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Affinity

® 

4 Birthing Bed

Instructions for Use

Product No. P3700

USR025

 

REV 13

Summary of Contents for Affinity 4

Page 1: ...Affinity 4 Birthing Bed Instructions for Use Product No P3700 USR025 REV 13 ...

Page 2: ......

Page 3: ...oot sectiona a Slide off foot section no longer available J One handle siderail release C EasyGlide Calf Supports K Removable headboard D OneStep Foot Supports L Lockout indicator E Fluid basin M Battery indicator F Central brake and steer pedal N Siderail lighting control optional G Storable labor grips O Air support system optional H CPR feature P Siderail communications package optional Patient...

Page 4: ...nd or Patients in EU Any serious incident that has occurred in relation to this device should be reported to the manufacturer and the competent authority of the Member State in which the user and or patient is established This manual USR025 was originally released and supplied in English For a list of available translations contact Hill Rom Technical Support Product images and labels are for illus...

Page 5: ... Inc Virex is a registered trademark of Diversey Inc Wex Cide is a trademark of Wexford Labs Inc Freedom Hill Hillrom Liberty Hill and Quick View are trademarks of Hill Rom Services Inc Affinity EasyGlide OneStep Point of Care SideCom and Stow and Go are registered trademarks of Hill Rom Services Inc For product support or to order additional copies of this manual USR025 contact your distributor l...

Page 6: ...iv Affinity 4 Birthing Bed Instructions for Use USR025 REV 13 NOTES ...

Page 7: ...regiver Bed Controls 10 Bed Up Down Hilow 10 Lockout Controls 11 Caregiver and Patient Bed Controls 11 Back Section Lumbar Mattress Control Optional 11 Foot Section 11 Head Section 12 Nurse Call Optional 12 Seat Section Mattress Control Optional 12 Patient Bed Controls 13 TV On Off Optional 13 Bed Frame Features 13 Central Brake and Steer 13 Automatic Tilt 14 CPR Release 14 Fluid Basin 14 Foot Sec...

Page 8: ...alf Support 21 Mattresses 21 Mattress Models 22 Non Air Mattress 22 Wood Headboards 22 Patient Positioning Labor and Birth 22 Upright Position Voiding Position 23 Lateral Position Sims 23 Kneeling Position 23 Legs Elevated With Foot Mattress 24 Squatting With The Labor Bar 24 Pushing With The Labor Bar 24 Pushing With The Labor Bar With Foot Supports 24 Pushing with Calf Supports 25 Epidural Spina...

Page 9: ...2 Headboards P3617 P3629 P923617 and P933617 33 Instrument Tray P278 33 Infusion Support System ISS P158 and P159 33 Labor Bar P3613 33 Oxygen Tank Holder P27605 33 Pendant Control Kit with Holder P5362 P3618 No Longer Available 34 Permanent IV Pole P222101 34 Procedural Light P7925D120 34 Rail and Hanger P53120120 and P17073001 34 Sheets SA1528 SA4585 SA1529 and SA4586 34 Slipcovers Head and Foot...

Page 10: ... Prepare the Bed for Use 40 Laundry Guidelines 41 Care of Wood Components 41 Mattress Care and Draping 41 Preventive Maintenance 42 Decommissioning and Disposal Instructions 43 Expected Life 43 Troubleshooting 44 Power Loss 44 Specifications 44 Electromagnetic Emissions Guidance 49 ...

Page 11: ...s to operate and control the product safely The maximum patient weight is 470 lb 213 kg The bed safe working load is 500 lb 227 kg Safe working load includes mattresses headboard patient weight any accessories or equipment on the bed caregiver weight and any visitors sharing the bed There are no known Contraindications for this product INTRODUCTION This document provides the information required f...

Page 12: ... your staff on the risks associated with electrical equipment Warning Incorrect use or handling of the power cord may cause damage to the power cord If damage has occurred to the power cord or any of its components immediately remove the Base from service and contact the applicable maintenance persons Warning To reduce the risk of electric shock the bed should only be connected to supply mains wit...

Page 13: ...ifornia to cause cancer and Lead and Di 2 ethylhexyl phthalate DEHP which are known to the State of California to cause birth defects or other reproductive harm For more information go to www P65Warnings ca gov SYMBOLS This document contains different typefaces and symbols to make the content easier to read and understand Standard text used for regular data Boldface text emphasizes a word or phras...

Page 14: ...lue Conforms to European requirements for class I medical devices in accordance with Directive93 42 EEC until May 25 2021 Regulation EU 2017 745 regulation by May 26 2021 Type B applied part according to IEC 60601 1 UL 60601 1 Medical Device Bed Up Bed Down control Do not step do not step on the Stow and Go Foot Section Blue and black is for B through D model beds Red and black is for E model and ...

