER AND SERVICE MANUAL

HYVAN

COMPACT ANAESTHESIA MACHINE



The HYVAN Compact Anaesthesia Machine

COPYRIGHT NOTICE: The information contained in this document is the sole property of HYVAN Anaesthesia Limited and may not be reproduced, copied stored in a retrieval system, or transmitted in whole or in part, in any form, or by any means electronic, mechanical, photocopy or otherwise without the permission of the company. This document may be revised or replaced by HYVAN Anaesthesia Limited from time to time and without notice. Users should ensure that they have the most current version applicable to their equipment. While the information contained herein is believed to be accurate, it is not a substitute for professional judgement. The equipment described in this document should only be used by trained professionals. HYVAN Anaesthesia Limited’s sole responsibility with respect to such equipment, and its use, is as stated in the limited warranty supplied with that equipment. Nothing in this document shall limit or restrict in any way HYVAN Anaesthesia Limited’s right to revise or otherwise change or modify the equipment without notice. As at August 2020, this manual is the current manual. All communications regarding the use, repair and service of the equipment described should be directed to: HYVAN Anaesthesia Limited 71 Bealey Avenue, Christchurch 8013, NEW ZEALAND. Email: [email protected] Telephone : Int +64 27 464 0107 Website: www.hyvan.co.nz

http://www.hyvan.co.nz/



Limited Warranty Statement

Equipment manufactured by HYVAN Anaesthesia Limited is warranted as set forth below. This warranty extends only to the Buyer purchasing the equipment directly from HYVAN Anaesthesia Limited or through its authorised distributors, as new equipment. This equipment is warranted by HYVAN Anaesthesia Limited to be free from defects in workmanship and materials for a period of 2 YEARS from date of delivery, provided that it is properly operated under normal conditions of use. HYVAN Anaesthesia Limited’s sole obligation under the foregoing warranty is limited to making repairs, replacement or issuing credit for equipment or parts thereof which are found to be defective. This equipment must be returned in original packaging, prepaid, to HYVAN Anaesthesia Limited after prior notification has been given and an RGA (Return Goods Authorisation) number obtained for the return. Silicone rubber parts, batteries and other parts which are subject to deterioration over which HYVAN Anaesthesia Limited has no control are warranted for 90 days from date of shipment. Repair (parts and labour) performed by HYVAN Anaesthesia Limited are warranted for 90 days. This warranty is limited to the replacement of previously installed parts which prove to have defects in workmanship. HYVAN Anaesthesia Limited shall not be liable for any consequential damages, or damages of any kind based upon a claim for breach of warranty other than as stated above. The foregoing warranty shall not apply, and HYVAN Anaesthesia Limited shall be relieved of any obligation or liability, if this equipment has been repaired or altered, including the use of components other than those manufactured or approved by HYVAN Anaesthesia Limited, by anyone other than those authorised by HYVAN Anaesthesia Limited, or if this equipment has been subject to abuse, misuse, negligence or accident. THE FOREGOING WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTY OF MERCHANTABILITY AND WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.

HYVAN Anaesthesia Limited, 71 Bealey Ave, Christchurch, New Zealand Tel: +64-27 464 0107. Email: [email protected]



General Precaution Patients on life-support equipment should be appropriately monitored at all times by competent medical personnel since life-threatening circumstances may arise that may not activate alarms. Use all appropriate alarms and ancillary monitors and follow the instructions in the operator's manual. It is imperative to check life-support equipment for proper operation before each use. This device should not be used in the presence of flammable anaesthetics. Attention is drawn to the Limited Warranty Statement.



Contents

1 DESCRIPTION OF OPERATION ........................................................................................... 7

1.1 Introduction ...................................................................................................................... 7

1.2 Oxygen ............................................................................................................................ 9

1.3 Compressed air ............................................................................................................. 10

1.4 Tidal volume flow control knob and solenoid ................................................................. 10

1.5 The bag-in-bottle ventilator ............................................................................................ 10

2 SPECIFICATIONS ................................................................................................................ 11

2.1 Physical specifications ................................................................................................... 11

2.2 Environmental requirements .......................................................................................... 11

2.3 Breathing system specifications .................................................................................... 11

2.4 Soda lime canister ......................................................................................................... 11

2.5 Ports and connections ................................................................................................... 11

2.6 Pressure gauge ............................................................................................................. 12

2.7 Anaesthetic gas scavenging .......................................................................................... 12

2.8 Pneumatic specifications ............................................................................................... 12

2.9 Vapouriser connections ................................................................................................. 12

2.10 Electrical specifications ................................................................................................. 12

2.11 Ventilator specification ................................................................................................... 13

2.12 Alarm settings ................................................................................................................ 13

3 OPERATING INFORMATION............................................................................................... 14

3.1 Preliminary set-up and check list: .................................................................................. 14

3.2 Ventilator Electronics and Alarm System ...................................................................... 15

3.3 Alarms ............................................................................................................................ 15

3.3.1 Supply Gas Alarms: ............................................................................................... 15

3.3.2 Patient Circle Pressure Alarms: ............................................................................. 15

3.3.3 Other Alarms: ......................................................................................................... 15

3.4 Control box settings ....................................................................................................... 16

3.4.1 Spontaneous Ventilation ........................................................................................ 16

3.4.2 Using the Ventilator ............................................................................................... 16

3.5 At the end of the operating session ............................................................................... 17

3.6 Control Box Indicators ................................................................................................... 17

3.6.1 Battery Gauge LEDs .............................................................................................. 18

3.6.2 Oxygen Failure LED .............................................................................................. 19

3.6.3 High Pressure / Low Pressure LEDs ..................................................................... 19

3.7 Paediatric use ................................................................................................................ 19

