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Guidance and manufacturer’s declaration – electromagnetic immunity

Immunity test

IEC 60601-1-2 test
level

Compliance level

Electromagnetic environment
- guidance

Electrostatic
discharge (ESD)
EN 61000-4-2

±2kV, ±4kV, ±8kV,
±15kV air
±8kV contact

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

Conducted
disturbances
inducted by RF
fields
EN 61000-4-6

3V in 0,15 MHz to 80
MHz
6V in ISM and amateur
radio bands between
0,15 MHz and 80 MHz
80% AM at 1 kHz

3V in 0,15 MHz to 80
MHz
6V in ISM and amateur
radio bands between 0,15
MHz and 80 MHz
80% AM at 1 kHz

Portable and mobile RF
communications equipment should
be used no closer to any part of the
product, including cables, than
1.0m, if the transmitter’s output

power rating exceeds 1W

Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,
should be less than the compliance

level in each frequency range

Interference may occur in the
vicinity of equipment marked with
this symbol:

Radiated RF
electromagnetic
field
EN 61000-4-3

Professional Healthcare
environment
3 V/m
80 MHz to 2,7 GHz
80% AM at 1 kHz

Proximity fields
from RF wireless
communications
equipment
EN 61000-4-3

385 MHz - 27 V/m
450 MHz - 28 V/m
710, 745, 780 MHz -
9V/m
810, 870, 930 MHz - 28
V/m
1720, 1845, 1970, 2450
MHz – 28 V/m
5240,5500, 5785 MHz -
9V/m

385 MHz - 27 V/m
450 MHz - 28 V/m
710, 745, 780 MHz - 9V/
m
810, 870, 930 MHz - 28
V/m
1720, 1845, 1970, 2450
MHz - 28 V/m
5240,5500, 5785 MHz -
9V/m

Electrical fast
transient/burst
EN 61000-4-4

±1kV SIP/SOP ports
±2kV AC port
100kHz repetition
frequency

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

Power frequency
Magnetic field
EN 61000-4-8

30A/m
50 Hz or 60 Hz

30A/m
50 Hz

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

Содержание ENTERPRISE 9000X

Страница 1: ...ENTERPRISE 9000X E9X with people in mind Instruction for Use 746 591 EN_12 12 2018 ...

Страница 2: ...group of companies unless otherwise stated ArjoHuntleigh 2016 As our policy is one of continuous improvement we reserve the right to modify designs without prior notice The content of this publication may not be copied either wholly or in part without the consent of ArjoHuntleigh ...

Страница 3: ...linen shelf Optional 25 Lifting pole and accessory sockets 26 Drainage bag rails 27 Head and foot boards 28 Adjusting the mattress platform 29 Patient controls 30 Caregiver controls 30 Patient handset Optional 32 Attendant Control Panel ACP 33 Function lockout 35 Adjusting the calf position 36 Backup battery 37 Duty cycle lockout 38 5 Advanced Features 39 Patient weighing system 39 VariZone patien...

Страница 4: ...ons which if not correctly followed could result in death injury or other serious adverse reactions CAUTION Indicates possible hazards in procedures or conditions which if not correctly followed could result in equipment damage or failure NOTE Explains or amplifies a procedure or condition ...

Страница 5: ...ty supply with a protective earth Do not smoke or use naked flames near this equipment and do not expose it to extremes of temperature Do not use electrically powered beds in the presence of flammable gases such as anaesthetic agents e g in operating theatres The bed is intended for indoor use only and should not be used outside a normal hospital environment Do not use accessories that have not be...

Страница 6: ... bed do not hold the side rails or any attached accessories Before operating the bed make sure the patient is positioned correctly to avoid entrapment or imbalance Take care when using equipment that needs to be positioned under the base frame to ensure there is no contact with any part of the bed frame or components Take care not to squeeze or trap trailing cables from other equipment between mov...

Страница 7: ...ot down tilt reverse Trendelenburg Manual selection of calf section vascular position Mattress support surface with removable panels Adjustable length mattress platform Drainage bag rails Underbed lights 125mm single wheel castors Full width brake bar Patient weighing and patient egress detection Optional features Anti Entrapment System 150mm single or dual wheel castors Bedstripper linen shelf 5t...

