LiquoGuard 7 Instruction Manual Sw Ver 20.03.13

IMPORTANT READ CAREFULLY BEFORE USE KEEP THESE INSTRUCTIONS FOR FUTURE CONSULTATION

© Möller Medical GmbH All rights reserved. No parts 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 technology, functions, specifications, design and information at any time and without prior notification.

LiquoGuard® 7 Table of contents

Table of contents 1

General safety instructions ... 9

1.1

Explanation of the safety symbols used ... 9 1.1.1

Symbols used in 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 ... 12

1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9

Explanation of the conventions applied ... 14 Manufacturer’s responsibility ... 14 Equipotential bonding... 14 Owner´s duty of care ... 15 Additional accessories ... 16 Single use ... 16 Declaration on DEHP ... 17 Application during defibrillation and for electrosurgical devices ... 17

2

Purpose ... 18

2.1 2.2 2.3 2.4 2.5 2.6 2.7

Indications of temporary intrathecal CSF drainage ... 18 Indications for permanent CSF drainage ... 19 Contraindications ... 19 Complications ... 19 Combination with other products, catheters and cannulas ... 20 Patient population & residual risk ... 21 Essential performance ... 21

3

Product description ... 22

3.1 3.2 3.3 3.4 3.5 3.6 3.7

Touchscreen ... 23 Bag holder ... 23 Universal bracket ... 23 Pump ... 23 LEDs ... 23 Connection options ... 24 User interface ... 25

3.8

3.7.1

Tab bar ... 26

3.7.2

Softkeys ... 27

3.7.3

Keyboard screen ... 27

Diagram dialog field ... 29 3.8.1

Diagram ... 30

3.8.2

Info bar ... 32 Page 3 of 136

LiquoGuard® 7 General safety instructions 3.8.3

Softkeys ... 33

4

Installation and startup... 37

4.1 4.2 4.3

Transport and storage instructions ... 37 Unpacking the device and inspecting delivery ... 37 Operating the LiquoGuard®7 ... 37 4.3.1

Hanging onto a standard rail ... 38

4.3.2

Installation on an infusion stand ... 38

4.3.3

Connecting and turning the device on ... 39

4.4

Suitable operating environment ... 40

5

Application and Operation ... 41

5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8

Installation and startup ... 41 Switching on the LiquoGuard®7... 41 Preparing the tubing set ... 42 Connecting the sensor cable ... 42 Inserting the tube ... 42 Connecting the catheter ... 43 Pressure sensor housing – Positioning and fastening ... 44 Changing drainage settings... 46 5.8.1

Pressure controlled drainage ... 46

5.8.2

Volume controlled drainage ... 47

5.9 Starting the application... 47 5.10 Pausing the application, only pressure monitoring ... 47 5.11 Interrupting the application ... 48 5.12 Changing the drainage set ... 49 5.13 Displaying drainage information ... 49 5.13.1

Alarms ... 49

5.13.2

Battery ... 49

5.14 Turning off the device... 49 5.15 Storage ... 50 6

Settings... 51

6.1

Drainage ... 51

6.2

6.1.1

Pset (set pressure value) ... 51

6.1.2

Upper Alarm... 52

6.1.3

Lower Alarm... 52

6.1.4

Vset ... 53

Alarm ... 54

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LiquoGuard® 7 Table of contents

6.3

6.2.1

General ... 54

6.2.2

Flow ... 55

6.2.3

Pulsation ... 57

6.2.4

Parenchymal/Tip sensor ... 59

6.2.5

Monitor/Nurse Call ... 59

6.2.6

CPP/cMAP Sensor... 59

Setup ... 59 6.3.1

Language ... 59

6.3.2

Display ... 60

6.3.3

Config ... 62

6.3.4

Operation ... 64

6.3.5

Service... 65

6.3.6

Presettings ... 68

7

Alarm signals and corrective measures ... 69

7.1

Presence of an alarm condition ... 69 7.1.1

Technical and physiological alarm conditions... 69

7.1.2

Pause alarm signal ... 70

7.1.3

System error ... 71

7.2 7.3 7.4 7.5 7.6 7.7

Testing alarm functions ... 72 Alarm system, dual safety ... 72 Alarm system overview ... 73 Alarm system description ... 80 Troubleshooting ... 83 Service ... 84

8

Care... 86

8.1 8.2 8.3 8.4

Cleaning and disinfection ... 86 Service ... 87 Replacing the battery ... 87 Disposal ... 87

