Eschmann VPX35 Manual de usuario

Ingenuity in

infection control

since 1830

User Manual

VPX35 &

VPX45

Advanced

Portable

Suction

Thank you for choosing Eschmann.

Eschmann design, manufacture and supply a range of market leading products

including Benchtop Autoclaves, Washer Disinfectors, Suction Units and Accessories.

For further information visit our website: www.eschmann.co.uk

About this Manual

Please read the manual before using the product for the rst time. Keep the manual

handy for quick reference. Always make sure that the manual is available for the

next user/owner of the product. The product(s) described by this manual must only

be operated and used by medically qualied personnel trained in the use of this

equipment. Contact Eschmann with your training requirements.

Pay particular attention to the safety notes, cautions and warnings provided in the

text, and also to those displayed on the product labels.

This product must be used and serviced in accordance with the procedures given in

this manual. Failure to do so could result in injury to patients and/or users, or damage

to the equipment.

The product must be serviced, at least, annually. Eschmann products must be

serviced and maintained by Eschmann trained engineers only. Failure to do so may

invalidate the warranty.

0086

216067-11 3

1Usability 4

2 Introduction 5

2.1 Technical Lifetime 5

2.2 Product Liability 5

2.3 Safety Instructions 5

2.4 Symbols 6

2.5 Compatibility of Materials 6

3 Instruction for use 7

3.1 Introduction 8

3.2 Deliverables 8

3.3 Pre Use Checks 8

3.4 Setting the Required Vacuum 9

3.5 Fitting/ Removing the Collection Jar 9

3.6 Overll Protection 9

3.7 Replacing the Hydrophobic Bacterial Filter 10

3.8 Replacing the Intemediate Tube 10

3.9 Using a Footswitch 10

4 Maintenance 11

4.1 After Each Day’s Use 11

4.2 Disinfecting and Cleaning the Unit 11

4.3 Sterilising the Jars 11

5 Troubleshooting 12

6 Disposal 12

6.1 WEEE Regulations 12

Appendix 1: Technical Data 13

Appendix 2: EMC Information 14

Appendix 3: Parts List 15

Contents

4 216067-11

Intended User The VPX35 and VPX45 must only be operated and used by medically qualied personnel

trained in the use of this equipment and adhering to the procedures provided in this manual.

Operators should be aware of the potential risks of ‘Cross Contamination’ and ‘Biological

Contamination’ whilst using them. All users should be familiar with the procedures for

dealing with and disposing of potentially contaminated components and liquids.

Medical Purpose The device provides the medical team with a method of evacuating uids from the patient.

Subsequent collection of the uid makes it possible to conduct analysis or disposal. The unit

is tted with lters to prevent uid from entering the unit should the collection jars overow.

Contraindications Mindful of the warnings and cautions prescribed within this manual, suctioning is a

necessary procedure for patients, for example where patients are unable to maintain a

patient airway. As determined by medically qualied personnel the conditions or factors that

serve as a reason to use or withhold a certain medical treatment are relative to the risks of

a worsening clinical condition. There is no absolute contraindication to suctioning as the

benets almost always outweigh the risk to the patient.

Patient Population The VPX35 and VPX45 can be used irrespective of a patient’s details, for example; weight

and height.

Care should be taken when using suction on a child. The vacuum should be adjusted to take

into account the type of procedure and the size of the patient.

Device Use The device is intended to be used with cannulas and other surgical accessories; the unit

itself does not contact the patient. The device is compatible with Collection Jars and single

use Disposable Liners, which are sold seperately. Refer to manufacturer’s Instructions. The

handle of the unit is contacted when the unit is moved, the power switch and suction ow

control is also contacted when required. The Collection Jars, Filters and Intermediate Tube

will be contacted by the user.

Note: The Collection Jars and Disposable Liners come into contact with bodily uids which

are not intended to be reintroduced into the body.

Device Application Environment: The VPX35 is ideally suited for emergency and general use throughout

the hospital.

The VPX45 is intended for use in the operating theatre and

throughout the hospital.

The Suction Units are NOT suitable for use in an MRI environment.

The Suction Units are NOT intended for eld and transport use.

The Suction Units are NOT approved for use in Pharyngeal procedures.

The Suction Units are NOT suitable for use in the presence of a

ammable anaesthetic mixture with Air or with Oxygen or Nitrous

Oxide (The devices are not rated as AP or APG).