Page 15: ...ordance with local regulations Manufacturer or distributor complies with the Waste Electric and Electronic Equipment Directive 2002 96 EC B through D Model Beds According to IEC 60529 rating for protection against fluid ingress and identified as equipment that is protected against vertically falling water when tilted up to 15 Room Light On Off control CAUTION Consult accompanying documents Back se...

Page 16: ...ut control label The switch in the up position indicates the lockout control is on The switch in the down position indicates the lockout control is off refer to the section titled Lockout Controls on page 11 for lockout status information Electric shock hazard Keep feet clear of this area do not step on the Stow and Go Foot Section Potential for injury Calf support release lever Lock and unlock po...

Page 17: ... standards shown in the Classification and Standards table on page 48 Note Affinity 4 bed weight excluding rated SWL is 244 kg 536 lb minimum Certified by Underwriters Laboratories Inc P3700E Serial Numbers that begin with M171AA and up to Serial Numbers beginning with O218AA as being in accordance with that which is shown in the Classification and Standards table see page 48 WARNING Consult accom...

Page 18: ...Identifying power inlet fuse or a battery power inlet fuse Consult accompanying documentation Room Light On Off control Warning Protective earth ground Must consult accompanying documentation Beds with grounding post only Seat section mattress control optional Lock and unlock position of the calf support TV On Off Audio control optional Calf support release lever CPR function Identifies the releas...

Page 19: ...ing documents Warning Safe working load foot section only Must consult accompanying documents Caution Connect to approved communication system only Consult accompanying documents Warning Electrical shock hazard Must consult accompanying documents Warning Must consult accompanying documents On the pendant and calf support Warning Use hospital grade receptacle only Must consult accompanying document...

Page 20: ...aution Make sure the bed does not touch the wall at the head end When the bed is raised it moves slightly towards the head end If the bed is too close to the wall damage could occur The Bed Up Down controls located on both siderails allow you to raise or lower the bed 16 41 cm The low position is for general use and to assist with patient egress while the high position is used for patient procedur...

Page 21: ...ss Control Optional The Back Section Mattress Lumbar control enables you to inflate or deflate the back section lumbar mattress in order to attain a degree of firmness or softness To inflate press and hold the Back Firm control plus sign until the desired firmness is attained To deflate press and hold the Back Deflate control minus sign until the desired softness is attained Foot Section The Foot ...

Page 22: ...the switch will flash indicating that the patient placed a nurse call When the nurse answers the LED indicator will turn on solid The nurse may then talk to you and you may speak into the speaker microphone WARNING Warning If the Nurse Call control does not operate make sure the patient knows that pressing the control will not call the nurse Patient injury may occur CAUTION Caution If power to the...

Page 23: ...ENTRAL BRAKE AND STEER WARNING To help prevent injury and or equipment damage obey these warnings Warning Unless you are to transport a patient always set the brakes when the unit is occupied Make sure the brakes are set before any patient transfer on to or off the bed Warning Keep feet out from under the brake steer pedal when you engage it CAUTION Caution Make sure the bed does not touch the wal...

Page 24: ... Remove Replace the lift off or slide off foot section fluid basin 1 Pull the fluid basin straight out 2 Slide the basin straight into the holding devices 3 Shake the basin gently to ensure it is securely seated To Remove Replace the Stow and Go Foot Section fluid basin 1 Pull the basin up and out of the foot section 2 Put the basin down in to the opening in the foot section FOOT SECTION LIFT OFF ...

Page 25: ...toward you while taking a step backward Turn the foot section so the stand is down and with the knees bent place it on the floor To Install 1 Grasp the foot section with both hands 2 Position the foot section onto the mounting brackets located on the bed frame 3 Lift Off Foot Section While holding the foot section level lift and slide it until the latches securely engage and a level surface is ach...

Page 26: ...e end of the foot section up The foot section will start to slide down under the bed 8 Lower the back edge of the foot section until it stops 9 Push the foot section under the bed until it stops WARNING To help prevent injury and or equipment damage obey these warnings Warning Make sure the foot section is securely locked in place when you install the mattress Warning Do not force the Stow and Go ...

Page 27: ...ge position squeeze the release latch again and return the supports to the desired position The maximum safe working load is 150 lb 68 kg HEADBOARD The headboard includes built in handles which aid in steering control and increase mobility The headboard assembly is removable To remove grasp the hand holds firmly and lift up To install align the headboard sockets with the posts on the bed frame and...

