Polaris 50 Minor Surgical light Instructions for Use June 2021

EN

1

SYMBOLS The warning symbols indicate all instructions that are important for safety. Failure to comply with them can lead to injury, damage to the luminaire or the equipment. In combination with the following signal words the warning symbols means:

DANGER Can lead to death or serious injury.

WARNING Can lead to injury Comply with operating Instructions

CE conformity mark

Protective earth, protection class I device

Neutral conductor/return conductor for the electrical current

Live conductor

Storage humidity

Storage temperature

Disposal

Manufacturer

24

EN

2

SAFETY INSTRUCTIONS



2.1

Intended use



The Polaris 50 luminaire is a minor surgical luminaire (treatment luminaire). It is an individual luminaire for use in operating rooms that is used near the patient to support diagnosis or treatment, which poses no risk to the patient in the event of any interruption caused by light failure. It is meant for continuous operation and is not intended to be combined with other medical devices.

2.2

 







  



 







  

User profiles

Medical professional A medical professional is any person who has completed medical training and is working in his or her professional field. Cleaning professional A cleaning professional is trained in national and jobrelated hygiene regulations. Electrician An electrician is trained in the fields of electronics and electrical engineering and is familiar with the relevant standards and regulations. Qualified professional A qualified professional is capable of mounting and dismounting the luminaire thanks to professional training, knowledge and experience and knowledge of the regulations.

2.3

The luminaire must not be covered by a cloth or any similar item while it is in operation. The ventilation openings (where they exist) must be free whenever the luminaire is in operation. The luminaire must not be operated near to external heat sources that exceed the maximum ambient temperature of the luminaire. The luminaire must not be used in environmental conditions other than those for which it is intended. The luminaire must only be used for the intended use described in this document. The manufacturer cannot be held responsible for any injury or damage that is caused as a result of any use other than the intended use or of any failure to comply with safety instructions and warnings. Polaris 50 Mobile The lamp must be secured while being transported within the clinic.

Safety instructions Operation by a medical professional The instructions form part of the product. They must be stored and made accessible to all subsequent users. Any work on the luminaire (including repairs) must be carried out by qualified electricians only. Mounting must be performed by a qualified professional only. The luminaire must not be altered or manipulated in any way. Only approved original parts must be used. Any use other than the intended use with original parts may give rise to other technical values and life-threatening danger. Operation in potentially explosive areas is prohibited. The luminaire power supply is a potential ignition source. The luminaire must only be operated in dry, dustfree rooms. The luminaire must not be left switched on without supervision. For luminaires in protection class I, it is essential for the earthing conductor to be connected to the luminaire housing. Do not use any luminaire that is damaged. Defective cables and a defective handle are also potential hazards. Do not place the cable close to any heat source or on sharp edges. Damage to the eyes. Never look directly into the light source. Replace any glass that is damaged before operating the luminaire again.



2.4

Warning levels DANGER

Indication of hazards that can lead to death or serious injury if measures are disregarded. WARNING Indication of hazards that can lead to injury if measures are disregarded. CAUTION Indication of hazards that can lead to damage to property if measures are disregarded.

In order to prevent electric shocks, only connect the luminaire to a power supply with an earth conductor. Never place additional loads on the luminaire head or the arm.

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EN

3

VARIANTS

3.1

Polaris 50 Ceiling

3.2

Polaris 50 Wall

3.3

Polaris 50 Mobile

3.4

Polaris 50 CSU*

*Details of the scope of delivery for the CSU as well as the mounting instructions for it are given in the enclosed documentation.

