WM-NP2 MOBILE WORKSTATION Instructions Issue 22 Jan 2020

Content Important Information - Please Read Before Use...

4

Intended purpose...

4

Contact

...

5

Instruction manual...

5

Signal words...

6

Chapter 1

Standard Sets...

7

1.1

Standard sets of components...

8

1.2

Optional accessories...

9

Chapter 2

Warnings and Cautions...

10

Chapter 3

Symbols...

14

Chapter 4

Preparation for Use...

18

4.1

Castors...

18

4.2

Shelf size...

18

4.3

Fixing positions of intermediate shelves...

20

4.4

Fixing position of the drawer unit...

23

4.5

Clip-in accessories...

28

4.6

Scope hanger assembly...

30

4.7

Keyboard assembly...

37

4.8

Removing and attaching the rear door...

38

4.9

Equipment installation...

38

4.10 Power connector...

42

4.11 General information...

42

4.12 Socket Adaptor Cable (Japan or USA)...

44

Chapter 5

Operation...

45

5.1

Operation...

45

5.2

Manoeuvring...

46

Chapter 6

Care, Inspection, Storage and Maintenance...

48

6.1

Care...

48

6.2

Inspection...

49

6.3

Storage...

50

6.4

Maintenance...

50

Chapter 7

Specifications...

52

7.1

WM-NP2 mobile workstation...

52

7.2

Separation transformer...

52

Chapter 8

Spare parts...

54

MOBILE WORKSTATION WM-NP2

1

2

Chapter 9

Technical Description...

55

9.1

EMC (electromagnetic compatibility)...

57

9.2

Essential performance with regards to EMC...

57

9.3

EMC environment...

57

9.4

Electromagnetic emissions...

58

9.5

Electromagnetic immunity...

58

9.6

Accessories, transducers and cables...

59

Chapter 10

Troubleshooting...

60

Chapter 11

End of Life...

61

MOBILE WORKSTATION WM-NP2

Important Information - Please Read Before Use

Important Information - Please Read Before Use Intended purpose Intended use and indications The WM-NP2 workstation 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 use and handling of the devices during endoscopic diagnostic and therapeutic procedures. If equipped with a monitor, the WM-NP2 workstation allows visualisation during the procedure. Do not use the device for any other purpose.

Contraindications There are no known contraindications.

Patient target group Not dedicated to any patient population.

Intended user  Medical use Only for use by a qualified healthcare professional in an adequate medical environment. These instructions for use do not explain or discuss clinical procedures.

 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.

4

MOBILE WORKSTATION WM-NP2

Important Information - Please Read Before Use

Clinical benefits The clinical benefit of the device lies in its functionality as described by its intended purpose.

Contact Manufacturer KeyMed (Medical and Industrial Equipment) LTD KeyMed House, Stock Road, Southend-on-Sea, Essex SS2 5QH United Kingdom www.olympus.com [email protected]

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 a serious incident occurs with the device, report it to the manufacturer and the relevant national authority.

 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.

Instruction manual Please read this manual carefully before attempting to use the Olympus WM-NP2 mobile workstation as it contains important information on the proper care, handling and use of the equipment. In addition, read the manuals of any other units (light source, endoscope, etc.) that form part of the system. If you have any questions or comments regarding the information in this manual, please contact Olympus. These instructions should be retained for reference during the life of the product.

MOBILE WORKSTATION WM-NP2

5

Important Information - Please Read Before Use

Signal words The following signal words are used throughout this manual: WARNING

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage. NOTE Indicates additional helpful information.

6

MOBILE WORKSTATION WM-NP2

Standard Sets

Chapter 1 Standard Sets The Olympus WM-NP2 mobile workstation has been designed to accommodate the Olympus video system center and associated ancillary devices as a practical mobile workstation to facilitate GI endoscopy, endoscopic ultrasound, respiratory and surgical endoscopic procedures. Please ensure familiarity with all important information prior to workstation operation. Refer to the following table to check that all items in the set ordered are present, and contact Olympus if any parts are damaged or missing.