Frequency of use: The Suction Units should not be used for continuous drainage of body

cavities although the pump is rated for continuous operation.

Mobility: These units are mobile surgical suction devices, operated from the

mains electrical supply.

Device Classication Suction units are non-surgically invasive active devices, intended to remove body uids or

other substances from the body, hence are Class IIa devices, derived from Rule 11 of Annex

IX of the Medical Devices Directive 93/42 as directed by the Medical Devices Regulations

2002 (SI 618), as amended by the EU Exit Regulations 2019 (SI 791) and 2020 (SI 1478)

Frequently used functions • On/o switch

• Vacuum gauge display

• Vacuum regulator

• Handle used for transporting unit

• Seperately supplied collection jars to be cleaned and sterilised.

• Seperately supplied single use Disposable Liners to be disposed of.

• Single use lter and Intemediate Tube Assembly to be disposed of.

• The lter should be changed immediately when contaminated or wetted.

1. Usability

216067-11 5

All users and operators should be made aware of warnings

and cautions and comply with them at all times.

Ensure you read the Safety Instructions (Section 2.3) to avoid

creating dangerous situations.

WARNING!

In order to function, the unit must always be

connected to a suitable power source.

WARNING!

Do not position the unit such that it is

dicult to disconnect the mains plug

from the mains power source.

CAUTION

No components in this unit can be serviced or

maintained whilst the unit is in use.

2.1. Technical Lifetime

This product has a technical lifetime of 7years. At the time

delivery the product fulls the existing regulations and

standards but as with all other electro-mechanical products,

the Eschmann VPX35/ VPX45 is subject to ageing and

wear, and even though the product may have undergone

regular service in accordance with the recommended device

schedule, Eschmann cannot guarantee the product’s safety

after the expiry of the technical lifetime.

Provision of spare parts and service by Eschmann after the

expiry of the specied technical lifetime does not mean an

extension of Eschmann Technologies Limited liabilities.

2.2. Product Liability

All liability in respect of the functioning of the Suction Unit will rest

with the user if

• The unit is used for other than its true intended purpose.

• The unit is not used in accordance with this UserManual.

• The unit is opened by, or assembled, maintained or

repaired by personnel who have not been fully trained

by Eschmann.

CAUTION

Reduced safety from using incorrect accessories. The

use of accessories which have not been recommended

by Eschmann may impair the safety and functioning

of the equipment. All question of any guarantee

is excluded if damage arises from the use of non-

recommended accessories or from improper use. Only

use original accessories recommended by Eschmann.

2. Introduction

WARNING!

To avoid risk of electric shock, this equipment

must only be connected to a mains supply with a

protective earth.

WARNING!

Risk to patients and sta from improper use.

Never use a unit for other than its intended purpose.

Eschmann are not responsible for any malfunction

in theunit if it is not used as specied.

Never use the unit for long term suction, such as

thedrainage of body cavities.

No modication of the equipment is allowed

2.3. Safety Instructions

• Various warnings, cautions and notes are made throughout

this manual. Each of these carries a special meaning and

should be read carefully.

• A WARNING is given when the safety of the patient or user

may be involved. Disregarding this information could result

in injury to the patient or user.

• A CAUTION is given when special instructions must be

followed. Disregarding this information could result in

permanent damage to the product.

• A NOTE provides specic information that makes important

instructions clear.

• The following safety instructions should be observed when

operating the Suction Unit:

• Use the Suction Unit only on a horizontal oor or surface.

• Do not leave the Suction Unit in a ‘trac’ area.

• Ensure lockable castors are ‘locked’ when the Suction Unit is

in use.

• If liquid or solid matter is drawn into the pump, the

unit must be withdrawn from use due to potential

contamination. Please contact your local authorised

Eschmann service engineer.

• A new Disposable Liner, Suction Tube (Between Disposable

Liner Lid and patient), Intermediate Tube Assembly and

Hydrophobic Bacterial Filter to be used for each patient.

• The Hydrophobic Bacterial Filter should be changed

immediately when contaminated or wetted.

• Clean and sterilise jars in accordance with manufacturer’s

instructions.

• If the vacuum reading or suction rate is too low, do not

continue to use the Suction Unit until this has been rectied.

• Do not obstruct or cover ventilation holes on the Suction

Unit.

• Do not leave part lled Disposable Liners/ jars in the

Suction Unit overnight. The Liners should be disposed of in

accordance with manufacturer’s instructions.

