4500 Instruction Manual Issue 15 Oct 2004

Index Description

Page

1

General Information

1

2

Device Delivery

1

3

Assembly and Preparations for Use: Assembly of mobile stand with basket

2

Assembly of universal clamp and cover

3

Air Pressure Connection

3

4

Technical Data

4

5

Operating Instructions Tourniquet Cuffs

4

6

Operating Instructions Tourniquet Device

5, 6

7

Safety Instructions

7

8

Functions of Digital Clock/Timer

8

9

Cleaning Instructions

8

10

Service

9

1 General Information

2 Device Delivery

Intended Use The Tourniquet 4500 is a pneumatic unit for use with Double Cuffs for Intravenous Regional Anesthesia (IVRA).

Device Delivery complete with: • hand inflation bulb for manual use • cover • air pressure tubing 4 m long • connection tubing to Tourniquet Cuff

Instruction Manual

Types of attachment according to:

Before use, review this manual with safety instructions carefully. This device is to be used only by trained medical personnel.

REF 19-14-500 Tourniquet with attachment device for theatre ceiling

Medical Device Directive This Tourniquet device complies with the requirements of the European Directive 93/42/EEC for medical devices.

REF 19-11-500 Tourniquet with steel clamp

Indications • Technical modification reserved! • Waste management of devices or spare parts has to be carried out according to valid local legal regulations.

REF 19-12-500 Tourniquet as table unit without cover

EC-certificate The device is certified by the TÜV Product Service GmbH for Qualitysystem. For more information contact VBM or see in the internet: http:www.vbmmedical.de Download QM-Certificates EC-Certificate Device Class IIa

REF 19-13-500 Tourniquet with universal clamp

REF 19-15-500 Tourniquet on mobile stand with basket

REF 19-22-500 Tourniquet on mobile stand with basket and without cover

Tourniquet Cuffs and further accessories are not included in the device delivery and have to be ordered separately. Detailed product information are available at VBM. -1-

3 Assembly and Preparation for Use500 Assembly of mobile stand with basket REF 19-15-500

Assembly of mobile stand with basket for table unit REF 19-22-500 • For assembly of mobile stand please see „Assembly of mobile stand with basket for accessories REF 19-15-500“ • Fix the square rail by means of the two hexagon socket screws to the support rod (see a) • Attach the fixation plate with the hexagon socket screw M6x10 to the support rod (see b)

• Insert the guide cap (6) into the base (1). • Attach the aluminium legs with lock-type rollers (2) to the base (1). • Attach the aluminium legs with ordinary rollers (3) to the base (1). • Fasten the aluminium legs with five hexagon socket screws M8x40 (4) and five lock washers (5) using the hexagon socket wrench (7). • Insert the support rod (8) into the base (1). • Fasten the hexagon socket screw M8x22 (9) with the lock washer (10) to the base (1) using the hexagon socket wrench (11).

b

a • Attach the fixation plate with the 2 hexagon socket screws M6x10 to the lower device housing (see c).

c Attach the angle bracket with basket with both hexagon socket screws M6x10 to the upper device housing.

• By means of the metal hook (see d) hang the basket to the square rail (see e).

d e Place the Tourniquet device with the angle bracket and basket onto the support rod. Insert the attached hexagon socket screw M8x25 with the serrated lock washer through the bore of the angle bracket into the bore of the support rod. Fasten the screw using the hexagon socket wrench.

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3 Assembly and Preparation for Use Assembly of the universal clamp (REF 19-13-500)

Air Pressure Connection Connect the air pressure tubing with the mounted quick connect coupling to the plug on the rear panel of the device. Connect the tubing’s other end (with an appropriate air pressure plug, not part of delivery) to the central air pressure supply.

Attach the universal clamp with the enclosed hexagon socket screws M6x25 either vertically or horizontally to the press nuts on the housing cover. Therefore the Tourniquet device can be fixed to each tabletop, operating table, rail or support rod.

By connecting to the central air pressure supply (pressure input min. 2 to max. 10 bar) the pneumatic indicator at the front panel of the device changes from white to green. The Tourniquet device is set in motion.

Assembly or Disassembly of the cover Detach the cover in the following manner: • Place the cover on the device top • Pull out both shafts with a flat nose pliers outside from the bearing bushes

Warning The pressure infusor has only to be used with compressed air!

