WM-DP3 MOBILE WORKSTATION Instructions for Use Aug 2020

Contents 1 Using this document... 5 1.1 User instructions... 5 1.2 Conventions throughout this document... 5 1.3 Safety-related information in this document... 6 2 Safety information... 7 2.1 Intended purpose... 7 2.2 Contact... 8 2.3 General safety notes... 9 3 Product description... 11 3.1 Basic set... 11 3.2 Optional accessories... 12 3.3 Scope of delivery... 14 3.4 Labels and symbols... 15 3.5 Power cable... 20 3.6 Warranty... 20 4 Before use... 21 4.1 Handling pre-installed features... 21 4.2 Removing and attaching the rear panels... 29 4.3 Installing medical electrical equipment ... 31 5 Maneuvering... 37 5.1 Specific safety notes for maneuvering... 37 5.2 Preparing for maneuvering... 38 5.3 Maneuvering the WM‑DP3 Mobile Workstation... 38 6 Use... 40 6.1 Specific safety notes for use... 40 6.2 Using the WM‑DP3 Mobile Workstation... 41 7 Reprocessing... 43 7.1 Safety notes for reprocessing... 43 7.2 Using reprocessing agents... 43 7.3 Cleaning and disinfection... 45

8 Maintenance... 48 9 Storage and disposal... 50 9.1 Storage... 50 9.2 Disposal... 50 10 Technical data... 51 10.1 Power cable... 51 10.2 Socket adaptor cable... 52 10.3 Protective earth terminal... 52 10.4 Winding... 53 10.5 Primary winding... 53 10.6 Secondary winding... 53 10.7 Potential equalization terminals... 54 10.8 Block diagram... 55 10.9 Safety standards for medical electric systems... 56 10.10 EMC Information... 58 10.11 Specifications... 61 11 Customer spare parts... 65 11.1 Rear panels... 77 12 Troubleshooting... 79 13 End of life... 80 14 Glossary... 81 15 Index... 83

Using this document

1 Using this document This chapter provides general information on how to use these instructions for use.

1.1 User instructions Before use, thoroughly read these instructions for use and the instructions for use of all other items that will be used during the procedure. If the required instructions for use are missing, immediately contact an Olympus representative. Keep the instructions for use in a safe, accessible location.

1.2 Conventions throughout this document This is the safety alert symbol. It is used to alert the user to potential physical injury hazards. Observe all safety messages that follow this symbol to avoid possible injury. This symbol indicates additional helpful information. 1. 2. 3.

A numeration indicates a sequence of actions.

•

Bullet points indicate individual actions.

►

Arrows indicate the results of actions.

-

Dashes indicate the listing of data, options or objects.

1) 2) 3)

Numbers with right parenthesis name elements in illustrations

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Using this document

1.3 Safety-related information in this document General safety notes General safety notes address risks that apply to the general use and handling of the product. Specific safety notes Specific safety notes address safety issues that are specific to the information and actions described in a chapter or section. Specific safety notes are located at the beginning of the corresponding chapter or section. Safety messages Safety messages focus on unexpected incidents that can occur during the intended purpose. Safety messages are placed in the context of such risks and actions. Safety messages are highlighted by the following signal words and symbols. WARNING Indicates a potentially hazardous situation which, if not avoided, can result in death or serious injury. CAUTION Indicates a potentially hazardous situation which, if not avoided, can result in minor or moderate injury. NOTICE Indicates a property damage message.

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Safety information

2 Safety information This chapter provides general safety information for using the product. The safety information includes the following. – Intended purpose – Manufacturer information and contact details – General safety notes

2.1 Intended purpose 2.1.1 Intended use and indications The WM‑DP3 Mobile Workstation Double Platform 3 is intended to assist endoscopic procedures using Olympus medical devices and their accessories within medical facilities by providing a stable mains power supply and a platform for the efficient use and handling of the devices during endoscopic diagnostic and therapeutic procedures. The WM-DP3 workstation can also allow visualisation during the procedure when connected to a monitor. Do not use the device for any other purpose. 2.1.2 Contraindications There are no known contraindications. 2.1.3 Patient target group Not dedicated to any patient population. 2.1.4 Intended user Medical use Only for use by a qualified physician or healthcare professional in a professional healthcare facility.

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Safety information Reprocessing Reprocessing of reusable products may only be performed by qualified hygiene personnel. Repair Repair of the product may only be performed by trained qualified servicing personnel that has been authorized by Olympus. Otherwise, Olympus cannot be held responsible for the safety and performance of the product. 2.1.5 Clinical benefit The clinical benefit of the device lies in its functionality as described by its intended purpose.