• Do not overll Disposable Liners/ jars. Liners should be

replaced in accordance with manufacturer’s instructions.

• Always have a stock of Eschmann approved spares and

accessories to hand. See Appendix 3 for a list of parts.

6 216067-11

2.4. Symbols

Symbol Meaning

Refer to warnings and cautions in manual

Refer to instructions in user manual

Type BF class of protection

Follow disposal regulations in the country

of use (WEEE directive symbol for Waste

Electrical and Electronic Equipment)

Fuse

Serial number

Catalogue reference

Date of manufacture

Manufacturer

Single use only, do not reuse

Use on alternating current only

Vacuum is increased by clockwise rotation

of this control

Patient connection side of Hydrophobic

Bacterial Filter

Footswitch

The UKCA marking of the product certies

that it complies with the Medical Devices

Regulations 2002 (SI 618), as amended by

the EU Exit Regulations 2019 (SI 791) and

2020 (SI 1478)

2.5. Compatibility of Materials

WARNING!

Never use disinfectants which contain acetone.

They may lead to damage or spoil the plastic parts

of the casing.

WARNING!

Aggressive substances may damage both the

Suction Unit and accessories. Follow the notes on

cleaning in Section 4.

WARNING!

Any potentially contaminated waste materials

produced during use should be disposed of safely

and carefully, taking into account any National,

Local or Hospital procedures which cover the

disposal of potentially contaminated liquid or solid

waste.

WARNING!

Risk of damage from using the wrong electricity

supply.

Improper use may lead to excess voltage in

the equipment which may transfer to the user.

Before using the equipment for the rst time,

ensure that the mains supply is correct for the

supply shown on the serial label on the back of

the unit.

Note: Damage to Suction Unit from ingress of liquids.

Avoid getting moisture on the mains inlet, the plug

or the switch.

Never dip the equipment into water or other liquids

(even when switched o).

Note: Damage to Suction Unit from overheating

Keep the Suction Unit and cable well away from

sources of heat.

0086

216067-11 7

XX/XX/XX

XXX

3-XX

VP35 GAREN

12345678910 11 12 13 14 15 16 17 18 19 20 21 22

721 22

1918

13109

Eschmann Holdings Ltd.

0.5

STATED OTHERWISE

VOLUME

50 100

DRAWN BY

CHECKED

AND SHARP EDGES

DO NOT SCALE OR GUESS

MATERIAL

FINISH

SCALE

TITLE

OF 1

ALL DIMS IN mm UNLESS

REMOVE ALL BURRS

Peter Road, Lancing

Tel: 01903 753322

1:5

West Sussex, BN15 8TJ

DATE

DRAWING NUMBER

SEE NOTES SIZE

ISSUE

SEE NOTES

SHEET

TOLERANCES UNLESS STATED

OTHERWISE:

LINEAR: 0 D.P: 0.75mm

1 D.P: 0.50mm

2 D.P: 0.25mm

ANGULAR: 0 D.P: 1

1 D.P:

ISSUE CHANGE DETAIL DATE CHG.BY

SCALE 1 : 1

DETAIL C

Figure 1: VPX35/VPX45 Suction Unit

1 = ‘On’ / ‘O’ Switch

2 = Vacuum Control Knob

3 = Mains Inlet

4 = Vacuum Gauge

5 = Intermediate Tube Assembly

6 = Jar (Sold seperately)

7 = Disposable Liner (Sold seperately)

8 = Hydrophobic Bacterial Filter

9 = Filter Mounting Block

10 = Lockable Castor (x 2)

11 = Non-Lockable Castor (x 2)

12 = Footswitch Connection

13 = Footswitch Override

XX/XX/XX

XXX

3-XX

VP35 GAREN

12345678910 11 12 13 14 15 16 17 18 19 20 21 22

721 22

1918

13109

Eschmann Holdings Ltd.

0.5

STATED OTHERWISE

VOLUME

50 100

DRAWN BY

CHECKED

AND SHARP EDGES

DO NOT SCALE OR GUESS

MATERIAL

FINISH

SCALE

TITLE

OF 1

ALL DIMS IN mm UNLESS

REMOVE ALL BURRS

Peter Road, Lancing

Tel: 01903 753322

1:5

West Sussex, BN15 8TJ

DATE

DRAWING NUMBER

SEE NOTES SIZE

ISSUE

SEE NOTES

SHEET

TOLERANCES UNLESS STATED

OTHERWISE:

LINEAR: 0 D.P: 0.75mm

1 D.P: 0.50mm

2 D.P: 0.25mm

ANGULAR: 0 D.P: 1

1 D.P:

ISSUE CHANGE DETAIL DATE CHG.BY

SCALE 1 : 1

DETAIL C

3. Instruction for Use

8 216067-11

3.1. Introduction

The Eschmann VPX35 and VPX45 Suction Units are mobile,

mains powered surgical Suction Units for the removal of

uids from patients.