4 TROUBLESHOOTING .......................................................................................................... 20

4.1 Ventilator will not cycle .................................................................................................. 20



4.2 Bellows will not stay inflated .......................................................................................... 20

4.3 Continuous Alarm .......................................................................................................... 20

4.4 Things to watch out for .................................................................................................. 20

5 PREVENTATIVE MAINTENANCE ....................................................................................... 22

5.1 Removal and Replacement of Bellows .......................................................................... 22

5.2 Disinfecting and Sterilizing Rubber Bellows .................................................................. 22

5.3 Battery ........................................................................................................................... 22


5.5 Water trap ...................................................................................................................... 23

5.6 Self Inflating Bag (SIB) .................................................................................................. 23

6 OTHER EQUIPMENT AND ACCESSORIES ....................................................................... 24

6.1 Vaporiser ....................................................................................................................... 24


6.3 Monitor ........................................................................................................................... 25

6.4 Charger .......................................................................................................................... 25

6.5 Gas supply ..................................................................................................................... 25

6.6 Patient ‘Circuits” and Ayres-T-piece .............................................................................. 26

6.7 Scavenge system and PEEP valve ............................................................................... 26

6.8 Aluminium transport box ................................................................................................ 27

6.9 Self-Inflating Bag (SIB) .................................................................................................. 27

7 Glossary ................................................................................................................................ 28

8 INTENDED USE ................................................................................................................... 29

9 DEVICE CLASSIFICATION .................................................................................................. 29

10 COMPLIANCE WITH STANDARDS ..................................................................................... 29

11 SERVICE LIFE ...................................................................................................................... 29

12 SAFETY AND MISUSE WARNINGS .................................................................................... 29

13 ELECTROMAGNETIC COMPATIBILITY: ............................................................................ 30

14 SYMBOLS & LABELLING..................................................................................................... 30

14.1 Product label .................................................................................................................. 30

14.2 Serial number ................................................................................................................ 31

14.3 Other labels ................................................................................................................... 31

15 ENVIRONMENTAL STATEMENT ........................................................................................ 35

15.1 Disposing of the medical device: ................................................................................... 35



1 DESCRIPTION OF OPERATION 1.1 Introduction

Figure 1 – HYVAN Alice

The HYVAN Alice is a portable anaesthetic machine that can be used for paediatric or adult patients. It consists of a pneumatically driven bag-in-bottle ventilator, circle absorber system and requires connection of a plenum vaporizer on a selectatec back bar. The anaesthetic gas vapour delivery system used should be compliant with IEC 80601-2-13. The ventilator is microprocessor-controlled and is a time-cycled, constant-flow generator. The ventilator drive gas can be either compressed air (preferentially) or compressed oxygen. The HYVAN has oxygen and medical air flowmeters and the oxygen and air gas supply can come from a variety of sources, such as cylinder, compressor, piped medical gases or from an oxygen concentrator. A rechargeable, 12 Volt, sealed lead acid battery supplies power to the electronics. The HYVAN has been designed to be reliable, robust and easily maintained in a small hospital workshop.



The HYVAN has been designed, developed and manufactured under ISO 13485 (certificate available on request). The machine is primarily designed for use in developing countries, but can also be used in a modern, academic hospital. Other uses include military and disaster relief. A model is available for veterinary use (The HyVet). The HYVAN is intended for use with non-flammable anaesthetic agents as specified in ISO 80601-2-13. Flammable anaesthetic agents, such as diethyl ether and cyclopropane, are not to be used in the HYVAN workstation. The HYVAN should be used with halogenated anaesthetic agent monitoring equipment complying with ISO/IEC 80601-2-55. A Multifunction Anaesthetic Monitor can be supplied with the HYVAN.

Figure 2 – System diagram

The HYVAN supports either a re-usable or disposable soda lime canister and is supplied with a ‘Royal’ reusable canister. A variety of disposable canisters are commercially available similar to the shoe fitting of the Anmedic “Q” system and the ADU:

Intersurgical IS Pac- 500g.

Armstrong Q Can (AMAB3802 – 800 g).

GE Aisys canister



A selectatec back bar (height adjustable) allows for a variety of plenum vaporisers to be fitted. An analogue pressure gauge provides a continuous indication of the patient circuit airway pressure. The HYVAN does not contain an APL valve (adjustable pressure limiting) - it makes use of the ventilator spill valve to automatically regulate patient circuit pressure. This means that the HYVAN cannot accidentally over-pressurise a patient. Airway pressure is measured by a solid-state, temperature-compensated pressure transducer and alarms are provided on detection of abnormal pressure levels. PEEP of approximately 3 - 4 cm water is provided by the ventilator during IPPV. A variable PEEP valve attached to the scavenge port allows PEEP and CPAP to be controlled. An anaesthetic gas scavenging system compliant with ISO 80601-2-13 should be connected to this port.

1.2 Oxygen Refer to the system diagram – green line As previously mentioned, oxygen can be supplied from a cylinder, pipeline or oxygen concentrator. A manometer beside the oxygen inlet measures the supply source pressure. The oxygen flush button supplies 45 litres/minute to the patient circuit. Oxygen is supplied to the oxygen flowmeter. It enters the circle (mixed with air if used) The gas mixture passes through the selectatec vaporizer and then enters the patient circuit after the one-way inspiratory valve. The expired gas from the patient enters via the expiratory port and passes through the soda lime canister. Compressed air preferentially drives the ventilator. If this air supply fails, the automatic drive gas changeover device immediately allows oxygen to drive the ventilator. A non-return valve prevents oxygen reflux into the air line. The air pressure drives a piston in the changeover valve. The pressure also operates a spool valve and prevents oxygen from flowing to the ventilator via the tidal volume flow control valve. If air pressure fails, this spool shuttles and allows oxygen to take over the role of the ventilator drive gas.



