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Drive 15903C Owner`s Manual CF REV 004
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1. arrive Owner s Manual REV 001 25 BED FUNCTIONS Danger Crush hazard Stay clear of this area during operation Crush point exists due to LOW BED CLEARANCE Do NOT place feet or other limbs under the frame when lowering the bed When lowering the bed be aware this may cause INJURY if limbs or personal items interfere with bed movement Stay clear of the frame and ensure children or pets are not under the bed before lowering the bed Hand Control Pendant Operation 4 FUNCTION HAND PENDANT o o 9 J 4 Function Hand Pendant e Hand held pendant can be plugged into the left or right side of the bed frame for the convenience of the resident e 1 Set of Buttons Head deck up and down e 2 4 Set of Buttons Foot deck up and down e 3 Set of Buttons Auto Contour raise and lower the head and foot decks at the same time e 4 Set of Buttons Bed frame up and down e When the green light on the pendant is lit this indicates the pendant is in use E TM drive Owner s Manual REV 001 26 EMBEDDED STAFF CONTROL PANEL OPERATION OPTION 5 Function e This controller is located on the footboard e The 1 button controls the raising and lowering of the head section o While in the locked position this panel feature will not work e The 2 button controls the raising and lowering of the foot section o While in the locked position this panel feature will not work e The 3 button controls the raisin
2. Lift power cord from control box and remove 2 wires from the terminal inside the control box e Dispose of the broken power cord e Reattach 2 new wires to terminal inside control box e Route the new power cord in the same manner as the original cord ensuring use of strain relief device e Replace tie wraps to hold power cord to frame e Screw 4 bolts back on to the control box e Plug power cord back into wall outlet END OF LIFE DISPOSAL e Many components of this product may be recycled e Please dispose of non recyclable items properly drive TROUBLESHOOTING GUIDE A WARNING Owner s Manual REV 001 36 Before doing any repairs or maintenance to the bed frame read all instructions cautions and warnings The repairs should be done by a skilled technician Effect Possible Cause Corrective Action When in the Trendelenburg or Reverse Trendelenburg position the bed begins to beep when raising lowering Bed does not stay in place Actuators are not working Actuators start reading for possible overload and stop so the bed does Floor lock is not engaged Black plunger is not hitting the floor or there is not enough resistance between floor and plunger Floor lock is not functioning Wire connections may be loose or damaged Hi Lo lockout may be on Faulty actuator When raising lowering the bed frame while in the Trendelenburg Reverse Trendelenburg position bed begins to raise low
3. Owner s Manual REV 001 1 for the road ahead anive Premier Full Electric Long Term Care Bed Model 15903C Owner s Manual Shown with Optional Assist Rails and Embedded Staff Control This manual must be given to the Owner User of this bed and should be read carefully before putting this product into use Keep manual in an accessible location for future reference Drive Medical Design amp Manufacturing 99 Seaview Blvd Port Washington NY11050 Phone 1 877 224 0946 Fax 516 988 4601 www drivemedical com g Owner s Manual REV 001 TABLE OF CONTENTS aNd ADO S arer N E E A 3 WV GTI GEA CIS cers E EA REE EEE 4 Features and Technical Specifications ccceeeeee eee eeeeeeeeeeeneeneeneeeeseess 5 General Saloy srra are aA sot canite sans EE a 10 CO AACS ren E E E E T AAE 13 Unpacking and Assembly sesssnsenssessesssesseeseeseresersessesssessessresseeseesees 14 Wall BOUNDO aane E E A E E A 15 Mattress Retainer ssususssesesesesesssesesesesesesesesesrsrsesesrsseeess 15 Head Foot Board Installation cccccceeeeeeeeeseeeeeteeeeeeeeeeeeees 17 Assist Bar ODUON cctacedadic aisetincecabdadseviwadsonatditahdeeeiaeseieenedess 19 Sleep Surface Deck Width Extension Option ccccece eee eee eee 21 Heel Lift Ratchet AdjUStMENT ccc cece ccc eee e cece ee eeeeeneseeeeeees 23 Battery Backup OPTION iscsiwesceeectesaecuwdavaatdiseeiseloeeeetannacem
4. A majority of service requests can be handled by the facility maintenance department with assistance from the Authorized Distributor s technical support dept Most parts can be shipped next day air at the customer s expense Bed Frame Serial Numbers When ordering parts or contacting an Authorized Distributor s Customer Service Department please include bed s model and serial numbers found on the identification labels The identification labels are located under the sleep deck on the frame rail below the head section on either side of the bed Drive Medical Design amp Manufacturing Made in China 99 Seaview Blvc Port Washington NY1105 Phone 1 877 224 094 Fax 516 988 4601 www drivemedical corn E TM drive Owner s Manual REV 001 40 APPENDIX SPECIAL NOTE For your convenience we have provided the January 2008 addition of the FDA s guide to bed safety This information from the FDA s brochure published by Hospital Bed Safety Workgroup is replicated verbatim the latest version is available at http www fda gov A Guide to Bed Safety Bed Rails in Hospitals Nursing Homes and Home Health Care The Facts Bed Rail Entrapment Statistics Today there are about 2 5 million hospital and nursing home beds in use in the United States Between 1985 and 2008 772 incidents of residents caught trapped entangled or strangled in beds with rails were reported to the U S Food and Drug Administration Of thes
5. Manual REV 001 12 A ENTRAPMENT WARNING Accurate assessment of the resident and monitoring of correct maintenance and equipment use are required to prevent entrapment For additional information on product and safety issues for bed frames and rails refer to product manuals specific to the product or accessories you have or are planning to install If bed frames have been serviced or any other adjustments have been made you must ensure all parts are securely back in place before operating the bed Other manufacturers assist bars or side rails may not be compatible and can lead to entrapment issues or harm to residents and staff Make sure mattress is the correct size for bed frame and the assist bars are secured to frame to decrease the risk of entrapment On March 10 2006 the U S Food and Drug Administration FDA released guidelines for reducing the risk of hospital bed entrapment entitled Hospital bed System Dimensional and Assessment Guidance to Reduce Entrapment This guidance document identifies potential entrapment areas within the bed frame rails and mattress and identifies those body parts most at risk for entrapment It also provides manufacturers with basic design criteria to consider when developing hospital convalescent beds recommends specific test methods to assess the conformance of existing hospital convalescent bed systems and answers frequently asked questions about entrapment issues The FDA Guidance document identifi