The basic product, as supplied, comprises a Suction

Unit, Hydrophobic Bacterial Filter and Intermediate Tube

Assembly.

The Suction Unit is compatible with seperately supplied

collection jars and Disposable Liners. (Collection Jars and

Disposable Liners are covered by seperate manufacturer’s

Instructions.

Suction Tubing between a Disposable Liner and patient is

not supplied by Eschmann and is the responsibility of the

user.

When the unit is fully connected up and switched on, the

vacuum pump produces a vacuum in the Intermediate Tube

(5) and tted, compatible Jar (6)/ Disposable Liner (7), which

exert suction on patient body uids via a user supplied

Suction Tube.

The Liquids are drawn and collected into a compatible Jar/

Disposable Liner. The tted Jar / Liner should be monitored

and replaced in accordance with manufacturer’s instructions.

Compatible Disposable Liners incorporate a mechanical

overow valve in the lid which shuts o the vacuum if the

maximum uid level is exceeded.

The suction level is set by means of the vacuum control

knob.

The unit may be footswitch enabled by the factory. These

units can be operated by a footswitch connected to the unit

A safety cut out at high temperatures prevents over-

heating of the Suction Unit and ensures that it switches o

automatically.

Note: All accessories should be used in line with their

instructions, where supplied.

Note: The four castors on the unit each have wheel

protectors (two per castor). After unpacking, and

before rst use, remove the wheel protectors by

rmly pulling the tab at the centre of each side

of the castors until the protectors come o.

3.2. Deliverables

The following items are delivered:

• Suction Unit

• User Manual

• Mains cable

• Intermediate Tube Assembly

• Hydrophobic Bacterial Filters

• Footswitch and hose (optional)

The following items are compatible with the VPX35 & VPX45

but sold separately. (Refer to Appendix 3).

• Collection Jars

• Disposable Liners

The following item is supplied by the user:

• Suction Tube (To patient)

3.3. Pre Use Checks and Set Up

Note: The Suction Unit must only be operated and used

by fully trained sta.

Note: Before using the Suction Unit for the rst time,

please familiarise yourself with these instructions

and how the unit works.

To ensure the Suction Unit operates eciently, the following

checks should be performed prior to each procedure:

1. Ensure the VPX35 or VPX45 is clean.

2. Inspect the pump casing for damage.

3. Check the mains lead prior to connection to the unit or

power source. Check the plug, and the entire length of the

cable for damage. Change the mains lead immediately

if any damage is found. An Eschmann mains lead will be

supplied with the unit and must be used with the unit.

4. Plug the mains lead into the unit and ensure the

connection is not loose or likely to fall out of the mains

inlet socket(3) during use.

5. Check that the two locking casters(10) function as

expected, and that when unlocked all castors are free

running.

6. Refer to manufacturer’s Instructions for pre use checks

and set up applicable to compatible Collection Jars and

Disposable Liners.

7. Inspect the Collection Jars and Intermediate Tube for any

damage.

8. Ensure that a Disposable Suction Liner is tted to

a Collection Jar in accordance with manufacturer’s

instructions.

9. Ensure that the Intermediate Tube is connected from

the Hydrophobic Bacterial Filter elbow connection to a

compatible Disposable Suction Liner vacuum port using

the Taper Connector.

10. Inspect the Vacuum Gauge(4) and Vacuum Control

Knob(2).

11. Where applicable check the Footswitch for damage.

12. Ensure a Hydrophobic Bacterial Filter (8) is tted.

13. Plug the mains lead into a power source.

14. Turn the unit to ‘On’. Check the ‘On / O’ switch(1) is

illuminated when in the ‘On’ position.

15. Check the pump is now running. If a Footswitchis in use,

the Footswitch will need to be pressed to activate the

pump.This is a latching system such that the pump will

continue to operate when the footswitch is released. If

the footswitch is pressed again the pump will cease to

operate.

WARNING!