Mount the cover to the device top as following: • Place the cover between the bearing bushes of the device cover. Please note that the coil tubings lie outwards through the spaces of the cover • Place both shafts left and right into the fixation bores so that the groove of the shaft shows inside • Both shafts are inserted as far as possible with a drift punch

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4 Technical Data

5 Tourniquet Cuffs

Weight (table unit)

3.74 kg

Dimensions Height Width Depth

150 mm 320 mm 200 mm

Operating pressure

2 – 10 bar

Regulation range

0 – 600 mmHg

Regulation accuracy

± 2 – 3 mmHg

Adjusted pressure limit

600 mmHg

Display accuracy of the gauge

± 10 mmHg

Time Alarm

Audible alarm when time reaches zero (countdown function)

Connection Tourniquet System

blue coil tubing (proximal) with female screw connector, red coil tubing (distal) with male screw connector

VBM offers the following double cuffs for Tourniquet 4500:

Fabric Cuffs With fabric cover, silicone bladder and plastic splint (REF 20-50-xxx)

Silicone Cuffs • with fabric cover, velcro clasp, silicone bladder, silicone splint (REF 20-60-xxx) • with silicone bladder, silicone splint and red and blue strap (REF 20-90-xxx) VBM double cuffs are colour-coded. The distal chamber of the double cuff is indicated red, the proximal chamber is indicated blue. The double cuffs have tube connections which avoid mix up: male screw connector for proximal chamber, female screw connector for distal chamber.

Attachment and Securing of the cuff See respective instructions for use included with each VBM Tourniquet Cuff.

Environmental conditions: Transport/Storage

-10 ... +60°C

Operation

+10 ... +40°C 30 ... 95% atmospheric humidity without condensation

Warning Choose the adequate cuff pressure depending on cuff size and systolic blood pressure in the extremity to guarantee a safe bloodless field and gentle treatment of the patient. The recommended cuff pressure is indicated in the corresponding instructions for use for VBM Tourniquet Cuffs. There you can also find the maximum cuff pressure, which should not be exceeded to prevent skin lesions. The duration of the cuff pressure must not exceed two hours.

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6 Operating Device

Instructions

Tourniquet

After securing the double cuff, the Tourniquet Device has to be operated in the following way:

Manual Use (Safety System)

1. Set the preselector of the precision pressure regulator anti-clockwise to zero.

The Tourniquet device can also be operated in manual mode with a hand inflation bulb. This offers two big advantages:

2. Connect the device to the central compressed air supply. The pneumatic indicator changes from white to green. The device is set in motion.

• It is possible to disconnect the Tourniquet device from the central compressed air supply in order to transport the patient with the Tourniquet in situ.

3. Link up connecting tubes of the double cuff with the screw connectors of the device (pay attention to the colour code).

• In case of an air pressure supply failure this guarantees that the operation can be continued safely.

4. Turn the pressure switch knob to “Proximal”. 5. Fill the blue proximal chamber by turning the precision pressure regulator to the desired value. The actual proximal chamber pressure is displayed constantly on the right gauge of the device. 6. The proximal chamber pressure can be regulated with the precision pressure regulator at any time. 7. After injection of the local anesthetic the distal chamber of the double cuff has to be inflated. Therefore the pressure switch knob has to be turned from “Proximal” to “Distal”. The distal chamber will now automatically inflate to exactly the same pressure as the proximal chamber. Both gauges will then indicate the same preselected pressure. However the distal chamber pressure can be regulated with the pressure regulator at any time.

In case of an air pressure supply failure or disconnection from the central compressed air supply the Tourniquet device automatically changes to the manual mode (see indicator). This means: 1. The actual selected cuff pressure remains constant in the Tourniquet system. 2. Further inflating of the cuff has to be done with the hand inflation bulb. 3. The cuff can be emptied by pressing the red (distal) or blue (proximal) flush button.

8. The proximal chamber can now be deflated by repeatedly pressing the blue proximal flush button. The proximal chamber is completely emptied if the pointer of the right gauge is decreased to zero. 9. After the operation has been finished the distal chamber has to be emptied slowly by turning the pressure regulator anti-clockwise to zero.

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6 Operating Instructions Tourniquet Device a) Analogic Gauges Pressure limit of 600 mmHg; display always the actual cuff pressure

d) Indicator Compressed Air / Manual

b) Precision Pressure Regulator Precise pressure regulation; automatic pressure compensation; safety knob prevents accidental movement; adjusted pressure limit of 600 mmHg

c) Colour Coded Coil Tubings (red and blue) With screw connectors to prevent incorrect positioning; built into device, therefore absolutely leak proof

e) Timer Countdown timer with alarm

c

a

d b e

f

h g

f) Flush Buttons (red and blue) Pushing deflates the cuff immediately, afterwards the cuff inflates back to the same pressure setting; excellent to check for bleedings and also for releasing anesthetic after I.V. Regional Anesthesia

g) Pressure Switch Knob Allows a quick and exact pressure switching from proximal to distal chamber

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h) Manual Safety System with Hand Inflation Bulb Changes automatically into manual mode in case of air pressure failure

7 Safety Instructions Air Pressure Connection

Manual Use

The Tourniquet device has to be used only with compressed air!

• Please notice that manual mode and pressure regulator are independent of each other. This means that if the device is connected to the central air pressure supply, the cuff will inflate to the setting of the pressure regulator independent from the pressure adjusted by means of the hand inflation bulb. Therefore it is very important to check the position of the pressure regulator knob.