Page 28: ...e night light is located on the bottom center of the bed frame BATTERY BACKUP The Affinity 4 Birthing Bed is designed with battery backup as a standard feature The battery allows the hilow foot and head motors to be activated from the siderail controls without power being supplied to the bed In addition the battery backup powers the nurse call function but it does not power any other bed functions...

Page 29: ...ol if equipped 3 Quickly press the trend like position handle see Trend Like Function on page 20 After the battery sleep function is canceled the bed will operate normally in Battery Backup for 3 minutes and 42 seconds after the last control is pressed SIDERAILS WARNING To help prevent injury and or equipment damage obey these warnings Warning Evaluate patients for entrapment risk in accordance wi...

Page 30: ...position the sleep surface in a Trend Like position push down on the handle and guide the bed to the desired degree up to 8 2 To level the sleep surface pull up on the handle and guide the bed to a level position OPTIONAL FEATURES AIR SUPPORT SYSTEM The Affinity 4 Birthing Bed features air surface controls located on both the outside and inside of the siderail for both seat and lumbar support Thes...

Page 31: ...for the Affinity 4 Birthing Bed not available for Stow and Go foot section Eight inch casters are no longer available CALF SUPPORT The standard calf support is included with the Affinity 4 Birthing Bed Additional calf supports are available as optional features and are identified in the Accessories section of this document see Accessories on page 29 MATTRESSES WARNING To help prevent injury and or...

Page 32: ...d increase mobility The headboard assembly is removable Beds with the push handle option will not have handles on the headboard To remove grasp the hand holds firmly and lift up To install align the headboard sockets with the posts on the bed frame and lower the headboard until it rest on the bed frame PATIENT POSITIONING LABOR AND BIRTH NOTE The Labor and Delivery Drape should be placed over the ...

Page 33: ... over the V Cut having her hold the labor grips for support 7 If the patient s legs are unstable position her feet with the soles together to prevent sliding LATERAL POSITION SIMS 1 With the bed in the lowest position and the head of the bed adjusted for the patient s comfort position the attached calf support with the foot end pointed toward the head of the bed 2 With the patient lying on her lef...

Page 34: ...way from the head of the bed 3 The patient may squat on the seat section holding the Labor Bar or sit with her feet on the foot section leaning forward onto the bar PUSHING WITH THE LABOR BAR 1 Raise the head of the bed to a comfortable position by pressing the Head Up control 2 Insert the labor bar into the support sockets so it angles away from the head of the bed 3 Lower the foot section if nee...

Page 35: ...he patient s legs on the calf supports 3 The patient may pull back on her knees without the need for the staff to assist her 4 Lower the foot section if desired EPIDURAL SPINAL LATERAL APPROACH 1 Lower and tuck away one siderail 2 Position the bed to a comfortable height and lower the head of the bed 3 Place the patient in a lateral recumbent position at the mattress edge EPIDURAL SITTING APPROACH...

Page 36: ...ce the patient in a sitting position 2 Pull up the labor grips 3 Position the patient s feet in the foot supports 4 Remove the foot section 5 Use the Foot control to raise or lower the Foot Supports 6 Tuck the end of the drape into the drainage pan and raise the bed to a comfortable height by pressing the Bed Up control WARNING Warning To avoid injury make sure the patient s hands are clear of the...

Page 37: ...o that they securely support the patient s perineum over the edge of the seat section Remove the foot section and raise the bed to a comfortable working height The drainage pan can also be removed for extra exposure HIGH MODIFIED TREND LIKE POSITION BIRTH AND REPAIR 1 Raise the bed to the desired height using the Hilow control 2 Raise the head section to the desired position by using the Head Up c...

Page 38: ...ning Unless you are transporting a patient always set the brakes when the unit is occupied Make sure the brakes are set before any patient transfer on to or off the bed Warning Make sure to have appropriate assistance when you transport a patient Warning The bed is intended to be used to transport patients with the foot end of the bed forward Prior to transport properly store the power cord to hel...

Page 39: ...22 kg P35745 Calf supports telescoping detachable 7 3 lb 3 31 kg P3705 Calf support and arm 6 4 lb 2 90 kg P3612TPA Comfort pad 9 8 lb 4 45 kg P7834 Drapes Medline Proxima 0 4 lb 17 kg P3623 Foley hook kit 0 8 lb 37 kg P451 Foot rest bar lift off only 5 3 lb 2 40 kg P7625 Full leg supports attached 4 2 lb 1 90 kg P7634 Full leg supports telescoping 8 0 lb 3 63 kg P3617 Headboard wood contemporary ...

