PST 500 Instructions for Use Ver 10

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PST 500 Manufacturer

Baxter Medical Systems GmbH + Co. KG Carl-Zeiss-Straße 7-9 07318 Saalfeld Germany Telephone: +49 3671 586-0 Fax: +49 3671 586-41165 [email protected] hillrom.com Baxter Medical Systems GmbH + Co. KG is a subsidiary of Baxter International Inc. The manufacturer is hereinafter referred to as Baxter.

Authorized Australian Sponsor

Technical Customer Service

Information about the document

Hill-Rom Pty. Ltd. 1 Baxter Drive Old Toongabbie NSW 2146 Australia The contact details for the current sites of the Technical Customer Service in the individual countries are listed on the Internet at hillrom.com. Original instructions for use Document number: Language ID: Version: Material number: Date of publication:

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The instructions for use are in print format and form part of the product delivery scope. This document applies to the following sales units: Designation

Material number

Operating table PST 500 Other applicable documents

The instructions for use for the operating table and for all products used apply. Operating tables from Baxter can be individually combined with various products. Baxter offers a variety of tabletop sections and accessories to equip the operating table. The possible combinations are listed in the compatibility matrix. The following additional documents are available on the internet at ois.hillrom.com/ois: Designation

Document number

Compatibility matrix

7990090

SVHC list (Substance of very high concern)

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4080100

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PST 500

Basic information After purchasing, the product is correctly and professionally handed over to the operator. The handover is carried out by a person authorised by the manufacturer and is documented with the aid of a handover report. On delivery, the packaging should be checked for any transport damage. In the event of damage, please contact the Technical Customer Services before unpacking the product. Ensure that you are familiar with the adjustment options and the operation of the product before using it. Pay attention to the signs on the product. About these instructions for use – The instructions for use contain important information on the safe and effective use of the product. – The instructions for use are part of the product and must be followed. – Read the instructions for use carefully and in full before using the product. The instructions for use must be properly understood. If anything is unclear, or if any questions arise about the product, please contact the manufacturer. – The instructions for use must be passed on in case of relocation or change of personnel. – The instructions for use must be available at the place where the product is used. – The instructions for use must be fully accessible to all users of the product at any time. – The diagrams in the instructions for use are a simplified version for basic comprehension. – Residual risks that may occur when handling the product are identified in the document using a signal word. The necessary safety measures and possible risks are listed if they are not observed. A corresponding signal word identifies the severity of the risk: Signal word

Meaning

DANGER

This signal word denotes a dangerous situation that will lead to immediate death or severe injury, unless precautionary measures are taken.

WARNING

This signal word denotes a dangerous situation that may lead to death or severe injury, unless precautionary measures are taken.

CAUTION

This signal word denotes a dangerous situation that may lead to moderate or slight injury, unless precautionary measures are taken.

NOTICE

This signal word denotes a situation that may lead to product or environmental damage, unless precautionary measures are taken.

© Baxter Medical Systems GmbH + Co. KG Reprinting, copying, or translating this document, in whole or in part, is prohibited without the express written permission of Baxter. All rights under the copyright laws are expressly reserved by Baxter.

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Contents

Contents 1 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8

Usage specifications... 11 Normal use... 11 Intended purpose... 11 Contraindication... 11 Patient definition... 12 User definition... 12 Use environment... 12 Storage and transport conditions... 12 Service life... 13

2 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.7.1 2.7.2 2.7.3 2.7.4 2.8 2.8.1 2.8.2

Safety... 14 Combination with other Baxter products...14 Combination with products of other manufacturers...14 Responsibility of the operator...14 Use of high-frequency (HF) surgical devices... 15 Use of defibrillators... 15 Malfunction due to other devices... 15 Behaviour in the event of a fault... 16 Operating table emergency mode... 16 Reset... 17 Emergency release of the parking brake... 17 Failure of the electrical functions on the operating table... 17 Signs... 18 Safety instructions... 18 Location and meaning... 18

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Unpacking the operating table... 21

