Moller Medical LiquoGuard 7 User manual

LiquoGuard®
CSF drainage pump
Instruction Manual
GB
7

© Möller Medical GmbH.
All rights reserved.
No part of this document may be reproduced or translated in any form or by any means without the prior
written permission of Möller Medical GmbH. The latest version of the information, specifications and
illustrations provided in this instruction manual is indicated by the version number on the last page. Möller
Medical GmbH reserves the right to make changes to the technology, functions, specifications, design and
information at any time and without prior notification.
Möller Medical GmbH, Wasserkuppenstraße 29-31, 36043 Fulda, Germany
Möller Medical GmbH, Wasserkuppenstraße 29-31, 36043 Fulda, Germany

LiquoGuard® 7
Table of contents
Page 5of 124
Table of contents
1General safety instructions .......................................................................... 9
1.1 Explanation of the safety symbols used ..............................................................9
1.1.1 Symbols used in the instruction manual.......................................................9
1.1.2 Symbols appearing on the device ................................................................9
1.1.3 Symbols appearing on the LiquoGuard® 7 display.....................................10
1.1.4 Symbols indicated on the retail packaging .................................................10
1.2 Explanation of the conventions applied.............................................................12
1.3 Manufacturer's responsibility.............................................................................12
1.4 Owner's duty of care .........................................................................................12
1.5 Additional accessories.......................................................................................14
1.6 Equipotential bonding........................................................................................14
1.7 Single use.........................................................................................................14
1.8 Declaration on DEHP........................................................................................14
2Purpose........................................................................................................ 15
2.1 Indications for temporary intrathecal CSF drainage...........................................15
2.2 Indications for permanent CSF drainage...........................................................16
2.3 Contraindications ..............................................................................................16
2.4 Complications ...................................................................................................17
2.5 Combination with other products.......................................................................17
2.6 Patient population & residual risk ......................................................................17
3Product Description .................................................................................... 19
3.1 Touchscreen.....................................................................................................20
3.2 Bag holder.........................................................................................................20
3.3 Universal bracket ..............................................................................................20
3.4 Pump ................................................................................................................20
3.5 LEDs.................................................................................................................20
3.6 Connection options ...........................................................................................22
3.7 User interface....................................................................................................22
3.7.1 Tab bar ......................................................................................................23
3.7.2 Softkeys.....................................................................................................25

LiquoGuard® 7
Table of contents
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3.7.3 Keyboard screen....................................................................................... 25
3.8 DIAGRAM dialogue field................................................................................... 27
3.8.1 Diagram .................................................................................................... 27
3.8.2 Info bar...................................................................................................... 28
3.8.3 Softkeys.................................................................................................... 30
4Installation and startup ...............................................................................32
4.1 Transport and storage instructions ................................................................... 32
4.2 Unpacking the device and inspecting delivery.................................................. 32
4.3 Starting up the LiquoGuard® 7.......................................................................... 32
4.3.1 Hanging onto a standard rail ..................................................................... 33
4.3.2 Installation on an infusion stand ................................................................ 33
4.3.3 Connecting and turning the device on ....................................................... 34
5Application and Operation..........................................................................35
5.1 Installation and startup ..................................................................................... 35
5.2 Turning the LiquoGuard® 7on .......................................................................... 35
5.3 Preparing the tubing set ................................................................................... 36
5.4 Connecting the sensor cable............................................................................ 36
5.5 Inserting the tube.............................................................................................. 36
5.6 Connecting the catheter ................................................................................... 38
5.7 Securing the pressure sensor housing ............................................................. 38
5.8 Changing drainage settings.............................................................................. 38
5.8.1 Pressure controlled drainage..................................................................... 39
5.8.2 Volume controlled drainage....................................................................... 39
5.9 Starting the application..................................................................................... 39
5.10 Pausing the application .................................................................................... 39
5.11 Interrupting the application............................................................................... 40
5.12 Changing the drainage set ............................................................................... 40
5.13 Displaying drainage information ....................................................................... 41
5.13.1 Alarms....................................................................................................... 41
5.13.2 Volumes.................................................................................................... 41
5.13.3 Battery....................................................................................................... 42
5.14 Turning the device off....................................................................................... 42
5.15 Storage ............................................................................................................ 43