9

Device options ... 88

9.1

Monitor/Nurse call ... 89

9.2

9.1.1

Patient monitor system... 89

9.1.2

Nurse call system... 90

Documentation ... 91 9.2.1

Patient data... 91 Page 5 of 136

LiquoGuard® 7 General safety instructions

9.3

9.4 9.5

9.6

9.7

10

9.2.2

Application data ... 92

9.2.3

Set marker ... 94

9.2.4

History ... 95

9.2.5

Printing ... 97

Presettings ... 99 9.3.1

Editing the LiquoGuard®7 presettings ... 99

9.3.2

Copy drainage settings to tubing set ... 101

Printing ... 101 Parenchymal/Tip sensor ... 102 9.5.1

Connecting the Parenchymal/Tip senor ... 103

9.5.2

Settings... 104

CPP/cMAP ... 107 9.6.1

Basic principles ... 107

9.6.2

Positioning the MAP sensor ... 107

9.6.3

Connecting the MAP sensor ... 108

9.6.4

cMap sensor settings ... 108

Lumbar infusion test ... 109 9.7.1

General description ... 109

9.7.2

Indications... 111

9.7.3

Contraindications ... 111

9.7.4

Complications ... 111

9.7.5

Combination with other products ... 112

9.7.6

Patient population ... 112

9.7.7

Residual risk ... 112

9.7.8

Execution of the lumbar infusion test... 112

9.7.9

Application and operation... 113

9.7.10

Settings... 116

9.7.11

Alarms ... 118

Appendix ... 119

10.1 Technical data... 119 10.2 Electromagnetic emission ... 122 10.3 Electromagnetic resistance ... 123 10.4 Recommended safety distances ... 125 10.5 Use in a CT and MRI environment ... 126 10.5.1

Important safety instructions ... 126

10.5.2

Measures to avoid image artifacts in MRI ... 127

Page 6 of 136

LiquoGuard® 7 Table of contents 10.5.3

After MRI imaging ... 128

10.6 Accessories ... 129 Index ... 134

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LiquoGuard® 7 General safety instructions

1 General safety instructions 1.1 Explanation of the safety symbols used In this instruction manual, visual symbols are used to highlight important instructions . These references are prerequisites for preventing hazards to patients and operating personnel, as well for avoiding damages or malfunctioning of the device.

1.1.1 Symbols used in instruction manual Caution

Information or help

1.1.2 Symbols appearing on the device Type BF applied part

Defibrillation-proof type CF applied part Serial number (the 4 digits indicate the ear and month of manufacture in YYMM format) Consult instructions for use

Follow instructions for use Complies with ANSI/AAMI ES 60601-1 CAN/CSA 22.2 No. 60601-1-08 Alternating current

Return and disposal according to WEEE Directive

Main alarm Backup alarm Main battery Page 9 of 136

LiquoGuard® 7 General safety instructions

Backup battery

ICP

Parenchymal or tip sensor connection (compatiple with Philips M1006B invasive pressure module connection). Patient monitor output (compatible with Edwards TruWave) “ON” for a part of equipment “OFF” for a part of equipment

Pcsf

Tubing set connection

In/Out

Connection for I/O connector Only the LiquoGuard®7 Multi-Hub accessory may be attached to this connection! USB host RJ45 network connection Connection to the nurse call system

The BF application parts (Pcsf and ICP) are specified as an application part.

1.1.3 Symbols appearing on the LiquoGuard®7 display Pump is in Pause mode Pump is in Application running mode All alarms are displayed and emitted

10:00

One or more alarms have been actively paused by the operator. Alarms are not emitted. The remaining time until the alarms are displayed again is shown. Drainage quantity counter off

off

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LiquoGuard® 7 General safety instructions Drainage quantity counter active. Message when the set drainage quantity is reached. All physiological alarms displayed and emitted.

5:00

All physiological alarms are suppressed, with the remaining time displayed until the alarm sounds again Keypad lock inactive Keypad lock active Main battery charge Presentation mode ready Softkey: press or save a screenshot Info bar: Printer is connected Set a marker for documenting events One or two USB memory sticks are connected Presetting is active (instead of X, the number of the presetting is indicated) LiquoGuard®7 connected to main power supply

;

Scale in/out of the time axis in HISTORY dialog field Selection of curves to be displayed Scaling of the axes to optimum Scaling the axes to maximum Clear history (graph, volume, alarms, patient data)

;

Move back and forth on the time axis in the History dialog field

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LiquoGuard® 7 General safety instructions 1.1.4 Symbols indicated on the retail packaging Consult instructions for use

Catalog number

Batch code Serial number (the 4 digits indicate the ear and month of manufacture in YYMM format) Use by date YYYY-MM-DD Sterilized using ethylene oxide Not suitable for use with MRI Limited suitability of tubing set for use with MRI. See details under symbol for the condition. Do not reuse

