ORL-E-922 Operating Instructions June 2006

Description ORL-E-922

The ORL-E-922 system includes a compact control unit in the foot pedal. Provision is made for the connection of either one or two BASCH autoclaveable motors with cables with optional peristaltic pump outlet. The pedal permits the alternative use of 2 BASCH motors over a speed range of 600 to 40 000 rpm. Thanks to a state-of-theart design concept, ORL-E-922 is proof against the penetration of fluids and will stand up to extreme conditions.The power of the BASCH motor and the simplicity and robustness of the foot-pedal meet the requirements of the most demanding user. The electronics includes a motor blocking protection. Corresponds to the European standard for medical equipment: - General safety regulations CEI/IEC 601-1 - Electromagnetic compatibility CEI/IEC 601-1-2

Environmental conditions Temperature; Working Humidity relative: Pressure atmosph. Transport and storage

+10°C (50°F) to +40°C (104°F) 30% to 60%, including condensation 700 hPa to 1060 hPa

Environmental conditions for a period of max. 15 weeks Temperature; -40°C (-40°F) to +70°C (158°F) Humidity relative: 10% to 100%, including condensation Pressure atmosph. 500 hPa to 1060 hPa

Environmental protection and Information for disposal of the instrument The disposal and/or recycling of materials must be performed in accordance with the directives and the legislation in force. This equipment needs to be recycled. Electrical and electronic equipment may contain dangerous substances which constitute health and the environmental hazards. The user must return the equipment to its reseller or establish direct contact with an approved body able to process and derive value from this type of equipment (European Directive 2002/96/CE).

Precautions regarding Electromagnetic Compatibility (EMC) Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the user's manual and in the present document. The ORL-E-922 system complies with the EMC requirements according to IEC 60601-1-2. Radio transmitting equipment, cellular phones, etc. shall not be used in the close proximity of the device since this could influence the performance of the device. Particular precaution must be considered during use of strong emission sources such as High Frequency surgical equipment and similar so that e.g. the HF cables are not routed on or near the device. If in doubt, please contact a qualified technician or Bien-Air. The ORL-E-922 system should not be used adjacent or stacked with other equipment. If adjacent or stacked use is necessary, the unit should be observed to verify normal operation in the configuration in which it will be used. WARNING!

The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by Bien-Air as replacements parts for internal components, may result in increased emissions or decreased immunity of the ORL-E-922 system. See “Accompanying documents EMC” on pages 35-36.

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Set for microsurgery

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Set for microsurgery Application

Product intended for professional use only.

Information

The technical specifications, illustrations and dimensions contained in these instructions are given only as a guide. They may not be the subject of any claim. The manufacturer reserves the right to make technical improvements to its equipment, without amending these instructions. The French original of this text conforms to the legal standards. For all additional information, please contact Bien-Air at the address indicated on the reverse.

Identification

By a label at the rear (fig. 18, pages 3 and 18), apparatus type indicating: Model type Foot-pedal reference number Power supply specification Output specification for the peristaltic pump List of protection symbols (description on page 19) Bien-Air serial number Diagram Key

Diagram Key

1 Transformer REF 1600228-001 (230 Vac) or REF 1600230-001 (100 Vac) 2 Main switch, on transformer 3 ORL-E-922 foot-pedal REF 1600359-001 4 Forward and reverse switch 5 Forward/reverse indicating lights Green = forward Orange= reverse 6 Green speed-range indicating lights. When all lights are off, the motor will not turn but the peristaltic pump can still function A: 600 6 000 rpm A + B: 2000 - 20 000 rpm A + B + C: 3000 - 30 000 rpm A + B + C + D: 5000 - 40 000 rpm 7 Green light indicating motor selection 8 Motor selector M1 or M2 9 Speed-band selector, one touch increases to the next band 10 On/off pedal with motor speed variation within the selected band 11 Motor REF 1600076-001 12 Motor cable REF 1600342-001 13 Speed-band selector, one touch decreases to the next band 14 Movable carrying handle 15 Switch for the peristaltic pump 16 Orange indicator light showing peristaltic pump selection 17 Power connector 24 Vac 18 Label (see indentification) 19 Connector for M2 motor 20 Connector for M1 motor 21 Connector for peristaltic pump

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Cable to motor

With additional cable for BASCH motor: Make sure that the back side of the motor and the cable connector are thoroughly cleaned. Bring the motor to the depicted position (fig. 24, page 2) and turn it until the correct position is found with locking (3 positions possible). Now screw the swivel nut to the stop.

Cable to pedal

The quick-connectors are water-tight and sturdy. Remove the black plastic plug(s) as required. Insert connector as shown on page 2 fig. 26, turn to find the correct position and push in. To release, pull on grooved ferrule. Once the transformer has been connected to the mains (230 Vac / 100 Vac) push the main switch to 0 and connect the cable to the foot-pedal, then connect the motor(s) and the peristaltic pump (optional).