1.3 Compressed air (refer to the system diagram – black dotted line) Compressed air enters the inlet. A manometer beside the air inlet measures the supply source pressure. Air is supplied to the air flowmeter. It mixes with oxygen and enters the circle via the selectatec vaporizer. The compressed air line bypasses the automatic drive gas changeover device. Thus, air is the preferential ventilator drive gas.

1.4 Tidal volume flow control knob and solenoid The compressed air (or oxygen) enters the tidal volume flow control valve. This is a needle valve and controls the flow of the drive gas. A solenoid is attached and this electronically controls the timing of the drive gas to the ventilator ‘bottle’. This metered drive gas then passes to the duckbill valve. Manipulating the Respiratory Rate and I:E knobs controls these ventilatory parameters. The self-inflating bag connection is before the duckbill valve. The duckbill valve allows the drive gas to flow to the ‘bottle’ on inspiration and be vented to the atmosphere on expiration. The SIB mimics the drive gas from the flow control valve allowing the anaesthetist to manually ventilate the patient.

1.5 The bag-in-bottle ventilator The ventilator is a minute volume divider. The bellows contain the ‘patient gases’ and when the bottle is pressurised, the bellows empty. The rate, I:E ratio and tidal volume are controlled by the 3 knobs on the electronics box. The ventilator has an inbuilt spill valve. This is set to allow a constant PEEP of approximately 3-4 cm water. The HYVAN utilises this spill valve as an automatic pressure limiting valve. A self-inflating bag (SIB) can be used for manual ventilation.



2 SPECIFICATIONS

2.1 Physical specifications Dimensions (HxWxL) 45cm x 40cm x 60cm

Weight - excluding soda lime canister and vaporiser

11 kg

Weight – including soda lime canister and vaporiser

18 kg

Materials - body High-impact plastic polymer

Materials - fittings Anodised aluminium / stainless steel

2.2 Environmental requirements Operation – including differential pressure sensors

Temperature 10-40 degrees C

Humidity 15-95% relative (non-condensing)

Altitude 500 to 800 mmHg

Storage (including differential pressure sensors

Temperature (excluding battery) 0-60 degrees C

Temperature (battery) 0-40 degrees C

Humidity 15-95% relative (non-condensing)

Altitude 500 to 800 mmHg

Electromagnetic compatibility

Immunity IEC 60601-1-2

Emissions CISPR 11

2.3 Breathing system specifications Breathing system is Circle Mode or attached Ayres –T- piece

2.4 Soda lime canister Capacity: 500 - 1000 g. Reusable or disposable type

2.5 Ports and connections Exhalation 22mm male OD ISO Taper (RED)

Inspiration 22mm male OD, 15mm female ID ISO Taper (GREEN)

Self-inflating bag inlet 22mm female ID



2.6 Pressure gauge Patient airway pressure scale range -20 to 80 cm H20 (-2 to 7.85 kPa)

2.7 Anaesthetic gas scavenging Outlet 30mm OD ISO Taper - male

2.8 Pneumatic specifications Gas supply

Options O2 Pipeline, cylinder or O2 concentrator

Air Pipeline, cylinder or air compressor

Pipeline 3 – 5 BAR

Connections DISS male, DISS female

Cylinder input Pin index preferred

Pressure gauge – gas supply

Oxygen 0 – 7 BAR

Air 0 – 7 BAR

Flowmeters

Oxygen 0-8 litres/min

Air 0-8 litres/min

O2 flush

30-50 litres/min Measured 45 LPM

2.9 Vapouriser connections Type Selectatec back bar Plenum vaporizer

Mount Variable and lock height adjustments

2.10 Electrical specifications Power supply

Internal Sealed Lead Acid 12V 2.2 Ah

Charger Sealed Lead Acid 12V Smart Charger, P/N Mascot Type 2240

Current (operational) 110 mA (max)

Current (standby) 240 uA



Operational time (fully-charged battery)

40 hrs

Fuses (External and Internal) F2AL 250V and F3.15AL 250V.

2.11 Ventilator specification Control interface

Battery condition Descending, 4-range LED

I:E ratio control type Rotary

I:E ratio control range OFF, 1:1, 1:2, 1:3, 1:4

Breaths/min control type Rotary

Breaths/min control range 0-30 breaths/min

Tidal volume (TV) control type Rotary

Tidal volume (TV) control range Variable to 1200 ml

2.12 Alarm settings Alarm Condition

Low pressure oxygen < 50% initial pressure (within pre-set limit)

Low patient airway pressure < 5cm H2O above PEEP

High patient airway pressure > 50cm H2O

Negative patient airway pressure < 4cm water for 3 seconds

Ventilator switched to off Mute with double press

Charger alarm Mute by unplugging charger from Hyvan or turning on mains at wall.

Mute alarm for 30s Single press

Mute alarm for 90s Press and hold for 2 seconds



3 OPERATING INFORMATION

3.1 Preliminary set-up and check list: 1. Ensure battery is fully charged. 2. Connect machine to gas supply (air/oxygen). 3. The HYVAN can be connected to an oxygen supply (eg pipeline, cylinder,

oxygen concentrator) AND a medical air supply (eg pipeline, compressor). The ventilator is driven by the compressed air supply. In the event of air pressure being unavailable, the oxygen supply will automatically switch to drive the ventilator.

