HSM 901 Instrument Table Instructions for Use 9th Edition Oct 2011

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INSTRUCTIONS FOR USE Instrument table

HSM 901 9th Edition / 2011 – 08

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Foreword

Thank you for deciding for a HAAG-STREIT instrument table. Provided you comply carefully with the regulations in this instructions for use, we can guarantee you the reliable and unproblematic use of our product.

Purpose of use

The instrument table HSM 901 is intended as a support for ophthalmological instruments. It is primarily employed by trained medical professionals in doctors’ surgeries, hospitals and universities. CAUTION: Federal law restricts this device to sale by or on the order of a physician or practitioner.

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Contents 1.

1.1 1.2 1.3 1.4 1.5 1.6

2.

2.1 2.2 2.3

Safety...4

Ambient conditions... 4 Shipment and unpacking... 4 Installation warnings... 4 Operation, environment... 5 Warranty and product liability... 5 Pictograms and type plate... 5

Appliance assembly / installation...6

Setting the lifting capacity (HSM 901 Manual) ... 6 Power supply in instrument table... 7 Head rest on instrument table... 7

3.

Components / overview...8

4.

Operation...9

5.

Technical data... 11

4.1 4.2 4.3 4.4 4.5

5.1 5.2 5.3 5.4 5.5

HSM 901 Manual... 9 HSM 901 Electric... 9 Cleaning... 10 Replacing fuses (for type E models only)... 10 Problems setting the height (for type E models only)... 10

6. 7.

Statutory regulations...12 Classification...12

71 7.2

EMC... 12 Standards... 12

8.

Environment...13

A.

EMC Supplement...14

A.1 A.2 A.3 A.4 A.5 A.6 A.7

General... 14 System components... 14 Significant operating characteristics... 14 Table 1: Emitted interference... 14 Table 2: Interference immunity... 15 Table 3: Immunity (not life-support equipment)... 16 Table 4: Recommended safe distances (not life-support equipment)... 17

HSM 901 Manual... 11 HSM 901 Manual with auxiliary springs... 11 HSM 901 Electric – with motorised column 230VAC (type E1)... 11 HSM 901 Electric – with motorised column 110VAC (type E2)... 11 Dimensions... 12

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1. Safety

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1.2 Shipment and unpacking • Before unpacking the instrument table, check whether the packaging shows

Symbols

Symbols correspond to the EN 980 and ISO 15223-1 standards. Further symbols used in this instructions for use are: FORBIDDEN! Failure to comply with these instructions can result in material damage and pose a danger to users and patients. WARNING! These instructions must be complied with absolutely to guarantee safe operation of the instrument and to avoid any danger to users and to patients. NOTE! Important notes! Please read carefully.

• • • •

traces of incorrect handling or damage. If this is the case, notify the transport company that has delivered you the goods. Check the instrument table for damage after it is unpacked. Make a report of any damaged parts. This must be signed by you and by the representative of the transport company. Leave the instrument a few hours in the opened packaging before commissioning (condensation). Return defective appliances in the appropriate packaging. Store packaging material carefully, so that it can be used for possibly returning the appliance or when moving.

1.3 Installation warnings • Only use an external, medical grade power supply approved by HAAG-STREIT (IEC/EN60601-1, UL60601-1, CAN/CSA C22.2 No 601.1-M90).

• Only use a type-approved, 3-pole electric power supply cable. • The plug, cable and protective conductor connection of the socket must function perfectly.

1.1 Ambient conditions

• Make sure that the instrument table is connected only to power supplies as

Transport: Temperature Atmospheric pressure Rel. humidity

-40°C to +70°C 500 hPa to 1060 hPa 10% to 95%

Storage

Temperature Atmospheric pressure Rel. humidity

-10°C to +55°C 700 hPa to 1060 hPa 10% to 95%

Use:

Temperature Atmospheric pressure Rel. humidity

+10°C to +35°C 800 hPa to 1060 hPa 30% to 75%

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• •

defined on the type plate. The instrument table must be completely disconnected from the AC supply before maintenance and cleaning work is performed. Computers and further ancillary devices (printers, etc.) must comply with the IEC/CEN 60601-1 standard, or be connected through galvanic isolation to external networks (isolating transformer, galvanic Ethernet isolator, etc.). A mains isolation transformer can be procured from your HAAG-STREIT dealer.