Important

Ensure that the power source voltage corresponds to that of the transformer provided.

Switching on

Press the main switch to 1 (see fig. 2, pages 3 and 18). Wait until the automatic control cycle, as shown by the indicator lights, is complete (ca. 6 sec). The motor is ready for use. You may now choose: • with or without peristaltic pump (see fig. 15 and 16, pages 3 and 18) • the motor (M1 initially), (see fig. 7 and 8, pages 3 and 18) • the direction of rotation of the motor (clockwise, when switched on) (see fig. 5 and 6, pages 3 and 18) • the speed range (see fig. 6, 9 and 13, pages 3 and 18) • put the main switch to 0 to turn off the system (see fig. 2, pages 3 and 18) It is recommended that the equipment be switched off when not in use for a prolonged period.

Important

After switching off the ORL-E-922 it is necessary to wait for ca. 10 seconds before switching on again.

Comments

The electronics has a motor blocking protection; this causes the 4 speed lamps to flash when the current is at its maximum and drops it to 1 A after 5 seconds. When this period is exceeded, only the first 2 lamps light alternately to indicate to the user that he must place the lever to the minimum setting in order to restart the motor. Also provided is a cable fault protection on the attachment. If t his is activated, the electronics cuts off the motor supply and the first 2 speed lamps flash as soon as the lever is lowered.

Technical data Power micro-cuts on the main The electronic is secured, the user must release the foot control to reset. The system initializes itself and the practician must reprogram it. In case of circuit-breaker in the BASCH cable, the 2 left warning lights for the micromotor 1 or the 2 right warning lights for the micromotor 2, are flashing.

Norms Bien-Air assumes the responsability that the product is in accordance with the medical devices directive 93/42/EEC (annex II).We declare to be certified EN ISO 9001 and EN 46001, we also respect the standards EN 980, EN 1441, EN 1639, EN 1640, EN ISO 1942,ISO 3964, EN 23964, EN ISO 9687, ISO/DIS 11498, and electrical standards EN 60 601-1-2 ( IEC 601-1-2), EN 55 011, EN 60 555-1-2-3, EN 61000-3-2 and EN 61000-3-3. Class ll equipment with double insulation BF type equipment (protected against electric shock with floating earth) Utilisation indoors Thermal circuit-breaker with auto-reset and disengagement value

Fused circuit-breaker with value Dust-proof and waterproof conformity with IEC / CEI 601 -1

0120

Unless specifically indicated otherwise, Bien-Air Surgery products are all in compliance with CE requirements.

The pedal complies with the requirements for the APG category according to EN 60601-1 and is suitable for use in the presence of an INFLAMMABLE ANAESTHETIC MIXTURE. Electrostatic (ESD)

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Junction

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Technical Characteristics ORL-E-922 Foot-pedal Description

Electronic controller for either one or two BASCH motors. The footpedal determines the speed within the limits of one of 4 possible bands (fig. 6, pages 3 and 18). Forward and reverse switch. Output for a peripheral accessory also included. All functions are shown by indicator lights.

Reference

1600359-001 (foot-pedal only)

Power input Power output

24 Vac 50/60 Hz 5A max 2 x 24 Vdc BASCH motor (REF 1600076-001) 1 x 30 Vdc 1 A for peristaltic pump

Rotation speed

See key to fig. 6, 9, and 13 on page 18

Insulation class Protection class

Il, type BF IP x7

Dimensions (W x H x L)

220 x 84 x 257 mm (8.66 x 3.3 x 10.12 in) with carrying handle folded horizontally

Weight

3.700 kg (130.51 oz)

Cleaning and disinfection

Use Spraynet cleaner, Bien-Air REF 1600036-006. Use disinfectants base on one of the following: • phenolic alcohol • up to 3 % glutaraldehydes • alcohols based on ethanol and methanol. Soak a clean cloth with a disinfectant and carefully clean the surfaces. Products not recommended: disinfectants containing acetone, chlorine and Javel water

Peristaltic pump Description

Unit powered and controlled by the ORL-E-922 manually controlled. Manual and electronic regulation of physiological serum flow.

Reference

1600232-001 (pump only)

Power

28 Vdc

Insulation class Protection class

Il, type BF IP x7

Flow rate of the pump

From 30 to 130 ml/min (10 values)

Dimensions (W x H x L)

185 x 95 x 225 mm (7.28 x 3.74 x 8.85 in) Height with clamp 470 mm (18.5 in)

Weight

Housing 2.400 kg (84.65 oz)

Cleaning and disinfection

Use Spraynet cleaner, Bien-Air REF 1600036-006. Use disinfectants base on one of the following: • phenolic alcohol • up to 3 % glutaraldehydes • alcohols based on ethanol and methanol. Soak a clean cloth with a disinfectant and carefully clean the surfaces. Products not recommended: disinfectants containing acetone, chlorine and Javel water

Motor BASCH

To obtain further details of your motor, refer to the instructions notice REF 2100044 supplied with your BASCH motor

Cabel for the BASCH motor

To obtain further details of the cable, refer to the instructions notice REF 2100015 supplied with your BASCH cable.