Страница 8: ...tion label this is located on the control box tray Specification label Caution Before using the bed ensure that the Power in rating on the specification label is compatible with the local electricity supply ArjoHuntleigh AB Hans Michelsensgatan 10 211 20 Malmö SWEDEN ...

Страница 9: ...rd M Bedstripper linen shelf Optional N Extension locking handle O Brake pedal bar P Accessory socket Q Extension catch bar R CPR release handle S Weighing movement detection system controls T 5th Wheel Optional U Drainage bag rail V Split side rail release lever W Anti entrapment sensor Optional X Castor Y Lifting pole socket Z Head end brake pedal Optional AA Roller buffer NOTE Flat deck sheets ...

Страница 10: ...sing homes and geriatric facilities Indications The bed is appropriate for high dependency patients who pose a movement and handling risk and or whose clinical condition requires that they are positioned with minimal physical handling Patients with a moderate amount of independence can at the caregiver s discretion use the controls to adjust their own position The mattress platform can be position...

Страница 11: ... patient weight 185kg Mattress 20kg Accessories including attached loads 45kg TOTAL 250kg The recommended patient size is weight equal or above 40kg height between146cm and 190cm and BMI equal or above 17 At the discretion of the carer patients taller than190cm may be accomodated by extending the bed refer to Bed length adjustment in Chapter 4 Ensure that the patient s height does not exceed the I...

Страница 12: ... frame and head board Disconnect the power supply cord from the electricity supply and store it as shown before moving the bed Before the first use or if the bed has been unused for more than three months read and understand this IFU and test the functionality of the bed to verify correct operation Refer to Preventive maintenance on page 49 for a list of functional tests CAUTION Before the first u...

Страница 13: ... 2 Removing the transport bolts Retain the bolts and washers in case the bed needs to be transported at a later date 1 2 2 1 CAUTION To prevent damage to the weighing mechanism replace the transport locking bolts and washers before transporting the bed This is not necessary when moving the bed short distances over smooth surfaces When replacing the transport locking bolts care must be take to avoi...

Страница 14: ...k onto the head board coil up the cable and place it over the hook as shown To isolate the bed from the electricity supply disconnect the mains plug from the socket outlet A potential equalisation terminal 3 is located at the head end of the bed When other electrical equipment is within reach of the patient or caregiver potential differences between the equipment can be minimised by connecting tog...

Страница 15: ...Mattress overlays are not recommended for use with this bed To ensure compliance with IEC 60601 2 52 an approved ArjoHuntleigh mattress should be used Compliance with this standard when using other mattresses must be validated by the user For more information on suitable mattresses and mattress replacements contact your local ArjoHuntleigh office or approved distributor A list of ArjoHuntleigh off...

Страница 16: ...stor see below is locked so that it cannot swivel This helps to keep the bed on a straight line BRAKE FREE STEER Using the steering castor Position the bed so that all the castors line up in the direction of travel Raise the pedals to lock the steering castor and move the bed by pushing it from the opposite end of the steering castor WARNING Operate the brake pedals with your feet while wearing su...

Страница 17: ...edals Fig 4 Head end brake pedal Foot Pedal for Adjustment of Bed Height Optional Bed height can be adjusted from bed control panels and from the foot pedal located near the foot end of the bed Lift cover of pedal with foot and press left side to raise the bed height Press right side of pedal to lower the bed height 1 ...

Страница 18: ...til it has contact with the floor 2 Check that the brakes are unlocked and the brake pedal is in the Free position See Fig 6 3 The bed is ready for movement Deactivate 5th Wheel 1 Step down on the foot end of the 5th wheel activation pedal A See Fig 5 2 Make sure the 5th wheel B is raised from the floor Fig 5 5th wheel activation pedal Fig 6 Free Position Foot End Head End A B Place Brake Pedal in...