26

EN_GB

4

SCOPE OF SUPPLY

4.2

4.1

Polaris 50 Ceiling

The following are included in the scope of supply:

The following are included in the scope of supply:

Polaris 50 Wall

1x luminaire head with sterilizable handgrip

1x luminaire head with sterilizable handgrip

1x wall arm 1x ceiling arm

1x wall joint 1x ceiling conduit

1x wall bearing 1x ceiling bearing

1x wall cover 1x ceiling cover

1x ring 1x ring

4x Fixing anchor bolt UPAT EXA 10/45,M10x122

27

EN_GB 4.3

Polaris 50 Mobile

The following are included in the scope of supply: 1x luminaire head with sterilizable handgrip

1x M4 socket screw

1x A fuse FST, F 1A 250 VAC, IEC 60127-2 1x caster

5 MONTAGE Polaris 50 Ceiling bearing 

1x power cable

1x lower support tube 

 

1x upper support tube



The mounting must only be mounted on ceilings having a concrete stability class B25 through B55 respectively C20/25 through C50/60. If there is any doubt, an authorized professional must confirm that mounting is possible on the mounting base being used. For other types of ceilings, a safe and sustainable ceiling anchor is to be planned. The transfer of the forces in the ceiling must be ensured. The applicable regional building regulations must be observed. A fault-free construction is assumed. It is essential to ensure that the ceiling bearing or fixing elements do not come into touch with the reinforcement components of the solid ceiling. Drilling must be executed by a competent specialist. The nuts must be tightened carefully by means of a torque wrench. A lightweight ceiling panel with a maximum thickness of 20 mm can be bridged with the fixing anchor bolt. If more than 20 mm thick, plaster or panels are to be removed prior to installation. DANGER Life-threatening danger from falling luminaire. 

1x cantilever arm

1x cable holder

28

The actual ceiling load depends on a variety of different factors. This can only be accurately determined for each particular case by a structural engineer.

EN_GB DANGER Mounting by qualified personnel 

Mounting must be done by qualified personnel only. Lack of appropriate knowledge could be life-threatening. 

DANGER Life-threatening danger from falling luminaire. 

Please use the fixing anchor bolt provided.

WARNING For safety reasons the responsible structural engineer must be informed of any incorrect drilling e.g. by the drilling in a reinforcement iron, as sufficient static and load balancing may be at risk.

WARNING Risk of injury from falling parts. 

Drill holes, then blow them out using bellows Drill nominal diameter = 10 mm Drill hole depth = 75 mm

Mounting must be performed by two people. CAUTION Use protective equipment in line with tool manufacturer's instructions.

CAUTION Use the load data table to determine which fastening material should be used 

5.1

Take account of linkage dimension before mounting

Load data

Polaris 50 Ceiling: Bending moment MB

200 Nm (147 lbf ft)

Vertical weight FG

5.2

130 N (30 lbf)

Attaching the ceiling bearing

  

Hold the ceiling bearing on ceiling and hit the fixing anchor bolt with a hammer and carefully tighten the nuts to 43 nm with a torque wrench. The vertical alignment of the ceiling bearing must be considered.

6 MOUNTING Polaris 50 Ceiling 6.1 Attaching the ceiling bearing 

Make 4 bore hole markings

DANGER Mounting by qualified personnel





Mounting must be done by qualified personnel only. Lack of appropriate knowledge could be life-threatening.



Please note the installation instructions for ceiling bearing under point 5.

Check clearances DANGER Electric shocks are life-threatening.  The luminaire must be isolated from the mains by an external all-pole switch.

29

EN_GB



Loosen the fastening bolts of the socket.

   

Use long nose pliers to pull the socket on the inner ring with cable fully out of the ceiling conduit.

 

Pull the luminaire cable of the ceiling conduit through the luminaire mount. Insert ceiling conduit into luminaire mount Secure using the M8 safety screw and nut 1

Saw ceiling conduit to the desired length at the top end using a metal saw and deburr.



Tighten M8 safety screw and nut 1 (20 Nm / 14.75 lbf ft) Tighten all 4 threaded pins 2 (5 Nm / 3,68 lbf ft) DANGER

Electric shocks are life-threatening.









30



Disconnect or remove fuses before carrying out any work on the mains connection



Connect to mains



Connect luminaire cable



Push cover and ring over the ceiling bearing and tighten them

Remove fastening screw.