2.2 Contact 2.2.1 Manufacturer KeyMed (Medical and Industrial Equipment) LTD KeyMed House, Stock Road, Southend-on-Sea, Essex SS2 5QH United Kingdom www.olympus.com 2.2.2 Incident reporting European Union If a serious incident occurs with the device, report it to the manufacturer and the relevant national authority. Eurasian Economic Union If an undesirable event occurs with the device, report it to the manufacturer or the authorized representative.

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Safety information Other regions If a serious incident occurs with the device, report it to the manufacturer and/or the relevant national authority according to national legislation.

2.3 General safety notes The following safety information addresses points that apply to the general handling and use of the product. This information is to be supplemented by the information given in each chapter of this document. CAUTION Risk of Injury Exceeding the maximum load capacity can cause structural failure and instability, resulting in injury. Refer to the maximum load capacity as specified in “10.11 Specifications” on page 61. CAUTION Risk of Injury Do not fit the MAJ-2149 Dual Monitor Arm to the WM-DP3 Mobile Workstation as this will exceed the maximum load capacity and cause instability, resulting in injury. Refer to section “3.2 Optional accessories” on page 12.

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Safety information NOTICE Risk of equipment damage Incorrect work practices when handling this product can result in equipment damage. Observe the following. – Only use the product in the environment specified in “Specifications” on page 61. – Only use products specified in “Basic set” on page 11 and “Optional accessories” on page 12 with this product. – Do not exceed the maximum load capacity as specified in section “10.11 Specifications” on page 61. Reprocessing of reusable products Reusable products must be reprocessed according to the applicable national and local standards and regulations.

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Product description

3 Product description This chapter provides information about the product and associated accessories.

3.1 Basic set Contact Olympus if any parts are damaged or missing. The WM‑DP3 Mobile Workstation is available in 1 basic set. Refer to the following table to check that all items in the set ordered are present. Product

Basic Set (UK, Europe, USA, Rest of the World)

WM‑DP3 Mobile Workstation

1

Workstation fitting kit, containing - 12 x cable ties - 1 x 4 mm hex key - 1 x 6 mm hex key

1

Separation transformer (market specific)

1

MAJ-2160 Irrigation Tube Holder

1

MAJ-2211 Side Handles

1

IEC lead set

1

Socket adaptor cable (USA only)

1

Instructions for use

1

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Product description

3.2 Optional accessories The following products can be used as optional accessories. NOTICE Risk of equipment damage The fitment of some accessories may not be possible when other accessories are fitted and can result in equipment damage. The MAJ-2149 Dual Monitor Arm is not compatible with the WM-DP3 Mobile Workstation. For any questions, please contact the Endoscope Service Center, a service center designated by Olympus or an Olympus branch or sales office.

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Code

Description

K10036766

Socket adaptor cable (USA)

MAJ-1635

EUS connector holder

MAJ-1639

Single CO2 holder (up to Ø140 mm)

MAJ-1642

IV Pole

MAJ-1650

Single CO2 holder (Ø140 mm to Ø205 mm)

MAJ-1653

Double CO2 holder

MAJ-1654

Equipotential terminal strip

MAJ-1657

Keyboard arm - side installed

MAJ-1663

EUS Arm mount kit

MAJ-1665

Camera head holder

MAJ-1685

IV Bag Hanger

MAJ-1938

Holder for HC-RP / UPD-3

MAJ-1985

Cylinder Hose with Switch Over Valve (PIN) / UHI-4

MAJ-1986

Cylinder Hose with Switch Over Valve (DIN) / UHI-4

MAJ-2145

ENT Scope Hanger

MAJ-2146

Sliding Keyboard Tray

MAJ-2154

Consumable Stowage Holder

MAJ-2158

Suction Jar Holder

MAJ-2159

Scope Pole Kit

MAJ-2160

Irrigation Tube Holder

MAJ-2165

Drawer Unit

Product description Code

Description

MAJ-2166

Sterile Water Holder

MAJ-2167

Nurses Control Arm

MAJ-2173

Side Shelf

MAJ-2216

LCD Monitor Arm 6.5-12 kg

MAJ-2217

LCD Monitor Arm 12-14 kg

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Product description

3.3 Scope of delivery The following section describes the scope of delivery of the basic set.

1) 2) 3) 4) 5)

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MAJ-2211 Side Handles (fitted) MAJ-2160 Irrigation Tube Holder (fitted) Socket adaptor cable (USA only) WM-DP3 Mobile Workstation instructions for use IEC lead set, containing: – 3 x cable universal IEC 320 0.8 m

Product description – 5 x cable universal IEC 320 1.5 m – 1 x cable universal IEC 320 M-FEM 2.5 m (in separate bag) 6) Separation Transformer (fitted) 7) Fitting kit for WM-DP3 Mobile Workstation, containing: – 1 x 4 mm hex key – 1 x 6 mm hex key – 12 x cable ties 8) Water bottle bracket (fitted)

3.4 Labels and symbols This section provides information on the labels and symbol on the product and on the packaging of the product. 3.4.1 Unique Device Identification Unique Device Identification is a label required by some countries’ regulations regarding identification of medical device. The following information is coded in the 2-dimensional barcode (GS1 Data Matrix). – (01) 14-digit GS1 Global Trade Item number. – (11) 6-digit date of manufacture. – (21) 8-digit serial number.