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Clamp

0.127 kg (4.48 oz)

Transformer To satisfy the IEC/CEI 601-1 standards, the transformer must be mounted to a partition wall. Reference

Power Primary

1600228-001 (230 Vac) European model 1600230-001 (100 Vac) Japanese model

230 Vac 50 Hz REF 1600228-001 Europe 100 Vac 50 / 60 Hz REF 1600230-001 Japanese

Secondary

24 Vac 50 / 60 Hz (5.11 x 3.98 x 3.66 in)

Power output

120 VA

Fuse Fuse Fuse

Thermal fuse 120°C (248°F) T 1A for REF 1600228-001 (230 Vac) Europe T 1,6 A for REF 1600230-001 (100 Vac) Japon

Electrical rigidity

4000 V

Insulation class Protection class

ll, type B IP 44

Dimensions (W x H x L)

130 x 101 x 93 mm (5.11 x 3.98 x 3.66 in)

Cable length

Primary 1,6 m (63 in) Secondary 4 m (157.48 in)

Weight

2.800 kg (98.77 oz)

Connexion

see fig. 28 page 2

Fixation Transformer fixed to a wall, in a height of 30 cm above the ground. See diagram of boring in the instruction and use plugs Ø 6x29 mm and screws of Ø 5x35 mm. Ø 6x29 mm

Diagram for mounting

Ø6

70 mm (2.76 in)

115 mm (4.52 in)

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L 35 mm

Ø 5x35 mm

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Technical Characteristics

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Guarantee Terms of guarantee Bien-Air Surgery grants the user a guarantee for its complete product range, covering any faulty functioning and defects in material or manufacture, for a period of 12 months from the date of the invoice. In the event of justified claims, Bien-Air Surgery or its authorised representative will fulfil the company’s obligations under this guarantee by repairing or replacing the product free of charge. Any other claims, of whatever nature, in particular in the form of a claim for damages and interest, are excluded. Bien-Air Surgery shall not be held responsible for damage or injury and the consequences thereof, resulting from: • excessive wear and tear • improper handling • non-observance of the instructions for installation, operation and maintenance • unusual chemical, electrical or electrolytic influences • poor connections, whether of the air water or electricity supply. The guarantee does not cover flexible “fibre optic” type conductors, or any parts made of synthetic materials. The guarantee shall become null and void if the damage and its consequences are due to improper manipulation of the product, or modifications to the product carried out by persons not authorised by Bien-Air Surgery. Claims under the terms of the guarantee will be considered only on presentation, together with the product, of the invoice or the consignment note, on which the date of purchase, the product reference and the Serial No. should be clearly indicated.

Generalities The device must be used by a competent person in accordance with the current legal provisions concerning industrial safety, health and accident prevention regulations, and these working instructions. In accordance with these requirements, the operator: •

must only use working devices that are in perfect working order; in the event of irregular functioning, excessive vibration, abnormal heating or other signs indicating malfunction of the device, the work must be stopped immediately; in this case, contact a repair centre that is approved by Bien-Air Surgery;

•

must ensure that the device is used only for the purpose for which it is intended, must protect himself, his patients and third parties from any danger, and must avoid contamination through the use of the product.

The device is intended for medical treatment only; any use other than that for which this product is intended is not allowed and may prove to be dangerous. The medical device meets all the current European legal requirements. The device is not authorised for use in an explosive atmosphere. Never immerse in disinfectant solutions. Rest the device on a suitable support in order to eliminate the risk of injury to you yourself, to your patient and to third parties. Only use maintenance products and/or components from Bien-Air Surgery. The use of other products and components can lead to annulment of the guarantee.

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Special precautions regarding electromagnetic compatibility (EMC) to be applied by installation Table 201 - Guidance and manufacturer's declaration - electromagnetic emissions for all EQUIPMENT and SYSTEMS Guidance and manufacturer's declaration - electromagnetic emissions The ORL-922 system is intended for use in the electromagnetic environment specified below. The customer or the user of the ORL-922 system should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11

Group 1

RF emissions CISPR 11

The ORL-922 system uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Class B

Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3

Not applicable

The ORL-922 system is suitable for use in all establishments, including domes-tic and those directly connected to the public low-voltage power supestablishments . ply network that supplies buildings used for domestic purposes.