MOBILE WORKSTATION WM-NP2

7

Standard Sets

1.1 Standard sets of components

too t toolti

B

(supplied boxed)

(supplied boxed)

tD t p too tooltip A

(supplied fitted)

C

(supplied fitted)

E F

(supplied boxed)

A B C D E F G H I J K

8

(supplied fitted)

WM-NP2 (incl. Transformer) MAJ-1641 LCD Monitor Arm MAJ-1640 Keyboard Tray MAJ-1638 Scope Pole MAJ-1653 CO2 Cylinder Holder Double MAJ-1643 Drawer Unit Blister pack Toolkit Blister pack Drawer key IEC lead set Socket Adaptor Cable USA Socket Adaptor Cable JP

1 Japan USA Europe UK ROW 1 1 1 1

2

USA

1 1 1 1 1

Standard set 3 4 Japan USA Japan Europe USA UK ROW 1 1 1 1

5 Japan USA Europe UK ROW 1 1 1

Europe UK 1 1 1

1

1

1

1

1

1

1 1 1

1 1

1 1 1

1 1 1

1 1 1

MOBILE WORKSTATION WM-NP2

6

1 1 1 1

Standard Sets

1.2 Optional accessories The following products may be used as optional accessories. Code

Description

K10036760

Socket Adaptor Cable JP

K10036766

Socket Adaptor Cable USA

MAJ-1635

EUS connector holder

MAJ-1638

Scope pole kit

MAJ-1639

Single CO2 holder (up to Ø140mm)

MAJ-1640

Keyboard tray

MAJ-1641

LCD monitor arm (up to 26”, 7 to 14kg)

MAJ-1642

IV Pole

MAJ-1643

Drawer unit

MAJ-1650

Single CO2 holder (Ø140mm to Ø205) - UK, Europe and Rest of World only

MAJ-1653

Double CO2 holder

MAJ-1654

Equipotential terminal strip

MAJ-1655

OEV261H Monitor PSU holder

MAJ-1656

Footswitch holder

MAJ-1657

Keyboard arm - side mounted

MAJ-1658

Universal stowage container

MAJ-1659

Equipment support rail

MAJ-1660

Cable retaining hook

MAJ-1662

Nurses control panel arm - short

MAJ-1663

EUS Arm mount kit

MAJ-1664

Nurses control panel arm - long

MAJ-1665

Camera head holder

MAJ-1666

Side shelf

MAJ-1679

LCD monitor arm (up to 32”, 13 to 15.5kg)

MAJ-1680

Monitor PSU holder (LMD-2451MT, LMD-3251MT or LMD-3251ST)

MOBILE WORKSTATION WM-NP2

9

Warnings and Cautions

Chapter 2 Warnings and Cautions Follow the warnings and cautions given below when handling this workstation. This information is to be supplemented by the warnings and cautions given in each chapter. The WM-NP2 is EMC-tested (Electromagnetic Compatibility) in conformity with IEC 60601-1-2 Edition 4 - EMC requirement. The WM-NP2 is tested for basic safety in conformity with IEC 606011 Edition 3.1. WARNING

• The WM-NP2 mobile workstation should only be used in a medical facility under the direction of a trained physician. • To prevent patient shock, the combination of equipment used on the WM-NP2 mobile workstation should never be applied directly to the heart. • After wiping with a piece of moistened gauze, dry the workstation and mounted devices thoroughly before using it again. If it is used while still wet, there is the risk of an electric shock. • Use personal protective equipment to guard against dangerous chemicals and potentially infectious material, otherwise, blood, mucus and other potentially infectious material from the patient could pose an infection risk. During cleaning, wear appropriate protective equipment, such as eye wear, face mask, moisture-resistant clothing and chemicalresistant gloves that fit properly and are long enough so that your skin is not exposed. • To prevent user or patient cross-contamination, do not hang contaminated endoscopes on the scope hanger. • (USA only): The power cord on this unit is fitted with a ‘hospital grade’ plug. Grounding reliability can only be achieved when this equipment is connected to an equivalent receptacle marked ‘hospital grade’. • (RoW only): 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. The cores of the cable are coloured in accordance with the following code: BROWN LIVE (‘HOT’) BLUE NEUTRAL GREEN/YELLOW EARTH (GROUND) Only suitably qualified personnel should fit the power plug to this cable. • To avoid risk of electric shock, this equipment must only be connected to a supply mains with a protective earth. • Do not modify this equipment without authorisation of the manufacturer. • The Olympus WM-NP2 is a medical device that requires safety measures in regards to EMC. The device must be installed and put into operation in accordance with the EMC information listed in Chapter 9 of this document. • Always use the supplied power cord. Use of any other power cord may cause a malfunction of the instrument or burns on the power cord. Additionally, the supplied power cord is for exclusive use with this instrument and must not be used with other devices.