4. Ensure the soda lime canister is applied and fresh soda lime is present. 5. Ensure the vaporizer is correctly applied to the selectatec back bar and

there is adequate volatile agent. The selectatec fitting is adjustable. Sit the vaporizer on the deck and raise the selectatec until it engages and is locked in. The vaporizer should not hang from the backbar. It should sit on the deck.

6. Ensure the water trap is empty of water. 7. Ensure the self-inflating bag (SIB) is attached 8. Check for leaks: Do this by occluding the patient circuit “Y” with your

thumb and use the oxygen flush to fully inflate the bellows. The flowmeter should be off. The bellows should remain at the top of the bellows chamber.

9. Oxygen pressure will switch on the machine. Check oxygen flow via flowmeter and oxygen flush. Check the alarms and battery status. (This is covered later)



3.2 Ventilator Electronics and Alarm System The HYVAN has a Sealed Lead Acid 12 V, 2.2 Ah rechargeable battery in the basement compartment. This battery provides DC to the HYVAN electronics. The battery is charged from the mains electricity by the smart charger unit provided. The battery charger SHOULD NOT be plugged into the HYVAN when the machine is in use.

3.3 Alarms

3.3.1 Supply Gas Alarms: When the HYVAN is inactive, it should be plugged into the mains electricity to keep the battery charged. When the oxygen or air supply is connected (eg to pipeline, cylinder, oxygen concentrator, compressor), the system will detect “pressure” and will wake up. An ascending staircase alarm will sound to indicate pressure has been sensed. This pressure will be measured (eg 60 psi pipeline) and if, at any stage, the pressure drops to half the initial value (ie 30 psi), an oxygen failure alarm will sound. Similarly, if the HYVAN is connected to a lower initial pressure (eg 15 psi from an oxygen concentrator), the oxygen failure alarm will sound should the pressure fall to half this value (7.5 psi). At the end of the operating session, when the HYVAN is disconnected from the supply gas, the pressure will fall to zero and this will sound a sustained oxygen failure alarm. This can be terminated by pressing the mute button for 5 seconds.

3.3.2 Patient Circle Pressure Alarms: High Pressure Alarm: This sounds when the pressure rises above 50 cm water. The ventilator will stop for one respiratory cycle and then resume. Low Pressure Alarm: This sounds when the pressure falls below 5 cm water above PEEP. The alarm ceases when circle pressure rises above this value. Negative Pressure Alarm: An alarm will sound if the patient generates a negative pressure of minus 4 cm of water for 3 seconds.

3.3.3 Other Alarms: Ventilator Turn off alarm: If the ventilator is operating and then switched off, an alarm will sound. This alarm is terminated by pressing the mute button twice in quick succession. The Charger alarm: If the charger is plugged into the Hyvan but not switched on at

the mains supply, there is a risk the battery will slowly discharge. To avoid this the charger should only be plugged in to the Hyvan when the mains supply is



turned on. An alarm will sound and this can only be muted by unplugging the charger from the Hyvan or turning on the mains power.

3.4 Control box settings

3.4.1 Spontaneous Ventilation

Connect oxygen pressure to turn the HYVAN on.

I/E Ratio – Set knob to OFF

Set oxygen flow on flowmeter.

Ensure the pressure control valve at top of bellows canister is closed.

Pre-oxygenate patient. The bellows act as a breathing bag and anaesthetist can visually check the rate and depth of breathing.

Use oxygen flush if required to fill the bellows.

Induce anaesthesia and turn on vaporizer. The patient can breathe spontaneously or anaesthetist can assist with the Self Inflating Bag.

3.4.2 Using the Ventilator Breaths/minute – Set to required breaths per minute.

I:E ratio - turn to required I:E ratio. (recommend 1:2) This will start the ventilator cycling

Tidal Volume – adjust the delivered tidal volume to desired level.

For example, for an 80kg adult, set Breaths/minute to 10, I:E ratio to 1:2, tidal volume to 400ml. This would result in a minute volume of 4.0 litres (400 x 10).



End of the operation: I:E ratio is turned to “OFF”. This stops the ventilator cycling, but the patient can breathe spontaneously or the anaesthetist can assist ventilation by compressing the Self Inflating Bag.

Notes:

The spill valve gives an automatic PEEP of approximately 3-4 cms of water. If more PEEP is required, this can be obtained by adjusting the PEEP valve on the scavenge port at the rear of the HYVAN. Once the PEEP setting exceeds 12 cms of water, the PEEP valve will make a vibrating sound to alert the anaesthetist.

If CPAP is required (eg laryngospasm), adjust the PEEP/CPAP valve at the scavenge port to obtain the desired CPAP.

When the ventilator is switched off, an alarm will sound that can be muted by pressing the mute button twice in quick succession.

3.5 At the end of the operating session Disconnect the patient circuit and clean as directed

Disconnect the oxygen and air supply. This will cause the oxygen failure alarm to sound. Mute alarm by pressing mute button for 5 seconds. This will also turn off the HYVAN.

Leave machine connected to mains via the battery charger. A battery protective feature is an alarm will sound if the charger is plugged into the Hyvan and NOT switched on at the wall. A slow blinking green LED indicates the battery is charging.

If the machine is going to be inactive for a few days, remove and empty the water trap, remove the soda lime canister and remove and bellows and allow to dry.

It is good practice to allow a flow of 1 litre/minute of compressed air to flow through the Hyvan for a few hours at the end of an operating list. This dries out the internal pneumatic system. Remember to place a tube from the green to the red connector to allow circulation of air throughout machine.

3.6 Control Box Indicators



3.6.1 Battery Gauge LEDs There are 4 LEDs to indicate the HYVAN state of charge as below:

Charger connected - a slow flashing green LED (top LED)

100%-75.1% - one solid green LED (top LED)

50.1%-75% - one solid green LED (second to top LED)

25.1%-50% - a solid yellow LED (third from top).