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NOTES! • The instrument table may be used only for the purpose described in this instructions for use. • Installation and operation by trained skilled personnel only. • The instrument table may not be transported, stored or operated outside the specified ambient conditions (see section 1.1). • Keep this instructions for use in a place where it is accessible at all times to persons who work with the instrument table. • Warranty claims can only be asserted if the instructions in this instructions for use have been complied with. • The manufacturer of the instrument table is not liable for loss or damage due to unauthorised use of the same. All warranty claims arising in this case are null and void. • Do not use electrically operated instrument tables in areas endangered by explosion; do not keep any volatile solvents (alcohol, benzine, etc.) and combustible anaesthetics in its vicinity. • Avoid moisture. • Housing parts may be removed and repairs performed by appropriately trained and authorised skilled personnel only. Incorrect repairs can pose considerable risks for operating staff and patients. • Only original HAAG-STREIT spare parts and original HAAG-STREIT accessories may be used for repairs. • Transport the instrument table over larger distances in its original packaging. The castors should be locked before using an instrument on the instrument table.

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1.5 Warranty and product liability • This instrument table left our factory in perfect condition. If you have any complaints, please contact your local HAAG-STREIT dealer.

• The manufacturer grants a warranty for the instrument table, the duration of

• • •

which is determined by the relevant authorised local HAAG-STREIT dealer and which must be enquired there. Malfunctions and defects which are caused by materials and design come under the manufacturer's warranty. Malfunctions and defects which are caused by incorrect use and external influences are excluded from the warranty. All warranty claims caused by interventions by unauthorised persons shall be rejected. Continuing to use a product damaged by incorrect handling can lead to personal injury. In this case, no liability is assumed by the manufacturer. Failure to observe the warnings and notes in these instructions for use will void all warranty and liability.

1.6 Pictograms and type plate

a) Protective conductor connection b) Pull out the mains plug! c) Please read carefully (in the instructions for use) d) Application part type B e) Manufacturer f) Serial number g) Environment h) HS reference number i) Date of manufacture c d e tp Ou

f

a g

Product: Instrument Table Type: HSM-901 / M

ut:

0-2

10

Electrical Rating: 100-240VAC, 50/60Hz, 10A Mechanical Charge: min. 5kg max. 52kg

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VA

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WARNING! • The doctor or the operator is obliged to inform the patient about the safety instructions concerning him and to ensure that these instructions are complied with.

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HAAG-STREIT AG Gartenstadtstrasse 10 3098 Koeniz, Switzerland

b h

i XXXX

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1.4 Operation, environment

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0A

,1

SN XXXXX Made in Switzerland 1123 1200160 01100

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2. Appliance assembly / installation WARNING! Check: Are the connection parts of the accessories in the correct position (screw connections, quick-release fasteners)?

2.1 Setting the lifting capacity (HSM 901 Manual) NOTE! The lifting capacity of the HSM 901 Manual is already correctly set with a HAAG-STREIT instrument when delivered. 1. Place the instrument on the instrument table. 2. When you press the adjustment lever, the table board moves a) upwards gently: Okay b) upwards strongly: The instrument is lighter than foreseen in the basic setting c) downwards: The instrument is heavier than foreseen in the basic setting 3. If 2b) or 2c) is the case, the lifting capacity must be reset. Reset lifting capacity 1. Raise the instrument table to its highest point. 2. Release the four oval head screws (19), hold the panelling steadily and carefully set down on the stand base. 3. Insert the Allen key into the adjustment screw (18) on the spring column stand. 4. The table board moves upward strongly (as in 2b). Reduce the lifting capacity by turning the Allen key counter-clockwise. 5. The table board moves downward (as in 2c). Increase the lifting capacity by turning the Allen key clockwise. 6. The lifting capacity is set correctly when the table board moves upwards gently when the adjustment lever is pressed. 7. Before reattaching the panelling, the weight of the panelling must be compensated for by turning the Allen key 13 turns clockwise. 8. Reattach the panelling.

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2.2 Power supply in instrument table NOTE! Observe the instructions for use for the corresponding HAAG-STREIT power supply!

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The following directives must be observed: • MDD 93/42/EEC or corresponding national standards: • IEC/EN 60601-1 General requirement for safety • IEC/EN 60601-1-1 Safety requirements for medical electrical systems • IEC/EN 60601-1-2 EMC

2.3 Head rest on instrument table • Connect the cable and power supply as described in the HAAG-STREIT “Power supply” instructions for use.

• Connect the multi-pole jump lead connection between the head rest and the instrument table (20).

WARNING! Cables must not be trapped as this can cause a short circuit!

21

22

• Affix the head rest tightly at the right place on the instrument table using the two cheese-head screws (22).

• Attach the handles (21). • Please observe the corresponding instructions for use if you wish to connect a slit lamp or biometer.

