AKRON STREAMLINE GYNAE Range Instructions for Use Rev 20 June 2018

WARNING To avoid injury, always read this Instructions for Use and accompanied documents before using the product. Mandatory to read the Instructions for Use

Design Policy and Copyright ® and ™ are trademarks belonging to the ArjoHuntleigh group of companies unless otherwise stated. © ArjoHuntleigh 2012. As our policy is one of continuous improvement, we reserve the right to modify designs without prior notice. The content of this publication may not be copied either wholly or in part without the consent of ArjoHuntleigh.

Contents Warnings, Cautions and Notes ... 3 General Warnings ... 3

1. Introduction ... 1 Product overview... 2

2. Clinical Applications ... 3 Intended use ... 3 Contraindications ... 3

3. Installation ... 4 Adjustable Foot ... 4 Electric models... 4

4. Operation ... 6 Elevation Controls ... 6 Electric Models... 6 Triple Foot Switch ... 7 Wheel Locking... 8 Casters (RWB - Retractable Wheel Base) ... 8 Backrest Operating Lever ... 8 Debris Tray... 9

5. Product Care ... 10 Cleaning / Decontamination ... 10 To Clean... 10 Chemical Disinfection... 10 Preventive maintenance... 11 Troubleshooting ... 13 Product lifetime ... 13

6. Accessories ... 14 Seat Extension (A7303) ... 15 Fold Down Extension Frame (A7333) ... 15 Leg Supports (A7309) ... 16 Arm Loops (A7310) ... 16 Head Support (AHC1) ... 17 Paper Roll Holder (A8611) ... 17 IV Pole (A7334) ... 17 Leg Stirrups (A3295) ... 18

7. Technical Data ... 19 8. List of Standards and Certificates ... 25 9. Warranty and Service... 25

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Warnings, Cautions and Notes

WARNING

Indicates possible hazards in procedures or conditions which, if not correctly followed, could result in death, injury or other serious adverse reactions.

Caution

Indicates possible hazards in procedures or conditions which, if not correctly followed, could result in equipment damage or failure. Explains or amplifies a procedure or condition.

Indicates an optional item or feature.

General Warnings

WARNING Keep these instructions in a safe place; you may need to refer to them later on. Read and understand these instructions before operating the couch. Caregivers must be trained in the proper use of this product, its functions and controls, and any accessories. These instructions are mandatory for the safe and effective use of this product, including the safety of patients and caregivers. Unauthorised modifications or repairs to this product may affect its safety and will invalidate any warranty. ArjoHuntleigh accepts no liability for any incident, accident or reduction in performance that may occur as a result of such repairs or modifications. Do not use electrically powered couches in the presence of uncontained flammable liquids or gases. The couch is intended for indoor use only.

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WARNING Do not use accessories that have not been designed or approved for use with couch. Always apply the brakes when the couch is stationary. When the couch is operated, make sure that obstacles such as furniture do not restrict its movement. Before operating the couch, make sure the patient is positioned correctly to avoid entrapment or imbalance. Take care not to squeeze or trap trailing cables from the handset and other equipment between moving parts of the couch. Be aware that cables, hoses, etc., may present a strangulation hazard. Take care not to allow clothing to become snagged on moving parts of the couch. Do not place the couch on an incline greater than 10° as this may, in extreme circumstances, cause the couch to overbalance. This equipment should not be used adjacent to other electrical equipment. If such use is necessary, normal operation of the equipment should be verified by observation. Medical Electrical Equipment maybe affected by portable and/or mobile RF communications equipment (e.g. mobile telephones). These products are not intended for Patient Transportation. Maximum Load 225kg (495lbs) must be distributed evenly. Do not concentrate weight on either side of the couch. Plug acts as a disconnecting device. Do not allow children to play with the couch at any time. This product contains small parts that may present a choking hazard to children if inhaled or swallowed. Adequately supervise children in the proximity of the couch. The patient should not be left on the couch unattended at any time. Do not use the couch in area of high humidity (e.g. the shower). To avoid the risk of electric shock, this product must only be connected to an electricity supply with a protective earth. Do not smoke or use naked flames near this equipment and do not expose it to extremes of temperature. Do not use electrically powered couches in the presence of flammable gases such as anaesthetic agents e.g. in operating theatres.

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Caution Electromagnetic Compatibility (EMC). This product complies with the requirements of applicable EMC standards. The use of accessories not specified by the manufacturer may result in increased emissions by, or decreased immunity of, the equipment, affecting its performance. Do not exceed the specified duty cycle as stated on the Product Identification Label.