LiquoGuard® 7
Table of contents
Page 7of 124
6Settings ........................................................................................................ 44
6.1 Drainage...........................................................................................................44
6.1.1 Pset (set pressure value) ...........................................................................44
6.1.2 High Alarm.................................................................................................45
6.1.3 Low Alarm..................................................................................................45
6.1.4 Vset............................................................................................................45
6.2 Alarm ................................................................................................................46
6.2.1 General......................................................................................................46
6.2.2 Flow...........................................................................................................47
6.2.3 Pulsation....................................................................................................48
6.2.4 Parenchym/Tip sensor ...............................................................................50
6.2.5 Monitor/Nurse Call .....................................................................................50
6.3 Setup ................................................................................................................51
6.3.1 Language...................................................................................................51
6.3.2 Display.......................................................................................................51
6.3.3 Config ........................................................................................................53
6.3.4 Operation...................................................................................................55
6.3.5 Maintenance ..............................................................................................57
7Alarm signals and corrective measures.................................................... 59
7.1 Presence of an alarm condition.........................................................................59
7.1.1 Technical and physiological alarm conditions.............................................59
7.1.2 Pause alarm signal.....................................................................................60
7.1.3 System error ..............................................................................................61
7.2 Testing alarm functions.....................................................................................62
7.3 Alarm system, dual safety.................................................................................62
7.4 Alarm system overview .....................................................................................63
7.5 Alarm system description..................................................................................73
7.6 Troubleshooting ................................................................................................75
7.7 Service..............................................................................................................77
8Care............................................................................................................... 79
8.1 Cleaning and disinfection..................................................................................79
8.2 Service..............................................................................................................79
8.3 Disposal............................................................................................................79
9Device functions.......................................................................................... 80

LiquoGuard® 7
Table of contents
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9.1 Monitor/Nurse call ............................................................................................ 82
9.1.1 Patient monitor system.............................................................................. 82
9.1.2 Nurse call system...................................................................................... 83
9.2 Documentation................................................................................................. 85
9.2.1 Patient data............................................................................................... 85
9.2.2 Application data......................................................................................... 85
9.2.3 Set marker................................................................................................. 88
9.2.4 History....................................................................................................... 88
9.2.5 Printing...................................................................................................... 90
9.3 Presettings....................................................................................................... 91
9.3.1 Applying Presets in LiquoGuard® 7............................................................ 92
9.3.2 Copy drainage settings to tubing set ......................................................... 93
9.4 Printing............................................................................................................. 95
9.5 Parenchymal/Tip sensor................................................................................... 96
9.5.1 Connecting................................................................................................ 97
9.5.2 Settings..................................................................................................... 98
9.6 Infusion test.................................................................................................... 100
9.6.1 General description................................................................................. 100
9.6.2 Indications............................................................................................... 102
9.6.3 Contraindications..................................................................................... 102
9.6.4 Complications.......................................................................................... 103
9.6.5 Combination with other products............................................................. 103
9.6.6 Patient population.................................................................................... 103
9.6.7 Residual risk............................................................................................ 103
9.6.8 Execution of the lumbar infusion test....................................................... 104
9.6.9 Application and Operation....................................................................... 104
9.6.10 Settings................................................................................................... 107
9.6.11 Alarms..................................................................................................... 109
10 Appendix.................................................................................................110
10.1 Technical data................................................................................................ 110
10.2 Electromagnetic emission............................................................................... 113
10.3 Electromagnetic resistance ............................................................................ 114
10.4 Recommended safety distances..................................................................... 117
10.5 Accessories.................................................................................................... 118

LiquoGuard® 7
General safety instructions
Page 9 of 124
1 General safety instructions
1.1 Explanation of the safety symbols used
In the present operating instructions visual symbols are used to highlight important
instructions. These references are prerequisites for preventing hazards to patients and
operating personnel, as well as for avoiding damages or malfunctioning of the device.
1.1.1 Symbols used in the instruction manual
Caution! Hazard for patients or operating personnel
Information or help
1.1.2 Symbols appearing on the device
Application part BF
Serial Number
1275
Conformity with Medical Device Directive EEC 93/42
Alternating voltage
Return and disposal according to WEEE Directive
Main alarm
Back-up alarm
Main battery
Back-up battery
ICP
Parenchymal or tip sensor connection (compatible with Philips
M1006B invasive pressure module connection)
Patient monitor output (compatible with Edwards TruWave)
I O
On switch (I = On; O = Off)