Insert ceiling conduit 1 into ceiling bearing 2 and drill a Ø9 mm (0.35”) hole 3. Use the existing hole in the ceiling bearing as a guide.

Insert cable with socket back into the ceiling conduit.

Align the threaded hole in the socket exactly with the existing hole in the ceiling conduit. Fasten using the fastening screw.

EN_GB 6.2

Mounting the ceiling arm WARNING

The cantilever arm is an injury hazard 



Do not remove the transport safeguard until after the luminaire head has been mounted.

Loosen the screw connection and remove the cover cap with connector



Continue with luminaire head mounting, see Chapter 9

7

MOUNTING - Polaris 50 Wall

 

Note: Fastening material is not included. We recommend the use of (not included in the delivery) counter-plates for fastening on a drywall.

7.1

Load data

Bending moment MB Vertical weight FG

7.2 

Attaching the wall bearing

Mounting by qualified personnel 

The luminaire will fall if fastening is done incorrectly 

150 N (34 lbf)

DANGER

Mount the ceiling arm WARNING

250 Nm (184 lbf ft)

The retaining ring must engage into the groove and must have the same clearance all round.

Mounting must be done by qualified personnel only. Lack of appropriate knowledge could be life-threatening. DANGER

Electric shocks are life-threatening. DANGER



There is a risk that the cantilever arm and the adapted end devices will fall 

The retaining ring may be prised open by a maximum of 1 mm wider than the shaft diameter during mounting. Wider opening by bending can lead to material damage and loss of safety integrity. During mounting ensure that the retaining ring engages correctly into the groove.

The luminaire must be isolated from the mains by an external all-pole switch.

CAUTION Take account of the wall bearing position 

The wall bearing must be aligned in accordance with the drawing



Failure to comply with correct alignment will compromise mechanical safety

CAUTION Use the load data table to determine which fastening material should be used

1 2 



Put the disc 1 in place first, then the retaining ring 2

Insert the connector with the cover cap and screw into place



Take account of linkage dimension before mounting



The selection of fastening material according to the "Load data" table and the safe execution of the attachment is the task of the person responsible for the installation.



The load-bearing capacity of the structure must be planned, inspected and confirmed by a structural engineer.



The applicable regional building regulations are to be observed.

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EN_GB CAUTION

DANGER

Take account of the wall bearing position

Electric shocks are life-threatening.



The wall bearing must be aligned in accordance with the drawing



Disconnect or remove the fuses before working on the mains connection



Failure to comply with correct alignment will compromise mechanical safety



Connect to mains



Push hood with ring onto the wall bracket



Connect luminaire cable

 

Push cover against the wall Tighten firmly with ring







Make 4 bore hole markings

Check clearance

Drill holes, then blow them out using bellows

7.3

Mounting the wall arm WARNING

The cantilever arm is an injury hazard 

Use tubular dowel for the selected screws and tighten



Wall bracket in vertical alignment, mount with M8 self-locking bolt 1 (20 Nm / 14.75 lbf ft) Tighten all 4 threaded pins 2 (5 Nm / 3,68 lbf ft)



32



Do not remove the transport safeguard until after the luminaire head has been mounted.



Loosen the screw connection and remove the cover cap with connector

EN_GB

8 MOUNTING - Polaris 50 Mobile



Mount the arm WARNING

The luminaire will fall if fastening is done incorrectly 

2





Remove M3 socket screws from the sides and detach power supply unit tray.



Loosen the 2 x M6 socket screws on the lower support tube Guide the lower support tube's cable through the roller stand Attach the lower support tube to the roller stand using the 2 x M6 socket screws (11.3 Nm / 6 lbf ft)

The retaining ring must engage into the groove and must have the same clearance all round.

1 



Put the disc 1 in place first, then the retaining ring 2

 



Push the lower support tube cables and the power supply unit cables of the same colour together until they click



Screw the power supply unit tray back in place using the M3 socket screw and serrated lock washer.