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1. Introduction The STREAMLINE ™ Gynae product range of treatment & examination couches, have been designed to cover a wide range of disciplines, from simple examination to heavier manipulative and manual therapy techniques. The STREAMLINE couches in this range provide ergonomic solutions to a variety of manual handling issues, benefiting both the patient and clinician. These products can be further enhanced with a wide range of additional accessories also available. These products are not designed to be used as a bed and are not suitable for sleeping on. You must read and fully understand this manual before using the system. This manual is your introduction to the following STREAMLINE couches:

• Gynae 1, model 2252 electric, • Gynae 2, model 2254 electric, • Gynae 3, model 2255 electric with tilt, • Gynae 3 Deluxe, model 2257 electric with tilt, • Gynae 3 Deluxe, model 2256 electric with tilt. The Couch should only be used for the purpose specified in its IFU. Any other use is prohibited. Always keep this Instruction for Use publication available for reference.

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Product overview

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1

8

7 6

10

3

2 1. Upholstery 2. Lifting arms 3. Rubber pedals 4. Electric actuator 5. Castors 6. Leg support 7. Arm loop 8. Paper roll holder 9. Detachable head cushion 10. Fold down extension frame

2

4

5

2. Clinical Applications WARNING To ensure the patient can use the couch safely, their age, size and condition should be assessed by a clinically qualified person.

Intended use This product is intended to position able patients (mainly females / some males) for examinations in a seated position, or with the leg raised in leg supports. Accessories allow for examination of females in the cervical area and male genitals. The couch is used in hospitals for Gynaecological, Colposcope procedures / investigations and Genitourinary medicine clinics (GUM Clinics), for cervical investigations. The couch can also be used in Private Clinics, Ante Natal Clinics, IV Fertilization Clinics, Maternity, Obstetrics and Sexual Health Clinics.

Contraindications The safe working load (SWL) of the couch 225kg The maximum recommended patient weigh 195kg Accessories (including attached loads) 30kg

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3. Installation Adjustable Foot

WARNING Lock all castors before adjusting.

A. Lock castors first. B. Adjust foot. C. Lock foot by tightening half nut.

Electric models Connect the mains plug to a suitable socket outlet. Make sure the mains plug is easily accessible so it can be disconnected quickly in an emergency.

WARNING Ensure mains supply cable is not stretched when connected. If the power cord or mains plug is damaged, the complete assembly must be replaced by authorised service personnel. Do not remove the fitted plug, or use a rewireable plug or adapter. Do not allow the power supply cord to trail on the floor where it may cause a trip hazard. Ensure, during couch use, no obstacles are in its path. Make sure the power supply cord does not become entangled with moving parts of the couch. Damaged cables can cause an electrocution risk when handled. Disconnect the power supply cord from the electricity supply before moving the couch. Ensure hand / foot switch leads are not trapped by moving parts of the couch.

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Caution Do NOT insert hands or feet into the mechanism as this could result in serious injury!

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4. Operation Elevation Controls

WARNING Safely position patient before elevating couch. Position all electrical cables away from the moving parts. Position hand/foot switch where accidental operation is not possible.

Electric Models Press

to move the section up.

Press

to move the section down.

The lockable handset has the facility to selectively disable couch functions to prevent use by the patient. Between each pair of push buttons is a small rotary lockout switch. To disable a function: fit the plastic key into the two holes in the lockout switch (A) and turn the switch clockwise to the Locked position (B). To enable a function: fit the plastic key into the two holes in the lockout switch and turn the switch anti-clockwise to the Unlocked position (C).

Caution To enable/disable a function the plastic key must be used. Only use the plastic key supplied. Using other tools may damage the switch.

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Footswitch Press

to move the section up.

Press

to move the section down.

Triple Foot Switch To use the triple foot switch: A. Remove existing hand switch from the control box. B. Plug in the 2R11227Z adapter D-sub lead into handset port on control box. C. Plug in the Triple Foot Switch into the 2R11227Z adapter.

The Triple Foot Switch is an optional extra for use with the Gynae 3 and Deluxe models only (2255, 2256, 2257).

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Wheel Locking

WARNING Lock all couch wheels/castors prior to patient transfer or treatment. These couches are not designed for the transportation of patients. Disconnect and coil electrical cord away from moving parts prior to repositioning couch.

Casters (RWB - Retractable Wheel Base)

Castors locked

Castors unlocked

Backrest Operating Lever I

Caution Support upholstery section while manually altering the angle. Apply pressure to ensure the upholstery is locked. If movement is detected, seek advice. A. Press lever UP to alter section angle. B. Support section when altering angle. C. Release lever to lock section in position.

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Debris Tray Caution Ensure Debris Tray is removed and frame positioned under seat prior to patient mounting or dismounting couch. A. To remove tray, lift out of frame and slide frame under seat. B. To insert tray, slide frame out and position debris tray into frame.

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5. Product Care WARNING Do not use Alkalis or other organic solvents for routine cleaning. Replace torn or damaged vinyl immediately. Always cover vinyl with fresh paper or sheet between patients. If contamination is known or suspected always decontaminate couch before use. Do not saturate hinge pin location and it is essential to ensure that they are dry before re-use. Disconnect any mains supply. Do not allow the mains plug or power supply cord to get wet.