Страница 19: ...the age size and condition of the patient before allowing the use of split side rails Split side rails are not intended to restrain patients who make a deliberate attempt to exit the bed Ensure that the mattress is suitable for use with split side rails see Mattresses and split side rails on page 15 To prevent possible entrapment make sure the patient s head and limbs are clear of the split side r...

Страница 20: ... arrest pull the CPR release handle 1 This will lower the backrest 2 to enable cardio pulmonary resuscitation to be carried out Fig 8 CPR backrest release WARNING The backrest can fall quickly keep hands clear to avoid trapping 1 2 Caution The manual CPR release should only be used in an emergency repeated everyday use can cause premature wear ...

Страница 21: ...ease the knob to hold the tray in the fully open position 3 Position the X ray cassette 4 on the tray with its bottom edge against the lip at the foot end of the tray WARNING Position the mattress platform at an ergonomic height to allow easy loading and removal of X ray cassettes Return the X ray cassette tray to its closed position below the backrest before raising or lowering the backrest Do no...

Страница 22: ...he top right hand corner of the X Ray cassette Use this feature to assist in accurate positioning X Ray Sitting Tool Release the knob to hold the tray in one of the latching positions After use pull the tray out to the fully open position and remove the X ray cassette Return the tray to the closed position below the backrest and replace the head board 3 4 ...

Страница 23: ...To extend the bed frame Pull the blue extension locking handle 1 Pull out the bed frame 2 to the required position and release the handle Fig 9 Extending the bed frame WARNING Install a suitable foam mattress extension squab at the head end when the bed is extended Always adjust the bed frame and mattress platform to the same length and make sure both are latched securely in position Level the mat...

Страница 24: ...m to the required position Release the catch bar Fig 10 Extending the mattress platform To shorten the bed Reverse the above procedure WARNING Take care not to pinch your fingers when lifting the catch bar WARNING After extending the mattress platform make sure the calf extension sheet is clipped over the end of the mattress platform frame 1 2 ...

Страница 25: ... sheets are being changed Pull out the bedstripper from its closed position below the foot board After use push the bedstripper back to its closed position Fig 11 Bedstripper linen shelf CAUTION The safe working load of the bedstripper is 20kg Level the mattress platform before using the bedstripper ...

Страница 26: ...sockets 1 are located at the head end of the mattress platform Sockets to support compatible accessories are located at the head end 2 and foot end 3 of the bed Fig 12 Lifting pole and accessory sockets head end Fig 13 Accessory sockets foot end 2 1 3 3 ...

Страница 27: ...h DIN accessory rails 2 Fig 14 Drainage bag rails and DIN rail CAUTION The maximum weight that can be safely supported by each drainage bag rail and DIN rail is 5kg 1 2 CAUTION Items placed on the drainage bag rails such as patient drains and urine bags are included in the weighing calculation and can influence measurement of patient weight see Advanced Features on page 39 ...

Страница 28: ...h two locking catches 1 to prevent accidental removal To unlock the head or foot board pull out the catches 2 and rotate them a quarter turn 3 the foot board can now be lifted off the bed Fig 15 Locking foot board foot end shown in this example After replacing the foot board on the bed rotate the catches until they spring back into the locked position 2 3 1 ...

Страница 29: ... achieved Movement will continue until the button is released or the limit of travel is reached Fig 16 Electrical box WARNING The controls require only a single press to activate To prevent unwanted movement of the mattress platform avoid leaning against the split side rails and keep equipment on and around the bed clear of the controls CAUTION Do not place anything on the electrical box 1 as it m...

Страница 30: ...ide rails Fig 17 Patient controls patient s left hand side Caregiver controls The caregiver controls are located on the outside panel of both head end split side rails Fig 18 Caregiver controls patient s right hand side WARNING The patient should be shown how to use these controls by the caregiver ...

Страница 31: ...rest and thigh sections to provide upright patient profiling the raised thigh section prevents the patient sliding down the bed The Bio Contour down button returns the mattress platform to a flat position Mattress platform height These buttons raise and lower the mattress platform When the mattress platform is lowered to 38cm above the floor it will pause then continue to lower until it reaches it...