4 4.1

Overview...24 Operating table and equipment... 24

5 5.1 5.2 5.2.1 5.2.2 5.3 5.4 5.5 5.6 5.6.1 5.6.2 5.6.3 5.6.4 5.6.5 5.6.6 5.6.7 5.6.8 5.6.9 5.6.10 5.6.11 5.7 5.8 5.8.1 5.8.2

Description...25 Overview of the operating table... 25 Control module overview... 27 Column keypad... 27 Remote control... 28 Coupling points... 30 Side rails... 31 Connections for cables... 32 Setting options... 32 Patient orientation... 32 Lift... 33 Tilt... 33 Trendelenburg... 33 Longitudinal slide... 34 Back section... 34 Leg section hinge... 34 Upper back section hinge... 34 Zero position... 35 Flex/Reflex... 35 Beach Chair... 35 Automatic collision prevention... 36 Visual indicators... 38 Column keypad... 38 Battery status display at the running gear... 40

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Contents 5.8.3 5.8.4 5.9 5.10 5.10.1 5.10.2 5.10.3 5.10.4 5.10.5 5.10.6 5.10.7 5.10.8 5.10.9 5.10.10 5.10.11 5.10.12 5.11 5.12 5.13 5.14

Fault code display at the running gear...40 LED strip on the running gear (light messaging system)... 41 Sound... 42 Maximum load... 43 Overview... 43 Operating tabletop with head section and leg section...44 Operating table top with head section, upper back section and leg section...46 Operating tabletop with seat plate extension and leg section... 48 Operating tabletop with universal plate and head section...49 Operating tabletop with Carbon 1200 tabletop segment...49 Operating tabletop with Carbon 600 tabletop segment...50 Operating tabletop with extension unit... 51 Operating tabletop with shoulder chair... 51 Operating tabletop with seat plate extension and ophthalmology adapter... 51 Operating tabletop with extension section Paediatrics... 52 Side rails... 53 Travel modes... 54 Internal power supply (Running on battery)... 54 External power supply (mains operation)... 55 Equipotential bonding... 55

6 6.1 6.2 6.2.1 6.2.2 6.3 6.4 6.5 6.6 6.7 6.8 6.8.1 6.8.2 6.9 6.9.1 6.9.2 6.9.3 6.9.4 6.9.5 6.9.6 6.9.7 6.9.8 6.9.9 6.9.10 6.9.11 6.9.12 6.9.13 6.10 6.11 6.12 6.13

Use...56 Safety instructions... 56 Function selection... 56 Mode of operation... 57 Key lock... 57 Overview of the use of the operating table... 57 Charging the batteries (external power supply)... 58 Connecting/separating the potential equalisation cable... 59 Fastening tabletop sections to the operating tabletop... 59 Fastening accessories on the side rail...60 Operating states...60 Switching on the operating table...60 Switching off the operating table...60 Adjusting the operating table... 61 Safety instructions... 61 Patient orientation... 61 Lift... 62 Tilt... 62 Trendelenburg... 62 Longitudinal slide... 63 Back section...64 Leg section hinges moving together...64 Leg section hinges separately... 65 Zero position... 65 Flex/Reflex... 65 Beach Chair... 65 Upper back section hinges...66 Activating the parking brake...66 Releasing the parking brake and moving the operating table... 67 Turn on/off floor lighting... 68 Decommissioning... 68

7 7.1 7.2 7.3

Cleaning and disinfection... 69 Introduction... 69 Cleaning and disinfection agents...69 Overview of cleaning and disinfection... 70

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Contents 7.4 7.5 7.6

Preparing the operating table... 70 Cleaning the operating table... 71 Disinfecting the operating table... 74

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Troubleshooting... 78

9

Maintenance...80

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Repair...80

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Disposal... 81

12 12.1 12.2 12.3

Technical data... 82 Device data... 82 SVHC (substance of very high concern)... 83 Electromagnetic compatibility... 84