6. P N TC60000007 Bed Frame Serial Numbers When ordering parts or contacting an Authorized Distributor s Customer Service Department please include bed s model and serial numbers found on the identification labels The identification labels are located under the sleep deck on the frame rail below the head section on either side of the bed drive FEATURES AND TECHNICAL SPECIFICATIONS Standard Features A EE HH HHH 76 80 and 84 Sleep Surface Travel Range Roll at any Height 6 875 30 875 Floor Lock System Roll at any Height Foot Pad Lock Mechanism Pendant Connection on left and right sides Cable connection for Staff Control Panel Welded Tubular Frame Slat Sleep Deck Wall Guard Heavy Duty Casters Adjustable Mattress Retainers Heel Lift Ratchet Beige Frame Color Accessories and Options HH HH Pressure Reduction Mattress Air Flotation Mattress Cushion Fall Mat Assorted Bed End styles amp colors 42 Width Extension Staff Control Panel Rotating Assist Bars Battery Back Up Trapeze Assembly Bed Transporter system Owner s Manual REV 001 5 Owner s Manual REV 001 6 TECHNICAL SPECIFICATIONS _76 80 84 76 80 84 85 4 89V4 93 14 Overall Length X1 w head amp foot boards 90 94 4 98 44 Overall a X ampe guard Head deck angle range 0 to 70 Thigh deck angle range Foot deck angle range 0 to 11 Trend
7. SIDE ELECTROMAGNETIC EMMISSION AND IMMUNITY This 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 table below Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT Miwa The use of ACCESSORIES transducers and cables other than those specified with the exception of transducers and cables sold by the manufacturer of the EQUIPMENT or SYSTEM as replacement parts for internal components may result in increased EMISSION or decreased IMMUNITY of the EQUIPMENT or SYSTEM E TM drive Owner s Manual REV 001 8 DECLARATION ELECTROMAGNETIC EMISSIONS Guidance and manufacturer s declaration Electromagnetic emissions The Drive Medical 15903C is intended for use in the electromagnetic environment specified below The customer or the user of this bed should ensure that it is used in such an environment Emissions Test Compliance Electromagnetic environment Guidance The Drive Medical 15903C must emit electromagnetic RF Emissions CISPR 11 Group B energy in order to perform its intended function Nearby electronic equipment may be affected RF Emissions The Drive Medical 15903C is suitable for use in all Harmonic Emissions establishments including domestic establishments and Not Applicable IEC 61000 3 2 those directly connected to the public power supply network that supplies b
8. and security e Reducing the risk of residents falling out of bed when being transported e Providing easy access to bed controls and personal care items Potential risks of bed rails may include e Strangling suffocating bodily injury or death when residents or part of their body are caught between rails or between the bed rails and mattress e More serious injuries from falls when residents climb over rails e Skin bruising cuts and scrapes e Inducing agitated behavior when bed rails are used as a restraint E TM drive Owner s Manual REV 001 41 e Feeling isolated or unnecessarily restricted e Preventing residents who are able to get out of bed from performing routine activities such as going to the bathroom or retrieving something from a closet Meeting Resident s Needs for Safety Most residents can be in bed safely without bed rails Consider the following e Use beds that can be raised and lowered close to the floor to accommodate both resident and health care worker needs e Keep the bed in the lowest position with wheels locked e When the resident is at risk of falling out of bed place mats next to the bed as long as this does not create a greater risk of accident e Use transfer or mobility aids e Monitor residents frequently e Anticipate the reasons residents get out of bed such as hunger thirst going to be the bathroom restlessness and pain meet these needs by offering food and fluids scheduling ampl
9. foot lift can once again be raised to the desired height E TM drive Owner s Manual REV 001 24 BATTERY BACK UP OPTION Tools Needed Phillips Screw Driver and 9mm Wrench and Socket A CRUSH HAZARD Installation of the battery backup creates a possible foot crush hazard Drive Medical recommends that the battery backup is installed on the side of the bed that is against the wall to minimize this crush hazard e Locate the mounting plate underneath the bed frame near the head of the bed e Attach the mounting bracket to the mounting plate by screwing 2 bolts at the top into the frame Secure the rest of the mounting bracket with the remaining 4 bolts and locknuts to the mounting plate e Slide the battery into place make sure it is secure into the mounting bracket e Attach the cord from the battery into the control box black color e The battery back up will now work if the bed becomes unplugged from the wall outlet or there is a power failure IMPORTANT INFORMATION ABOUT YOUR BATTERY BACKUP The battery backup should be used for EMERGENCY PURPOSES ONLY DO NOT use the battery backup to demo or display a bed If the battery backup is used it MUST be recharged before becoming drained and dormant If the battery is run dead and left for any extended portion of time the battery can go into HIBERNATION and cannot recover or be recharged Drive Medical cannot be held responsible for improper backup use
10. on bed Pinch point exists between the assist bar and the floor at the lowest position which may cause INJURY to oneself or others Do NOT place feet beneath the assist bar g Owner s Manual REV 001 21 SLEEP SURFACE DECK WIDTH EXTENSION ASSEMBLY Tool Less Assembly e Determine if you will be making the bed frame a 39 or 42 bed frame Use only 1 Width Extension if a 39 bed frame is required Use both Width Extensions if a 42 bed is required e Remove the deck width extension assemblies from their packaging e DONOT remove the strings attached to the Width Extension they are there to prevent losing the clamps e There are four 4 sections to each side of the Width Extension Piece together and insert the four 4 3 16 x 1 bolts into the hinge points as shown FULLY TIGHTEN Owner s Manual REV 001 22 NOTE This will make it easier to grasp and attach to the bed deck Remove the 4 knobs that are attached to the width extension 2 on the head section and 2 on the foot section these will be used to tighten the width extension to the bed frame Remove the 2 knobs underneath the bed frame at the mid section this is where the width extension guides will be placed Line the extension up to the sleep deck and use the guides at the middle section of the extension and slide into the slots under the sleep deck attached to the mid section of the frame Replace knobs that were remove