10

MOBILE WORKSTATION WM-NP2

Warnings and Cautions

WARNING

• The WM-NP2 should be used in accordance with the following. Otherwise, the workstation will be ‘top heavy’ and may lose stability and topple, causing equipment damage and/or personal injury. - Do not attach more than one LCD monitor arm to each side of the workstation. - LCD monitor arms and monitors should not be installed and used on an empty workstation. - LCD monitor arms and monitors should be installed after all other equipment is installed on an appropriate place on the workstation. - Do not install monitor control arms on the same side as CO2 holders or other side-mounted accessories. - Refer to the following table and diagram for loading restrictions when using both the MAJ-1664 Nurses Control Panel Arm and the MAJ-1641 LCD Monitor Arm.

Maximum load for combined use of MAJ-1641(1) and MAJ-1664 (2) MAJ-1641(1)

MAJ-1664 (2)

” 14 kg

” 5 kg

” 11 kg

” 7 kg

” 9.8 kg

” 9 kg

MOBILE WORKSTATION WM-NP2

11

Warnings and Cautions

CAUTION

• Do not exceed the load capacity detailed in Chapter 7. • Do not lean or stand on any part of the mobile workstation or accessory as failure of the product may result. • When assembling equipment onto the mobile workstation, the installation should meet the requirements of the safety standard for medical electrical systems, as described in section 4.11. • Before commissioning an installation including a separation transformer, ensure its rating will not be exceeded by the equipment connected to it. • When configuring a system, the user should ensure that there is sufficient spare equipment available that in the event of a fault in any part of the system, the endoscopy procedure may be completed or terminated without endangering the patient. • When installing the mobile workstation in the procedure or operating room, ensure that the mains cable has sufficient slack that it cannot be pulled taut as the mobile workstation is moved around the working area. If necessary, relocate the mains connector to a nearer supply socket. • Spray type medical agents, such as lubricants, anaesthetic or alcohol, should be used away from the mobile workstation. • Keep open containers of liquid away from electrical equipment used on the mobile workstation to prevent operator electrical shock and equipment damage. Do not use the system if liquid has entered the equipment. • To minimise risk of injury, it is recommended that heavy items are placed on the mobile workstation by two people working together. Ensure electrical items used on the mobile workstation are positioned centrally on the shelves. • Never place any items on top of a monitor (if fitted) as these may topple when the mobile workstation is moved. • The electrical resistance of the conductive antistatic castors should be tested at regular intervals in accordance with ISO 2878 to assess antistatic effectiveness. • Avoid contact of the castor wheels with oil and avoid a build up of floor cleaning wax and polish as these will impair the antistatic effectiveness of the castors. • Store and use the WM-NP2 mobile workstation within the environmental conditions described in Chapter 7; failure to do so may lead to equipment malfunction or failure. • Before attempting to move the workstation outside the procedure room, ensure that the endoscope and fluid containers are removed. • There are no operator-serviceable components on the WM-NP2 mobile workstation. Refer servicing to qualified service personnel. • Before commencing shelf adjustment, ensure equipment is disconnected and removed from the shelf. • To minimise the risk of injury and/or damage, do not fit accessories other than those described in Section 1.1 to the WM-NP2 mobile workstation.