13 13.1 13.2 13.3

Product certification... 87 European Union... 87 Ukraine... 87 Serbia... 87

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Usage specifications

1

Usage specifications

1.1

Normal use Normal use entails the following: – The positioning and task-specific transport of a patient before/ during/after surgery within a specifically designated operating theatre or surgical ward. The patient is positioned on the PST 500 operating table in accordance with general practice and teaching, as described e.g. in the technical literature. – Cleaning the operating table surfaces and pads with suitable means according to the directives of the medical facility. – Storage of the operating table and the associated tabletop sections in a room intended for that purpose. – Regular maintenance of the operating table in accordance with the prescribed maintenance intervals by qualified service technicians. – Initial operation by the operator. – Repair and disposal of the operating table must be performed by qualified technicians as required. Appropriate use includes chapters 1.2, 1.4, 1.5, 1.6 and 1.7.

1.2

Intended purpose The PST 500 medical device is a mobile, configurable operating table intended to be used with additional, specific tabletop sections, pads and accessories to position patients during surgery, from the administration of anaesthetic to the actual surgery and recovery from anaesthetic. The tabletop sections and accessories must be intended for the combination with the operating table. The operating tabletop offers the option of X-raying patients outside the operating table column from an anterior or posterior direction using a conventional X-ray device. The operating table is also used for task-related patient transfer within the operating theatre. The mobile operating table is only intended for use in human medical applications.

1.3

Contraindication Transport of unrelated objects, devices, or materials on the PST 500 operating table is prohibited. The PST 500 operating table is not suitable for positioning of patients other than for the intended purpose. It is not permitted to exceed the approved maximum load capacity. No sharp-edged objects may be placed onto the pads. No adhesive film may be applied to the pads. Damaged pads may no longer be used. Damaged mains power cables may no longer be used. The use of the operating table in combination with flammable mixtures of anaesthetic agents is prohibited.

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Usage specifications Changes to the medical device by the operator are prohibited. The patient’s arms and legs may not extend beyond the end of the operating tabletop in a longitudinal direction. Exempt from this are accessories that are intended for this purpose.

1.4

Patient definition All patients up to a weight of 454 kg can be positioned on the PST 500 operating table. Depending on the tabletop sections used, the approved load capacity may be reduced to 135 kg. The conditions for the different load scenarios for the operating table are set out in chapter 5.10.

1.5

User definition The PST 500 operating table may only be used and operated by qualified staff. Staff training will be carried out by the manufacturer or by other persons accredited by the manufacturer. The primary users are medically trained specialists. These include the following: – Anesthesiologists – Surgical nursing staff – Surgeons of various specialisations The cleaning staff is included among the primary users. They interact with the mobile operating table for cleaning purposes. No patients are present during cleaning. The cleaning staff has been trained to handle the mobile operating table.

1.6

Use environment Temperature: Humidity: Air pressure: Operating altitude:

+10 °C to +40 °C 20 % to 80 % 54 kPa to 106 kPa ≤ 5000 m

The operating table must not be used in areas where there is a risk of explosion.

1.7

Storage and transport conditions The operating table must be stored and transported under the following conditions:

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Temperature:

-20 °C to +60 °C

Humidity:

10 % to 95 %

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Usage specifications

Air pressure:

54 kPa to 106 kPa

Fragile packaged goods

Top

Protect against moisture

Limited stackability

1.8

Service life The service lifetime is 10 years, if used normally.

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Safety

2

Safety

2.1

Combination with other Baxter products The operating table should be used with other Baxter products. Approved products are listed in the compatibility matrix 1). Baxter offers a variety of tabletop sections and accessories for addition to the operating table. Not all products are available in all countries. Detailed information is available from Baxter sites, which can be found worldwide. Contact details are available online at hillrom.com.

2.2

Combination with products of other manufacturers The operating table is not intended for use with products of other manufacturers (third-party products) and where Baxter has not conducted any compatibility tests. However, Baxter does not exclude the possibility of use with third-party products. If the operator intends to combine the operating table with third-party products, the operator is responsible for this combination. Baxter does not take any responsibility for the combination of the operating table with third-party products. The guarantee/ warranty for Baxter products may become void if they are combined with third-party products.

