Hillrom Affinity 4 Instructions For Use Manual

Hillrom Affinity 4 Instructions For Use Manual

Birthing bed
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Affinity
4 Birthing Bed
®
Instructions for Use
Product No. P3700
USR025 REV 13

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Summary of Contents for Hillrom Affinity 4

  • Page 1 Affinity 4 Birthing Bed ® Instructions for Use Product No. P3700 USR025 REV 13...
  • Page 3: Quick View™ List Of Bed Features

    QUICK VIEW™ LIST OF BED FEATURES Caregiver-Side Control Patient-Side Control Item Description Item Description V-cut or straight-cut mattress 8° trend-like position Lift-off, Stow and Go® Foot Section or One-handle siderail release Slide off foot section EasyGlide® Calf Supports Removable headboard OneStep®...
  • Page 4: Revision

    © 2020 by Hill-Rom Services, Inc. ALL RIGHTS RESERVED. PATENTS / PATENT hillrom.com/patents May be covered by one or more patents. See the above Internet address. The Hill-Rom companies are the proprietors of European, US, and other patents and pending patent applications.
  • Page 5 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.
  • Page 6 NOTES: Affinity® 4 Birthing Bed Instructions for Use (USR025 REV 13)
  • Page 7: Table Of Contents

    Table of Contents Quick View™ List of Bed Features..............i Revision.
  • Page 8 Table of Contents Labor Grips................18 Night Light .
  • Page 9 Table of Contents With Calf Supports ..............27 With Full Leg Supports .
  • Page 10 Table of Contents Prepare the Bed for Use..............40 Laundry Guidelines .
  • Page 11: Intended Use

    Intended Use INTENDED USE The Affinity® 4 Birthing Bed is intended to be used as a birthing bed for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market. It is not intended for use as a general hospital bed. The intended users of this product are healthcare employees who have been trained to use the product, and who have the physical strength and cognitive skills to operate and control the product.
  • Page 12: Safety Information

    Safety Information SAFETY INFORMATION WARNING: Obey all warnings throughout this document. Failure to do so could cause injury and/or equipment damage: • Warning—Read and understand all warnings in this document and on the unit itself prior to use with a patient. •...
  • Page 13: Symbols

    Symbols CAUTION: Obey all cautions throughout this document and also the safety information below. Failure to do so could cause equipment damage: • Caution—Do not sore anything under the bed. • Caution—Use only parts and accessories from Hill-Rom. Do not modify or change the bed system without approval from Hill-Rom.
  • Page 14: Product Symbols

    Symbols RODUCT YMBOLS These symbols are on the product and may or may not be on your model of the Affinity® 4 Birthing Bed: Symbol Description Symbol Description All Affinity® 4 Models Catalog number Serial number Manufacturer Date of manufacture Warning: Do Not Use Conforms to European with Oxygen Tents—...
  • Page 15: B Through D Model Beds

    Symbols Symbol Description Symbol Description Nurse call (refer to the Do Not Push—do not section titled “Nurse use the headboard to Call (Optional)” on push the bed. On wood page 12 for nurse call headboards without switch information). integrated push handles.
  • Page 16 Symbols Symbol Description Symbol Description CPR function— TV On/Off/Audio Identifies the release control (optional). lever that can be used to manually drop the inclined head section, in order that cardiopulmonary resuscitation can be performed without delay. Safe working load. Lockout control label— The switch in the up position indicates the = kg...
  • Page 17: E Model And Newer

    Symbols Symbol Description Symbol Description E Model and Newer According to IEC 60529, Total bed weight, rating for protection including the rated safe against fluid ingress working load (SWL), is and identified as 470 kg (1036 lb); and equipment that is where the rated SWL for protected against the bed-frame includes...
  • Page 18 Symbols Symbol Description Symbol Description Medical Bed for Adults. Lockout control label— (P3700E Serial Numbers The switch in the up after those that begin position indicates the with S361AA) lockout control is on. The switch in the down position indicates the lockout control is off (refer to the section titled “Lockout...
  • Page 19 Symbols Symbol Description Symbol Description Warning: Bed safe Warning: Engage foot working load. section latch—Stow and Go® Beds. Must consult accompanying documents. Warning: Maximum Warning: Lift-off foot patient weight. section—engagement advisory. Must consult accompanying documents. Warning: Safe working Caution: Connect to load—foot section only.
  • Page 20: Point-Of-Care® Bed Controls

    Point-of-Care® Bed Controls POINT-OF-CARE® BED CONTROLS The Affinity® 4 is electrically operated using siderail or pendant controls. The hilow, head, and foot functions can be operated by battery backup, if necessary. WARNING: To help prevent injury and/or equipment damage, obey these warnings: •...
  • Page 21: Lockout Controls