25% or lower - a flashing red LED (deep discharge warning condition) The battery gauge also provides the charging state as per the table below when the HYVAN is ‘off’ or ‘on’ (ie the HYVAN is connected to oxygen pressure).

IMPORTANT:



If the charger is plugged into the Hyvan but not turned on at the wall, the charge battery alarm will flash and sound. This can only be muted by either switching on at the wall or removing the charger from the Hyvan.

3.6.2 Oxygen Failure LED This light appears when the oxygen supply fails and a loud high priority alarm sounds. This can be silenced for 30 seconds by pushing the mute button.

3.6.3 High Pressure / Low Pressure LEDs These indicate (and sound) when patient circuit pressure rises above 50 cm water or falls below 5 cm water (above PEEP) respectively.

3.7 Paediatric use For paediatric use, either an Ayres-T- Piece can be attached to the green outlet or, alternatively, the circle system can be utilized. There is minimal resistance to inspiration and expiration and thus the HYVAN allows the child to breathe spontaneously. The breathing is visible by the bellows movement. On the top of the bellows canister is an adjustable pressure limiting valve. This should be closed at all times unless the anaesthetist wishes to adjust it for pressure control ventilation. Pressure Control mode is ideal for paediatric anaesthesia as pressure can be controlled by the anaesthetist. The absence of an APL valve removes the risk of accidently hyper-inflating the child's lungs. Many anaesthetists prefer to use the Ayres-T-Piece for children under 10 kg. The T piece is connected to the green connector and a minimum gas flow of 3 x the minute volume should be used. The airway pressure is indicated on the patient manometer. The bag must be open ended.



4 TROUBLESHOOTING 4.1 Ventilator will not cycle Check for the following:

Pressure source inadequate (pressure should be at least 40 psi)

Supply Pressure hose kinked

Tidal Volume knob is off - (turn it clockwise) – recommend 1:2

4.2 Bellows will not stay inflated Check for the following:

Insufficient oxygen gas flow via flowmeter

Bellows not properly attached to chamber base

Hole in bellows

Leak in anaesthesia circuit

Patient circuit disconnect

Leaky spill valve in ventilator (needs expert attention)

4.3 Continuous Alarm Check for the following:

Oxygen supply failure – oxygen failure alarm will be on

Airway pressure less than 4 cm water above PEEP -?leak or disconnect.

Scavenge port blocked

Sensing transducer fault (expert attention required)

4.4 Things to watch out for If the ventilator is being driven by compressed air (the usual situation) and

the compressed air fails, the oxygen drive switch over may not occur automatically. Alarms will sound. The problem is residual backpressure in the air line preventing the shuttle from moving. The solution is to bleed some air by opening the air flowmeter and the oxygen drive to the ventilator will immediately start.

Always check that the pressure control valve on the top of the ventilator canister is closed.

Check the water collection bottle. Ensure it is empty and firmly screwed in.

When using the reusable soda lime canister, ensure both foam filters are in place at the bottom of the canister. The foam prevents particulate soda lime from entering the machine. Replace the foam periodically.

The patient manometer should be set to zero. It can be adjusted by removing the plastic bung on the glass face and turning the screw with a small screwdriver.

Check the red and green ports at the left hand front of the machine are firmly screwed in.

The ABS plastic body may be damaged by spilt Isoflurane. Ensure the stainless steel drip tray is in place under the vaporiser and always be careful to avoid spillage when refilling the vaporizer.



The ventilator canister is removed by firm anti-clockwise rotation. And once clear of the lugs, it can be lifted off. DO NOT ATTEMPT TO LOOSEN THE FOUR SCREW BOLTS.

The oxygen and air connection to the Hyvan: These DISS fittings should be finger tightened. Do no use a spanner or wrench.

Changing the soda lime canister during anaesthesia. There is no absorber bypass switch on the Hyvan. A fresh canister can be swapped in 2 seconds and this should be done when the ventilator is in the expiration phase of the cycle. With good technique, less that 100 ml will be lost from the patient circuit.

The PEEP valve is on the scavenge port at the back of the Hyvan. It should be fully open as there is a fixed PEEP of 3-4 cm of water (this has been achieved by adjusting the spill valve inside the ventilator – only qualified personnel should adjust this). Should more PEEP (or CPAP) be required, the PEEP valve on the scavenge port can be adjusted accordingly. Once 12 cm of PEEP has been achieved, the valve will vibrate loudly. This is a warning to the anaesthetist that a high level of PEEP is present.

Volume gradations are marked on the ventilator canister. THESE ARE NOT ACCURATE AND ONLY GIVE A ROUGH GUIDE TO THE TIDAL VOLUME BEING DELIVERED. This is due to varying patient compliance etc. It is best to determine the appropriate tidal volume by reference to the end tidal CO2 and the chest movement.

For paediatric ventilation, it is preferable to use PRESSURE CONTROL. This allows small tidal volumes and prevents the inflation pressure rising above a pre-set level.

During spontaneous ventilation, the anaesthetist can take over and manually assist respiration simply by squeezing the self-inflating bag.

After several years of usage, the lead acid battery may fail and require replacement. This can be done by unscrewing the retaining bracket. This task should be performed by qualified personnel and it is important the replacement battery is the correct size and capacity.

The rubber bellows may perish after many years of usage and require replacement.

There is always a risk of soda lime dust and water entering the airways and obstructing tubes or causing valves to leak. This can be checked by removing the base of the machine and examining for leaks etc. This is a job for qualified service personnel.