Accessories • Make sure to select the right cuff size for the respective extremity. VBM offers a complete range of Tourniquet cuffs. • VBM Tourniquet cuffs and the coil tubings of the Tourniquet device have male and female screw connections to prevent mistakes. If cuffs of other manufacturers are used, first ensure that there is compatibility between the fittings. • Also insure that damaged cuffs and connections are no longer used. • Make sure that the red part of the VBM double cuff is put on distally.

• Please also notice when using the device in manual mode possible leakage will not at all be compensated automatically. Therefore the device should normally be used with compressed air. The manual safety system is an additional option in case of air pressure failure.

Before Use Before each use of the Tourniquet device check that the entire Tourniquet system is fully functional and air-tight. Therefore the cuff can be put around a bottle and inflated to the maximum pressure of 600 mmHg. After that disconnect the Tourniquet device from the central air pressure supply. The pneumatic indicator changes from green “Compressed Air” to white “Manual”. Check the pressure constancy on the analogic gauge. The pressure on the gauge should not decrease more than 30 mmHg within 5 minutes. If there is more pressure decrease, the device has to be inspected as described in “Inspection”.

Operating • Before the cuffs are connected to the Tourniquet device, always check that the pressure regulators are turned anti-clockwise to zero. • Never clamp off the tubings between the device and the cuff. • During inflation of the cuff make sure that the cuff is filling properly by touching it with the hand. • During the operation check the cuff pressure continuously on the gauge. The gauge of the device always displays the exact pressure in the cuff. Any pressure decrease is indicated on the gauge.

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8 Operating Instructions Digital Clock/ Timer

9 Cleaning Instructions

Tourniquet Device

2 1 3

Cleaning Wipe the device with a soft and damp cloth. Disinfection Wipe the device with a cloth that has been dampened with commercially available disinfectants in low concentration. Never immerse the Tourniquet unit in liquids!

10

4

9

5 6

7

Sterilisation Do not sterilise the Tourniquet unit!

8

The Digital Clock / Timer for clock time and timing (countup and countdown) is operated in the following way:

Tourniquet Cuffs

Functions of Keyboard: 1 displays time in hours 2 displays time in minutes 3 displays time in seconds 4 Clock button 5 Hour button 6 Start/Stop button 7 Minute button 8 Reset button 9 Second button 10 Timer button

Cleaning, Disinfection, Sterilisation See respective instructions for use included with each VBM Tourniquet Cuff.

Setting the Clock: • Press the Clock button down for approximately 3 sec. until the digits flash in display • Press HR button to advance to correct hour; continue also with MIN and SEC button; to fast forward hour or minutes, hold the respective button down • Press clock button to start clock • Press Start/Stop button for 3 seconds to change between AM and PM Setting Timer for Countdown: • Press Timer button; press Reset button to clear display to zero • Press HR, MIN and SEC buttons to display the desired time in hours, minutes or seconds; when holding about 2 seconds the digits will advance rapidly • Press Reset button once to correct and for new time setting • Press Start/stop button to start countdown • Press Start/Stop button once to interrupt countdown, then Start/Stop button once to continue timing • When the countdown reaches zero, an alarm will sound (duration 1 minute); at this moment the timer will automatically count up in seconds to show the time elapsed since the alarm sounded The alarm and count-up can be stopped by pressing the Start/Stop button Setting Timer for Count-up: • Press Timer button; Press Reset button to clear display to zero • With timer cleared to 0:00 00 , press Start/Stop button; Timer will begin counting up in seconds • To stop the count-up, press Start/Stop button once • To continue the count-up, press Start/ Stop button once more

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10 Service Inspection If the pressure decreases more than 30 mmHg in 5 minutes (see “Safety Instructions”), check the Tourniquet device for leakage in the following way: • Check the connection between device and cuff; reconnect the screw connectors; inspect the sealing ring in the female screw connector for any damage • Inspect the cuff and the connection tubings for damage • Then disconnect the cuff from the device and close the screw connector of the coil tubing with the attached thread plug; if the pressure decreases again, the leakage is in the device; then the device must be sent to VBM for further inspection; otherwise the Tourniquet Cuff has to be replaced. In case of other defects or irregularities, please contact VBM or the authorised VBM service. If necessary, the device has to be inspected by VBM.

Repairs Repairs may only be carried out by VBM or the authorised VBM service. Otherwise VBM cannot be held responsible for safety, reliability and performance of the device. Any guarantee or warranty claims against VBM are invalid if the user or an un-authorised service agency attempts the repair of a defect. To ease the repair of the device return it together with a detailed description of the defect. As a protective measure for the safety of VBM staff submit the device or cuffs to a complete cleaning and disinfection (see cleaning instructions). The VBM Service is entitled to refuse to repair soiled or contaminated items for reasons of safety.

Inspection by manufacturer After an operating time of 5 years the device should be sent to the manufacturer for inspection.

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