(01) 00000000000000 (11) 000000 (21) 00000000

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Product description

The UDI can be found on the base shelf at the front of the WM‑DP3 Mobile Workstation. 3.4.2 Symbols on the workstation Symbol

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Description

Source

Refer to instructions for use

ISO 7010-M002

Mains power ON / OFF switch

IEC 60417-5010

Product description MDR EU regulatory requirement (Class I)

Manufacturer

Max laden weight

Manufacturer

Unit complies with China RoHS 2 requirements

China RoHS 2 – Management methods for the Restriction of the Use of Hazardous Substances in Electrical and Electronic Products, January 2016

CE marking indicating that the device is in conformity with the applicable requirements set out in applicable European Union harmonization legislation.

MDR (EU) 2017/745

Medical Device

423 kg 933 lbs

3.4.3 Packaging symbols Symbol

Description

Source

Consult instructions for use

ISO 15223-1

Catalogue number

ISO 15223-1

Keep dry

ISO 15223-1

Manufacturer

ISO 15223-1

Keep away from sunlight

ISO 15223-1

Stacking limit by number

ISO 7000

Fragile, handle with care

ISO 15223-1

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Product description This way up

ISO 7000

Lot number

ISO 15223-1

Temperature limitations

ISO 15223-1

Serial number

ISO 15223-1

Humidity limitation

ISO 15223-1

Atmospheric pressure limitation

ISO 15223-1

MDR EU regulatory requirement (Class I)

Manufacturer

Unit complies with China RoHS 2 requirements

China RoHS 2 – Management methods for the Restriction of the Use of Hazardous Substances in Electrical and Electronic Products, January 2016

Medical Device

3.4.4 Symbols on separation transformer Symbol

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Description

Source

Refer to instructions for use

ISO 7010-M002

Warning to observe rules regarding the use of multiple socket outlets

EN ISO 7010-W001

Equipotentiality terminal

IEC 60417-5021

Input

IEC 60417-5034

Output

IEC 60417-5035

Product description Symbol

Description

Source

Alternating current

IEC 60417-5032

Weight

EN ISO 7000-430

Remote switch

Manufacturer

Non-inherently short circuit proof separation transformer

IEC 60417-5220

According to European Directive 2012/19/EU on Waste Electrical and Electronic Equipment, this symbol indicates that the product must not be disposed off as unsorted municipal waste, but should be collected separately.

EN 50419

Indicates the unit has been independently assessed for compliance with UL and CSA standards as a Recognized Component of The WM‑DP3 Mobile Workstation (MAJ-2156 only).

EN 60601

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Product description

3.5 Power cable The WM‑DP3 Mobile Workstation includes a power cable appropriate to the model of separation transformer fitted and the intended market area, as listed in “Technical data” on page 51. – MAJ-2156 (USA): The power cable on this unit is fitted with a ‘hospital grade’ plug. Grounding reliability is achieved when this equipment is connected to an equivalent receptacle marked ‘hospital grade’. – MAJ-2157 (Rest of the World): The power cable on this unit is terminated in flying leads, for a suitable plug to be fitted according to the area of intended use. Only suitably qualified personnel should fit the power plug to this cable. The cores of the power cable are colored according to the following code. – Brown: live (‘hot’) – Blue: neutral (‘cold’) – Green/yellow: earth (‘ground’) WARNING Risk of electric shock Connecting the power cable to a mains electricity without protective earth can result in electric shock. Always connect the power cable to a mains electricity with protective earth.

3.6 Warranty Any warranty claims towards Olympus are forfeited if the user or unauthorized persons attempt repair or modification of the product. No warranty is provided for any damage due to misuse of the product.

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Before use

4 Before use This chapter provides information for installation and connection of the WM‑DP3 Mobile Workstation and its accessories.

4.1 Handling pre-installed features 4.1.1 Braked castors The WM‑DP3 Mobile Workstation has braked castors. To maintain the antistatic effectiveness of the braked castors, observe the following. – Avoid contact of the braked castors with oil. – Avoid a build up of floor cleaning wax and polish. Using the castors

● Lock and release the braked castors as shown. ● Ensure all braked castors are released before moving the WM‑DP3 Mobile Workstation. ● Always lock braked castors when the WM‑DP3 Mobile Workstation is not being maneuvered.

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