Страница 32: ...ee page 31 Patient handset WARNING Store the handset on the side rail using the clip on the back this will help to prevent accidental operation of the controls The patient should be shown how to use the handset by the caregiver Take care not to squeeze or trap the handset cable between moving parts of the bed ...

Страница 33: ...on page 37 Mattress platform height These buttons raise and lower the mattress platform When the mattress platform is lowered to 38cm above the floor it will pause then continue to lower until it reaches its minimum height 40cm on beds with 150mm castors WARNING Before lowering the bed make sure that the space between the mattress frame and chassis is free of persons limbs bedding or other objects...

Страница 34: ...to 45º to prevent the patient from tipping forwards The Auto Chair down button returns the mattress platform to a flat and level position Tilt angle This button lowers the head end of the mattress platform Trendelenburg position This button lowers the foot end of the mattress platform reverse Trendelenburg position CPR position If the patient suffers a cardiac arrest press and hold the CPR button ...

Страница 35: ...indicator LED above each function button shows its current status LED on function locked LED off function unlocked When all functions are locked or unlocked as required press the Function Lock button again or wait for five seconds The indicator above the Function Lock button will go out and the lockout settings are stored NOTE When a function is locked any associated functions are automatically di...

Страница 36: ...on frame Lift the calf section upwards 1 until it latches 2 Fig 20 Changing from Fowler position left to vascular To return the calf section to the Fowler position Use the caregiver controls or ACP to lower the thigh section to the flat position then raise the thigh section again 1 2 WARNING Take care when lifting the calf section Observe local manual handling guidelines ...

Страница 37: ... bed functions remain operational If a continuous warning tone sounds when operating the bed the battery is between 10 and 75 charged In this condition all bed functions remain operational If the ACP battery indicator lights red the battery is less than 10 charged In this condition all functions are locked CAUTION To ensure the battery is kept fully charged and prevent damage to the battery the be...

Страница 38: ...of low power mode The bed will return to low power mode two minutes after the last control button was pressed Duty cycle lockout Continuous operation of the controls may exceed the duty cycle of the bed s electrical system causing the indicators above the buttons to flash After 30 seconds the indicators will light and all functions are locked If this happens wait for at least 18 minutes then follo...

Страница 39: ...to or removed from the bed without affecting the indicated patient weight Zero this button is used to reset the weighing system when the bed is first set up and before a new patient uses the bed Select Weight Display this button allows the patient weight to be displayed rounded to the nearest 100g or 500g WARNING The weighing system should only be used by staff trained in the correct use of the we...

Страница 40: ...ould keep clear of the bed Ensure that the patient pillows and bed linen do not touch the head board during weighing Fig 22 Areas of patient weighing influence CAUTION Any item attached to or placed on any part of the bed other than the head board Fig 22 Item 1 and head end lifting pole accessory sockets Fig 22 Item 2 will influence the patient weighing system Make sure the mains cable is free of ...

Страница 41: ...mpensation feature if adding or removing items from the bed such as linen or accessories WARNING The weighing system is intended to provide reference data only The weighing system is not intended to provide readings upon which medication dosage decisions are made CAUTION The weighing system MUST be zeroed every time a new patient is to be placed on the bed CAUTION The weighing system MUST be zeroe...

Страница 42: ...ity allows weight up to a maximum of 100kg to be added to or removed from the bed without affecting the indicated patient weight 1 With the patient lying on the bed press the Auto Compensation button once 2 The display will show a moving circular pattern until a stable weight reading is obtained 3 The display will show to indicate that the system is in Auto Compensation mode 4 Add or remove access...

Страница 43: ...ange when the mattress platform is tilted The tilt angle is shown as a positive value for head down tilt and a negative value for foot down tilt Display Cause Solution E001 Zero on battery power Connect bed to mains supply and re initialise the weighing system see page 41 E002 Auto Compensation weight decrease more than 100kg Replace weight removed from bed E003 Auto Compensation weight increase m...