2.3

Responsibility of the operator The operator is the natural or legal person who directly operates the product for commercial or economic purposes or allows a third party to use it. The operator has legal product responsibility regarding the protection of personnel or third parties. The medical devices may only be operated and used according to their intended purpose and the general rules of technology. The medical devices may only be operated or used by persons who have the training or knowledge required to do this. Training on the proper handling of the medical device is required. However, training is not required when the medical device is selfexplanatory or when instructions for a product with the same design have already been provided. Interconnected medical devices, as well as those combined with accessories, including software or other objects, may be operated and used only if they are suitable for use in this combination, taking into account their intended purpose and the safety of patients, users, employees or third parties. Before the medical device is applied, the user must ensure that the product is operational and in an appropriate state and the user must further have read the instructions for use as well as other, attached, safety-relevant information and maintenance instructions. The instructions for use and the instructions provided with the medical device must be stored in a way that ensures that the user can access the information required for using the medical device at any time. 1)

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Document number 7990090

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Safety The user and/or the patient must report any serious incidents related to the use of the medical device to the manufacturer and the relevant authorities of the member state of which the user and/or the patient is a resident.

2.4

Use of high-frequency (HF) surgical devices The operating table dissipates electrostatic charges according to the currently valid regulations and standards. The operating table is suitable for the use of high frequency surgical devices. The functions of the operating table that are driven by electric motor may be interrupted by the simultaneous use of high-frequency surgical devices. The use of high-frequency surgical devices exposes the patient to a risk of burns. The following safety measures must be strictly adhered to: – Please observe the instructions for use of the device manufacturer. – Only place the patient onto dry cloths or pads. The patient must not come into contact with damp materials. – The patient must be placed onto the operating table, so that they are insulated from metal parts (operating table, accessories) and conductive cushions or hoses.

2.5

Use of defibrillators The operating table dissipates electrostatic charges according to the currently valid regulations and standards. The operating table is suitable for the use of defibrillators and defibrillator monitors. The use of defibrillators exposes the patient and the user to a risk of burns. Personnel is at risk of electric shocks. The following safety measures must be strictly adhered to: – Please observe the instructions for use of the device manufacturer. – All accessories that are not specially protected against defibrillators must be removed from the patient’s body. – All personnel must step back from the operating table before the defibrillation procedure.

2.6

Malfunction due to other devices The medical or non-medical devices of other manufacturers might use the same frequency range as the operating table and the infrared remote control. If devices using the same frequency range or a multiple of the frequency range are operated in one room, they may interfere with one another. This may cause the operating table to malfunction. Examples of possible sources of interference: – Electronic control gear (ECG) for fluorescent lamps – HF surgical devices – Radio remote controls for other devices (e.g., monitors) – Very bright indoor lighting

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Safety Moreover, interference may result when using the operating table with the infrared remote control if the PST 500 operating table is located in the same room as a TruSystem 7000 or TruSystem 7500 operating table which has been switched on.

2.7

Behaviour in the event of a fault Depending on the nature of the current fault, the following functions will be available at the operating table: – Emergency operation – Reset – Emergency release of the parking brake Independently, the operating table should be separated from the power mains and the Technical Customer Service should be informed in case an electrical function of the operating table fails.

2.7.1

Operating table emergency mode The emergency mode of the operating table ensures the Trendelenburg function in the case of a functional failure. The emergency mode has to be manually activated by the user at the column keypad. Handling the operating table in emergency mode: – The Trendelenburg function can be executed with the column keypad. The back section and leg section functions can be performed with the remote control, if these functions have not failed. All other functions are not available in emergency mode. – The operating table cannot be operated with the infrared remote control and the foot control. – The functions move at a slower speed and a continuous warning tone will sound. – The end positions are not monitored, and collision monitoring is not active.

i20

16

Activate the emergency mode in the event of a function failure: 1. Press the [i20] key on the column keypad for at least 10 seconds. A warning tone sounds and is continuously repeated. Only release the key once the signal sound is off. The indicator next to the [i20] button lights up. 2. Complete the current operation. Attention: do not run the operating table functions up to the end position. 3. Inform the Technical Customer Service if the operating table has a defect. Use of the operating table in emergency mode may not be continued. The operating table can be reset to normal operation once it is fully functional and no defects are present. For this purpose, switch the operating table off and then switch it back on. The power-off button must be pressed and held down for at least 3 seconds.