11. place if the floor lock or bed casters are left unlocked Involuntary bed movement may lead to property DAMAGE or resident INJURY Never leave a bed unattended while the floor lock is not engaged FLOOR LOCK OPERATION A CRUSH HAZARD Possible Injury may occur when activating the Foot Lock Mechanism This feature is designed to be activated by your foot Using your hand could result in injury e Press the floor lock bar down once with your foot to engage floor lock e Two black plungers extend to the floor on each side of the bed in between the wheels indicating that floor lock is engaged e With the floor lock engaged this will prevent the bed from moving e Press the floor lock bar down once again with your foot and this will disengage the floor lock lf Owner s Manual REV 001 30 e A YELLOW indicator will appear on top of the caster covers on each side of the bed indicating the floor lock is now disengaged e The two black plungers will also now be off of the floor indicating that the floor lock is disengaged e With the floor lock disengaged the bed will move in all directions A CAUTION Moving the bed while the floor lock is engaged may cause DAMAGE to the bed Do not move the bed until the floor lock is disengaged BED HEAD END CASTER STEER MECHANISM e Steer mechanism Bale is on either side of the head end resting on caster cover e Align caster with the caster assembly and lower the bale
12. the footboard bracket 2 using 3 bolts NO IV holder Repeat for 2 bracket Owner s Manual REV 001 18 Head Board Foot Board Cam Lock on Frame Support Bracket w IV Pole Bracket Assembly lift up Holder e Open the cam locks on the support assembly e Insert the tubes of the headboard footboard mounting brackets into the slots of the frame support assembly e NOTE The mounting brackets on the footboard face toward the inside of the bed and those of the headboard face away from the bed e Slide headboard footboard tube down until it stops e Close the cam locks to lock the headboard footboard in position Cam Lock on Frame Support Assembly down locked position ADDITIONAL INSTRUCTIONS FOR EMBEDDED STAFF CONTROL PANEL EQUIPPED FOOTBOARD OPTION e Route the cable from the control panel toward the control box keeping clear of any areas that could pinch or abrade the cable e Secure the cable to the frame in several locations along its length drive Owner s Manual REV 001 19 ASSIST BAR ASSEMBLY OPTION Tool Less Assembly e To install assist bar s locate the bracket under the sleep deck a e Slide the assist bar onto the bed frame and line up with bracket underneath the sleep deck e Insert screws and use 2 Knobs to hold Assist Bar in place e Tighten knobs until Assist Bar is secure against the bracket e If Assist Bar is loose continue to tighten until it is secur
13. the mattress retainers at the head and foot section If the bed frame has been previously adjusted to 80 or 84 length you will need to move head and foot section mattress retainers to 76 position if desired Mattress Length e Ifyou are using an 80 mattress you will need to move the head and foot section mattress retainers to the 80 slots which is the middle position Owner s Manual REV 001 16 Mattress Length OoOO OOOO O If you are using an 84 mattress you will need to move the head and foot section mattress retainers to the 84 slots which are the last slots closest to the head and foot boards Mattres Length Mattress retainers on the perimeter of the sleep deck should be moved in the upward position in order to keep mattress centered on the support deck Once retainers are adjusted correctly place mattress on mattress support deck The mattress should now be snug against all of the mattress retainers and no gaps are present Ensure mattress does not compress below 1 5 under resident weight drive Owner s Manual REV 001 17 HEADBOARD AND FOOTBOARD INSTALLATION AND ADJUSTMENT NOTE 3 16 Hex key required for initial mounting of headboard and footboard support assemblies This tool is also required for bed length adjustment e Insert headboard or footboard frame support assembly whichever is appropriate for the end of the
14. 240V 50 60Hz Max 3 15A CAUTION MADE INCHINA REV 04 in mo item 15901C Duty Oyaa aoe a 204 KG 450LBS www drivemedical com x j ETL CLASSIFIED lf Ve 99 seaview Boulevard dQ NOT EXCEED amp MAXIMUM LOAD CAPACITY Conforms to ANSI UL STD 60601 1 Port Washington NY 11050 A OF BED IS 204KG 450LBS aN DO NOT place feet or other objects beneath i i DJE Stay clear of the Bed Frame and ensure children Assist Rail When Assist Rail is installed pets or other items are not under the bed before lowering Crush point exists due to LOW BED CLEARANCE Lowering the bed without care may cause INJURY P N TB60000000 REV 01 on bed Pinch Point Crush Hazard exists between the Assist Rail and the floor when bed is at lowest position which may CAUTION cause INJURY gt REV 03 P N TC60000006 Ensure the Assist Rail is in the Upright Vertical DO NOT place feet or other locked position before lowering bed Failure to objects beneath Assist Rail position Assist Rail in upright position may cause When Assist Rail is installed the bed to become UNSTABLE due to interference on bed Pinch Point Crush between the assist rail and the floor when lowering Hazard exists between the CAUTION the bed An unstable bed may tilt causing property Assist Rail and the floor damage or personal injury REV 03 P N TC60000009 when bed is at lowest position CAUTION which may cause INJURY REV 03
15. 9 Guidance and manufacturer s declaration Electromagnetic Immunity The Drive Medical 15903C is intended for use in the electromagnetic environment specified below The customer or the user of the Drive Medical 15903C should ensure that it is used in such an environment Immunity test IEC 60601 test level Compliance Electromagnetic environment guidance level Portable and mobile RF communications equipment should be used no closer to any part of the Drive Medical 15903C including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2VP d 1 2VP 80MHz to 800MHz Conducted RF 3 Vrms d 1 2VP 800MHz to 2 5MHz IEC 61000 4 6 150 kHz to 80 MHz Where P is the maximum output power rating of the Radiated RFIEC 3V m transmitter in watts W according to the 61000 4 3 80 MHz to 2 5 GHz Transmitter manufacturer and d is the recommended separation distance in meters m 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 the following symbol Q NOTE At 80MHz and 800MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structu
16. bed you are working on e There are mounting positions for 3 different mattress lengths 76 80 and 84 Choose the one appropriate for your mattress e Both ends of the bed need to be used for the extension to be complete e When the frame support assembly bar is pulled out to the first slots A it is at the 76 length e When the frame support assembly bar is pulled out to the first slot at the head of the bed and second slot at the foot of the bed B it is at the 80 length e When the frame support assembly bar is pulled out to the second slot in both head and foot ends B it is at the 84 length e Thread the 3 16 bolt into both sides of the bed frame to hold the headboard footboard frame support assemblies in place NOTE This location can be changed at any time by removing the 3 16 bolts and sliding the support assembly to the desired position Possible injury or death may occur if the use of a mattress is not long enough so the gap between the mattress and head and foot board is minimized enough to prevent the resident from getting their head neck caught in the gaps Ensure total length of bed frame does not present a safety hazard or impair access in room Place new mattress against Mattress Retainer and be sure mattress covers entire length of mattress support surface e Attach the headboard to the headboard bracket using 3 bolts IV holder facing the outside Repeat for 2 bracket Attach the footboard to