LiquoGuard® 7
General safety instructions
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PCSF
tubing set connection
In/Out
Connection for I/O connector (currently no function)
USB host
Network connection RJ45 (currently no function)
Connection to diagnostics run system
1.1.3 Symbols appearing on the LiquoGuard® 7 display
Pump is in Pause mode
Pump is in Application run mode
Alarm pause inactive
Alarm pause due to one or more alarm conditions active
Keypad lock inactive
Keypad lock active
Softkey: press or save a screenshot
Info bar: Printer is connected
One or two USB memory sticks are connected
Pre-setting is active (instead of X, the number of the pre-setting
is indicated)
LiquoGuard® 7is in Application run mode
LiquoGuard® 7is connected to main power supply
;
Scale in/out of time axis in History dialogue field
;
Move back and forth on time axis in History dialogue field
1.1.4 Symbols indicated on the retail packaging
Observe the instruction manual

LiquoGuard® 7
General safety instructions
Page 11 of 124
Purchase order number
Lot description
Serial Number
Unit quantity in packaging
Expiry date
Sterilised with ethylenoxide
Not suitable for use with MRI
Single use
Do not resterilise
Do not use if packaging is damaged
Stacking restriction, stack may consist of max. 4 packages
Store in a dry place
Restriction on storage humidity
Restriction on storage temperature
Manufacturer
Total length
The use of the LiquoGuard® 7CSF drainage pump is subject to a thorough knowledge
and observance of the present instruction manual which is an integral part of the delivered
product. Store this instruction manual carefully. The present instructions are not a
substitute for training of the owner / operator by a medical device consultant approved by
the manufacturer. The device must be used only by persons who have the required
training or knowledge and experience.

LiquoGuard® 7
General safety instructions
Page 12 of 124
If components are used that do not correspond to the original parts of the
manufacturer, the performance, safety and EMC behaviour may be impaired.
1.2 Explanation of the conventions applied
Various typefaces are used in these instructions for easier reference.
Typeface
Application
Bold
Buttons used in operating procedures
Small capitals
Dialogue fields and submenus in running text
Italics
Device functions, buttons and references to
chapters and sections in running text
1.3 Manufacturer's responsibility
The manufacturer is responsible for the safety, reliability and serviceability of the device in
the following cases:
Where assembly, upgrades, adjustments, changes or repairs are performed only
by persons authorised by the manufacturer.
Where the electrical installation of the area used for medical purposes complies
with the applicable requirements and regulations (e.g. VDE 0100, VDE 0107 or
IEC specifications).
Where the device is used in accordance with the user manual.
Where the regulations specific to a region or country are observed.
The manufacturer undertakes to accept returned old devices according to the Electronic
Equipment Act.
1.4 Owner's duty of care
The owner of the device must accept responsibility for the proper operation of the medical
device. The user is obliged to fulfil all duties in accordance with the Medical Devices
Operator Ordinance and is fully responsible for all activities when using medical products.
Only qualified personnel may operate the LiquoGuard® 7. This operating manual does
not replace the instruction of the user by the medical product consultant. Clinical
application may only be performed according to instructions of qualified personnel.

LiquoGuard® 7
General safety instructions
Page 13 of 124
Any modifications to the LiquoGuard® 7are prohibited. Liquids must not
penetrate parts of the device which carry electrical voltage.
Ensure that no cleaning spray enters the connector socket.
Disconnect the plug of the LiquoGuard® 7before cleaning.
Do not turn the pump rotor opposite to the flow direction indicated if the tube is
already connected to the pump. This may present a danger to the patient.
Do not use any other accessories to obtain an accurate pressure measurement,
besides a Heidelberger extension with a maximum length of 30 cm, fitted
between the catheter and the tubing set.
The tubing set can remain attached to the patient during computer tomography
(CT). The LiquoGuard® 7must be disconnected.
Application during magnetic resonance tomography (MRT) or near an MRT
device is prohibited. Remove the entire tubing set.
Use the device only on a mains power supply fitted with a protective earth
conductor. The mains voltage must conform with the indications provided on the
identification plate on the back.
Replace any connection cable in the case of even minor damage and take care
not to roll over the cables.
Keep cables far from sources of heat. This is to prevent the insulation from
melting, potentially causing a fire or electrocution.
Do not force the connector plug into the socket.
Do not pull on the cable when removing the plug. If necessary, loosen the plug
interlock to remove it.
Position the LiquoGuard® 7so that it can be easily disconnected from the
mains power supply.
Do not subject the LiquoGuard® 7to strong heat or fire.
Do not subject the LiquoGuard® 7to strong impacts.
If heat, fumes or smoke are emitted from the LiquoGuard® 7, disconnect the
mains plug of the device immediately.
Do not use water on the LiquoGuard® 7to extinguish a fire.
Observe also the safety instructions in the operating manuals of the devices used in
conjunction with the LiquoGuard® 7.

