VMX-1010A User Manual June 2010

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USER MANUAL

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MANUEL D’UTILISATION

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MANUALE PER UTILIZZATORE

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MANUAL DE USUARIO

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BETRIEBSANLEITUNG

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UŽIVATELSKÁ PŘÍRUČKA

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GEBRUIKERSHANDBOEK

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E N G L I S H CONTENTS

1 INTRODUCTION...3 2 SAFETY INSTRUCTIONS...4 A INTENDED USE B CONTRA-INDICATION C WARNINGS

3 STATUTORY RECOMMENDATIONS...7 A CONFORMITY B ELECTROMAGNETIC COMPATIBILITY C MEDICAL DEVICE VIGILANCE D END-OF-LIFE

4 DESCRIPTION OF FRONT AND BACK PANEL...8 5 SPECIAL FEATURES...9 A ENHANCED SAFETY B NORMAL MODE C RADIOLOGIST MODE D EXTERNAL DESUFFLATION E MONITORING OF BOTTLE PRESSURE F LCD DISPLAY G FILTERING

6 TESTING AND INSTALLATION...12 A INSPECTION OF THE DEVICE B ACCESSORIES C OPTIONAL EXTRAS D ELECTRICAL CONNECTIONS E EQUIPOTENTIAL BONDING F CONNECTION TO GAS BOTTLE G DISCONNECTING THE GAS BOTTLE

7 ESTABLISHING AND MAINTAINING COLONIC DISTENSION...14 A OPERATING THE MACHINE B CONNECTING AND DISCONNECTING THE TUBING ON THE MACHINE C CHANGING SETTINGS VIA THE MENU D SELECTING THE PRESSURE SETPOINT E SELECTING THE FLOW SETPOINT F STARTING THE INSUFFLATION G SLIGHT OVERPRESSURE - SLOW DESUFFLATION H LARGE OVERPRESSURE - RAPID DESUFFLATION I MONITORING THE FLOW J MONITORING THE VOLUME OF GAS CONSUMED K AUTOMATIC PAUSING OF INSUFFLATION L MONITORING AVAILABLE GAS LEVEL M END OF COLONIC DISTENSION

8 FAULTS AND ALARMS...20 9 CLEANING / SERVICING / MAINTENANCE...21 A CLEANING / DECONTAMINATION B SERVICING / MAINTENANCE

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10 SYMBOLS USED...22 11 TECHNICAL SPECIFICATIONS...23 12 ANNEX...24

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E N G L I S H 1

INTRODUCTION

Thank you for placing your trust in us by purchasing this product. Text marked by the symbol

must be given particularly careful attention.

Text marked by the symbol

is provided for information.

Abbreviations/terms frequently used in this User Guide: > l/min litres per minute > mmHg millimetres of mercury

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E N G L I S H 2

SAFETY INSTRUCTIONS

Read this manual carefully before using the device, especially the sections dealing with safety conditions and environmental requirements for the equipment.

A INTENDED USE This machine is designed to be used exclusively for virtual colonoscopy, which is a non-invasive radiological examination procedure using an X-ray or CT scanner during which carbon dioxide gas (CO2) is introduced into the colon for diagnostic purposes. It provides a completely safe means of performing colonic distension.

The purpose of this User Guide is not to instruct the user in how to carry out a virtual colonoscopy, but to explain in simple terms how the apparatus is used.

B CONTRA-INDICATION The use of this device is contra-indicated whenever virtual or conventional colonoscopy is contra-indicated.

This device is contra-indicated for hysteroscopic insufflation; it must not under any circumstances be used for intra-uterine distension.

C WARNINGS

This apparatus should be used exclusively by a radiology physician with experience in this technique.

In case of an emergency requiring insufflation to be suspended, the technician must shut off the CO2 supply by quickly disconnecting the administration tube from the exit port of the machine. > Always ask the patient to tell the technician if the examination becomes painful.