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3. Components / overview

1. Cold light source (optional) 2. Power supply 3. Right drawer (without cold light source) 4. Slide plate 5. Rail cover / track 6. Cover cap (cable) 7. Recess for illumination control “in table” (only for LED) 8. Table board “Standard” 9. Left drawer (without power supply) 10. Adjustment handle (type M) or rocker switch (type E) – operation: see page 9 11. Panelling 12. Stand base 13. Instruments cable 14. Type plate 15. Fuses 16. Electric power supply cable 17. Rear castors with brake 18. Table top “Workstation” 19. Table top “Imaging” NOTE! The left drawer (9) can be replaced with a power supply (2). The right drawer (3) can be replaced with a cold light source (1).

18 6

19 6

1 2

3 4 5 6 7 8 9 10 11 12

13 14 15 16 17

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4. Operation

4.1 HSM 901 Manual (type M) • The HSM 901 Manual is equipped with a mechanical spring column stand which • • •

can be adjusted to fit the weight of the instrument table and the instrument on the table. The height can be adjusted via an adjustment level on the underside of the table. Pressing the adjustment level releases the block and the table can be set to the required height. The height adjustment function is blocked when the adjustment lever is released. WARNING! The height should only be adjusted when an instrument is in place. The lifting capacity must be set correctly. (See 2.1 Setting the lifting capacity)

Type M

4.2 HSM 901 Electric (type E1 / E2) • The HSM 901 Electric is equipped with an electrical motorised column. • The height can be adjusted via a rocker switch. • The rocker switch can be found on the underside of the table top. • Press it right to raise the table top or left to lower it. WARNING! When a dust cover is used: risk of overheating! Type E1 / E2

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4.3 Cleaning

It is sufficient to wipe the instrument table with a soft cloth. In addition, the table can also be cleaned with a lint-free cloth lightly moistened with water and mild soap. WARNING! Avoid liquids. Under no circumstances should solvents, alcohol, corrosive or abrasive agents be used.

4.4 Replacing fuses (HSM 901 Electric) • Disconnect the electric power supply cable (23). • Pull out the insert (24). • Replace the fuses (25). • Push the insert back in. • Reconnect the cable.

23

24

NOTE! Observe the fuse size! See 5.3 / 5.4

4.5 Problems setting the height (HSM 901 Electric) • The overheating protection has been triggered: • •

wait 30 minutes and then try again. Check that the electric power supply cable is correctly inserted. Check the fuses, see 4.4.

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T 10 A (2x)

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5. Technical data

Please see the type plate for the model type designation.

5.1 HSM 901 Manual Minimum force Payload Minimum height Maximum height Total lift Castors: Brakes: Voltage Frequency Connected load Supplementary electric power supply socket Weight

5 kg 31 kg 710 mm 870 mm 160 mm 4 2 100 - 240 VAC 50 / 60 Hz 10 A 100 - 240 VAC 10 A 40.7 kg

5.2 HSM 901 Manual with auxiliary springs Minimum force Payload Minimum height Maximum height Total lift Castors: Brakes: Voltage Frequency Connected load Supplementary electric power supply socket Weight

26 kg 52 kg 710 mm 870 mm 160 mm 4 2 100 - 240 VAC 50 / 60 Hz 10 A 100 - 240 VAC 10 A 40.7 kg

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5.3 HSM 901 Electric 230 VAC (type E1) Minimum force Payload Minimum height Maximum height Total lift Castors: Brakes: Voltage Frequency Connected load Supplementary electric power supply socket Weight Fuses

0 kg 70 kg 724 mm 924 mm 200 mm 4 2 220 - 240 VAC 50 Hz 10 A 220 - 240 VAC 10 A 33 kg 2 x T10 A – HS part number 3000482

5.4 HSM 901 Electric 110 VAC (type E2) Minimum force Payload Minimum height Maximum height Total lift Castors: Brakes: Voltage Frequency Connected load Supplementary electric power supply socket Weight Fuses

0 kg 70 kg 724 mm 924 mm 200 mm 4 2 100 - 120 VAC 60 Hz 10 A 100 - 120 VAC 10 A 33 kg 2 x T10 A – HS part number 3000482

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5.5 Dimensions

Instrument table HSM 901 'Standard' (Manual / Electric) Table board: L: 660 mm B: 380 mm Base area: L: 560 mm B: 660 mm

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6. Statutory regulations

• HAAG-STREIT AG maintains a quality management system in accordance with EN ISO 13485:2003.

