Clinic System Hardware Users Guide Ver 1.4

Clinic Hardware User’s Guide

Table of Contents Explanation of Symbols ...2 Table of Contents ...3 Important Information...4 General Information...4 Overview...7 Pressure Transducer Holder, 4 PvB Inlets ...8 Connections...9 EN 60601-1 ...11 Maintenance ...12 Calibration...15 Optional Parts and Accessories...15 Cleaning ...16 Warnings and Precautions...18 Technical Issues ...20 Trouble Shooting...20 Warranty...21 Technical Data ...24 Flow Meter – Spinning Disc ...24 Weight Cell Flow Meter ...24 Wireless Weight Cell Flow Meter ...24 Pressure Transducer ...24 EMG Channel (optional)...25 Puller with Arm...25 Water Pump...26 Infused Volume Meter ...26 Technical specifications of the device ...27

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Clinic Hardware User’s Guide

Important Information Notice To All Operators Caution: United States Federal law restricts this device to use by or on the order of the Physician. The Clinic should be used only by individuals who have been trained and authorised by their physician All operators should read this User’s Manual. Do not attempt to operate the Clinic until all instructions and procedures in this manual have been read and thoroughly understood. Failure to comply with instructions may compromise the performance of the instrument. This is a class A product. The product is suitable for use in all establishments other than domestic. This product is allowed in domestic establishments under the jurisdiction of a health care professional (according to EN 60601-1-2 clause 36.201.1.8).

General Information This system has been designed and tested in accordance with IEC 60601-1 Medical Electrical Equipment. The present manual contains some information and warnings which will have to be followed by the user to ensure safe operation and to retain the system in safe condition. This system is intended to be used by qualified medical personnel, knowledgeable in the field of the system and with the appropriate education and special training. The system has been designed for indoor use at temperatures between +10°C and +40°C (+50°F to +104°F). The mains plug must only be inserted in a mains socket outlet provided with a protective earth contact. It is forbidden to use extension cords. WARNING Any interruption to the protective earth conductor inside or outside the system or disconnection of the protective earth connector is likely to make the system dangerous. Intentional interruption is prohibited. The protective earth (ground) conductor should be checked regularly.

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Clinic Hardware User’s Guide For the combination of this system with other devices and / or for its connection to installations, the following applies: 1 When connecting medical equipment being supplied from an outlet located in a non-medically used room, or when connecting non-medical electrical equipment to this system, please pay attention to the requirements of IEC 60601-1-1, Safety Requirements for medical electrical systems. 2 When the system is connected to its mains supply, connectors may be live, and any opening of covers or removal of parts possible only with the aid of a tool is likely to expose live parts. 3 The system must be disconnected from all voltage sources before being opened for any adjustment, replacement, maintenance or repair. 4 Service must be referred to Mediwatch UK Ltd authorised service personnel, except for such works described in this manual as being performed by the operator. 5 Make sure that only fuses with the required rated current and of the specified type are used for replacement. The use of makeshift fuses and the shortcircuiting of fuse holders are prohibited. 6 Where more than one piece of equipment is connected to a patient, attention must be paid to the summation of patient leakage currents. 7 Whenever it is likely that the protection has been impaired, the system shall be made inoperative and be secured against any unintended operation. 8 In that case, call qualified service personnel to conduct at least a functional test and additionally a safety check including 1) an insulation test, 2) a ground continuity test and 3) a leakage current test, according to IEC 60601-1. 9 The protection is likely to be impaired if, for example, the system: - Shows visible damage - Fails to perform the intended function(s) - Has been subjected to severe transport stresses.

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Clinic Hardware User’s Guide Statement of Intended Use Urodynamics The Clinic system is intended for urodynamics testing. The Clinic system is intended to assist practitioners in executing specific urodynamics test protocols, collecting data during protocol execution, analysing collected data, preparing written reports and archiving patient and testing information. General indications for use include use in patients with lower urinary tract voiding or continence problems, and more specifically incontinent patients, patients with bladder outlet obstructions, patients with neurogenic bladder dysfunction and some children with complex voiding / incontinence problems.