> The machine may release CO2 into the ambient atmosphere if used incorrectly or in case of a malfunction. Use and store the machine in a well ventilated place. Also make sure that all connections to the CO2 bottle are properly made and the fittings have no visible damage. In the event of an unexpected rapid release of CO2, evacuate the premises until properly ventilated. > Excessive absorption of CO2 results from excessive flow or excessive pressure, or both. Adequate respiration will help prevent problems related to CO2.

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E N G L I S H 2

> The colon can be adequately distended by pressure in the range 15 to 25 mmHg. The selection of a pressure setpoint or of a flow setpoint superior to 3L/min is only justified for obese patients. > Compatibility between this device and MRI scanners has not been verified; it must therefore not be placed in an MRI examination room. > Metabolic acidosis and resultant cardiac irregularity

Prolonged intra-colonic pressures greater than 20 mm Hg should be avoided; this will increase the amount and rapidity of intra-vasation. This can cause any of the following: - Decreased respiration with compromised diaphragmatic excursion - Decreased venous return - Decreased cardiac output - Acidosis > Idiosyncratic reactions

In patients with microdrepanocytic disease, sickle cell disease or pulmonary insufficiency, use of these devices may pose increased risks of metabolic imbalance related to excessive CO2 absorption. > In certain rare cases, accidental intravasation of CO2 may present a risk of embolism.

> The absorption of CO2 can cause irritation of tissues coming into direct contact with carbonic acid.

> Tubing and Filter The use of a 0.027 micron hydrophobic bacterial and viral filter is essential to prevent patient crosscontamination.

To ensure patient safety, it is essential to use VIMAP single-use tubing fitted with a viral hydrophobic filter and to replace the tube set for each patient. The use of any other tubing is prohibited.

Usable tubings: Reference VIMAP > AS-S-R35-B linked to AS-Y-XX10A > AS-S-R50-B linked to AS-Y-XX10A > AS-L-R35-B linked to AS-Y-XX10A > AS-L-R50-B linked to AS-Y-XX10A > AS-Y-L-R35A > AS-Y-L-R50A

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E N G L I S H 2

> High-pressure hoses

Check that the high-pressure gas lines are properly connected before opening the gas cock. There is a risk that a poorly-made connection could open abruptly and cause injury. > CO2 Gas Bottle

Use only medical grade CO2 in bottles pressurised to 70 bars maximum.

High-pressure medical CO2 is commercially available in bottled form. Carefully read and follow the warnings, safety precautions and instructions for use of these bottles. Failure to comply with these instructions carries a risk of serious injury or death. > To avoid electrocution, the power supply cord must only be connected to a properly earthed outlet. > Follow the instructions for use and storage.

> Do not expose the device to excessive quantities of dust.

> This unit must only be opened by a technician approved by the manufacturer.

> Do not insert metal objects into the device to avoid the risk of electrocution, fire, short-circuit or hazardous emissions. > Do not expose the device to water vapour or splashing or install in an area subject to very high levels of humidity. > Only use accessories supplied with the device or recommended by the manufacturer as optional extras. > Do not connect this device to any other.

> This device must not be used in the presence of inflammable anaesthetics. > This device was not designed for use in an ionising environment.

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E N G L I S H 3

A CONFORMITY

STATUTORY RECOMMENDATIONS

This device was designed and manufactured by a company with a certified quality system. It conforms to the requirements of European Directive 93/42/CEE on medical devices. It therefore conforms in particular to specific standards on electrical safety (IEC) and electromagnetic compatibility (EMC).

B ELECTROMAGNETIC COMPATIBILITY

Although this product is compliant with the standards on electromagnetic compatibility (Annex), it is possible that, in some very specific circumstances, it could disturb other devices or may itself be subject to disturbance by other devices or by an unfavourable electromagnetic environment. The following is recommended to avoid this type of situation:

> Ensure the quality of the power supply (in particular the earthing system for all apparatus and racks); > Keep the device away from electromagnetic sources (e.g. mobile telephones, GSM telephones,compressors, motors, transformers, HF generators in general, etc.).