17. ble beep System is now synchronized E TM drive Owner s Manual REV 001 38 Drive Medical Warranty Drive Medical s 15903C Premier Long Term Care Beds are guaranteed for a 3 year period from the date of delivery This guarantee is against defects in materials and craftsmanship under normal use and service This 3 year warranty includes electrical and mechanical parts and components Bed mounted accessories and Head Foot boards are covered for 1 year Welds are covered under a limited lifetime warranty of the product Steel structural components are covered under the 15 year warranty from the date of delivery During the warranty period defective items will be repaired or replaced at Drive s option at no charge Limited Lifetime warranty on welds 15 year warranty on structural steel frame 3 year warranty on electrical and mechanical parts and components 1 year warranty on all other parts and components e The Premier bed should only be used for its intended purpose and must be maintained and serviced in accordance with the instructions contained in this User Manual e This warranty will not apply if damage or mechanical failure is caused by abuse improper assembly use cleaning repair accident negligence unauthorized alteration or use in inappropriate environmental conditions or failure to maintain the product consistent with user and service instructions e Any change adjustments or repair not performed by an Aut
18. d and tighten until secure to the mid section Now begin at either head or foot section and replace the plastic forming clamps and knobs to the Width Extension Make sure all knobs are tightened or the width extension will not be secure to sleep deck Repeat process for other side if additional width is desired NOTE This optional bed expansion kit expands the bed from 35 wide to 39 wide with one 1 Width Extension and 35 wide to 42 wide with two 2 Width Extensions It is HIGHLY recommended that a 500 Ib capacity mattress be used such as a Drive Medical 42 wide Pressure Redistribution Mattress MVE Owner s Manual REV 001 23 HEEL LIFT RATCHET ADJUSTMENT e With the knee foot section set at the preferred position you can raise the manual foot lift section e There are six fixed stops on the manual foot lift adjustment that can be set at varying heights e The manual foot lift section must be raised slowly to properly engage each stop The foot lift section will not lower past the nearest engaged stop e The foot section of the bed deck cannot be fully lowered without first manually adjusting the foot lift section to its lowest position e To reset the ratchet mechanism and lower the manual foot lift section to its lowest position raise the manual foot lift section to the highest setting and lower it in one motion to the flat position e Once in its lowest position the manual
19. e ASSIST BAR A assist BAR SIDE RAIL WARNING Other manufacturers assist bars and side rails may not be compatible and can lead to entrapment issues or harm to patients Only compatible Drive Medical assist bars and rails may be used on this bed Make sure mattress is the correct size for bed frame and the assist bars are properly secured to frame to decrease the risk of entrapment A ENTRAPMENT WITH ASSIST BAR Resident entrapment with assist bars may cause injury or death To prevent resident entrapment the mattress must fit bed frame and side rails snugly Please follow the manufacturer s instructions and monitor resident frequently Please read and understand the owner user manual prior to placing this bed into service If assist bar is positioned incorrectly this may result in RESIDENT ENTRAPMENT To prevent RESIDENT ENTRAPMENT the bar needs to be placed in the correct area as shown in the instructions above M la 7M Ve Owner s Manual REV 001 20 A CAUTION Assist bar position may cause the bed to become UNSTABLE due to the interference between the assist bar and the floor when lowering the bed An unstable bed may tilt and or cause property damage or personal injury Before lowering the bed ensure the assist bar is in the VERTICAL UPRIGHT position When the assist bar is in the lowered position it is recommended that the bar is positioned toward the head of the bed A CRUSH HAZARD Crush Hazard when installed
20. e reports 460 people died 136 had a nonfatal injury and 176 were not injured because staff intervened Most residents were frail elderly or confused NOTE In this brochure the term resident refers to a resident of a nursing home any individual receiving services in a home care setting or residents in hospitals Resident Safety Residents who have problems with memory sleeping incontinence pain uncontrolled body movement or who get out of bed and walk unsafely without assistance must be carefully assessed for the best ways to keep them from harm such as falling Assessment by the resident s health care team will help to determine how best to keep the resident safe Historically physical restraints such as vests ankle or wrist restraints were used to try to keep residents safe in health care facilities In recent years the health care community has recognized that physically restraining residents can be dangerous Although not indicated for this use bed rails are sometimes used as restraints Regulatory agencies health care organizations product manufactures and advocacy groups encourage hospitals nursing homes and home care providers to assess residents needs and to provide safe care without restraints The Benefits and Risks of Bed Rails Potential benefits of bed rails include e Aiding in turning and repositioning within the bed e Providing a hand hold for getting into or out of bed e Providing a feeling of comfort
21. e toileting and providing calming interventions and pain relief When bed rails are used perform an on going assessment of the resident s physical and mental status closely monitor high risk residents Consider the following e Lower one or more sections of the bed rail such as the foot rail e Use a proper size mattress or mattress with raised foam edges to prevent residents from being trapped between the mattress and rail e Reduce the gaps between the mattress and side rails Which Ways of Reducing Risk are Best A process that requires ongoing resident evaluation and monitoring will result in optimizing bed safety Many residents go through a period of adjustment to become comfortable with new options Residents and their families should talk to their health care planning team to find out which options are best for them Resident or Family Concerns About Bed Rail Use If residents or family ask about using bed rails health care providers should e Encourage residents or family to talk to their health care planning team to determine whether or not bed rails are indicated e Reassure residents and their families that in many cases the resident can sleep safely without bed rails e Reassess the need for using bed rails on a frequent regular basis To report an adverse event or medical device problem please call FDA s MedWatch Reporting Program at 1 800 FDA 1088 For additional copies of this brochure see the FDA s website at htt