Страница 44: ... of patient movement detection Egress this button activates deactivates patient movement detection and decreases the sensitivity of the system Operation Before activating patient movement detection make sure that The patient s weight has been measured and recorded All additional items e g accessories have been accounted for using the Auto Compensation function The weighing system display is blank ...

Страница 45: ...hed release the button To reduce the patient movement detection threshold Press and hold the In Bed button the flashing indicator will move towards the left When the required threshold is reached release the button After a few seconds the indicator will stop flashing and remain lit to show that patient movement detection is active If movement of the patient above the set threshold is detected an a...

Страница 46: ...are four infra red sensors 1 one above each castor which generate an invisible beam around the base of the bed 3 If the beam is interrupted e g by a patient s limb while the mattress platform is lowering the mattress platform stops moving and the weighing system display shows Upward movement of the mattress platform is not affected 1 2 2 3 NOTE The anti entrapment system may also be triggered if t...

Страница 47: ...ss platform sections top view To replace each section make sure it is correctly positioned on the mattress platform frame then press down firmly until it snaps into place Replace the calf extension sheet 1 by clipping it over the end of the mattress platform frame WARNING Disconnect the bed from the electricity supply before starting any cleaning or maintenance activity The bed will still operate ...

Страница 48: ...illion 0 1 of available chlorine In the case of pooling body fluids e g blood the concentration of NaDCC should be increased to 10 000 parts per million 1 of available chlorine Use of other disinfectants ArjoHuntleigh recommends sodium dichloroisocyanurate NaDCC as a disinfectant because it is effective stable and has a fairly neutral pH Many other disinfectants are used in healthcare facilities a...

Страница 49: ...und may compromise the safety of both the patient and caregiver Preventive maintenance can help to prevent accidents NOTE Product cannot be maintained and serviced while in use with the patient Actions to be done by caregiver Daily Weekly Check operation of split side rails Visually check castors Check operation of the manual CPR release handles on both sides of the bed Visually check power supply...

Страница 50: ... linen shelf Optional remains in its closed position when maximum foot down tilt is applied Check that the bed operates correctly using the backup battery as described in the section Battery test on page 51 Check operation the of castors paying special attention to braking and steering functions Check that the calf section moves to the Fowler position when the thigh section is raised Check that th...

Страница 51: ...eight position 5 Lower the mattress platform to minimum height 6 Apply maximum head down tilt Trendelenburg 7 Return the mattress platform to the level position then apply maximum foot down tilt reverse Trendelenburg If this test is not completed successfully connect the bed to the electricity supply for at least eight hours to recharge the battery then perform the test again If the bed fails a se...

Страница 52: ...s displayed Control button pressed for more than 90 seconds Remove pressure from control buttons If error code does not clear call an ArjoHuntleigh approved service engineer Mattress platform cannot be lowered and error code AES is displayed Anti Entrapment system activated Remove obstruction s from below the mattress platform If bed still cannot be lowered call an ArjoHuntleigh approved service e...

Страница 53: ...ht removed from bed Error code E003 Auto Compensation weight increase more than 100kg Remove added weight from bed Error code E102 A stable weight reading was not obtained within 10 seconds Refer to the points listed in the section Accuracy on page 40 Symptom Possible Cause Action ...

Страница 54: ...cified performance and safety provided it has been maintained and operated in conditions of normal use in accordance with the requirements in these instructions Indication Possible cause ACP mattress platform height and head down tilt indicators flashing Height actuator fault foot end ACP mattress platform height and foot down tilt indicators flashing Height actuator fault head end ACP backrest in...

Страница 55: ...on assembly ENT ACC10 ACP holder ENT ACC11 Additional hooks for IV pole ENT ACC14 Power supply cord storage hook supplied with bed ENT ACC15 Oxygen bottle holder for B5 cylinder ENT ACC18 Urine bottle holder ENT ACC19 Heavy duty IV pole ENT ACC24 Transducer mounting pole ENT ACC26 Head end traction assembly ENT ACC32 ITU head end panel head board ENT ACC34 Oxylog equipment bracket ENT ACC40 Bed pa...