C MEDICAL DEVICE VIGILANCE

Like any medical system, this device is subject to the requirements relating to medical device vigilance. It is imperative therefore that any malfunction be promptly notified to the competent authority and to the manufacturer, giving as much detail as possible. See last page for manufacturer's contact details.

D END-OF-LIFE

This device is marked with the recycling symbol in compliance with European Directive 2002/96/ on Waste Electrical and Electronic Equipment (WEEE). By disposing of this device properly you are helping to prevent any harmful effects on the environment and human health. The symbol marked on the device and/or present in the accompanying documentation indicates that this product may not under any circumstances be treated as domestic refuse. It must therefore be taken to a waste collection centre with facilities for recycling electrical and electronic equipment. Disposal must be carried out in compliance with the waste disposal regulations applicable in the country of installation. For further information on the processing, recovery and recycling of this equipment, please address any enquiries to your local authority, waste collection contractor, or directly to your reseller. VMX-1010A - 011329D - 06/2010

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E N G L I S H 4

DESCRIPTION OF FRONT AND BACK PANEL The Figures are at the beginning of the manual Reference on Front Panel A B

C

D

5″7 inch LCD screen Alarm indicator

Patient insufflation tube port

External desufflation tube port

E

Stop insufflation / Reset counters and parameters by default

G

Select and confirm knob

I

Run/Standby LED

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Reference on Back Panel 1

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Start insufflation

Run/Standby button

Description

CO2 inlet

On/Off switch

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Fuse compartment

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Earthing socket

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Description

Mains socket Label

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E N G L I S H 5

A ENHANCED SAFETY

SPECIAL FEATURES

> Self-test

Auto-calibration of the device and testing of its vital functions takes just a few seconds at the starting of the device. > Tube detection

The device will not start without an external desufflation tube being connected (impossible to connect a single tube for safety reasons). > Automatic control of insufflation flow

This device automatically controls the insufflation flow to maintain a colonic distension pressure equal to the pressure setpoint. The selected flow is a maximum flow which will not necessarily be reached. > Additional pressure sensor

The coherence of the measurements is monitored continuously so that, in case of a fault in the measuring circuit, the insufflation cycles can be stopped if the slightest doubt arises. > Safety valves

In case of failure at the pressure reducer, a first safety valve limits the pressure to 0.8 bars +/-0.1 bars. A second valve limits the insufflation pressure to 65 mmHg maximum.(+/- 5mmHg). > Message display "Colon insufflated"

When the volume of CO2 insufflated is greater than 1,1l and according to the flow and pressure variations.

B NORMAL MODE

In this mode, the pressure setting can be adjusted to between 5 and 25 mmHg and the insufflation flow between 1 and 3 litres/minute. The device starts in this mode by default.

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E N G L I S H C RADIOLOGIST MODE

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This mode should be used for more complicated cases such as obese patients. In this mode the pressure setting can be adjusted to between 12 and 35 mmHg and the insufflation flow between 1 and 4 litres/minute. To activate this mode it is necessary to increase the pressure setting and accept a confirmation message.

This mode must be activated exclusively by a radiology physician with experience in this technique.

D EXTERNAL DESUFFLATION

The device has a system to allow the desufflation of CO2 to the outside of the device to avoid:

> overpressure in the colon, > backflow of fluid into the device, thus avoiding any risk of damage or contamination.

E MONITORING OF BOTTLE PRESSURE

When the bottle pressure reaches the 20 bars threshold, the device communicates to the user via: > Display of bottle pressure in the alarm messages field > A red LED illuminated continuously

When the bottle pressure reaches the 10 bars threshold the device is prevented from starting.

F LCD DISPLAY

For enhanced communication with the user and to improve usability, we have equipped our latest range of insufflators with a 5″7 LCD display. It provides a clear display of the following in 5 different languages: > Alarms and error messages in text format > Number of exams performed(in the Menu) > Duration of examinations, > Indication of pressure setpoint and actual pressure in mmHg > Indication of flow setpoint and actual flow in litres/minute > Indication of CO2 volume consumed in litres > Indication of machine status: RUN /PAUSE /STOP > Choice of 5 languages > At the starting : Number of exams performed before Service

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E N G L I S H G FILTERING

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> CO2 bottle side

A particulates filter is placed at the CO2 inlet to prevent the ingress of dust sometimes present in the CO2 bottles. > Patient side

To ensure patient safety, it is essential to use VIMAP single-use tubing fitted with a viral hydrophobic filter and to replace the tube set for each patient. The use of any other tubing is prohibited.