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Safety 2.7.2

Reset If the operating table does not respond to the commands, you will need to turn the operating table off and then back on. If switching off is not possible either, press the Reset key: 1. Push down the red circle on the sign and thus activate the [24] button below it. The operating table is being switched off. Switching off occurs irrespective of whether the operating table is in battery or mains power mode. 2. Use the column keypad [i1] to switch the operating table back on. Continued use of the operating table is prohibited when an error code is shown on the display at the running gear or a fault message is show on the display of the remote control. 3. Inform the Technical Customer Service irrespective of whether the operating table is faulty or not. The service technician will check the operating table and replace the sign.

24 i1

The operating table may not normally be switched off with the reset key.

2.7.3

Emergency release of the parking brake If the parking brake of the operating table cannot be released with the remote control or the column keypad, use the emergency release at the running gear. The button is at the head end of the running gear and is covered by an adhesive sign. After emergency release, the Technical Customer Service must be informed.

25

2.7.4

Release the parking brake of the operating table with the emergency release: 1. Push down the red circle on the sign and thus activate the [25] button below it. The retractable feet in the wheels are withdrawn and the operating table can be freely moved again. It is possible that the operating table can only be moved to a limited extent. 2. Notify the Technical Customer Service.

Failure of the electrical functions on the operating table According to the current state of technology, failure of an operating table cannot be completely excluded, in which case the electrical functions of the operating table would no longer be available. In this rare case, do not continue to use the operating table and inform the Technical Customer Service.

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Safety

2.8

Signs

2.8.1

Safety instructions – Signs on the product inform about residual risks during use or provide useful additional information. – The device label and all signs must be undamaged and attached at the specified locations on the product. A damaged, illegible or missing device label/sign must always be replaced. – Pay attention to the signs on the product. – Signs may not be changed or removed.

2.8.2

Location and meaning

I I K A

C

J

K

N

B

F

H

D

L

34

35

O

M

G E

[34] [35] No.

Sign

Head end of the operating table Foot end of the operating table

Meaning

[A]

Operating table name

[B]

Current software version of the operating table

[C]

Movable mass (max. weight of the operating table and the patient)

[D]

Observe the instructions for use

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Safety

No.

Sign

Meaning

[E]

Permitted operating voltage range

[F]

Mains input fuse type

[G]

Connector for the potential equalisation cable

[H]

[A] A

[B]

B

Reset button Switch off the operating table. Emergency release button Release the parking brake of the operating table.

[I]

Connection socket for the cable remote control and the foot control

[J]

[A] [B] A

WARNING! Before transporting the patient, lower the operating table until the sign is completely obscured.

B

[K]

Positioning aid for the extension adapter (#1850992)

[L]

–

[M]

Not available

–

[N]

Not available

–

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PATENTS / PATENT www.hillrom.com/patents May be covered by one or more patents. See above Internet address. The Hillrom companies are the proprietors of European, US, and other patents and pending patent applications.

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Safety

No.

Sign

[O]

Operating table device label

Meaning Manufacturer Unique Device Identification (UDI) comprising: – Data Matrix Code – (01) Global Trade Item Number (GTIN) – (11) Date of manufacture (year/month/day) – (21) Serial number – (240) Material number Baxter material number Serial number Medical device Product is declared compliant with Regulation 2017/745/EU concerning medical devices. All-round splash protection The product must be disposed of in accordance with the requirements of Directive 2012/19/EU on WEEE II and relevant national regulations at a suitable waste disposal point for the recycling of electrical and electronic devices. Caution! Note the warning information in the Instructions for Use! Level of protection against electric shock: Applied part type B Date of manufacture (year/month/day)

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