Страница 56: ... 8 max at 100V a c 50 60Hz Duty cycle 10 2 min on 18 min off Safety standards USA Canada EN IEC 60601 1 2005 AMD1 2012 ANSI AAMI ES60601 1 2005 AMD 1 2012 CAN CSA C22 2 No 60601 1 14 IEC60601 2 52 2015 Electric shock protection Class I Type B EMC Complies with EN 60601 1 2 2002 and 2007 Potential equalisation terminal Complies with EN IEC 60601 1 2005 AMD1 2012 Liquid ingress protection IPX4 Backu...

Страница 57: ...andard 203cm Position 3 Extended 215cm Overall width 103cm Height of mattress platform centre of seat section to floor With 125mm castors 32cm to 76cm Curved Deck Sheets 34cm to 78cm Flat Deck Sheets With 150mm castors 34cm to 78cm Curved Deck Sheets 36cm to 80cm Flat Deck Sheets Head down tilt angle 12 min Foot down tilt angle 12 min Mattress size refer to the section Mattresses on page 15 Positi...

Страница 58: ...e following conditions Temperature 10 C to 50 C 14 F to 122 F Relative humidity 20 to 90 at 30 C non condensing Atmospheric pressure 700hPa to 1060hPa CAUTION If the bed is stored for a long time it should be connected to the electricity supply for 24 hours every three months to recharge the backup battery otherwise it may become unserviceable Symbols Safe working load Maximum patient weight Alter...

Страница 59: ...sation terminal Protective earth ground Recommended mattress size Recommended patient size Total weight of the equipment including its safe working load Calf section vascular position Mattress platform extension Calibration expiry Label Calibration expiry Label France kg 40 146 cm BMI 17 kg lb kg lb kg lb 1 2 3 4 5 6 7 8 9 10 11 12 INSTRUMENT RECONNU CONFORME LIMITE DE VALIDITE 20XX ...

Страница 60: ...on Label RH Refer to manual Indicates min max temp for use of weigh scales Metrology Notified Body number complies with NAWI directive 2014 31 EU Fictitious example above included 15 representing 2015 for year of affixing and 1234 representing metrology Notified Body M15 1234 ...

Страница 61: ...the statutory rights of the consumer For service maintenance and any questions regarding this product please contact your local ArjoHuntleigh office or approved distributor A list of ArjoHuntleigh offices can be found at the back of this manual Have the model number and serial number of the equipment to hand when contacting ArjoHuntleigh regarding service spare parts or accessories ...

Страница 62: ...ir base stations walkie talkies etc can affect this equipment and should be kept at least 1 5 m away from the equipment WARNING Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation If such use is necessary this equipment and the other equipment should be observed to verify that they are operating normally Guidance and man...

Страница 63: ...te survey should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with this symbol Radiated RF electromagnetic field EN 61000 4 3 Professional Healthcare environment 3 V m 80 MHz to 2 7 GHz 80 AM at 1 kHz Professional Healthcare environment 3 V m 80 MHz to 2 7 GHz 80 AM at 1 kHz Proximity fields from RF wireless communications eq...

Страница 64: ... 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 product is used exceeds the applica...

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Страница 67: ...y promo arjo com MIDDLE EAST Huntleigh Middle East Of ce G005 Nucleotide Complex Biotechnology Research Park P O Box 214742 Dubai United Arab Emirates Tel 971 0 4 447 0942 E mail Info ME arjo com NEDERLAND Arjo BV Biezenwei 21 4004 MB TIEL Postbus 6116 4000 HC TIEL Tel 31 0 344 64 08 00 Fax 31 0 344 64 08 85 E mail info nl arjo com NEW ZEALAND Arjo Ltd 34 Vestey Drive Mount Wellington NZ AUCKLAND ...

Страница 68: ...fective everyday care early mobilisation safe patient handling venous thromboembolism prevention pressure injury prevention hygiene routines bariatric care and diagnostics With extensive know ledge and experience we strive to improve efﬁciency and ensure a safer and digniﬁed environment for caregivers and their patients ArjoHuntleigh AB Hans Michelsensgatan 10 211 20 Malmö Sweden www arjohuntleigh...

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