    Point-of-Care® Bed Controls NOTES: • If the foot section is at its lowest position when the bed is lowered, the bed will stop at a higher position to ensure that the foot section does not interfere with the base. • If the bed is in the low position and the Trend-Like function is activated, the bed will rise to the appropriate height to allow the bed to move to the full Trend-Like position.
  • Page 22: Head Section

    Point-of-Care® Bed Controls Head Section The Head Up/Down controls located on both siderails enable you to raise or lower the head section of the bed. The head section can be raised to any angle of inclination up to 63°. To raise—press and hold the Head Up control to raise the head section of the bed.
  • Page 23: Patient Bed Controls

    Bed Frame Features To inflate or deflate the seat section from the patient controls—press and hold the Patient Seat Inflate control (plus sign) or the Patient Seat Deflate control (minus sign). NOTE: The auto-inflate function runs for 20 to 25 seconds before shutting off. ATIENT ONTROLS TV On/Off (Optional)
  • Page 24: Automatic Tilt

    Bed Frame Features UTOMATIC • As the head section is raised, the seat section gradually tilts up from 0° to 15°. • As the head section is lowered, the seat section gradually returns to a flat position. CPR R ELEASE The CPR Release enables the caregiver to save valuable time in an emergency.
  • Page 25 Bed Frame Features • Slide-Off Foot Section: Squeeze the release levers to disengage the foot section, and slide the section toward you (bending your knees) while taking a step backward. • Lift-Off Foot Section: With the knees bent, place it on the floor with the perineal stand down to hold it upright.
  • Page 26: Stow And Go® Foot Section

    Bed Frame Features ® F TOW AND ECTION To Remove 1. Adjust the foot section so that the top of the mattress is about waist high. 2. Pivot the foot supports laterally. 3. Fold up the sides of the foot section mattress. 4.
  • Page 27: Onestep® Foot Supports

    Bed Frame Features ® F UPPORTS The OneStep® Foot Supports can be simultaneously positioned up or down, through use of the motor powered foot section yoke. This foot section yoke controls the overall height up and down. Each support can be independently positioned by using the mechanical release latches at the end of the foot supports.
  • Page 28: Labor Grips

    Bed Frame Features ABOR RIPS Ergonomically correct labor grips comfortably accommodate patients of all sizes. The handles are covered with a non-porous, fluid resistant foam that is comfortable for mothers to squeeze. To Activate 1. To raise the labor grip, grasp the grip, and rotate it from under the bed until it clicks in place.
  • Page 29: Battery Sleep

    Bed Frame Features CAUTION: Caution—Remove the battery if the bed will not be in service for extended periods of time. Failure to do so could result in damage to the life of the battery, or damage to the bed. Contact the appropriate maintenance personnel, and refer to the Affinity®...
  • Page 30: Trend-Like Function

    Optional Features CAUTION: Caution—Before you raise or lower a siderail, make sure that the area around the siderail is free of objects and devices. Failure to do so could cause equipment damage. The bed has two siderails, one located on each side. The siderails contain caregiver and patient siderail controls, and can be adjusted between the upright and lowered positions.
  • Page 31: Siderail Controls

    Mattresses IDERAIL ONTROLS ® C UILT OMMUNICATION YSTEM ONTROLS PTIONAL Every Affinity® 4 Birthing Bed with siderail controls is pre-wired to accommodate the SideCom® Communication System now or in the future. The SideCom® Communication System enables integration of the backlit nurse call, entertainment (radio and TV), and lighting in the siderails. The optional Universal TV is also available.
  • Page 32: Mattress Models

    Patient Positioning—Labor and Birth ATTRESS ODELS The bed is available in two options: the V-Cut or Straight-Cut. V-Cut Straight-Cut Non-Air Mattress pressure redistribution foam mattress is available. EADBOARDS The wood headboards include built-in handles which aid in steering control and increase mobility. The headboard assembly is removable. Beds with the push handle option will not have handles on the headboard.
  • Page 33: Upright Position/Voiding Position

    Patient Positioning—Labor and Birth PRIGHT OSITION OIDING OSITION 1. Raise the head of the bed to a comfortable position by pressing the Head Up control. 2. Lower the foot section by pressing the Foot Down control. 3. Place the patient in an upright position.
  • Page 34: Legs Elevated With Foot Mattress

    Patient Positioning—Labor and Birth LEVATED ATTRESS This position is useful for various clinical reasons during antepartum care, postpartum care, and anesthesia administration when a patient’s legs require elevation. It may also be used for patient comfort. To Adjust 1. Raise the foot section to its highest position. 2.
  • Page 35: Pushing With Calf Supports

    Patient Positioning—Labor and Birth USHING WITH UPPORTS WARNING: Warning—Make sure the calf supports are securely locked in place before use. Injury and/or equipment damage may occur. To Adjust 1. Adjust the head of the bed to approximately 30°, by pressing the Head Up control.
  • Page 36: Straight Line Trend-Like Positioning