The Hyvan is a stable machine. However a monitor placed on the monitor shelf is vulnerable and should be secured by a strap.

If the ventilator is switched off, an alarm will sound. This is to alert the anaesthetist that the ventilator is off and can be muted by a double press on the mute button.



5 PREVENTATIVE MAINTENANCE 5.1 Removal and Replacement of Bellows

Rotate canister in anti-clockwise direction until the 4 small lugs are exposed then gently lift the canister upwards (the monitor support doesn't need to be removed). DON’T ATTEMPT TO UNSCREW THE FOUR SCREW BOLTS.

Remove bellows over the lip of the bellows block.

Replace the bellows by opening over the lip and pulling down over lip with the thumb and forefinger.

Replace canister. It is a good idea to remove the bellows each weekend and hang them up to dry. A potential problem – especially in tropical countries – is the accumulation of moisture in the internal tubing. This warm moist environment encourages the growth of fungi etc. We strongly recommend connecting the machine to air and opening the air flowmeter to 1 litre/minute for several hours. This will dry the internal tubes and bellows etc. Remember to connect the green to the red connector.

5.2 Disinfecting and Sterilizing Rubber Bellows Autoclaving – DO NOT AUTOCLAVE BELLOWS Boiling – DO NOT BOIL THE BELLOWS Sterilizing Agents – Recommend only using warm soapy water or dilute hypochlorite solution. Afterwards rinse the bellows thoroughly in cold water, wipe dry and allow to dry completely at room temperature. Dry heat – DRY HEAT MUST NOT BE USED. Ethylene Oxide – OK to use but make sure the ventilator is operated for at least 3 minutes to remove any trapped ethylene oxide before attaching patient.

5.3 Battery The Lead Acid battery can be expected to last for 3-5 years before requiring replacement. It is an easy matter to open the base and remove the battery bracket. This should be done by qualified service personnel and the appropriate replacement battery inserted.

5.4 Soda lime canister Several reusable and disposable soda lime canisters can be attached to the HYVAN. The 'shoe' fits the Anmedic 'Q' system and the ADU. HYVAN provides a ‘Royal’ reusable canister. Suitable disposable canisters include the Intersurgical IS Pac (500 g), the Armstrong Q Can (AMAB3802 (800 g)) and the GE Aisys canister. Warning:



It is essential that a foam rubber insert is fitted to the base of the canister when using the re-usable canisters, to prevent soda lime dust entering the machine. Replacement foam inserts can easily be made from an appropriate piece of open cell polyurethane foam rubber.

5.5 Water trap This small bottle should be unscrewed and emptied of any accumulated water on a regular basis. Ensure it is firmly screwed in. It can leak if loose.

5.6 Self Inflating Bag (SIB) The SIB should be left attached to the machine at all times. It is isolated from the patient circuit and therefore does not require sterilizing.



6 OTHER EQUIPMENT AND ACCESSORIES This section includes all other items required to use the HYVAN Alice machine, including the vaporiser, soda lime canister, monitor, patient ‘circuits’, charger, scavenge, gas connections and storage box.

6.1 Vaporiser The HYVAN should be used with an ISO 80601-2-13 compliant anaesthetic gas delivery system that is regularly calibrated to ensure volatile agent output concentration is accurate. It can accommodate a wide variety of plenum vaporisers via the selectatec backbar fitting, which is height adjustable. Ensure the vaporiser sits on the deck and is firmly locked into the selectatec fitting, do not allow the vaporiser to ‘hang’ from the backbar:

Sit the vaporiser on the deck and raise the backbar until the two spiggots engage.

Lock the vaporiser in place with the rotating latch handle.

Tighten the rear wing nut to secure the vaporiser. Always remove the vaporiser when transporting. If the vaporiser is carried in the transport box it should be detached and wrapped securely in bubble wrap. A vaporiser weighs approximately 7 kg and could damage the Hyvan if the box is dropped.

6.2 Soda lime canister The HYVAN can accommodate a variety of soda lime canisters – disposable and reusable. They must have a ‘shoe’ fitting similar to the Anmedic “Q”system and the ADU. HYVAN Anaesthesia supplies the reusable “Royal” canister. Ensure that a clean foam insert is placed at the bottom of each chamber. These can be washed and, in due course, replaced with open cell polyurethane foam rubber. Warning: It is essential to avoid contamination of the Hyvan pneumatic system with soda lime dust. We recommend using the commercially available disposable sodalime canisters. Suitable disposable canisters include the Armstrong Q Can (AMAB3802 (800 g), the Intersurgical IS Pac (500 g) and the GE Aisys canister.



To prevent a gas leak, make sure the canister is firmly seated and clipped into the shoe. The top of the reusable canister should be firmly clipped on.

6.3 Monitor The HYVAN should be used with an ISO 80601-2-13 compliant monitor and alarm system. HYVAN Anaesthesia recommends ALWAYS using a monitor when anaesthetising. The minimum parameters should include ECG, SpO2, NIBP. Ideally the parameters should also include end tidal CO2, oxygen and volatile agent analysis. The monitor should be firmly secured to the monitor shelf by a screw bolt of external strapping. The monitor will provide an additional, independent alarm system to compliment the Hyvan indication system.

6.4 Charger A Mascot 12 V, 1.3 amp sealed lead acid battery charger is provided. This is a smart charger. The HYVAN will run on a fully-charged battery for approximately 40 hours. HYVAN Anaesthesia recommends that the charger is plugged in at the end of the list and the battery recharged overnight. Note: If the charger is plugged into the HYVAN but not turned on at the wall, the battery will slowly drain. To prevent this, the HYVAN includes an alert that will sound if the charger is plugged into the Hyvan but not turned on at the wall. This alert can only be silenced by either switching on at the wall or unplugging the charger from the HYVAN. When the charger is plugged in and turned on, the top battery gauge green LED will blink slowly to indicate charging is occurring. When the charger is removed, the battery charge status will be indicated by the appropriate LED on the display. To check the battery charge status when the HYVAN is not in the ready state, press the battery condition button and the charge level is indicated by the battery scale LEDs.