22. ede ieee 24 oA U Eie i E A E E EE E E E PE ars sue E E 25 Embedded Staff Control option sssssssseseecesresersrssrrsrseerersrerrerseeseee 26 Bed Mobilization and Stabilization ccccccee cece ee ee cece ee eeeceeeeeeeeneeas 29 Care ANd MaiNteNANCE ccecec cece eee e teen ee eee eee essen een een eee eee eeeeeeee cases 31 Cleaning INStructiONS ccc cece ee eee cee eeeeeeeeeceeeeesseseseeeeeeneees 31 General Preventative Maintenance ccceeeeeeeeeeeeeeeeueeeeeeees 32 Servicing Motor Actuator control Box Power Cord ccseeececceceeeeeeneneeeees 34 Trouble Shooting GUIdE ccc cee cece eee eens eee ee senses eeeeeseeeneenes 36 V p2cscncccomseeteccssentaceptenetebereidericeseee E E EE E ne senss 38 POO A aca eE E E EE E A 39 FDA Jan 2008 A guide to Bed Rail Safety Bed Rails in Hospitals Nursing Homes and Home Health Care The Facts 2 E TM drive Owner s Manual REV 001 3 STANDARD SYMBOLS USED IN THIS MANUAL This manual includes important information about safety of personnel and equipment As you read through this manual be aware of the Symbols and their meaning Note The information contained in this document is subject to change without notice DANGER Information that appears under the DANGER description concerns the protection of personnel from direct and pending hazards that if not avoided will result in immediate serious personal injury or death in add
23. elenburg Capable es Reverse Trendelenburg Capable Yes 110V AC 240VAC Input Voltage 50 60Hz Actuator Voltage 24V DC Mattress Thickness Range 5 5 to 7 Mattress Width 36 or 42 Mattress Length 76 to 84 Assist Bars add 3 to each side of the bed Requires Embedded Staff Control footboard panel Without H F boards mattress or accessories This includes the weight of the resident resident and all other accessories including but not limited to mattresses head footboards assist bars etc oe E TM drive Owner s Manual REV 001 7 General information This medical bed is a class II type B IP54 medical device The recommended environment for operation of the bed is listed below Ambient temperature 10 C 40 C 50 F 104 F Relative humidity range 30 75 Atmospheric pressure 86KPa 106Kpa The recommended environment for storage transportation is listed below Ambient temperature 10 C 50 C 14 F 122 F Relative humidity range 10 93 Atmospheric pressure 86KPa 106KPa NOTE The information in this document is subject to change without notice Caution This bed frame complies with EMC requirements of IEC 60601 1 1 Radio transmitting equipment cell phones or similar electronic devices used in proximity of the bed may affect the beds performance There are no known contra indications for use of this product LEFT RIGHT REFERENCE GRAPHIC SIDE RIGHT
24. er then stops and beeps Yellow indicator on caster housing is visible There may be an object in between the floor and black plunger the floor may be slippery Floor lock stuck in one position Visually check wire connections They may be loose or frayed The light on the attendant control panel is on Disconnect power cord from bed that is not functioning and use on another bed that is functioning Reconnect the power and test functions on that bed A faulty actuator will not work with any connection port The bed must be leveled out before you can raise lower it Make sure the Trendelenburg Reverse Trendelenburg position is no longer being used Activate floor lock Yellow lock should NOT be visible Clean the floor remove any objects that may be in the way Make sure the floor is dry Contact an Authorized Distributor or Drive Medical for assistance 1 800 371 2266 Reconnect any loose wires and or power cords If cord is frayed replace immediately Unlock panel by pushing lock button and light should go off Contact an Authorized Distributor or Drive Medical for assistance 1 800 371 2266 Actuators are not working cont Bed stalls while operating Bed not steering correctly Bed is out of synchronization Faulty pendant Thermal shut down Bed is only moving straight forward not side to side Bed is moving side to side The motor becomes unplugged The bed becom
25. es caught on chair rail Check pendant cord connection power supply Hi Lo lockout is off and pendant is not functioning Disconnect pendant cord connection with a functioning pendant if available Connect and test functions Bed works for a short period of time the cuts out Check for obstructions or any interference with bed frame such as window seal or too much weight on bed frame Steering mechanism Bale is down Steering mechanism Bale is up The motor becomes unplugged and it gets plugged back in and the synchronization is off The bed gets caught on the chair rail and it causes the bed to go into tilt position Owner s Manual REV 001 37 Contact an Authorized Distributor or Drive Medical for assistance 1 800 371 2266 Wait a period of time before using the bed frame again DO NOT keep trying to override this as it will shorten the life of your product Bed is intended to be used for 2 min then allowed to rest for 20 min Push steering mechanism Bale up and bed will move in desired position Push steering mechanism Bale down and bed will move straight Remove at least one end on both of the Hi Lo Actuators on the bed Retract the actuators all the way by pressing the bed up and down buttons at the same time Once both actuators have retracted fully this can happen at different speeds the green LED at the top of the handset will light the controller will click and emit an audi
26. es specific dimensional criteria on potentially injury threatening gaps and spaces that can occur between bed system components such as side rails when improperly installed Drive Medical s Long Term Care beds and approved accessories are manufactured to be in conformance with these guidelines Please be aware that entrapment issues can still arise when components and accessories are not properly installed on the bed Itis important for the provider or facility staff to recognize they have an equal role in complying with the FDA guidelines to help ensure resident safety and avoid injuries Copies of this document can be obtained from the FDA website http www fda gov medicaldevices deviceregulationandguidance guidancedocuments ucm072662 htm E TM drive Owner s Manual REV 001 13 COMPLIANCE INFORMATION Matching the correct bed components to meet regulatory specifications can be complicated Drive Medical offers a wide variety of compatible options and an Authorized Distributor can assist your facility in selecting correct components or accessories that is recommended for the specific bed model issis RAIL WARNING Other manufacturers assist bars and side rails may not be compatible and can lead to entrapment issues or harm to patients Only compatible Drive Medical assist bars and rails may be used on this bed Ensure mattress is the correct size for bed frame mattress retainers are in place and the assist bars are secured to f