Do not resterilize

Do not use if package is damaged

Stacking restriction, stack may consists of max. 4 packages

Keep dry

Humidity, limitation

Temperature limit

Manufacturer

Page 12 of 136

LiquoGuard® 7 General safety instructions Date of manufacture YYYY-MM-DD Total length Blood pressure, invasive measurement Follow the instructions for use Quantity Type BF applied part Keep away from sunlight

Caution! Observe transport and storage conditions. Attention: Under US Federal law, this device may be sold only to a physician or ordered by a physician. For further information about symbols used please refer to our homepage: www.moeller-medical.com/glossary-symbols The use of the LiquoGuard®7 CSF drainage pump is subject to thorough knowledge and observance of this 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. If components are used that do not correspond to the original equipment manufacturer parts, the performance, safety and EMC behaviour may be impaired.

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LiquoGuard® 7 General safety instructions 1.2 Explanation of the conventions applied Various typefaces are used in these instructions for easier reference. Typeface

Application

Bold and italics

Buttons used in operating procedures

SMALL CAPITALS

Dialog fields and submenus in running text.

Italics

Device options, 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 authorized 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 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.

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LiquoGuard® 7 General safety instructions 1.5 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 fulfill all duties in accordance with the regulatory requirements and is fully responsible for all activities when using medical devices. Only qualified personnel may operate the LiquoGuard®7. This instruction manual does not replace training of the user by the medical device consultant. The training is carried out when the product is delivered by a medical device consultant authorized by the manufacturer with the aid of all products necessary for use. The operator must ensure that staff are trained on a regular basis by a qualified person (ideally a medical device consultant authorized by the manufacturer) if the safe use of the product on the patient cannot be guaranteed due to inadequate training. Clinical application may be only according to instructions of qualified personnel. Any modifications to the LiquoGuard®7 are prohibited. Liquids must not penetrate parts of the device which carry electrical voltage. Ensure that no cleaning spray enters the connector socket. Before cleaning, unplug the LiquoGuard®7 connector plug and turn the device off. 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. To obtain an accurate pressure measurement, do not use any other accessories except a suitable extension tube with a maximum length of 30 cm, fitted between the catheter and the tubing set. Never attach filters (e.g. bacteria filter) between the catheter and drainage bag. Application on computer tomographs The tubing set may remain attached to the patient during computer tomography (CT). The LiquoGuard®7 must be disconnected. Application on magnetic resonance tomographs The tubing set may remain attached to the patient during MRI imaging exams. The LiquoGuard®7 must be disconnected and must be located outside the magnetic field (another room, screened). It is essential to observe the further measures for use in an MRI environment from page 126 and in the instruction manual of the respective tubing sets. 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 connecting cable in the case of even minor damage and take care not to roll over the cables. Page 15 of 136

LiquoGuard® 7 General safety instructions Keep cables away 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®7 so that it can be easily disconnected from the mains power supply. Do not subject the LiquoGuard®7 to strong heat or fire. Do not subject the LiquoGuard®7 to strong impacts. If heat, fumes or smoke are emitted from the LiquoGuard®7, disconnect the mains plug of the device immediately. Do not extinguish the LiquoGuard®7 with water in the event of fire. Also observe the safety instructions in the instruction manuals of the devices used in conjunction with the LiquoGuard®7. Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

1.6 Additional accessories Additional accessories, which are beyond the scope of delivery of the present device and are connected to the analog and digital interfaces of the device, must be proven to comply with the relevant IEC specifications (e.g. IEC 60601 for electrical medical devices). Furthermore, all configurations must satisfy the current version of the system requirements according to standard IEC 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 IEC 60601-1.

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 and sterilization can adversely affect essential material properties and product parameters and thus result in product failure. Dispose of the used single-use product according to your hygiene requirements. To prevent leakage from the tubing set, ensure that all stopcocks are closed when disposing of the drainage and infusion set.

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LiquoGuard® 7 General safety instructions 1.8 Declaration on DEHP The LiquoGuard®7 tubing sets do not contain any bis (2-ethylhexyl) phthalate (DEHP).