• The instrument table HSM 901 was developed and designed taking the IEC / • • •

Instrument table HSM 901 'Workstation' (Manual / Electric) Table board: L: 1050 mm B: 423 / 380 mm Base area: L: 560 mm B: 660 mm

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EN 60 601-1, IEC / EN 60 601-1-2 and DIN / EN 14971 standards into account. Production, testing, set-up, maintenance and repairs are performed taking international standards into account. The IEC / EN 60 601-1-1 standard must be observed when using different medical and/or non-medical electrical appliances in combination. The CE mark confirms the instrument table HSM 901’s compliance with the 93/42/ EEC and 2004/108/EC directives and the conformity module A. A copy of the declaration of conformity and the EMC information (electromagnetic compatibility) for this product can be requested from HAAG-STREIT at any time. The statutory accident regulations must be observed.

7. Classification

IEC / EN 60 601-1 standard As equipment safety class I Operating mode: Continuous operation CE Directive 93/42/EEC Class I

7.1 EMC

Instrument table HSM 901 'Imaging' (Manual / Electric) Table board: L: 1200 mm B: 563 / 390 mm Base area: L: 560 mm B: 660 mm

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The instrument table fulfils the requirements on electromagnetic compatibility according to IEC / EN 60601-1-2. The instrument table is constructed in such a way that the generation and emission of electromagnetic interference is limited to the extent that other devices are not disturbed in their use in accordance with the regulations and so that it itself has appropriate immunity to electromagnetic interference.

7.2 Standards EN ISO 13485:2003 IEC / EN 60 601-1 IEC / EN 60 601-1-2 DIN / EN 14971

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8. Environment

• Electrical and electronic devices must be disposed of • •

separately from domestic refuse. This instrument table was made available for sale after 13.08.2005. Disposal through the local collecting point or your HAAGSTREIT dealer. This guarantees that no hazardous substances enter the environment and that valuable raw materials are recycled.

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A. EMC Supplement

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A.2 System components

The instrument table HSM 901 is comprised of the following equipment: • Motorised column

A.1 General

WARNING! • Electrical medical devices and systems are subject to special measures concerning EMC and must be installed in accordance with the EMC instructions contained in this accompanying document. • Portable and mobile HF communication systems may interfere with electrical medical devices.

A.3 Significant operating characteristics

The instrument table HSM 901 is intended as a support for ophthalmological instruments. It is primarily employed by trained medical professionals in doctors’ surgeries, hospitals and universities.

A.4

Table 1: Emitted interference

Guidelines and manufacturer's declaration – Electromagnetic emissions The instrument table HSM 901 is designed to be operated in an environment as described below. The customer or user of the instrument table HSM 901 should ensure that it is operated in such an environment. Emitted interference measurements Compliance

Electromagnetic environment / Guidelines

HF emissions pursuant to CISPR11

Group 1

The instrument table HSM 901 uses HF energy exclusively for its internal functioning. Therefore, its HF emission is very low, and interference with neighbouring equipment is unlikely.

HF emissions pursuant to CISPR11

Class B

Emission of harmonics pursuant to IEC61000-3-2

Class A

The instrument table HSM 901 is suitable for use in facilities other than the residential area and facilities such as those directly connected to a public grid which also supplies buildings used for residential purposes.

Emission of voltage fluctuations / flickers pursuant to IEC 61000-3-3

Not applicable

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Table 2: Interference immunity

Guidelines and manufacturer's declaration – electromagnetic immunity The instrument table HSM 901 is designed to be operated in an environment as described below. The customer or user of the instrument table HSM 901 should ensure that it is operated in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment / Guidelines

Electrostatic discharge (ESD) pursuant to IEC61000-4-2

±6 kV contact discharge ±8 kV air discharge

±6 kV contact discharge ±8 kV air discharge

Flooring should be made of wood or concrete, or be covered with ceramic tiles. If the floor is covered with synthetic material, the relative air humidity must be at least 30%.

Electrical fast transients / bursts pursuant to IEC61000-4-4

±2 kV for power lines

±2 kV for power lines

The quality of the supply voltage should conform to that of a typical business or hospital environment.

Surges pursuant to IEC 61000-4-5

±1 kV for symmetrical voltages ±2 kV for asymmetrical voltages

±1 kV for symmetrical voltages ±2 kV for asymmetrical voltages

The quality of the supply voltage should conform to that of a typical business or hospital environment.

Voltage drops, short interruptions and fluctuations in the supply voltage according to IEC61000-4-11

< 5% UT(> 95% drop in UT) for½ period < 40% UT(> 60% drop in UT) for5 periods < 70% UT(> 20% drop in UT) for25 periods < 5% UT(> 95% drop in UT) for5 s

< 5% UT(> 95% drop in UT) for½ period < 40% UT(> 60% drop in UT) for5 periods < 70% UT(> 20% drop in UT) for25 periods < 5% UT(> 95% drop in UT) for5 s

The quality of the supply voltage should conform to that of a typical business or hospital environment If the user of the instrument table HSM 901 requires continued function even in the event of interruptions in the energy supply, the instrument table HSM 901 should be powered from an uninterruptible power supply or a battery.