27. g and lowering of the head and foot section simultaneously Auto Contour e The 4 button controls the raising and lowering of the bed frame e The 5 button controls trendelenburg and reverse trendelenburg positions Trendelenburg and Reverse Trendelenburg e Trendelenburg Reverse Trendelenburg positioning and Hi Lo Lockout option with the Attendant Control Panel o While in the locked position these panel features will not work o While in the unlocked position all features will work e The contour position will work in the lock or unlocked position A CAUTION The use of Trendelenburg and Reverse Trendelenburg function may not be suitable for certain residents This function should only be used with the recommendation from medical personnel A Bed Length Extension should not be used on a bed that has the Trendelenburg and Reverse Trendelenburg function po drive Owner s Manual REV 001 27 PENDANT HOLDER AND LOCATION A ELECTRICAL SHOCK HAZARD Prior to working with any electrical parts such as the 13 pin hand held pendant motor actuators or control box make sure the power to the bed frame is disconnected e The pendant holder is to be placed on the side of the assist rail e The pendant then slides into the holder within easy reach of the resident e To relocate the pendant to the other side of the bed raise the bed to the highest position then unplug the main power cord from wall outlet e Atthe opp
28. have stress fractures e Ensure no tubes are bent E TM drive Owner s Manual REV 001 33 ANNUAL INSPECTION e Perform all Semi Annual inspections plus Mattress Support Surface Frame and Base Assemblies e Inspect welds on the mattress support surface frame and base assemblies for stress fractures e Verify all fasteners are tight e Inspect fasteners for wear or damage e Inspect bed and Assist Bars Rails bolts if loose tighten and if missing replace e Lubricate clevis pins at hinge points e Lubricate Hi Lo tracks of bed for smooth travel Actuators e Inspect push tubes and end connections of all actuators for excess wear or bending e Verify that all clevis pins are in place Casters e Check that locks on casters lock properly if equipped e Check that all casters roll properly e Check Floor Brake mechanism for proper function roll at any height model e Check head end caster alignment Bale mechanism to verify proper function roll at any height model NOTICE TO MAINTENANCE STAFF e Carry out all adjustment and cleaning procedures as specified e Assembly of this bed and modifications made during the actual service life require evaluation to the requirements of IEC 60601 1 and IEC 60601 2 38 E TM drive Owner s Manual REV 001 34 SERVICING Actuators and Control Box are light gray A ELECTRICAL SHOCK HAZARD Possible Shock Hazard may occur if the Control Box is not unplugged from the wall o
29. horized Distributor or technician will void the warranty e This warranty is extended only to the original owner who purchased this product new and unused from Drive Medical or a Drive Medical Authorized dealer Distributor Warranty is not extended and is not transferable or assignable to any subsequent purchaser or future owners e Drive Medical s liability shall not exceed the original purchase price of this product e Any Repair work or replacement components provided shall not extend the warranty beyond the original warranty period e Request for Warranty coverage must be accompanied by valid serial number from the bed Coverage is void if serial number has been removed defaced or altered Weld life time defined as 20 years from date of delivery E TM drive Owner s Manual REV 001 39 PARTS Long Term Care beds contain a variety of parts that wear from normal use Some products are not covered under the 3 year warranty but do fall under the 90 day warranty such as DC batteries Drive Medical s responsibility under this warranty is limited to supplying replacement parts servicing or replacing at its option which is found to be faulty by Drive Medical Warranty replacement parts are covered by the warranty until the product s 3 year warranty period expires For warranty replacement Drive Medical may request that broken parts be sent back to them for evaluation A credit will be issued only after the inspection SERVICE
30. ion against possible shock hazard and should only be used with a properly grounded 110 VAC to 240 VAC 50 60 Hz electrical outlet DO NOT under any circumstances cut or remove the grounding prong DO NOT open any actuators control boxes or pendants Service is only to be performed by authorized service personnel If unauthorized service is performed on any components the warranty is void e DO NOT use an extension cord e DO NOT allow the cord electrical outlets electrical control box or hand pendant to become wet or submerged e DO NOT operate the bed if any electrical component such as the power cord electrical outlet connections motor actuator or mechanical component has malfunctioned or has been damaged in any way A WARNING This electric bed is NOT designed to be used as a resident transport device Please use an approved resident transport device when moving a resident DO NOT use assist bars as handles for moving the bed DO NOT roll the bed over any power or pendant cords e Possible Injury may occur due to falls if bed is not kept in lowest height position except when care is being provided e Bed should be at lowest suitable height for Resident entry and exit e Possible Injury or Death may occur due to pendant cord being a source for entangling Resident Residents with decreased mental acuity should NOT have access to pendant e Possible Injury or Death may occur if bed is pushed over abrupt thresholds while bed is occu
31. ition to damage of the equipment A WARNING Information that appears under the WARNING description concerns the protection of personnel from potential hazards that if not avoided can result in serious injury or death equipment damage or both A CAUTION Information that appears under the CAUTION description concerns the protection of personnel from potential hazards that if not avoided may result in minor injury equipment damage or both A ELECTRICAL SHOCK HAZARD Disconnect power before servicing Maintenance Repairs to be performed by trained personnel only Improper use will result in serious injury or death OPEN FLAME OR EXPLOSIVE GASES DO NOT Use near open flame or explosive gasses A A CRUSH HAZARD Danger Crush hazard Stay clear of this area during operation NOTE Information that appears under the NOTE description gives added information which helps in understanding the item being described E TM MVE Owner s Manual REV 001 4 WARNING LABELS The following warning labels are placed on specific areas of the bed to help alert you to conditions that can damage the bed or cause injury Labels should not be removed from the bed under any circumstances IEC60601 2 38 IEC60601 1 2 DO NOT EXCEED 204KG CNi YS Certified to CANICSA STD C22 2 Intertek NO 601 1 M90 C h O i C Ph 1 877 224 0946 Fax 516 998 4601 e P 54 Long Term Care Bed T 450LBS 3188074 P N TP60000042 ong le are pe 100