LiquoGuard® 7
General safety instructions
Page 14 of 124
1.5 Additional accessories
Additional accessories, which are beyond the scope of delivery of the present device and
are connected to the analogue and digital interfaces of the device, must be proven to
comply with the relevant EN specifications (e.g. EN 60601 for electrical medical devices).
Furthermore, all configurations must satisfy the current version of the system
requirements according to standard EN 60601-1. Any operator connecting the additional
devices is responsible for configuring the system and for ensuring that the current version
of the system requirements satisfy standard EN 60601-1.
1.6 Equipotential bonding
It is important to limit potential variances between the different parts of a system within the
patient's environment. . In limiting this potential variance by using a system of protective
earth conductors, the quality of the connection is of utmost importance. It is, therefore,
essential to avoid a failure in the protective devices in each part of the system.
In the case of failure of the protective earth conductors of a device, a potential
variance can occur at the housing of the device and present a danger for the
operator and the patient. Do not touch the patient and the device
simultaneously.
1.7 Single use
The re-use of a single-use product presents a potential risk of infection for the patient or
operator. Contaminated products can damage health, and cause illness or even death of
the patient. Cleaning, disinfection or sterilisation can adversely affect essential material
properties and product parameters and thus result in product failure.
Dispose of the used single-use product according to hygiene requirements. To prevent
leakage from the tubing set, ensure that all stop cocks are closed when disposing of the
drainage and infusion set.
1.8 Declaration on DEHP
The LiquoGuard® 7tube product family does not contain any Bis(2-ethyhexyl)phthalate
(DEHP).

LiquoGuard® 7
Purpose
Page 15 of 124
2 Purpose
The Möller Medical GmbH LiquoGuard® 7CSF drainage pump is a pressure-controlled
peristaltic pump. The LiquoGuard® 7drainage set is a single-use accessory designed to
be used only with the LiquoGuard® 7CSF drainage pump. The LiquoGuard® 7and the
LiquoGuard® 7drainage set are specifically designed to pump CSF from the ventricular
system and lumbar area of the patient on the basis of the CSF pressure or when the
Parenchymal/Tip sensor function or a suitable parenchymal sensor is used. The
LiquoGuard® 7drainage set is compatible with all conventional ventricle catheters with
an internal diameter greater than/equal to 1 mm and length less than/equal to 350 mm, as
well as lumbar drainage catheters with an internal diameter greater than/equal to 0.7 mm
and length less than/equal to 800 mm.
The LiquoGuard® 7infusion test set is a sterile single-use accessory and must only by
used in conjunction with the LiquoGuard® 7CSF drainage pump. The LiquoGuard® 7
CSF drainage pump, together with the LiquoGuard® 7infusion test set and the lumbar
infusion test function, are designed to ensure the flow of up to 100 ml of infusion solution
(physiological saline solution or CSF replacement fluid) at a consistent volume into the
spinal canal, with simultaneous pressure measurement (see Page 100).
The LiquoGuard® 7may only be used in monitored medical areas in hospitals.
The purpose of the LiquoGuard® 7is not to form a diagnosis, but to support in
forming a diagnosis.
2.1 Indications for temporary intrathecal CSF drainage
Generally, the LiquoGuard® 7 does not change the indication for an intrathecal CSF
drainage in any patient, nor does it influence the therapeutic concept, type of treatment,
therapy objectives or therapy duration.
The most fundamental characteristics of the LiquoGuard® 7are comparable with those of
other CSF drainage systems on the market. Therefore the listed indications for CSF
drainage must be understood in the broadest sense, without presupposing the use of the
LiquoGuard® 7system or any specific comparable CSF drainage system, as these
systems are interchangeable with each other at all times without the need for a change in
therapy or further surgery.