Page 40: ... kg SA1528 Sheets V cut complete 1 0 lb 45 kg SA4585 Sheets V cut two piece 1 0 lb 45 kg SA1529 Sheets straight edge complete 1 0 lb 45 kg SA4586 Sheets straight edge two piece 1 0 lb 45 kg P3627 Slipcover head section straight edge 1 7 lb 0 77 kg P3628 Slipcover head section V cut 1 7 lb 0 77 kg P3630 Slipcover foot section V cut 1 1 lb 0 50 kg P3631 Slipcover foot section straight edge 1 1 lb 0 ...

Page 41: ...ck when in the upright position 4 Adjust the calf support using the release handle To unlock the calf support pull the release handle a 1 4 turn toward the foot end To lock it push the release handle a 1 4 turn toward the head end NOTE Check for pressure points and make appropriate adjustments For TALL PATIENTS angle the support downward For SHORT PATIENTS angle the support upward The maximum safe...

Page 42: ... into the supports 2 Both full leg supports are interchangeable right and left 3 For leg support installation place the rod into the steel sockets located at the point where the foot section attaches to the yoke 4 Drop them into the sockets and rotate until you hear the support lock 5 Rotate the supports so that the black knob faces inboard toward the patient and leave the knob loose 6 For large p...

Page 43: ...ke WARNING Warning The instrument tray is for medical equipment only Do not stand or sit on the instrument tray Do not place an infant on the instrument tray Personal injury can occur The maximum safe working load is 25 lb 11 kg NOTE The Instrument Tray is not available on the Affinity 4 Birthing Bed that has the Stow and Go Foot Section option INFUSION SUPPORT SYSTEM ISS P158 AND P159 The P158 tr...

Page 44: ...e 1 Grasp and hold the upper section of the IV pole Push the upper collar down and lower the upper pole section into the lower pole section 2 Lift the lower section of the IV pole up and lower the pole down to the stored position behind the headboard The poles should rest in the storage slots provided on the bed frame CAUTION Caution Make sure any IV pole mounted infusion pumps are not in the dire...

Page 45: ... is for the U cut slipcover and the P3731 is for the V cut slipcover PUSH HANDLES P1983A01 The push handles are located on the head end of the bed and are used to move the bed Remove from the Stowed Position Pull the push handles upward until they lock in position To Stow WARNING Warning Make sure the patient or caregiver hands are not in the path of travel while you lower the transport handles In...

Page 46: ...tient movement Warning Failure to remove lines from the Line Manager before you transfer the patient could cause patient injury or equipment damage Warning Do not use the line manager to move the bed Warning Do not use tape to hold lines inside the line manager A Line Manager is on each side of the head end of the bed The Line Manager helps to keep lines such as IV infusion lines suction lines oxy...

Page 47: ...and put it straight up 2 Make sure that the pole drops and locks into position 3 Raise the upper section of the pole to the desired height The IV pole is ready for use To Store WARNING To help prevent injury and or equipment damage obey these warnings Warning Make sure the patient hands are not in the path of travel while you lower the IV pole Warning When lowering the upper section of an IV pole ...

Page 48: ...uid spills occur outside of what is seen in normal use immediately do as follows a Unplug the bed from its power source b Remove the patient from the bed c Clean the fluid spill from the bed system d Have maintenance examine the system completely e Do not put the bed back into service until it is completely dry tested and found to be safe to operate CAUTION To help prevent equipment damage obey th...

Page 49: ...h with a new or clean cloth wipe soaked in tap water When you perform the detailed cleaning steps please note the following A reusable or disposable microfiber cloth or a Clorox HealthCare Bleach Germicidal Wipe is recommended as the wiping cloth Always replace the wiping cloth when visibly soiled Always replace the wiping cloth between steps spot clean clean and disinfect Always use Personal Prot...

Page 50: ... headboard and mattress and siderails and mattress Upper frame Base frame Power cord Patient pendant handheld remote and pendant cord Accessories Mattress top and bottom c Examine the following for damage Top mattress cover Bottom mattress cover and mattress retaining snaps Zipper closure d Damaged items may require the mattress to be replaced STEP 2 Disinfection a With a new or clean wiping cloth...

Page 51: ...ping with a dry cloth At no time should a wet cloth be allowed to lay on the surface Any liquid spilled on the surface should be wiped up immediately Any liquid allowed to lay on the surface unattended may damage the finish For protection of the finish we recommend using a liquid type furniture polish Polish about once a month and wipe off any excess with a soft dry cloth Have any nicks or scrapes...

Page 52: ...te records and maintain the Affinity 4 Birthing Bed For the preventive maintenance schedule refer to the Affinity 4 Birthing Bed Service Manual 195826 For service and or technical information other than that specified in this document refer to the Affinity 4 Birthing Bed Service Manual 195826 Trade Name Type Manufacturer Trade Name Type Manufacturer A33 Quartenary Airwick LPH Phenolic Vestal Absol...