32. maintenance requirements and costs Always service the bed at the required intervals E TM drive Owner s Manual REV 001 32 MAINTENANCE Inspection of All Components Receipt of assembled bed e Check bed components for obvious damage e Inspect power supply cords for cuts and or damage e Check that actuator cords are connected properly to the controller e Verify proper functionality of all features QUARTERLY MAINTENANCE CHECK e If the bed has a battery unplug from the wall outlet and validate function The battery may be built in or portable e Inspect bed and Assist Bars Rails bolts if loose tighten and if missing replace e Lubricate clevis pins at hinge points e Lubricate tracks of bed for smooth travel SEMI ANNUAL INSPECTION e Perform all Quarterly inspections plus Control Box e Check power cord for chafing cuts or wear e Ensure all attachment hardware and brackets are tight e Check electrical connections for wear or fractures e Verify that all actuator connections are tight Actuators e Check actuator cords for chafing cuts or wear e Check to make sure actuators do not bind at any point throughout their full range of motion Pendant e Check pendant cord for chafing cuts or wear e Check all pendant buttons for proper function Authorized Accessories e Inspect all fasteners for looseness and wear Replace or tighten as necessary e Ensure proper function of accessory e Ensure welds do not
33. make sure everything is plugged into the control box and no wires are loose If wires are not in control box match up by the color coded system See instructions below NOTE DO NOT remove zip ties that are holding cords underneath bed frame INITIAL INSPECTION Inspection of All Components Receipt of assembled bed e Check bed components for obvious damage e Inspect power supply cords for cuts and or damage e Check that actuator cords are connected properly to the controller e Verify proper functionality of all features ONCE ASSEMBLED drive Owner s Manual REV 001 15 ASSEMBLY WALL BUMPER INSTALLATION The wall bumper is designed to prevent damage to facility walls by keeping the head end of the bed spaced away from the wall e Locate the wall bumper assembly over the front horizontal leg tube e Adjust Wall Bumper to extend beyond headboard and use tethered pins to lock in place MATTRESS RETAINER ADJUSTMENT Tools Needed 3 16 Hex Key Mattress Retainer is designed to keep the mattress in place on the sleep surface Based on the mattress length determine the length of sleep surface required Please read important information on Mattress Retainer and follow installation instructions Use the 76 80 and 84 guide on the head and foot section to place your mattress retainer in the correct location for the mattress being used e New beds are factory set for a 76 bed frame there is no need to move
34. osite end of the Hand Pendant lift up the locking bracket that holds the pendant cable plug to the frame connection and unplug the pendant cord from the frame connection e On the other side of the bed lift up the cable locking bracket on the frame connection and line up the cable pins then carefully push cable plug into the frame connection and push cable locking bracket down around pendant cable plug e Plugin main power cord to wall outlet and test pendant functions arrive Owner s Manual REV 001 28 POWER CORD STORAGE e Power cord strain relief hook is located underneath the bed frame at the head of the bed and keeps the power cord off the floor and protects the power cord from getting severed or run over e Ifthe power cord is not in place under the bed untie the power cord and stretch out toward the head of the bed e Unscrew the cap that is attached to the power cord and run cord down through the hook e After the cord is through the hook screw the cap together this will hold the power cord in place NOTE Disconnect the main power cord from the wall outlet and store the power cord when the bed is not in use Ensure the power cord is placed on the sleep deck and not hanging off the bed where it may be damaged Secure the power cord to the head of the bed when moving the bed drive Owner s Manual REV 001 29 BED MOBILIZATION AND STABILIZATION A WARNING Involuntary bed movement may take
35. our facility is recommended e Keep all moving parts including the mattress deck sleep surface main frame and all drive actuators and moving components free of obstructions e NEVER permit more than one 1 person in on the bed at any time The weight capacity of this bed is 500 pounds including all accessories and options e Body weight should be evenly distributed over the sleeping surface of the bed Avoid situations where entire body weight is on a raised head or foot surface This includes while assisting the user in repositioning or transferring in or out of bed e NEVER allow anyone under the bed at any time e Supervision is required when this product is operated by or near children or people with disabilities e Ensure that the individual using this bed is properly positioned particularly when the bed is being operated or moved e DO NOT let any limbs or body parts protrude over the side or between bed components especially when the bed is being moved or operated e Caster and floor locks if equipped shall be used except when bed is being moved When transferring a resident into or out of the bed always engage the floor lock and lock the caster s Bed is not intended for patient transport DP exis No modification of this equipment is allowed Only items that have been specified as part of this bed or that have been specified as being compatible with this bed shall be connected to it E TM drive Owner s
36. over the caster e With the bale in place the head end of the bed will tend to track in a straight line e When used in conjunction with engaged Floor Lock system Bale will help prevent side to side bed movement and should be in the lowered position at all times except when bed is being moved by staff member E TM drive Owner s Manual REV 001 31 CARE AND MAINTENANCE MD auo If improperly performed equipment or property DAMAGE or resident INJURY is possible during maintenance Cleaning Instructions e If possible remove resident before cleaning bed e Unplug power supply cords prior to cleaning e Ensure all electrical parts motors control boxes pendant and cables are not broken and all housing components are unplugged Ensure that NO liquids enter electrical components e Remove all gross solid contaminants then wash and sanitize all components DO NOT submerge the bed frame or electrical components e Use standard water pressure DO NOT power wash or steam clean any parts e Do NOT use Solvents alcohol bleach caustic agents high acid or alkaline solutions or petroleum based products to clean the bed surface e Rinse completely with water Maximum temperature 110 F or 43 C e Ensure all components are dry before using or storing Note This bed is NOT compatible with wash down tunnels A WARNING Failure to properly maintain your bed may decrease the life expectancy of your product and increase product