Push the cables of the upper and lower support tubes together until the click

Insert the connector with the cover cap and screw into place

Continue with luminaire head mounting, see Chapter 9

33

EN_GB 1 2







Put the disc 1 in place first, then the retaining ring 2.



Insert the connector with the cover cap and screw into place



Continue with luminaire head mounting, see Chapter 9

Place the upper support tube onto the lower support tube

Screw the cable holder firmly onto the upper support tube using the M4 socket screw (2.4 Nm / 1.8 lbf ft) WARNING

Never unscrew the upper cable holder injury hazard. 

 



34

When both cable holders are unscrewed, the connecting piece is loose and falls downward, which could lead to injury and/or damage to the cable and/or the device.

Remove M8 hex screw on the upper support tube Remove cover cap with connector

Insert the spring arm and secure with M8 hex screw, tighten as far as it will go.

EN_GB

9

MOUNTING - luminaire head

10

OPERATION

Polaris 50 Mobile DANGER Electric shocks are life-threatening. 

Remove screw and take off the protective cap



Do not insert any power cable that is damaged.



If there is any sign of damage to the power cable, replace it immediately with a new one.



The supply voltage and frequency must match the data on the type plate.



Only connect to the mains power supply with a protective conductor

NOTE 

Insert luminaire head.

Polaris 50 Mobile 



When the power cable is not in use, reel it onto the cable holder

Turn sleeve to insert securing segment

1 2   



Insert cable 1. Connect cable to the power supply Operate switch 2. There are two 1 A fuses upstream from the switch WARNING

Turn sleeve back and secure with screw

Risk of eye damage WARNING

 Never look directly into the beam of light

Danger from falling luminaire head. 

Ensure that the safety element has been correctly installed.



An incorrectly mounted luminaire head can cause injury.



Tighten the luminaire head's friction lock as required

Polaris 50 Ceiling, Wall, Mobile, CSU

 

Switch on luminaire using the rotary knob. Perform a function test before each use: All LEDs in the light cone must illuminate

CAUTION The rotary knob can not be removed.



Attach hand grip.

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EN_GB

11

DISINFECTION CLEANING AND STERILIZATION

CAUTION

DANGER Electric shocks are life-threatening. 

Remove the connector from the power supply and put the switch in the "OFF" position.

To minimize the risk of disease transmission, in addition to complying with this user manual, you must also comply with the applicable occupational health and safety regulations and the requirements of national bodies with responsibilities for hygiene and disinfection.

11.1 

CAUTION Damage to property caused by incorrect cleaning 

  

No cleaning agents containing alcohol, solvents, chlorine or abrasive products must be used Concentrated disinfectants may damage the cover. Comply with mixing ratios recommended by manufacturers. Unsuitable cloths can cause scratches.

NOTE Dirt decreases luminosity  

Clean regularly to keep the cover clean. Disinfection by spraying and/or wiping is permitted.

Sterilisable hand grip

Sterilization must be carried out in accordance with ISO 17665-1 (Sterilization of health care products - Moist heat).

CAUTION Damage to the hand grip 

Do not sterilize with hot air



Package the hand grip in a sterile pouch before sterilization.  The hand grip is designed exclusively for damp sterilization with 3 times fractioned pre-vacuum and saturated steam with the following parameters: Temperature 134°C Overpressure

2.0 bar

Dwell time

6 min

Vacuum drying

20 min

WARNING Warning against burns



Clean the PMMA cover using a chamois with glass cleaner.



The hand grip must be cooled to room temperature before use.



After sterilization check the hand grip for mechanical integrity. Do not use damages hand grips.



12

SAFETY INSPECTIONS DANGER



Disinfectant spraying is horizontal positions only.

permitted

in

NOTE Disinfect external luminaire parts using the following prescribed diluted products:    

36

Lysoformin® Dismozon® Hexaquart®plus Sagrotan® quick disinfectant cleaner

Electric shocks are life-threatening.  

Remove the connector from the power supply and put the switch in the "OFF" position. The connector cable must be checked for damage at least once per year.