Caution For use under constant control by an operator on patients who are not anaesthetised. Not intended for intravenous pumping.

Warning The system is not intended for use with anaesthetic gases – danger of electrical ignition.

Warning You must consider the consequences carefully before changing the security values for a test. The maximum pressure is set to 150 cmH2O and the pump stops when infused volume is 1000 ml.

Contraindications Urinary tract infection. WARNING Only use this equipment for the purpose intended by the manufacturer, i.e. carrying out tests on patients and possibly subsequent report generation. Do not install any other software than the Mediwatch “Endorsed” Clinic Software. Mediwatch Plc assumes no responsibility if the system is not used as described in this manual. WARNING The system is not compatible for use in a MRI magnetic field. WARNING Electrical equipment for medical use requires special EMC precautions, and needs to be installed and serviced according to the EMC documentation of the system. CAUTION Portable and mobile RF communication equipment can affect electrical equipment for medical use. CAUTION A constant hardware fault could cause the pump to rotate as soon as the pump lid is closed. Reopening the lid stops the pump. CAUTION In the United States, Federal Law restricts this device to sale by, or on the order of a physician or licensed practitioner. Page 6 of 28

Clinic Hardware User’s Guide

Overview 7

1

8 9

2

10

3 4 5

11 12 6

1

Flat-screen

7

O-Pole

2

Keyboard & Mouse

8

4 Pressure DIN box

3

Patient unit

9

Transducer holder

4

Printer

10

Water Pump

5

Mini-PC

11

Spinning Disk Flow Meter

6

Power Supply

12

Wireless Weight Cell Flow Meter

Optional Pressure Transducer Connections

1

Transducer holder & cable management 2

Pressure transducer

3

EMG connection cable

Transducer connection

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4

Clinic Hardware User’s Guide

Pressure Transducer Holder, 4 PvB Inlets

Pressure Connection Box, 4 DIN Inlets (Optional)

The system is of Type BF, i.e. the applied part is electrically isolated.

All optional devices are examples only.

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Clinic Hardware User’s Guide Patient Unit

Connections

24V 1 Power inlet

6 Earth / ground connection

H2O / CO2 2 Outlet for loudspeaker feature. The function is only supported if the system is installed using the PC Card Interface.

7 Connection for Water Pump Unit (H2O) (optional pump). CO2 is for future use.

PC 3 Mini-PC connection

8 Infused Volume Meter connection: For future use. P1-P4

4 Puller connection (optional)

9 Pressure inputs used for connecting pressure transducers or tip transducer catheters (optional). EMG

5 Flow Meter connection (optional)

10 EMG input (optional)

IMPORTANT Since the patient connections are galvanically isolated, do not connect “patient earth / ground” to the instrument’s protective earth / ground (yellow/green jack) or to any other kinds of “earth/ground”.

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Clinic Hardware User’s Guide Overview of Cable Connections

H

G

E

A

Isolating Transformer

F

E

Power Supply for Patient Unit

Use only Power Supply provided (SINPRO MPU 50-108) B

Printer (optional)

F

Power Supply for Mini-PC

C

Patient Unit

G

Optional Video Capture Device

D

Mini-PC and Flat-screen

H

Keyboard & Mouse

Cable Connections Before operating the system, the system parts should be connected. 1 2 3 4 5

Connect all signal interface cables on the drawing (solid black / thin). Connect all power interface cables on the drawing, except for the main cables to the wall outlet (red / dotted). Connect the mains cable to the wall outlet / Turn on the main switch of the wall outlet. Turn on the switch on the isolating transformer (A). Turn on the switch on the Mini-PC and Flat-screen (D).