Page 53: ... the decommissioned bed or accessory is not fit for use Hill Rom recommends dismantling the bed in accordance with the instructions provided in the service manual Hill Rom recommends that all oil and hydraulic fluids are removed from the product before recycling or disposal if applicable Always check and comply with all local and national regulations and facility protocols when decommissioning a p...

Page 54: ... A bed fuse has blown During a power loss the bed can operate on battery backup See Battery Backup on page 18 Always check the battery charge status on the siderail The bed may not be functioning due to the battery being drained and the bed needing to be plugged into its appropriate power source SPECIFICATIONS Product Identification Product Number Description P3700B Affinity 4 Birthing Bed introdu...

Page 55: ... foot 3 5 8 9 cm Detachable Power Cord IEC 320 interface US 84 213 cm international 98 248 9 cm Caster Size 6 15 cm or 8 20 cm Head Section Inclination maximum 63 Seat Section Inclination maximum 15 Bed Height Range Lift off foot section 19 0 33 75 48 3 85 7 cm Bed Height Range Stow and Go foot section 19 5 33 75 49 5 85 7 cm Bed Height Range Lift off with mattress 24 0 38 75 60 9 98 4 cm Bed Heig...

Page 56: ...Specifications 46 Affinity 4 Birthing Bed Instructions for Use USR025 REV 13 Bed Dimensions see Specifications on page 45 ...

Page 57: ...AC 230V AC Power input 5A 4A 2A Frequency 50 60 Hz Condition Range Air system optional fuse beds with Serial Numbers below R297AAXXXX 2 A 250 V 5 x 20 mm UL 198G Fast Acting Battery fuse 10 A 32 V ATO Mains fuse 100 V bed model 5 A 125 V 5 x 20 mm UL 198G Slo Blo or equivalent Mains fuse 120 V bed model 4 A 125 V 5 x 20 mm UL 198G Slo Blo or equivalent Mains fuse 230 V bed model 2 A 250 V 5 x 20 m...

Page 58: ...ive 1907 2006 Serial Numbers after H297AA4665 and up to Serial Numbers beginning with O218AA IEC and EN 60601 1 2 nd Edition UL 60601 1 2006 IEC and EN 60601 2 38 A1 CAN CSA C22 2 No 601 1 M90 A1 and A2 Serial Numbers before O079AA IEC and EN 60601 1 2 2nd Edition CAN CSA C22 2 No 60601 1 2 03 A1 Serial Numbers after O078AA IEC and EN 60601 1 2 3rd Edition CAN CSA C22 2 No 60601 1 2 2007 P3700E be...

Page 59: ... they operate as intended Make sure the P3700 bed operates correctly when it is used near other electronic devices Portable and mobile radio frequency RF communications equipment can affect electrical equipment Degree of Protection Against Electric Shock of the Applied Part Type B Classification according to Directive 93 42 EEC Class I Degree of Protection Against Ingress of Water IPX2 P3700 model...

Page 60: ...into service according to the EMC information supplied in the following tables Guidance and Manufacturer s Declaration Electromagnetic Emissions The P3700 Affinity 4 Birthing Bed is intended for use in the electromagnetic environment specified below The customer or the user should make sure that they are used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF ...

Page 61: ... power quality should be that of a typical commercial or hospital environment Power Frequency Magnetic Fields IEC 61000 4 8 3 A m see Note 1 30 A m see Note 2 3 A m see Note 1 30 A m see Note 2 Mains power quality should be that of a typical commercial or hospital environment When the inputs are greater than 5 5 Vrms it may dam age the speaker system Voltage Dips Short Interrupts Variations On Pow...

Page 62: ... Corresponding information shown is with respect to the 3 rd Edition of EN IEC 60601 1 2 and is relevant for all P3700 Affinity 4 units having serial numbers beginning with and up to T242AA Note 2 Corresponding information shown is with respect to the 4 th Edition of EN IEC 60601 1 2 and is relevant for all P3700E Affinity 4 units having serial numbers beginning with and after T242AA Note 3 UT is ...

Page 63: ...Power W Distance m ImmunityTest Level V m 385 380 390 TETRA 400 Pulse modulation 18 Hz 1 8 0 3 27 450 430 470 GMRS 460 FRS460 FM 5 kHz deviation 1 kHz sine 2 0 3 28 710 704 787 LTE Band 13 17 Pulse modulation 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation 18 Hz 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 ...

Page 64: ...nt Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 1 2 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated ...

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