1.9 Application during defibrillation and for electrosurgical devices Do not touch the patient, table or instruments during defibrillation. The measurement accuracy can be impaired during defibrillation. The recovery time of the device is less than 10 seconds. The recovery time has no effect on patient or device safety. During defibrillation, use only accessories stated in this instruction manual. When using electrosurgical devices, the LiquoGuard®7, the LiquoGuard®7 Multi-Hub and the transducers used do not include any protective measures against burning. The LiquoGuard®7 can be used in combination with electrosurgical devices. Nevertheless, the strong electromagnetic faults which occur in the direct vicinity of electric motors, power lines, PCs, monitors or other, possibly faulty, electrical devices can, in individual cases, impair the functionality of the device. Consider such faults when observing inexplicable phenomena on the device. The proper operation of the device can be restored as follows: • • • • • •

Position the pressure sensor housing as far away as possible from the electrosurgical electrodes. Set up the devices at a safe distance from each other, check their functionality and test them for plausibility. Make sure that the laid patient cables do not touch as electromagnetic coupling is possible during energy input via the electrosurgical device. Make sure that no cables are in contact with the patient. Take all the necessary precautions to avoid malfunctioning. Note the instructions and recommendations from the manufacturer of the electrosurgical device.

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LiquoGuard® 7 Purpose

2 Purpose The Möller Medical GmbH LiquoGuard®7 CSF drainage pump is a pressure-controlled peristaltic pump. The LiquoGuard®7 Drainage Set is a sterile single-use accessory designed to be used only with the LiquoGuard®7 CSF drainage pump. The LiquoGuard®7 CSF drainage pump with the LiquoGuard®7 Drainage Set are specifically designed to pump CSF from the ventricular system and the lumbar area of the patient on the basis of CSF pressure, or when the Parenchymal/Tip sensor and a suitable parenchymal sensor is used, from the ventricular system of the patient on the basis of parenchymal or CSF pressure. The LiquoGuard®7 Drainage 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®7 Infusion Test Set is a sterile single-use accessory and must be used only in conjunction with the LiquoGuard®7 CSF drainage pump. The LiquoGuard®7 CSF drainage pump, together with the LiquoGuard®7 Infusion 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 108). The LiquoGuard®7 may be used only in monitored medical areas in hospitals. The purpose of the LiquoGuard®7 not to form a diagnosis, but to support in forming a diagnosis.

2.1 Indications of temporary intrathecal CSF drainage Generally, the LiquoGuard®7 does not change the indication for 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®7 system are 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®7 system 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. Communicating hydrocephalus This condition includes all clinical pictures in which CSF production is temporarily in disproportion to CSF resorption, usually during cerebral hemorrhage (subarachnoid hemorrhage, intraventricular hemorrhage), 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.

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LiquoGuard® 7 Purpose Non-communicating hydrocephalus CSF drainage is temporarily impaired by a partial or complete occlusion of the CSF draining paths. This case can arise with masses (tumors, cysts, hemorrhage, congenital malformation) near the foramen of Monro, of the 3rd ventricle, the aqueduct, the 4th ventricle or the foramen of Monro and the foramina of Luschka. Therapy-resistant cerebral swelling CSF drainage may be indicated in therapy-resistant cerebral swelling caused, for example, by cranial-cerebral injury, cerebral hemorrhage or subarachnoid hemorrhage or by cerebral swelling due to tumors, inflammation or hypoxia, in order to reduce intracranial pressure, and to bypass trepanation (the removal of a cranial bone). Forced CSF pressure reduction In cases of endovascular or open surgical procedures such as in aortic aneurysms, the CSF pressure is forcibly lowered so as to achieve better arterial perfusion of distal spinal segments and thus to reduce the risk of paraplegia, for example. Lumbar CSF drainage and pressure-controlled drainage may be indicated both intra- and postoperatively.

2.2 Indications for permanent CSF drainage If permanent CSF drainage is indicated (e.g. in normal-pressure hydrocephalus), 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 ventriculoperitoneal shunt or a ventriculoatrial 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.

2.4 Complications • • •

Meningitis Encephalitis Ventriculitis Page 19 of 136

LiquoGuard® 7 Purpose • • • • • • • • • • • • • • • •

Myelitis Nosocomial infection Cerebral hemorrhage Epidural hematoma 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, catheters and cannulas The LiquoGuard®7 may be used only with the application parts LiquoGuard®7 Drainage Set REF. No.: 00003497 (1600 mm) or REF. No.: 00003501 (2000 mm), equivalent versions, see Appendix 10.6 or LiquoGuard®7 Infusion Test Set REF. No.: 00003499 (2000 mm) of Möller Medical GmbH. The LiquoGuard®7 Drainage Set is connected to a surgically implanted CSF draining catheter and does not come into contact with the body. The LiquoGuard®7 Drainage Set may be connected only 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®7 Tubing Set may be used only with the Möller Medical CSF bag provided. To make an extension, all the usual extension tubes may be connected to the LiquoGuard®7 Drainage Set that are suitable for arterial pressure measurement (sufficient rigidity of the tube), not longer than 30 cm, and have an inner diameter greater than or equal to 2 mm.

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