If the Suction Unit is footswitch enabled, it is

possible for the pump to be disabled even when

mains power is applied. In this circumstance

the orange “footswitch override” light will be

illuminated.

16. To re-enable the pump, should the footswitch be

unavailable, use the footswitch override (13). Once the

pump is running again, the override light will no longer be

illuminated.

17. Check the suction performance of the unit. Turn the

vacuum control knob(2) fully clockwise. This will give

maximum vacuum. Blank o the suction either at the

lter or at the jar. The vacuum gauge (4) should rise to a

reading of at least 660mmHg or above for the VPX35 or

720 mmHg for the VPX45.

Note: A stock of Eschmann accessories and spares should

always be available.

216067-11 9

3.4. Setting the Required

Vacuum

Once switched on, set the required vacuum by placing a

nger over the inlet nozzle of the compatible Liner lid to

which the Intermediate Tube(5) is connected. Turn the

vacuum control knob(2) clockwise to increase the suction

or anti-clockwise to decrease the suction until the desired

vacuum is indicated on the Vacuum Gauge(4).

When the suction is applied to the patient, if a dierent

vacuum is required, turn the vacuum control knob(2)

clockwise to increase or anti-clockwise to decrease the

vacuum, as required.

Once the unit is no longer required, switch it o using the

‘On / O’ switch(1).

Note: The VPX35 or VPX45 may be Footswitch enabled.

This is a latching system such that the pump

will continue to operate when the footswitch

is released with the mains switched to the ‘On’

position. If the Footswitch is pressed again the

pump will cease to operate.

3.5. Fitting/Removing the Jar and

Disposable Liner

WARNING!

Risk to health from dealing with infectious or

pathogenic organisms.

CAUTION

Switch the Suction Unit o before removing or replacing

Collection Jars or Disposable Liners.

To t or remove compatible Jars and Disposable Liners, refer

to the manufacturer’s Instructions.

WARNING!

Any potentially contaminated waste

materials produced during use should be

disposed of safely and carefully, taking into

account any National, Local or Hospital

procedures which cover the disposal of

potentially contaminated liquid, solid or

waste.

3.6. Overll Protection

Do not overll Collection Containers. Disposable Liners

should be changed in accordance with manufacturer’s

instructions.

Overfull protection is built into the lid of compatible

Disposable Liners. Refer to the Disposable Liners

manufacturer’s Instructions.

10 216067-11

3.7. Replacing the Hydrophobic

Bacterial Filter

CAUTION

DO NOT use substitutes for the specied

Hydrophobic Bacterial Filter, see parts list in

Appendix 3.

Change the Filter, immediately if it becomes

wet or contaminated.

The Hydrophobic Bacterial Filter is single use.

To replace the Hydrophobic Bacterial Filter, remove the

Intermediate Tube from the elbow tting at the inlet side of

the lter. Remove the lter and elbow tting from the lter

mounting block by carefully pulling the lter upwards. Take a

new lter and insert the lter outlet connection into the lter

mounting block by gently pushing the lter down. Ensure

the lter is fully seated in the mounting and is the right way

around (See illustration above). Fit a new elbow to the lter

inlet connection (Elbow supplied with the lter). Reconnect

the intermediate tube to the new elbow tting.

3.8. Replacing the Intermediate

Tube Assembly

The Intermediate Tube Assembly is single use.

Remove the intermediate Tube Assembly (Comprising the

Intermediate Tube and Taper Connector), which is connected

from the Hydrophobic Bacterial Filter (8) to the Disposable

Liner lid.

Take a new Intermediate Tube Assembly and t to the

Hydrophobic Bacterial Filter by attaching the free end to

the elbow tting. Connect the Taper Connector, attached at

the other end of the Intermediate Tube, to the connector

labelled “Vacuum” on the Disposable Liner lid.

3.9. Using a Footswitch

Use only the Eschmann approved Footswitch (see appendix 3

for part number).

Note: A Footswitch can only be tted to a unit that has

been footswitch enabled from the factory.

Connect the end of the Footswitch hose to the Footswitch

connection (12).

When the unit is switched on, activating the Footswitch will

switch the pump on and o.

WARNING!

If the Suction Unit is Footswitch enabled,

it is possible for the pump to be disabled

even when mains power is applied. In this

circumstance the orange “Footswitch

override” light will be illuminated.

To re-enable the pump when the Footswitch is unavailable,

use the Footswitch override (13).

Hydrophobic Bacterial Filter

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