6.5 Gas supply The Hyvan is supplied by oxygen or medical air. The supply source can be cylinder, piped wall or oxygen concentrator/air compressor.



The two gases enter the Hyvan via DISS fittings. The ideal pressure is 4 Bar (60 psi) supplied from cylinders or the piped medical gas system. An oxygen concentrator will only provide a gas pressure of approximately 10 psi and a flow of approximately 10 lpm. THE HYVAN WILL NOT TURN ON UNLESS AN INPUT PRESSURE OF 5 PSI IS ACHIEVED. However, the gas will flow through the system and flowmeters. When using an oxygen concentrator, be aware that the oxygen flush will be sluggish and the ventilator will not operate (the ventilator needs a pressure of 25 psi to function).

6.6 Patient ‘Circuits” and Ayres-T-piece The Hyvan is a circle-based anaesthetic machine and there are many commercially made disposable and reusable circuits available. HYVAN Anaesthesia recommends usage of a filter at the patient/circuit interface. Circuits should be drained of accumulated water and hung up to dry at the end of the list. Circuits should be checked for leaks prior to each anaesthetic. The inspiratory limb is connected to the green outlet and the expiratory limb to the red inlet. A small paediatric circuit should be used for children. There is minimal resistance to inspiration or expiration within the HYVAN and it is safe to allow the child to breathe spontaneously. An Ayres-T-piece can be connected to the green inspiratory outlet (it will not connect to the red inlet).

6.7 Scavenge system and PEEP valve The HYVAN should be used with an ISO 80601-2-13 compliant gas scavenging system. The orange scavenge outlet is located at the back of the Hyvan. It is a male, tapered 30 mm fitting and is connected to the scavenge system. A variable PEEP valve can be attached to the fitting. It allows a PEEP (or CPAP) of up to 30 cm water to be given. Note: The Spill valve within the ventilator generates a PEEP of 3-4 cm of water which is ideal for most anaesthetics. However, if higher PEEP is required, the external PEEP valve allows this. Check the PEEP (CPAP) pressure on the patient



manometer. A safety feature is the external PEEP valve will vibrate loudly above 12 cm of water. This alerts the anaesthetist that PEEP is being applied.

6.8 Aluminium transport box A chequered aluminium transport box is available. The rubber inserts ensure the HYVAN is firmly and safely secured during transport. When placing the HYVAN into the box, the soda lime absorber must be removed and the HYVAN can be tilted to the left and lowered into the box. The other fittings, attachments etc can be packed in around the machine. Note: If transporting, check with airlines/freight forwarders about shipping with the battery. Most airlines will be happy to leave the sealed lead acid battery in-situ, but some may require the terminals to be disconnected or the battery removed entirely and carried separately. A battery data sheet can be provided for the shipping agent. WARNING: DO NOT leave the transport box sitting in the sun. Very high temperatures can be attained within the closed box and this may damage the Hyvan or the rubber inserts.

6.9 Self-Inflating Bag (SIB) The self-inflating bag is a 2 litre silicone “resuscitation bag” attached to the right rear SIB port of the Hyvan via a 1.5 metre length of clear corrugated hose and is required to allow manual ventilation of the patient. Many compatible bag brands are commercially available, the commonly available AMBU resuscitation bag & valve system is a typical example. The anaesthetist can use the SIB to manually ventilate the paralysed patient or assist with spontaneous respiration. This bag is not part of the patient circuit and therefore requires no sterilization etc. It is important to appreciate that the anaesthetist will not detect the patient’s breathing via the SIB.



7 Glossary APL - The APL (Adjustable Pressure Limiting) Valve is part of the anaesthetic breathing system in most anaesthetic machines. The Hyvan does not have this valve and utilizes the ventilator spill valve to automatically dump excess gases. A separate system is used to generate PEEP and CPAP PEEP – Positive end-expiratory pressure (PEEP) is the positive pressure that remains in the airway at the end of the respiratory cycle (end of exhalation). It is greater than the atmospheric pressure in mechanically ventilated patients. IPPV - Intermittent positive pressure ventilation. Can be volume or pressure controlled and is a mode of ventilation (does not require any spontaneous respiratory effort from the patient). It is not synchronised with patient's respiratory effort. CPAP – Continuous positive airway pressure is a form of positive airway pressure (PAP) ventilation in which a constant level of pressure above atmospheric pressure is continuously applied to the upper airway. The application of positive pressure may be applied for laryngospasm, sleep apnoea or to reduce the work of breathing. SIB – Self Inflating Bag

https://en.wikipedia.org/wiki/Positive_airway_pressure

https://en.wikipedia.org/wiki/Positive_airway_pressure

https://en.wikipedia.org/wiki/Atmospheric_pressure

https://en.wikipedia.org/wiki/Respiratory_tract#Upper_respiratory_tract

https://en.wikipedia.org/wiki/Work_of_breathing



8 INTENDED USE The HYVAN Alice is a compact anaesthetic machine for use by qualified anaesthetists. The machine is battery operated and requires connection to pressurised oxygen. It is circle based and has a soda lime absorber to remove carbon dioxide from expired air. Basic machine indications are provided, but safe anaesthesia also requires the use of an external multifunction patient monitor. It is strongly recommended that agent analysis is used. CAUTION:

The HYVAN can be used without a monitor. HYVAN Anaesthesia Limited strongly recommends using a monitor that measures ECG, SpO2, and blood pressure. Ideally it should also measure end tidal CO2, oxygen and volatile agent concentrations. HYVAN Anaesthesia can supply a Biolight monitor that measures all these parameters. A gas bench (sidestream or mainstream) is also available.