NOTE  

Maintenance and repairs must only be carried out by qualified electricians. The corresponding user profile is described in Chapter 2, Safety instructions

EN_GB 12.1

Setting the spring force

compatible with recycling so that a high proportion of the materials used in these products can be recycled or converted into energy after the end of service life. They contain no materials that are dangerous or that need to be monitored.

CAUTION The spring force is set at the optimum setting in the factory

14



ACCESSORIES

Pull cover off sideways Hand grip (order no. G27960)

15

Set the spring force 1:  + increase (if the cantilever arm lowers by itself)  - reduce (if the spring is set too high) until the desired stability is reached  Put cover back on sideways

13

ADDITIONAL INSTRUCTIONS

The luminaire itself is maintenance-free. You can obtain additional documents about this product from the manufacturer upon request. These luminaires do not affect any other devices. To save energy, the luminaire should only be switched on when actually needed.

DEMOUNTING DANGER

Electric shocks are life-threatening. 

Remove connector from the power supply and put the switch in the "OFF" position before demounting. DANGER

Never unscrew the upper cable holder injury hazard. 

13.1

When both cable holders are unscrewed, the connecting piece is loose and falls downward, which could lead to injury and/or damage to the cable and/or the device.

Disposal Do not dispose the luminaire and/or lamp in household refuse. Dispose the luminaire and/or lamp at a disposal point in accordance with local regulations or take them to a dealer that provides an appropriate disposal service. Cut off the cable directly on the housing. The products listed above are more than 95% recyclable. The luminaires have been constructed to be

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16

TROUBLESHOOTING

Fault

Possible cause

Troubleshooting

User profiles

The luminaire does not light

Contact problem

Switch on again

All

The luminaire does not light

Lamp defective

Contact manufacturer service

By manufacturer service only

The luminaire does not light

No mains voltage

Check mains voltage, check all connections

Electrician

The luminaire does not light

1 A fuses defective (Polaris 50 Mobile only)

Replace fuses (2 pcs. are fitted)

Electrician

17

TECHNICAL DATA

Electrical: Nominal input voltage

100 - 240 VAC

Frequency range

50 / 60 Hz

Power consumption

30 W (42-52 VA)

Input current

0.42A

Power factor

0.69

Integrated electronic transformer

24 V DC output

Approval

ETL / cETL

Illumination*: Central illuminance at 1.0 m (3.28 feet)

60,000 lux

Light field diameter d10 at 1.0 m (3.28 feet)

Ø = 16 cm (6.3”)

Light field diameter d50 at 1.0 m (3.28 feet)

Ø = 8.5 cm (3.3”)

Colour temperature

4500 K

Colour rendering index Ra

95

Colour rendering index R9

90

Total irradiance Ee at maximum intensity

200 W/m2

Ratio irradiance Ee to illuminance Ec

3.5 mW/m2/lx

Photobiological safety (EN/IEC 60601-2-57)

Risk Group 1 (low risk)

Residual light intensity when shading using one shade

< 1%

Residual light intensity when shading using two shades

56%

Light intensity in tube

96%

Residual light intensity in tube with one shade

< 1%

Residual light intensity in tube with two shades

55%

Depth of illumination L1 + L2

120 cm (47.2”)

*Illumination data -10% / +20% tolerance Environmental conditions for transport, storage and operation: Ambient temperature (storage and transport)

-20 °C to +70 °C (-4 °F to +158 °F)

Ambient temperature (operation)

10 °C to +35 °C (+50 °F to +95 °F)

Relative humidity (non-condensing)

max. 75%

Weight:

38

EN_GB Luminaire head

3 kg (6.614 lb)

Polaris 50 Ceiling

13 kg (28.66 lb)

Polaris 50 Wall

13 kg (28.66 lb)

Polaris 50 Mobile

20 kg (44.09 lb)

Polaris 50 CSU

10 kg (28.66 lb)

Operating mode: Operating mode

Continuous operation

Classification: Polaris 50

Class I

Degree of protection as per IEC 529 Luminaire head

IP 20 IP 43 (horizontal position)