    Patient Positioning—Labor and Birth TRAIGHT REND OSITIONING 1. Pull the CPR Release to lower the head of the bed to a full flat position. 2. Push down on the Trend-Like handles (located on either side of the bed) and guide the bed to the desired degree, up to 8°. 3.
  • Page 37: Delivery Table Mode

    Transport the Patient ELIVERY ABLE 1. Slide the patient down so that her buttocks are at the division in the mattress. 2. Lower the foot section to its lowest position. With Calf Supports 1. Position the attached calf supports, and place the patient’s legs in the supports.
  • Page 38: Transport Safety Information

    Transport the Patient Make sure the patient, equipment, and all lines are placed within the perimeter of the bed for intra- hospital transport. Fully extended IV poles could damage doorways or ceiling fixtures. Lower poles before patient transport. Make sure that the Nurse Call system cables are correctly connected after transport.
  • Page 39: Accessories

    Accessories WARNING: (Warnings continued) To help prevent injury and/or equipment damage, obey these warnings: • Warning—Remove the arm board, and store the calf support and foot supports before transporting. • Warning—During transport, use caution so the bed does not tip or overbalance. •...
  • Page 40: Anesthesia Screen-P9625 (No Longer Available)

    Accessories Product Number Description Weight 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...
  • Page 41: Calf Supports-P3705, And P35745

    Accessories —P3705, Release Handle (P3705A shown) UPPORTS P35745 The P3705 calf supports are permanently attached to the foot support for easy access. The removable P35745 calf support (not shown) is fully padded with telescoping height adjustment; it is installed the same as the P7625C and Unlocked Locked P7634C full leg supports (see page 32).
  • Page 42: Foley Hook Kit-P3623

    Accessories —P3623 OLEY This kit can be mounted to either side of the bed frame near the labor grip. The maximum safe working load is 10 lb (4.5 kg). —P451 This bar provides a convenient foot rest for the physician (or obstetrician) and is for lift off versions only.
  • Page 43: Headboards-P3617, P3629, P923617 And P933617

    Accessories The maximum safe working load is 60 lb (27 kg). —P3617, P3629, P923617 P933617 EADBOARDS The P3629 blow-molded headboard is available in five woodgrain laminate options and two color laminate options. The P3617 contemporary wood headboard and P933617 FreedomHill™ wood headboards are available in light and medium oak stain options.
  • Page 44: Pendant Control Kit With Holder-P5362, P3618 (No Longer Available)

    Accessories —P5362, P3618 (N ENDANT ONTROL IT WITH OLDER ONGER VAILABLE This kit contains a pendant control and holder to control the bed high/low, head up/down and foot up/down functions. The holder clamps to the bed side rail. Make sure you stow the pendant and pendant cable when it is not in use or when you transport the bed.
  • Page 45: Slipcover Upgrade Kits-P3730 And P3731

    Accessories The head section slipcover is simply placed over the head section mattress for protection from normal wear and tear and from fluids. Foot Section Slipcover The foot section slipcover is simply placed over the foot section mattress for protection from normal wear and tear and from fluids. Number Description P3627...
  • Page 46: Line Manager-P3733

    Accessories —P3733 ANAGER WARNING: Warning—To help prevent injury and/or equipment damage, obey these warnings: • Warning—Do not use the Line Manager for ventilator circuits. • Warning—Failure to keep aseptic lines separate from non-aseptic lines may cause cross contamination. • Warning—Do not hang cords on the Line Manager.
  • Page 47: Permanent Iv Pole-P3732

    Accessories IV P —P3732 ERMANENT The Permanent IV Pole option consists of one IV pole that supports up to two IV pumps plus bags. The IV pole is attached to the bed frame near the corner of the headboard. The IV pole can support up to 40 lb (18 kg).
  • Page 48: Cleaning And Disinfecting

    Cleaning and Disinfecting CLEANING AND DISINFECTING WARNING: To help prevent injury and/or equipment damage, obey these warnings: • Warning—The potential for electrical shock exists with electrical equipment. Failure to follow facility protocol could cause death or serious injury. • Warning—Unplug the bed from its power source, and activate the lockout switches before cleaning or service.
  • Page 49: Cleaning And Disinfection

    Cleaning and Disinfecting Hill-Rom recommends to clean and disinfect the bed and mattress before first patient use, between patient uses, and regularly during extended patient stays. Some fluids used in the hospital environment, such as iodophor and zinc oxide creams, can cause permanent stains.
  • Page 50: Step 1: Cleaning

    Cleaning and Disinfecting STEP 1: Cleaning a. As necessary, first remove visible soil from the bed and the mattress using a wiping cloth soaked with an approved cleaner/disinfectant (see “Table 1: Approved Cleaners/Disinfectants” on page 39). • Give special attention to seams and other areas where soil may accumulate. •...
  • Page 51: Laundry Guidelines