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Clinic Hardware User’s Guide EN 60601-1 CAUTION When connecting options such as monitor(s), network modem(s), video capture devices and/or printer(s), attention must be paid to EN 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety

Potential equalisation terminal A potential equalisation terminal is accessible to the operator for the connection of a potential equalisation conductor to meet EN 60601-1 section 8.6.7

Collateral Standard Safety Requirements for Medical Electrical Systems When connecting to a medical appliance with an F-type applied part or some additional equipment complying not with EN 60601-1 but with the relevant safety standard for such equipment, the additional equipment: 1)

must either be placed outside the patient environment (the patient environment is any area in which intentional or unintentional contact can occur between patient and parts of the system (e.g. a printer) or as a result of some other person touching parts of the system)

or 2)

if placed within the patient environment, must be: a) provided with additional protective earthing.

or b)

3)

supplied from an extra isolating transformer Please refer to EN 60601-1.

When connecting to a network a 10/100 Base-T ethernet data isolator should be used to maintain patient safety according to EN 60601-1.

Mini-PC Connection CAUTION Please ensure any accessory connected to the Mini-PC connectors must comply with EN60101-1 and if it requires a mains supply, it must be supplied through the isolation transformer.

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Clinic Hardware User’s Guide

Maintenance General Maintenance Maintenance to be performed by the operator comprises cleaning and disinfecting the system and cleaning, and sterilisation of the attached transducers and accessories. Switch off the mains before cleaning the system. Please carefully follow the instructions for use recommended by the manufacturer or local hygiene authority (for example disinfectant sprays for nonimmersible surfaces, instruments and equipment). The following disinfectants can be used: • • • •

Aldehydes (NuCidex ) Corsoline Sporicidin Chlorates (Diversol BX ) ®

®

®

®

Be careful not to drip water or disinfectant directly into the input or output plugs and other openings in the cover, especially the keyboard. Remove excess disinfectant with a dry cloth. CAUTION Do not use solvent, silicon-based or abrasive cleaning agents. Make sure that no liquids enter the device through apertures in the enclosure. Clean the Mini-PC regularly with a damp sponge. CAUTION Do not use alcohol, spirits or ammonia.

Safety Checks The following safety checks should be conducted by qualified personnel at least once a year and in the event of repair: 1 2 3 4 5 6

Inspection for visible damage to equipment. Inspection of mains cord and connecting cables. Checking of transducers, cables and patient connections. Measurement of insulation resistance. Measurement of leakage current. Resistance measurement of protective earth conductor.

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Clinic Hardware User’s Guide Maintenance of the Puller Mechanism The Puller Head (1) must be sterilised or disinfected before each patient examination. The Motor Housing (2) must be cleaned or disinfected once a week. The Arm (3) must be cleaned or disinfected as required, or at the same time as the system. Before cleaning, disinfection and sterilisation remove visible contaminating organic materials using a brush or a cloth. Be careful not to drip water, or disinfectants directly into the cable plug and other openings in the motor housing. Remove excess disinfectant and water with a dry cloth. The recommended Cleaning method is wiping off with hot soapy water at max. 60°C (140°F). Disinfection methods using NuCidex , Corsoline , Sporicidin , Diversol BX , Ivisol or Jodoson are recommended. ®

®

®

®

®

Sterilisation methods such as Autoclaving (max. 140°C, 284°F), Irradiation (2.5 Mrads) or Ethylene Oxide can be used. WARNING Carefully follow the instructions for use, recommended by the manufacturer of the disinfectants and treatments, or local hygiene authorities.

Puller Head   

Remove the puller head from the puller motor by loosening the knurled screw. When replacing the puller head after sterilisation, engage the spindle by turning it. Tighten the puller head using the knurled screw. After wet sterilisation, run the puller mechanism back and forth to prevent dripping during the test.

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®

Clinic Hardware User’s Guide Maintenance of the Water Pump The Water Pump Unit must follow the general maintenance guidelines for the system. The pump is separated from the infusion liquid by the sterile pump tube. NOTE: When the pump door is closed, the infusion set should be able to stay open without dripping into the drip chamber. If it cannot then use the 2.5mm Allen Key provided with the system to rotate the two bolts underneath the front of the pump 4.25 turns inwards from flush.