Classification under 93/42 EEC - Appendix IX (medical device class) U.S. FDA Device Class

Class I Class I

Electrical safety test and EMC according to:

ANSI/AAMI ES60601-1 CAN/CSA-C22.2 No 60601-1 EN/IEC 60601-1 EN/IEC 60601-2-41 EN/IEC 60601-1-2

According to standard 93/42/EWG

Class 1

GMDN code

12276

Service life of light source: Service life

30,000 h

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18

NOTES ON THE ARM SYSTEMS

18.1 Cleaning and disinfection DANGER Electric shocks are life-threatening. The devices can conduct electricity and must be handled with care during cleaning and disinfection. • If there is a power plug remove it from the socket. • Do not use spraying methods for cleaning and/or disinfection. • Do not spray liquid into the openings of electrical power sockets, gas sockets or devices, or allow liquid to enter these.

position, the cantilever arm will spring up, possibly causing serious injury. Only remove the luminaire head if the cantilever arm is in the upper position. 1. Disconnect the device from the power supply/remove the plug from the mains and ensure it cannot be switched on again. 2. Place cantilever arm in the upper position. 3. Unscrew the brake screw (1) so that the sleeve (2) can be turned. 4. Turn the sleeve (2) through 180 degrees until the securing segment (3) appears in the slot (4). 5. Hold the luminaire head (5) firmly and remove the securing segment (3) using a narrow flat-bladed screwdriver. Remove luminaire head (5) from the connection. 6. Put protective cap in place.

Recommended cleaning agents Use mild soap solutions or standard detergents as cleaning agents. Wipe down the surfaces of the equipment with a dampened cloth. If necessary, use small quantities of mild soap solution as a cleaning agent. Then wipe the outer surfaces with a soft, clean cloth until they are completely dry. Disinfection procedure Disinfection by wiping is intended to be the standard disinfection procedure for the support arm system. Hygiene guidelines and corresponding safety measures must be determined by the operator for the disinfection procedures that are applied. • After the contamination by any potentially infectious material (such as blood, secretions or excrement), the areas must be disinfected immediately in a targeted way. • Comply with application concentrations. • Wipe the area to be disinfected rather than spraying it. • Do not use areas that have been wiped until the disinfectant is dry.

18.2 Testing DANGER Electric shocks are life-threatening. During all testing work, disconnect the device from the power supply/remove the plug from the power socket and secure the device so that it cannot be switched on again. Annually: • Paint damage • Cracks in plastic parts • Deformation of the support system • Loosening of parts • Check the fastening screw on the underside of the stand base, tighten it if necessary. Every 2 years: The securing element of the cantilever arm must be checked and greased by a qualified professional

18.3 Demounting for servicing DANGER Injury hazard The cantilever arm is under a high spring load. If the luminaire head is not moved to the upper cantilever arm

40

1 Brake screw 2 Sleeve 3 Securing segment 4 Slot 5 Luminaire head terminal

19

ELECTROMAGNETIC COMPATIBILITY (EMC) Electromagnetic emission guidelines

The medical device is intended for operation in an electromagnetic environment such as the one specified below. The user must ensure that it is operated in such an environment. Emissions In accordance with Electromagnetic environment High-frequency emissions Group 1 The medical device uses HF energy exclusively for its internal (CISPR 11) function. This means that its HF emissions are very low, and it is unlikely, that adjacent electronic devices will receive interference. High-frequency emissions Class A The health care product is designed for use in non-residential homes (CISPR 11) and those that are connected directly to a public low voltage distribution systems that also supplies the home. Emissions from harmonics (IEC 61000-3-2) Emissions from voltage fluctuations/flicker (IEC 61000-3-3)