Not applicable

Table 202 - Guidance and manufacturer's declaration - electromagnetic immunity for all EQUIPMENT and SYSTEMS Guidance and manufacturer's declaration - electromagnetic immunity The ORL-922 system is intended for use in the electromagnetic environment specified below. The customer or the userof the ORL-922 system should assure that it is used in such an environment. Immunity test IEC 60601 Compliance level Electromagnetic environment test level guidance Electrostatic discharge (ESD)

±6 kV contact

±6 kV contact

±8 kV air

±8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient/burst

±2 kV for power supply lines

±2 kV for power supply lines

Mains power quality should be that of a typical commercial or hospital environment.

IEC 61000-4-4

±1 kV for input/output lines

Not applicable 1)

Surge

±1 kV line(s) to line(s)

±1 kV differential mode

IEC 61000-4-5

±2 kV line(s) to earth

±2 kV common mode

<5 % UT (>95 % dip in UT) for 0,5 cycle

<5 % UT (>95 % dip in UT) for 0,5 cycle

40 % UT (60 % dip in UT) for 5 cycles

40 % UT (60 % dip in UT) for 5 cycles

70 % UT (30 % dip in UT) for 25 cycles

70 % UT (30 % dip in UT) for 25 cycles

<5 % UT (>95 % dip in UT) for 5 sec

<5 % UT (>95 % dip in UT) for 5 sec

3 A/m

3 A/m

IEC 61000-4-2

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/60 Hz) magnetic field

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the ORL-922 system requires continued operation during power mains interruptions, it is recommendedthat the ORL-922 system be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

IEC 61000-4-8 NOTE UT is the a.c. mains voltage prior to application of the test level. 1) NA: cables shorter than 3 metres

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Table 204 - Guidance and manufacturer's declaration - electromagnetic immunity for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacturer's declaration - electromagnetic immunity The ORL-922 system is intended for use in the electromagnetic environment specified below. The customer or the user of the ORL-922 system should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the ORL-922 system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

d = 1 .2 P

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2,5 GHz

d = 1 .2 P

80 MHz to 800 MHz

d = 2 .3 P

3V

800 MHz to 2,5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

3 V/m

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ORL-922 system is used exceeds the applicable RF compliance level above, the ORL-922 system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the ORL-922 system. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Table 206 - Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM - for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the ORL-922 system The ORL-922 system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ORL-922 system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ORL-922 system as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power Separation distance according to frequency of transmitter m of transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz d = 1 .2 P

d = 1 .2 P

d = 2 .3 P

0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1.2 1.2 2.3 1 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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Bien-Air Surgery SA Sales & Marketing Länggasse 60 Case postale 6008 CH-2500 Bienne 6 Switzerland Tél. + 41 (0) 32 344 64 40 Fax + 41 (0) 32 344 64 45 [email protected] Bien-Air Deutschland GmbH Surgery Jechtinger Strasse 11 D-79111 Freiburg Tel. +49 (0)761 4 55 74-0 Fax +49 (0)761 47 47 28 [email protected] Bien-Air España SA Surgery Calle Villarroel 7, pral. 2a E-08011 Barcelona Tel. +34 (93) 423 97 20 +34 (93) 425 30 40 Fax +34 (93) 423 98 60 [email protected] Bien-Air USA, Inc. Surgery 17880 Skypark Circle Suite 140 Irvine, CA 92614 USA Phone 1-800-433-BIEN Phone 949-477-6050 Fax 949-477-6051 [email protected] Mandataire établi dans la CEE Bien-Air France Sàrl Surgery 131, Boulevard Péreire F-75017 Paris Tél. +33 (0)1 47 64 13 49 Fax +33 (0)1 40 54 91 43 [email protected]

Bien-Air Italia s.r.l. Surgery Via Vaina 3 I-20122 Milano Tel. +39 (02) 58 32 12 51-52-54 Fax +39 (02) 58 32 12 53 [email protected] Bien-Air UK Limited Surgery 63, The Street Capel, Surrey RH5 5JZ Tel. +44 (0)1306 711 303 +44 (0)1306 712 505 Fax +44 (0)1306 711 444 [email protected] Bien-Air Asia Ltd. Dental Nishi-Ikebukuro Daiichi-Seimei Bldg. 10F 2-40-12 Ikebukuro, Toshima-ku Tokyo, 171-0014, Japan

Tel. +81 (3) 5954-7661 Fax +81 (3) 5954-7660 [email protected] Beijing Bien-Air Medical Instruments Technology Service Co. Ltd. Room 2106, The Exchange Beijing Yi 118 Jianguo Road Chaoyang District Beijing 100022, China

Tel. +86 10 6567 0651 Fax +86 10 6567 8047 [email protected]

Bien-Air on Internet: www.bienair.com

REF 2100055/06.06

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