Caution Do not use Phenol-based solutions or abrasive compounds or pads during the decontamination process as these will damage the surface coating. Avoid immersing electrical parts in water during the cleaning process.

Cleaning / Decontamination Frequency of routine couch cleaning will depend on exact application, local policy and contamination status.

To Clean

Clean all exposed surfaces and remove any organic debris by wiping with a cloth moistened with a simple (neutral) detergent and water.

Chemical Disinfection We recommend a chlorine-releasing agent, such as sodium hypochlorite, at a strength of 1,000ppm available chlorine (this may vary from 250ppm to 10,000ppm depending on local policy and contamination status). Use low strength solution for upholstery. Wipe all cleaned surfaces with the solution, then wipe with a cloth moistened with water and dry thoroughly. Alcohol based disinfectants (maximum strength 70%) may be used as an alternative. Ensure the product is dry before storage. If an alternative disinfectant is selected from the wide variety available we recommend that suitability for use is confirmed with the chemical supplier prior to use.

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Preventive maintenance This product is subject to wear and tear during use. To ensure that it continues to perform within its original specification, preventive maintenance procedures should be carried out at the intervals shown.

WARNING This list indicates the minimum recommended level of preventive maintenance. More frequent inspections should be carried out when the product is subjected to heavy use or aggressive environments, or where required by local regulations. Failure to carry out these checks, or continuing to use the product if a fault is found, may compromise the safety of both the patient and caregiver. Preventive maintenance can help to prevent accidents. To isolate the couch from the electrical supply, disconnect the electrical power cable from socket outlet. Product cannot be maintained and serviced while in use with the patient. Actions to be done by caregiver

Daily

Weekly

Check patient handset and cable



Visually check castors



Visually check power supply cord and mains plug



Examine the accessories (if applicable)



Visually check the upholstery



Check gas strut controls and moveable sections for their full range of movement for locking.



If the result of any of these tests is unsatisfactory, contact ArjoHuntleigh or an approved service agent.

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WARNING The procedures below must be carried out by suitably trained and qualified personnel. Failure to do so may result in injury or an unsafe product. Actions to be done by qualified personnel

Once a year

Carry out a full test of all electrical couch positioning functions (backrest, height, tilt, etc.).



Check operation of the manual backrest/footrest.



Check operation of the castors, paying special attention to braking.



Examine the power supply cord and mains plug; if damaged, replace the complete assembly; do not use a rewireable plug.



Examine all accessible flexible cables for damage and deterioration.



Check all accessible nuts, bolts and other fasteners are present and correctly tightened.



Check any accessories fitted to the couch, paying particular attention to fasteners and moving parts.



WARNING All electrical checks should be performed by a suitably qualified and licensed electrician.

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Troubleshooting If the equipment fails to operate correctly, the table below suggests some simple checks and corrective actions. If these steps fail to resolve the problem, contact ArjoHuntleigh or an approved service agent.

Symptom

None of the actuators work

One actuator does not work

Castor does not rotate or swivel

Possible Cause

Action

Mains cable disconnected

Check the mains cable is plugged in and the electricity supply is okay

Fuse blown

Check fuse in mains plug (where fitted)

Control handset disconnected

Check handset is plugged into the control box

Functions disabled

Enable the functions on handset using the plastic key

Actuator cable disconnected

Check actuator cable is plugged into both the actuator and control box

Function disabled

Enable a function on handset using the plastic key

Brake applied

Release brake

Product lifetime The lifetime of this equipment is typically ten (10) years from manufacture date. “Lifetime” is defined as the period during which the product will maintain the specified performance and safety, provided it has been maintained and operated in conditions of normal use in accordance with the requirements in these instructions.

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6. Accessories Recommended accessories for the Streamline Gynae product range are shown in the table below:

Streamline Gynae 3, model 2255 with tilt

Streamline Gynae 3 Deluxe, model 2257 with tilt

Streamline Gynae 3 Deluxe, model 2256 with tilt

Weight of accessory

Accessory number

Streamline Gynae 2, model 2254

Accessory description

- Optional Accessory Streamline Gynae 1, model 2252

- Standard accessory

G1

G2

G3

3D

3D

[kg]

Seat Extension

A7303



N/A

4.5

Fold Down Extension Frame

A7333

N/A



3.3

Leg Support (requires A7317 sliding leg support kit)

A7309











2.0

Arm Loops (only for 64cm upholstery) (requires A7318 accessory mounting bracket)

A7310











1.5

Detachable Head Cushion

AHC1











0.6

Streamline Clinical Paper Roll Holder

A8611











0.5

Akron IV pole (requires A7320 fixing bracket)

A7334

1.3

Leg Stirrups

A3295

1.7

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