LiquoGuard® 7
Purpose
Page 16 of 124
Communicating hydrocephalus
This condition includes all clinical pictures in which CSF production is temporarily in
disproportion to CSF resorption, usually during cerebral haemorrhage (subarachnoid
haemorrhage, intraventricular haemorrhage), encephalitis and cranial-cerebral injuries. In
most cases the cause is resorption dysfunction by obstruction of the Paccioni granulation.
There is no alternative treatment to intrathecal CSF drainage for these clinical pictures.
Non-communicating hydrocephalus
CSF drainage is impaired by a partial or complete occlusion of the CSF draining paths.
This may occur through masses (tumours, cysts, haemorrhage, congenital malformation)
near the foramen Monroi, the 3rd ventricle, the aquaduct, the 4th ventricle or the foramen
Monroi and the foramina Luschkae.
Therapy-resistant cerebral swelling
The application of CSF drainage may be indicated in therapy-resistant cerebral swelling
caused, for example, by cranial-cerebral injury, cerebral haemorrhage or subarachnoid
haemorrhage or by cerebral swelling due to tumours, inflammation or hypoxia, in order to
reduce intracranial pressure and to bypass trepanation (the removal of a cranial bone).
2.2 Indications for permanent CSF drainage
If permanent CSF drainage is indicated (e.g. in normal-pressure hydrocephalus), a
temporary CSF drainage would be indicated only for diagnostic purposes (e.g. b-wave
diagnostics), but not for continuous therapy. This would indicate a CSF shunt system,
usually a ventriculo-peritoneal shunt or a ventriculo-atrial shunt.
2.3 Contraindications
Absolute contraindications
Coagulation dysfunction
Thrombocythemia
Relative operative contraindications
Superficial or deep infections of skin, bone, meninges or brain. Especially in infections of
the brain, meninges or cerebral chambers (encephalitis, meningitis and ventriculitis),
dysfunctional CSF resorption indicates relief, as does simultaneous intake of intrathecal
antibiotics in the case of ventriculitis.

LiquoGuard® 7
Purpose
Page 17 of 124
2.4 Complications
Meningitis
Encephalitis
Ventriculitis
Myelitis
Nosocomial infection
Cerebral haemorrhage
Epidural haematoma
Spinal cord injury
Nerve injury
Cone and cauda injury
Back pain
Cerebral swelling
Slit ventricles
Overdrainage
Underdrainage
Disconnection
Bent tubes
Interrupted tube flow (bent tube, occluded tube system (blood clots or detritus))
Death
2.5 Combination with other products
The LiquoGuard® 7 may only be used in conjunction with the LiquoGuard® 7
drainage set REF.-No.: 00003497 (1600 mm or REF.-No.: 00003501 (2000 mm)
manufactured by Möller Medical GmbH.
The LiquoGuard® 7drainage set is connected to a surgically implanted CSF draining
catheter and does not come into contact with the body. The LiquoGuard® 7drainage set
may only be connected to a ventricle drainage catheter with internal diameter ≥ 1 mm and
length ≤ 350 mm or lumbar drainage catheter with internal diameter ≥ 0.7 mm and length
≤ 800 mm.
The LiquoGuard® 7tubing set may only be used together with the Möller Medical CSF
bag provided.
2.6 Patient population & residual risk
There are no restrictions with regard to the patient population. The device can be used on
patients from any age group, with any health condition and from any ethnic group.
The patient does not operate the device.

LiquoGuard® 7
Purpose
Page 18 of 124
The LiquoGuard® 7is designed to ensure at least one alarm trigger between pressure
measurement and alarm generation during an error. The residual risk for the patient exists
mainly in the selection of parameters unsuitable for the patient or other application errors.
The operator must be aware of this risk.
For application during computer tomography (CT), the tubing set may remain
attached to the patient. The LiquoGuard® 7must be disconnected.
Application during magnetic resonance tomography (MRT) or near an MRT
device, is prohibited.

LiquoGuard® 7
Product Description
Page 19 of 124
3 Product Description
Figure 1: Left view of the LiquoGuard® 7.
Figure 2: View of the LiquoGuard® 7 from above.
Bag holder
Universal bracket
Carrying handle
Pump
Touchscreen
LEDs

LiquoGuard® 7
Product Description
Page 20 of 124
3.1 Touchscreen
User input in the LiquoGuard® 7is performed via the touch-sensitive, resistive surface
(touchscreen, see Figure 2) of the display. Use a finger or suitable input pen to make
entries. To select a button on the screen, apply light pressure on the touchscreen in the
area of the button.
3.2 Bag holder
The V-shaped holder located on the side(see Figure 1) is used to support the CSF
drainage bag (CSF bag). Pull one of the holder ends in the direction of the display and
turn upwards until the holder engages.
3.3 Universal bracket
The LiquoGuard® 7can be hung by means of the universal bracket located on the back
of the device (see Figure 1), onto a standard rail or a bar (diameter 18 mm to 25 mm).
3.4 Pump
The integrated peristaltic pump located on the upper part of the LiquoGuard® 7(see
Figure 2) ensures the mechanical deformation of the fitted tube, allowing for the flow of
CSF through the tube.
3.5 LEDs
Figure 3: LEDs located on the front of the LiquoGuard® 7, indicate alarm conditions and battery
charge.
The LEDs of the LiquoGuard® 7provide information on active alarm conditions and
charge status of the internal battery (see Figure 3).
Main alarm
Backup battery
Main battery
Backup battery