37. p www fda gov cdrh beds For more information about this brochure contact Beryl Goldman at 610 335 1280 or by e mail at bgoldman kendaloutreach org She has volunteered to answer questions For information regarding a specific hospital bed contact the bed manufacturer directly E TM drive Owner s Manual REV 001 42 Developed by the Hospital Bed Safety Workgroup e AARP e ABA Tort and Insurance Practice Section e American Association of Homes and Services for the Aging e American Health Care Association e American Medical Directors Association e American Nurses Association e American Society for Healthcare Engineering of the American Hospital Association e American Society for Healthcare Risk Management e Basic American Metal Products e Beverly Enterprises Inc e Care Providers of Minnesota e Carroll Healthcare e DePaul College of Law e ECRI e Evangelical Lutheran Good Samaritan Society e Hill Rom Co Inc e Joerns Healthcare Inc e Joint Commission on Accreditation of Healthcare Organizations e Medical Devices Bureau Health Canada e National Association for Home Care e National Citizens Coalition for Nursing Home Reform e National Resident Safety Foundation e RN Systems e Stryker Medical e The Jewish Home and Hospital e Untie the Elderly The Kendal Corporation e U S Food and Drug Administration Updated January 2008
38. pied This bed was not designed to transport residents DO NOT plug anything into housing components of bed pendants or actuators while power cord is plugged into the wall outlet Any cords or medical tubing used on or with this bed MUST be routed and secured properly to ensure that they DO NOT become entangled kinked or severed during normal operation of the bed g Owner s Manual REV 001 11 Possible Injury or Death may occur if replacement parts are not provided by the manufacturer or Authorized Distributor Possible Injury or Death may occur if accessories are not provided by an Authorized Distributor Please contact an Authorized Distributor for accessories that are compatible before use of bed OPEN FLAME OR EXPLOSIVE GASES DO NOT use near explosive gases Possible Fire Hazard if the use of nasal mask in 2 bed tent O2 administering equipment If O2 tent is being used it should not fall below mattress deck The pendant should not be placed in oxygen enriched environment such as an O tent A CRUSH HAZARD Possible Injury may occur when activating the Foot Lock Mechanism This feature is designed to be activated by your foot Using your hand could result in injury r T Drive Medical Premier beds are intended for use within an institutional healthcare environment ie Skilled Nursing Transitional Care Rehabilitation Care and Assisted Living Compliance with the regulations and guidelines as specified by y
39. rame to decrease the risk of entrapment MATTRESS SPECIFICATIONS A WARNING Possible ENTRAPMENT Hazard may occur if you do not use the recommended specification mattress Resident entrapment may occur leading to injury or death e A mattress may not be included with this bed It is recommended that a 36 wide mattress that is made to fit the length of a 76 80 or 84 bed frame is used such as a Drive Medical Pressure Reduction Mattress Mattress height must be a minimum of 5 inches and maximum of 8 inches e Also available are Drive Medical s assortment of mattress overlays and Low Air Loss flotation mattress systems E TM drive Owner s Manual REV 001 14 UNPACKING AND ASSEMBLY UNPACKING INSTRUCTIONS Tools needed wire cutters or pliers A CAUTION DAMAGE to the equipment may occur if the incorrect zip ties are removed e If the carton is in an upright position slowly lower to the floor and position with casters down e It may be necessary for two or more people to help in lowering the bed e Cut black strapping around box remove box ends and plastic surrounding bed frame e Cut zip ties to remove wall guard at the head of the bed e Cut the zip ties to remove mattress retainers on each side of the bed e Remove ties from pendant e Remove any remaining zip ties or foam left on bed frame e Locate power cord and plug into grounded 110 240 VAC outlet e Raise the bed frame and check to
40. res 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 Drive Medical 15903C is used exceeds the applicable RF compliance level above the bed should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Drive Medical 15903C P Over the frequency range 150 kHz to 80 MHz field strengths should be less than V V m E TM drive Owner s Manual REV 001 10 GENERAL SAFETY NOTE DO NOT operate this product without first reading and understanding this user manual Damage or injury may result from improper use of this product The information contained in this document is subject to change without notice The Drive Medical roll at any height beds are intended for use within an institutional healthcare environment Drive Medical recommends compliance to Application Environment 3 ie Skilled Nursing Transitional Care Rehabilitation Care and Assisted Living environment A ELECTRICAL SHOCK HAZARD This bed is equipped with a three prong grounding plug for protect
41. uildings used for domestic Voltage fluctuations purposes flicker emissions IEC 6100 3 3 Recommended separation distances between portable and mobile RF communications equipment and the Drive Medical 15903C The Drive Medical 15903C is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the Drive Medical 15903C can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the bed as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum output power m of transmitter w 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2vP d 1 2vP d 2 3VP For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters 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 accordable to the transmitter manufacturer NOTE I 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 E TM drive Owner s Manual REV 001
42. utlet before any maintenance is performed on Motor or Control Box ACTUATORS AND CONTROL BOX INFORMATION Cord and Socket Identification e Attendant Control Green e Hand Held Pendant Red e Head Section Motor Black e Foot Section Motor Yellow e Hi Lo Motor Blue e Hi Lo Motor White e Battery Back Up Black Removing Control Box e Unplug main power supply from the wall outlet e Unplug connections for all actuators and accessories e Separate the control box from the actuator e Reinstall the control box on the actuator e Plug all connections back into control box following color coding e Test function Replacing Actuators e Unplug power supply cord from the wall outlet e Identify the actuator to replace e Tip bed on its side to remove the Hi Lo actuators e Unplug actuator cord from control box e Actuator is held in place by 2 clevis pins e Remove bowtie clips from clevis pins e Slide the clevis pins out of the holes e You can now replace the actuator e To reassemble bed reverse previous steps and make sure to Assemble clevis pins as originally installed with bowtie clips Zip ties should be replaced with cords to their original position and routing direction to the control box ee drive Owner s Manual REV 001 35 Replacing the AC Power Cord tools needed T10 Star Key e Unplug power cord from wall outlet e Locate power cord end on control box e Unscrew 4 bolts from the control box e
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