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E N G L I S H 6

TESTING AND INSTALLATION

A INSPECTION OF THE DEVICE

Any damage, malfunction or missing accessory must be reported immediately or confirmed by the carrier and/or reseller by registered letter so that it can be covered by the warranty as appropriate.

Retain the original packaging so that the machine can be returned for annual maintenance. Attach a document giving your name, address and reason for returning the machine (problem found).

Place the machine on a flat dry surface. This apparatus must be operated in the horizontal position and must be placed higher than the patient to prevent any backflow of liquid through the tubing.

B ACCESSORIES

Your product is supplied complete with the following accessories: 1 > User manual 1 > 2.50 m mains power cord 1 > Wrench for connection of high-pressure hose

C OPTIONAL EXTRAS

> VIMAP single-use tube > PIN INDEX connector DIN 477-1 n° 6 or US 7/16″. > High-pressure CO2 delivery hose (Pmax : 200 bars), 1m long, standard bottle connector DIN 477-1 n° 6 or US 7/16″.

D ELECTRICAL CONNECTIONS

Check that the characteristics of the main power supply are 100 to 230VAC and 50 Hz - 60 Hz with a power requirement of 55 VA.

Connect the power supply cord on the back panel at [4]. Connect the power supply cord to the electrical supply.

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E N G L I S H 6

In the United States and Canada, use the Hospital Grade power cord provided, which must be connected to a Hospital Grade mains power outlet.

This device is protected by 2 x 2.5A slow-blow power fuses (UR) on the back panel at [3]. Do not use fuses with different ratings or fuses that are not UR certified.

E EQUIPOTENTIAL BONDING

Measures to safeguard against electrostatic discharge (ESD) are as follows: • Equipotential bonding of all apparatus to be connected. Attach the bonding cable to the connector [5] on the back panel. • Use only the accessories specified.

F CONNECTING TO THE GAS BOTTLE

Maximum allowable operating pressure (70 bars)

Install the CO2 gas bottle vertically and securely, with the head uppermost, on the same stand as the insufflator if possible. Never use the device if it is connected to a bottle placed horizontally or upside down.

Check that the seal is present on the high-pressure hose on the bottle side (DIN only).

Using the wrench provided, tighten the fitting connected to the bottle outlet, then tighten the fitting connected to the insufflator inlet port [1].

G DISCONNECTING THE GAS BOTTLE

Before unscrewing the high-pressure hose, check that the bottle valve is closed, then reduce the pressure in the circuit by loosening the connector slightly.

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E N G L I S H 7

ESTABLISHING AND MAINTAINING COLONIC DISTENSION This apparatus is intended exclusively for colonic distension. Any use for other purposes constitutes misuse of the product for which the user will be liable and for which the manufacturer accepts no liability. The safety features incorporated into this device do not in any way release medical personnel from their responsibility to monitor and keep a constant check on the patient's condition.

A OPERATING THE MACHINE User action

Move the back panel switch [2] to "I" Open the gas bottle Press the button [H] on the front panel

SELF-CALIBRATION takes a few seconds.

You can now connect the tubing as described in the next section.

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Machine reaction

The machine powers up and the front panel indicator [I] flashes

The front panel indicator [I] is illuminated. A welcome screen appears showing the number of exams that can be carried out before maintenance The machine performs a self-calibration

The machine is ready to start.

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E N G L I S H 7

B CONNECTING AND DISCONNECTING THE TUBING ON THE MACHINE The manufacturer accepts no liability in case of incident or malfunction resulting from the use of damaged or unsuitable tubing. Do not use tubing if the packaging is damaged. Tubing is for single use, do not re-sterilise or re-use. The use of a hydrophobic bacterial and viral filter is essential to prevent patient cross-contamination. Open the tubing film pack. Connect the tubing to the patient outlet port of the device (gas outlet).