Cleaning the rollers If the pump stops for no apparent reason, excessive friction between the rollers and pump tube due to blocked rollers might be the cause. Salification (salting) between the rollers and the pump wheel may also block the rollers. 1 2 3 4 5 6

Remove the cover of the pump unit by unscrewing the 4 screws in the bottom of the unit. Dismantle the screw and the nut connecting the pump wheel to the motor shaft. Pull the pump wheel out of the pump housing. Clean the pump wheel in hot water (65-90°C), until the rollers are free of salification and turn easily. The pump wheel must then be air-dried (i.e. using compressed air). The inner bearings and rollers, in particular, must be carefully dried. Lubricate the inner bearings using ordinary bearing grease (available from bicycle shops).

7

Push the pump wheel into the pump housing and assemble with the screw and nut through the motor shaft.

1

Motor Screw Salifications Inner Bearings

3 5 7

2 4 6 8

Shaft Pump Wheel Nut Rollers Page 14 of 28

Clinic Hardware User’s Guide

Calibration Recommended Calibration Periods All equipment used for quantitative registration of physical parameters has to be calibrated to ensure accurate and reliable measurements as a basis for diagnostic decisions. Unit

Period

Water Pump

Each time the infusion set is changed

Pressure Channels

At least once a week, or whenever a transducer is replaced

Puller

At least twice a year

Spinning Disc Flow Meter

Once a week

Weight Cell Flow Meter

At least twice a year

Infused Volume Meter

At least twice a year

Wireless Weight Cell Flow Meter

At least twice a year or when reason to doubt the logger arises such as accidently damaging the unit when it is dropped.

Optional Parts and Accessories Use only the parts as listed below or alternatives recommended by Mediwatch: Part Number Description Manufacturer 9034K0103 9034K0202 9023H0074 E0016

Spinning Disc Flow Meter Weight Cell Flow Meter Puller Mechanism Wireless Weight Cell Flow Meter

Mediwatch Mediwatch Mediwatch Mediwatch

9013L4402 9013L0322 9013S0222 9021S0232 9021P1872 9013C0122 9013C0142 9013C0742 9013C0312 9013S0744 9013S0774 9013L0332 9013L4812 9021L0203

20 x St. Mark's Pudendal Electrodes Cable for St. Mark's Pudendal Electrode Pre-Gelled Small Surface Electrode Pre-Gelled Large Surface Electrode Surface EMG Electrode Set 1 pc Cable for Surface Electrodes with 2 x 0.7mm connector Cable for Surface Electrodes with 3 x 0.7mm connector Electrode Cable, Ground, Hush Yoke Cable 1.5 m, 1.5-DIN Ground Electrode 75cm x 20mm Ground Electrode 45cm x 20mm Cable for disposable Anal Sphincter Electrode 25 x Disposable Anal Sphincter Electrodes 25 x Vaginal surface electrodes

Mediwatch Mediwatch Mediwatch Mediwatch Mediwatch Mediwatch Mediwatch Mediwatch Mediwatch Mediwatch Mediwatch Mediwatch Mediwatch Mediwatch

There is also a complete range of urodynamic consumables available from Mediwatch or their distributor, including water-charged catheters, air-charged catheters, pressure transducers, EMG electrodes, and H2O infusion tube sets. Page 15 of 28

Clinic Hardware User’s Guide

Cleaning Device Cleaning – Main Unit (Cart, Mini-PC, Printer, O pole) • • •

•

Wipe the device gently using a damp cloth. Dry using a new tissue or dry cloth. If required use a hard surface wipe. Allow the system to dry To mildly disinfect the device, use a cloth damped with 70% or less alcohol solution. Do not soak the device in an alcohol solution. Devices can be disinfected using Sani-Cloth (available from Mediwatch, or other sources), germicidal disposable wipes by Professional Disposables International. Use according to the manufacturers directions. Other hard surface wipes can also be used.