    Cleaning and Disinfecting Laundry Guidelines Laundry can be used as a pre-cleaning step for the Affinity® 4 head and foot slipcovers. Launder the slipcovers, then follow the Cleaning and Disinfection instructions. Machine wash the slipcovers as follows: 1. Remove the head and foot slipcovers from the mattress. 2.
  • Page 52: Preventive Maintenance

    Preventive Maintenance The following products have been tested by the Herculite Laboratory and have been found not to have a harmful effect on Dartex® fabrics when used in accordance with manufacturer’s recommended dilution. Trade Name Type Manufacturer Trade Name Type Manufacturer Quartenary Airwick...
  • Page 53: Decommissioning And Disposal Instructions

    Decommissioning and Disposal Instructions DECOMMISSIONING AND DISPOSAL INSTRUCTIONS Customers should adhere to all federal, state, regional, and/or local laws and regulations as it pertains to the safe disposal of medical devices and accessories. If in doubt, the user of the device shall first contact Hill-Rom Technical Support for guidance on safe disposal protocols.
  • Page 54: Troubleshooting

    Troubleshooting TROUBLESHOOTING WARNING: Warning—Only facility-authorized personnel should troubleshoot the Affinity® 4 Birthing Bed. Troubleshooting by unauthorized personnel could result in personal injury or equipment damage. OWER A power loss can occur under these conditions: • The bed power cord has been unplugged from the AC power outlet. •...
  • Page 55 Specifications Specifications Feature Dimension Overall Length (maximum) 90" (229 cm) (B through C model beds) 92" (234 cm) (D model and newer beds) Length from roller bumpers to break in seat section 61 7/8” (157 cm) Length from break in the seat section to end of bed 28 1/8” (71 cm) Maximum Width (siderails stored) 36"...
  • Page 56 Specifications Bed Dimensions (see “Specifications” on page 45) Affinity® 4 Birthing Bed Instructions for Use (USR025 REV 13)
  • Page 57 Specifications Environmental Conditions for Transport and Storage Condition Range Temperature -40°F(-40°C) to 158°F (70°C) Relative humidity 95% non-condensing Pressure 500 hPa to 1060 hPa Environmental Conditions for Use Condition Range Temperature 59°F (15°C) to 104°F (40°C) ambient temperature Relative humidity range 10% to 85% non-condensing Altitude Medical electric equipment rated to operate at an altitude...
  • Page 58 Specifications Applied Parts (in accordance with IEC 60601-1) Siderails Headboard Foot section—lift-off and Stow n Go Labor grips Mattress Labor bar Attached calf support Detachable telescopic calf support Detachable non-telescopic calf support Detachable telescopic leg support Detachable non-telescopic leg support Armboard Nurse Call Connection Requirements For information about the Nurse Call connection requirements, refer to the SideCom®...
  • Page 59: Electromagnetic Emissions Guidance

    Specifications Degree of Protection Against Electric Shock of the Type B Applied Part Classification according to Directive 93/42/EEC Class I Degree of Protection Against Ingress of Water IPX2—P3700 model versions B through D IPX4— P3700E Affinity® 4 beds Degree of Protection Against the Presence of Not for use with flammable anesthetics Flammable Anesthetic Mixtures Mode of Operation...
  • Page 60 Specifications WARNING: Warning—Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the P3700 Affinity® 4 Birthing bed, including cables specified by the manufacturer. Equipment performance may be impacted.
  • Page 61 Specifications Electromagnetic Immunity Guidance Guidance and Manufacturer's Declaration - Electromagnetic Immunity 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 it is used in such an environment. EN and IEC 60601-1-2 Electromagnetic Environment—...
  • Page 62 Specifications Guidance and Manufacturer's Declaration - Electromagnetic Immunity - Continued The P3700 Affinity® 4 Birthing Bed is intended for use in the electromagnetic environment specified below. The cus- tomer or the user should make sure it is used in such an environment. Immunity EN and IEC Electromagnetic Environment—Guidance...
  • Page 63 Specifications IMMUNITY to Proximity Fields from Radio Frequency Wireless Communications Equipment In addition to the Radiated RF IEC 61000-4-3 as shown in the table above, the P3700E Affinity® 4 Birthing Bed with serial numbers after T242AA hav been tested as specified in the table below. Test Band Service...
  • Page 64 Specifications Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the P3700 Affinity® 4 Birthing Bed The P3700 Affinity® 4 Birthing Bed is intended for use in an electromagnetic environment in which radiated RF distur- bances are controlled. The customer or the user of the P3700 can help prevent electromagnetic interference by main- taining a minimum distance between portable and mobile RF communications equipment (transmitters) and the P3700 as recommended below, according to the maximum output power of the communications equipment.

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