Position the other portion of the tubing in the external desufflation valve.

The tube must be inserted freely without kinking and must not be blocked. Do not interchange the two tubes, they have different diameters. > Refer to the tubing manual for patient-side connections.

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E N G L I S H 7

C CHANGING SETTINGS VIA THE MENU The MENU is displayed on start up and the user can reach it. To change a setting, scroll to the desired setting using the selector knob [G]. Press the knob to select: > Language option: English, French, German or Dutch (according to the version), Italian and Spanish. (English is the default setting). > Number of interventions performed. > Duration of last intervention > Adjust contrast > Recommended pressure

The setting is highlighted on the display

Turn the knob to scroll through the range of values and press to accept. To go back select "Back" and validate. The recommended starting pressure is limited to 22 mmHg max

D SELECTING THE PRESSURE SETPOINT

This operation must always be performed by or under the supervision of a radiology physician.

By default the insufflator starts with a pressure setpoint of 15 mmHg. This value can be changed (Part C) and saved but will be limited by the recommended pressure. Select the colonic distension pressure to between 6 and 35 mmHg using the selector knob [G]. The pressure most commonly used is 15 mmHg. As a safety precaution, you will be asked to confirm any setting above 25 mmHg.

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E N G L I S H 7

E SELECTING THE FLOW SETPOINT

This operation must always be performed by or under the supervision of a radiology physician.

By default the insufflator starts with a flow setpoint of 3 litres; this value can be modified between 1 and 4 litres and saved via the main display (saving limited to 3 litres). Select the flow setpoint (maximum flow) from 1, 2, 3 and 4 litres/minute using the selector knob [G]. As a safety precaution, you will be asked to confirm the change from 3 to 4 litres/minute.

F STARTING THE INSUFFLATION Insufflation will start when the RUN button [F] located on the front panel is pressed. A screen icon indicates the activation of RUN mode. The MENU is not accessible while the machine is running. To access the menu insufflation must be stopped by pressing button [F]. Insufflation starts by increasing the flow without exceeding the selected maximum flow. Once the pressure setpoint is reached, insufflation stops. Insufflation restarts when the intracavity pressure falls below the pressure setpoint. The pressure and flow setpoints can be modified at any time.

G SLIGHT OVERPRESSURE - SLOW DESUFFLATION When the intra-colon pressure exceeds the pressure setpoint by 2 mmHg for a duration of 3 seconds the message "OVERPRESSURE" is displayed and a slow desufflation is initiated to keep the colon inflated while eliminating the overpressure. A visual alarm indicator [B] is activated during the overpressure.

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E N G L I S H 7

H LARGE OVERPRESSURE - RAPID DESUFFLATION When the intra-colon pressure exceeds the pressure setpoint by 10 mmHg the message "OVERPRESSURE" is displayed and a rapid desufflation is initiated for 3 seconds to reduce the overpressure. A visual alarm indicator [B] and an audible alarm (beep) are also activated.

I MONITORING THE FLOW The instantaneous flowrate is indicated in litres/minute on the LCD screen. It will not exceed the maximum flow setpoint.

J MONITORING THE VOLUME OF GAS CONSUMED The volume of gas consumed is indicated on the LCD display in litres to within a decilitre. This counter is activated when the RUN button [F] is pressed and is reset to zero when the machine is switched off or when the RESET button [E] is pressed.

K AUTOMATIC PAUSING OF INSUFFLATION After 5 litres of CO2 have been insufflated the device displays PAUSE in the alarm field and stops the insufflation of gas (flow 0 litres/minute). Desufflation is not activated, making it possible to keep the colon distended if there are no leaks. A single press of the RUN button will restart the insufflation. Beyond 5 litres, the device will pause at 2.5 litre intervals up to 12.5 litres. At 12.5 litres, the examination is stopped, the machine stops completely and rapid desufflation is initiated.

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