Flow Meter (Spinning Disc) • Slowly pour clean water through the flow unit after each patient to flush the urine through the unit. Wash in hot water with detergent. • After the procedure has finished, remove and wash the jug in hot water with detergent. • If deep cleaning is required the jug can be steam sterilised. • DO NOT USE Milton Solution which will eat the stainless steel and destroy the jug. • The funnel, spinning disk and pot can be cleaned using detergent and hot water. They should be allowed to dry. • They can be wiped over with hard surface wipes, or Sani Cloths as above. Weight Cell Flow Meter • The weight cell jugs should be removed and cleaned using hot water and a mild detergent and left to dry. • They can be wiped over with Sani Cloth or a hard surface wipe. • The Weight Cell Flow Meter should not become contaminated with patient’s fluids. • If this happens, wipe over the device with Sani Cloths, hard surface wipes, or damp cloth. • Allow the device to dry before reuse. Check operation of the device before reuse.

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Clinic Hardware User’s Guide Pressure transducers.  The pressure transducers are covered with a membrane and no patient contact should occur.  The Medex pressure transducer and cable can be wiped with hard surface wipes and allowed to dry. Water Pump.  The water pump is not require to be dismantled for cleaning in normal use.  The water pump door should be opened and the water pump roller and door should be wiped over using a damp cloth, or hard surface wipes as above.  No patient fluids should come into contact with the water pump. Infused Volume Meter  The Infused Volume Meter should not come into contact with the patient, in normal use.  Wipe over the device at the end of the clinic with hard surface wipes. Puller Mechanism.  The puller mechanism does not come into contact with the patient in normal use.  The puller can be wiped with a dampened cloth hard surface wipes.  If deeper cleaning is required the puller spindle can be removed and steam sterilised.  The motor assembly cannot be steam sterilised. • • • •

•

NOTE: Always follow these basic precautions for cleaning and high level disinfection: DO NOT soak the device in alcohol. Alcohol is nearly inactive against certain organisms. DO NOT rub the device with an abrasive sponge when washing with soap and water. Use a soft cloth or towel. NOTE: DO NOT immerse any part of the system, or the peripheral devices in any liquid to facilitate cleaning (with the exception of the funnel, jug and spinning disk). NOTE: Sani Cloth should not be used on any part that is introduced directly into the human body, or with the bloodstream. For more information please see manufacturers’ information.

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Clinic Hardware User’s Guide Agents and procedures that may damage the unit: Some agents and procedures damage devices. Use of any of the following procedures or products WILL VOID your device warranty. • • • •

Acetone, Methanol, Denatured ethyl alcohol, Mineral oil, Iodine Any lotions or gels containing perfume Autoclaving Soaking the device in chlorine bleach

Handling and Care Although the device is produced with the utmost care and only the highest quality components are used, maintenance will be necessary from time to time to ensure trouble-free operation. • • •

A contract for yearly service can be made with your local representative. Remove loose dust from the exterior with a soft cloth or a dry brush. A solution of water with a mild detergent may be used. Avoid abrasive cleaners.

Warnings and Precautions Always follow these basic precautions: • Inspect the cables daily for damage to the cable or connector. • DO NOT use cables that are cracked or damaged • To avoid the risk of explosion the equipment must not be operated in the presence of flammable anaesthetics • To avoid the risk of shock do not open the equipment. Refer servicing to qualified personnel only • Be careful not to place the patient in contact with the urodynamic equipment or other devices. If the equipment is defective, there is a risk of electrical shock. • The use of non-Mediwatch components with this device may result in damage to Mediwatch components • Do not position ME equipment to make it difficult to operate the disconnection device when an appliance coupler or separable plug is used Page 18 of 28