Class A

Compliance

Electromagnetic interference resistance guidelines The medical device is intended for operation in an electromagnetic environment such as the one specified below. The user must ensure that it is operated in such an environment. Interference resistance to IEC 60601-1-2 testing Conformity level of Electromagnetic environment level the medical device Electrostatic discharge Contact discharge: ± 8 ± 8 kV Floors made of timber, concrete or ceramics (ESD) kV ± 15 kV tiles are preferred. Where synthetic floor (IEC 61000-4-2) Air discharge: ± 15 kV covering is used the relative humidity should be at least 30%. Fast transients/ Power supply cables: ± ± 2 kV The quality of the mains power supply should electrical disturbance 2 kV Not applicable match that of a typical business or hospital variables/ Longer input and environment. bursts (IEC 61000-4-4) output cables: ± 1 kV Surge voltages/surges Common mode voltage: ±2 kV The quality of the mains power supply should (IEC 61000-4-5) ±2 kV ±1 kV match that of a typical business or hospital Differential mode environment. voltage: ±1 kV Magnetic field in the power 3 A/m 3 A/m In proximity of this medical device, do not supply frequency operate devices with unusually strong (50/60 Hz) network-frequency magnetic fields (IEC 61000-4-8) (transformer stations etc.) . Voltage dips and short Cut >95 %, 0.5 periods Cut >95 %, 0.5 periods The supply voltage quality should be that of interruptions Cut 60 %, 5 periods Cut 60 %, 5 periods a typical business or hospital environment. If to the power voltage Cut 30 %, 25 periods Cut 30 %, 25 periods the user requires continued function during (IEC 61000-4-11) Cut >95 %, 5 seconds Cut >95 %, 5 seconds any interruption of the energy supply system, we recommend that the medical device be powered by an uninterrupted power supply or a battery. Radiated HF disturbance 80 MHz to 2.5 GHz: 3 3 V/m Recommended minimum distance of variable V/m portable and mobile radio devices of PEIRP (IEC 61000-4-3) radiated power to the medical device, including its cables: (1.84 m x PEIRP)1) Conducted HF disturbance 150 kHz to 80 MHz: 3 V 3 V Recommended minimum distance of values portable and mobile radio devices of PEIRP (IEC 61000-4-6) radiated power to the medical device, including its cables: (1.84 m x PEIRP)1) 1) For PEIRP, use the maximum “equivalent isotropic radiated power” of the adjacent radio device in watts. High-frequency emissions can also occur in the environment of devices with the symbol . The field strength of stationary, portable or mobile radio transmitters at the location of the medical device should be less than 3 V/m in the 150 kHz to 2.5 GHz frequency range, and less than 1 V/m above 2.5 GHz. Recommended safe distances from portable and mobile HF communications equipment The safe distances listed below correspond to the data in IEC 60601-1-2. Max. PEIRP (W) 150 kHz to 2.5 GHz All other frequencies Examples 0.03 0.32 m (1.05 ft) 0.96 m (3.15 ft) e.g. WLAN 5250 / 5775 (Europe) 0.10 0.58 m (1.90 ft) 1.75 m (5.74 ft) e.g. WLAN 2440 (Europe)

41

EN_GB 0.17 0.20 0.25 0.41 0.82 1.00 1.64 3.28

42

0.76 m (2.49 ft) 0.82 m (2.69 ft) 0.92 m (3.02 ft) 1.18 m (3.87 ft) 1.67 m (5.48 ft) 1.84 m (6.04 ft) 2.36 m (7.74 ft) 3.33 m (10.93 ft)

2.28 m (7.48 ft) 2.47 m (8.10 ft) 2.76 m (9.06 ft) 3.53 m (11.58 ft) 5.00 m (16.40 ft) 5.52 m (18.11 ft) 7.07 m (23.20 ft) 10.00 m (32.81 ft)

e.g. Bluetooth, RFID 2.5 GHz e.g. WLAN 5250 (not in Europe) e.g. UMTS mobile phones e.g. cordless DECT telephones e.g. RFID 13.56 MHz e.g. WLAN 5600 (not in Europe) e.g. GSM 1800/GSM 1900 e.g. GSM 900 mobile telephones, RFID 868 MHz