9 DEVICE CLASSIFICATION The HYVAN Alice compact anaesthesia machine is a Class IIa Medical Device.

10 COMPLIANCE WITH STANDARDS The HYVAN Alice compact anaesthesia machine is an anaesthetic workstation, comprising an anaesthetic gas delivery system, and anaesthetic breathing system and an anaesthetic ventilator, that has been designed to ISO 80601-2-13:2011+A1:2015+A2:2018.

11 SERVICE LIFE If the product has not been abused and all maintenance instructions as described in the maintenance section have been properly followed, the expected service life (i.e. minimum serviceable life expectancy) of the product is five (5) years. After this period, product reliability can no longer be guaranteed and HYVAN Anaesthesia recommends the product be replaced for safety reasons. HYVAN Anaesthesia accepts no responsibility/liability for product failure if the product is continued to be used after the expected service life period has expired.

12 SAFETY AND MISUSE WARNINGS (from risk analysis) Do not install, maintain, or operate this equipment before you have read and understood all the instructions and the manuals for this product. Follow the



instructions in the manuals. If you do not follow all instructions, injury or damage may result. Do not try to open or disassemble the unit — there are no user-serviceable parts inside. The operator has the responsibility to keep the unit in a good safe operating condition. In the case of failure of the anaesthesia machine, the lack of immediate access to appropriate alternative means of ventilation can result in a patient injury. If used with a MEDICAL GAS PIPELINE SYSTEM, a malfunction of the gas pipeline system can cause one or more components of the anaesthesia machine to simultaneously stop operation. Most electronic equipment is influenced by Radio Frequency Interference (RFI). Be careful when portable communications equipment is used in the area around such equipment. HYVAN Anaesthesia Ltd has made every effort to ensure that RFI does not change the behaviour of the machine, but very strong signals could still cause a problem. No modification of this equipment is allowed.

13 ELECTROMAGNETIC COMPATIBILITY: The HYVAN Alice compact anaesthesia machine has been tested to confirm compliance with the following appropriate EMC standards: Electromagnetic emissions: CISPR 11 Electromagnetic immunity: IEC 60601-1-2

14 SYMBOLS & LABELLING 14.1 Product label

Manufacturer’s name and address

Device type

Mass of machine Model number Serial number



The product label contains the name and address of the manufacturer, the type of device, the model number and serial number (see below) of the product and the mass of the product.

14.2 Serial number The serial number on a HYVAN Alice machine includes the model number, the date of manufacture and a unique serial number for the particular product. The format of the unique serial number, as shown in the product label photograph above, is:

YYMnnnnn where:

YY is the year of manufacture (e.g., 2020 in this case)

M is the month of manufacture, using the letters A to L (A = Jan, B = Feb, C = Mar, D = April etc.)

nnnnn is a unique 5 digit sequential number. Example: The above machine was number 2 manufactured in April 2020.

14.3 Other labels There are 2 fuses, that are both labelled, an external fuse and an internal fuse

External, 2A fuse – F2AL, 250V

Internal, 3.15A fuse – F3.15AL, 250V



There is a label advising users to read the instruction manual before using the device:

Self inflating bag inlet:

Control panel symbols:

Flowmeters and oxygen flush:

Read instruction manual before use

Battery and battery gauge Mute alarm

Patient pressure



Inspiratory and expiratory ports:

Oxygen, air and scavenge ports:

Oxygen flush

Oxygen flowmeter – litres/minute oxygen

Air flowmeter – litres/minute air

Expiratory port – arrow denotes flow direction

Inspiratory port – arrow denotes flow direction

Scavenge port

Oxygen inlet

Air inlet



Inlet pressures



15 ENVIRONMENTAL STATEMENT The Hyvan body and base are constructed from ABS (Acrylonitrile Butadiene Styrene) plastic. This will soften at temperatures greater than 80º Celsius. If ignited, it burns slowly and gives off acrid fumes. ABS polymers are resistant to aqueous acids and alkalis but are sensitive to aromatic hydrocarbons and acetone. In particular care should be taken to avoid isoflurane coming into contact with ABS. Waste Anaesthetic Gases: These gases should be delivered to the scavenge port and thence vented to the atmosphere via the connected theatre scavenge system. If such a system is not available, the waste gases should be captured by a charcoal filter device. Waste gases must not be vented directly to the operating theatre. Soda Lime: Soda lime is caustic and care should be taken to avoid contact with skin or eyes. The used soda lime should be packed in a sealed container and delivered to your local waste management service for disposal. Battery Disposal: The sealed lead acid battery usually lasts for 3-5 years. When exhausted, the battery should be removed and delivered to your local waste management organisation. The battery should not be thrown into a fire or forced open as there is a risk of explosion or harm from caustic materials.

Warning: Risk of Infection. The device and its components must be cleaned before disposal.

15.1 Disposing of the medical device:

As a general rule, the Hyvan and its components should be thoroughly cleaned before presentation to the expert waste management service.

At the end of its service life the Hyvan can be disposed of. Its disposal should be discussed with your local waste management experts. Parts (eg ABS plastic and battery) may be recycled.

PCB: When the Hyvan is disposed of, the waste management service should be alerted that it contains a small Printed Circuit Board containing a small amount of lead.

user and service manual - hyvan

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