NOTE: UT = grid AC voltage before application of the test levels.

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Table 3: Immunity (not life-support equipment)

Guidelines and manufacturer's declaration – Electromagnetic immunity The instrument table HSM 901 is designed to be operated in an environment as described below. The customer or user of the instrument table HSM 901 should ensure that it is operated in such an environment. Electromagnetic environment - Guidelines Portable and mobile radio equipment shall not be used any closer to the instrument table HSM 901, including the cables, than the recommended safe distance calculated in accordance with the equation appropriate for transmission frequency. Immunity test

IEC 60601 test level

Compliance level

Recommended distance:

Conducted HF interference pursuant to IEC61000-4-6

3Veff 150 kHz - 80 MHz

3Veff

D = 1.2

P

Radiated HF interference pursuant to IEC61000-4-3

3 V/m 80 MHz -2,5 GHz

3Veff

D = 1.2 D = 2.3

P 80 MHz - 800 MHz P 800 MHz - 2,5 GHz

With P as the nominal output of the transmitter in watts (W) in accordance with the specifications of the transmitter manufacturer and D as the recommended safe distance in metres (m). According to an on-site investigation(a), the field strength of stationary radio transmitters is lower for all frequencies than the compliance level(b). Interference is possible in the environment of devices that bear the following symbol. NOTE 1: for 80 MHz and 800MHz the higher value shall apply. NOTE 2: these guidelines may not apply in all situations. Electromagnetic wave propagation is influenced by the absorption and reflection of buildings, objects and people. a) The field strength of stationary transmitters, e.g. base stations of cordless telephones and land mobile services, amateur radio stations, AM and FM radio and television broadcasting stations, may not, in theory, be precisely predetermined. To determine the electromagnetic environment resulting from stationary HF transmitters, an on-site inspection is recommended. If the calculated field strength at the site of the instrument table HSM 901 exceeds the above-mentioned compliance level, the instrument table HSM 901 must be monitored with regard to its normal operation at each application site. If any unusual operating characteristics are observed, it may be necessary to take additional measures, e.g. reorientation or relocation of the instrument tableHSM 901. b) Above the frequency range of 150kHz to 80 MHz the field strength is less than 3 V/m.

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Table 4: Recommended safe distances (not life-support equipment)

Recommended safe distances between portable and mobile HF communication devices and the instrument table HSM 901. The instrument table HSM 901 is designed for operation in an electromagnetic environment in which radiated HF interference is controlled. The customer or user of the instrument table HSM 901 can help to prevent electromagnetic interference by maintaining minimum distances between portable and mobile HF communication systems (transmitters) and the instrument table HSM 901, as recommended below in accordance with the maximum output of the communication system. Nominal output of the transmitter (W)

Safe distance according to transmission frequency (m) 150 kHz - 80 MHz D = 1.2 P

80 MHz - 800 Mhz D = 1.2 P

800 MHz - 2,5 GHz D = 2.3 P

0.12 0.01 0.12 0.23 0.38 0.1 0.38 0.73 1.2 1 1.2 2.3 3.8 10 3.8 7.3 12 100 12 23 For transmitters with a nominal output not listed in the above table the distance (m) D can be calculated using the equation that applies to the respective column, where P is the nominal output of the transmitter in watts (W) in accordance with the specifications of the transmitter manufacturer.

NOTE 1: to calculate the recommended safe distance of transmitters in the frequency range of 80 MHz to 2.5GHz an additional factor of 10/3 was used to reduce the probability of interference from a mobile/portable communication device inadvertently brought into the patient area. NOTE 2: these guidelines may not apply in all situations. Electromagnetic wave propagation is influenced by absorption and reflection of buildings, objects and people.

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For further questions please contact your HAAG-STREIT representative at:

http://www.haag-streit.com/contact/contact-your-distributor.html

C

US

1250

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PRODUCTS CERTIFIED FOR BOTH THE U.S AND CANADIAN MARKETS, TO THE APPLICABLE U.S. AND CANADIAN STANDARDS

HAAG-STREIT AG Gartenstadtstrasse 10 3098 Koeniz, Switzerland Phone +41 31 978 01 11 Fax +41 31 978 02 82 eMail [email protected] Internet www.haag-streit.com

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