Clinic Hardware User’s Guide • • •

•

• • •

•

as isolation means. To prevent hazards, refer to your local requirements for adequate electrical installation in the case of class II type BF equipment. Do not subject the equipment to excessive shock The manufacturer, assembler, installer or importer considers himself responsible for the effects on safety, reliability and performance of this product only if: • Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorised by him. • The electrical installation of the relevant room complies with IEC requirements. • The product is used in accordance with the instructions for use. While there is no danger to the patient with an implantable pulse generator, stimulation equipment could cause mechanical damage to the IPG if used directly over the device’s implant site. Do not use the equipment in locations subject to intense electric or magnetic fields Do not use the equipment near devices generating high frequencies. If used near such devices, the equipment may malfunction or adversely affect the device. To guarantee proper unit operation, do not operate the device in an environment with a temperature in excess of 10 - 40 °C. If the equipment is used in a small room the temperature may rise. Proper ventilation must be provided. Avoid installation near a heater or in direct sunlight.

Cautions •

Warning: There is a possible explosion hazard if the Clinic is used in the presence of flammable anaesthetics.

Connections to External Ports All equipment connected to external ports must comply with EN 60601-1. Also, any electrically powered equipment connecting to these ports must not be accessible to a patient (Unless complying with EN 60601-1).

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Clinic Hardware User’s Guide

Technical Issues Avoiding, Identifying and Resolving Adverse Electromagnetic Effects Although the system has been tested satisfactorily to Electromagnetic Comparability Standards, it is recommended that the device is not used simultaneously on a patient, with other active diagnostic devices such as blood pressure monitoring equipment. An indication of adverse electromagnetic effects from the Clinic on another electronic device would be a degradation of performance in that other device when the Clinic is operated simultaneously. If such interference is suspected, separate the two devices as much as possible, or discontinue simultaneous operation, if practical, and contact Mediwatch UK Limited. The Clinic will operate normally in the proximity of other potential interference sources, and has demonstrated immunity at a field strength of 3 V/m (per EN 60601-1-2). In the event of any external electrical disturbance causing an abnormal condition, ensure the device has shut down, switch the device back on and continue using the device as normal. No other precautions need be taken as regards exposure in reasonably foreseeable environmental conditions to magnetic fields, pressure or variations in pressure, acceleration, or thermal ignition sources. The mains plug must only be inserted in a mains socket outlet provided with a protective earth contact. It is forbidden to use extension cords. WARNING Any interruption to the protective earth conductor inside or outside the system or disconnection of the protective earth connector is likely to make the system dangerous. Intentional interruption is prohibited. The protective earth (ground) conductor should be checked regularly.

Trouble Shooting •

Refer to technical reference guide (5024M009X)

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Clinic Hardware User’s Guide

Warranty Mediwatch UK Ltd guarantees the Clinic against defects in material and workmanship. This guarantee applies for 1 (one) year from the date of purchase from Mediwatch UK Ltd. This guarantee is given only to the original purchaser of the Clinic. *This guarantee does not cover equipment sold as used. Pursuant to this guarantee, Mediwatch UK Ltd will repair or replace products which prove to be defective during the guarantee period, provided that the repair is performed by Mediwatch UK Ltd or a Mediwatch authorised service organisation, and the instrument is returned to Mediwatch UK Ltd for service. In some countries, this guarantee statement is for information only. Specific guarantee terms may be found in the sales contract.

Disclaimer of Additional Guaranties There are no understandings, agreements, representations, of guarantees, expressed or implied (including guarantees of merchantability or fitness for a particular purpose) other than those set forth in the preceding section. The contents of this User’s Guide do not constitute a guarantee.

WEEE Directive - Device and Battery Disposal When the device reaches the end of its useful life please dispose of it in accordance with European Directive 2002/96/EC or local government regulations or at a recycling centre. Please ensure that you refer to any local restrictions on disposal and recycling. Alternatively please contact your local Clinic entity or distributor where you purchased the unit to arrange for it to be recycled.

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