12

MOBILE WORKSTATION WM-NP2

Warnings and Cautions

CAUTION

• The maximum storage load of each drawer is 5kg, otherwise stability may be compromised. • Ensure each drawer is locked when moving the workstation. • Take care not to trap fingers when opening/closing or repositioning the drawer unit. • When installing a keyboard on the keyboard tray, ensure the cable passes around the outside of the sliding runner, otherwise the cable may be pinched when operating the sliding tray. • Prior to moving the workstation, ensure that the keyboard tray is fully located in the storage position. • Check all equipment connectors on a regular basis to ensure there are no loose connections.

MOBILE WORKSTATION WM-NP2

13

Symbols

Chapter 3 Symbols The following symbols are used on the WM-NP2. UDI label UNIQUE DEVICE IDENTIFICATION A label required by some countries’ regulations regarding identification of medical device also known as Unique Device Identification. The following information is being 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

Symbol

Description

Source

Refer to instructions for use

ISO 7010-M002

Consult instructions for use

ISO 15223-1

General warning sign

ISO 7010-W001

This is a medical device according to MDR (EU) 2017/745

Manufacturer

Serial number

ISO 15223-1

Batch code

ISO 15223-1

Catalog number

ISO 15223-1

Federal (USA) law restricts this device to sale by or on the order of a physician

FDA

Medical Device

14

MOBILE WORKSTATION WM-NP2

Symbols

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

Manufacturer

ISO 15223-1

Date of manufacture

ISO 15223-1

Fragile, handle with care

ISO 15223-1

Keep dry

ISO 15223-1

Keep away from sunlight and heat

ISO 15223-1

Temperature limits

ISO 15223-1

Humidity limits

ISO 15223-1

Atmospheric pressure limits

ISO 15223-1

Stacking limit by number

ISO 7000

This way up

ISO 780

In accordance with European Directive on Waste Electrical and Electronic Equipment (WEEE), this symbol indicates that the product must not be disposed of as unsorted municipal waste, but should be collected separately

European Directive

MOBILE WORKSTATION WM-NP2

2002/96/EC

15

Symbols

16

Weight

ISO 7000

Equipotentiality terminal

IEC 60878

Alternating current

IEC 60417

Remote switch

IEC 60617

Mains power ON/OFF switch

IEC 60417-5010

Input

IEC 60417-5034

Output

IEC 60417-5035

Short-circuit-proof transformer

IEC 60417

Indicates the unit has been independently assessed for compliance with UL and CSA standards

EN 60601

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

Compliance to the Korean Electrical Appliance Safety Control Act (Act 6019)

Korean Electrical Appliance Safety Control Act (Act 6019)

MOBILE WORKSTATION WM-NP2

Symbols

Compliance to the METI-PSE (Electrical Appliances and Materials Safety Act) regulations – only applicable for Japan

METI-PSE regulations (Electrical Appliances and Materials Safety Act) Japan

Do not push

ISO 7010-P017

Stability warning

Manufacturer

Maximum laden weight

Manufacturer

Maximum load

Manufacturer

eIfU - IfU available online

ISO 15223-1

Translation

ISO 7000

280 kg 617 lbs

10kg

olympus-europa.com

MOBILE WORKSTATION WM-NP2

17

Preparation for Use

Chapter 4 Preparation for Use 4.1 Castors 1.

The workstation has 4 braked castors. Ensure all brakes are applied prior to use and released before moving the workstation. NOTE Brakes should always be applied when the workstation is not being maneuvered.

Figure 4.1 2.

To lock and unlock the castor brake, refer to Figure 4.2.

Figure 4.2

4.2 Shelf size Refer to Figure 4.3 for the size of equipment that can be mounted on the product's shelves.

18

MOBILE WORKSTATION WM-NP2

Preparation for Use

Top shelf

Dimensions in mm

470 325 409

439

Middle shelf

512

473

Base shelf

470

479

617

480

Figure 4.3

MOBILE WORKSTATION WM-NP2

19

Preparation for Use

4.3 Fixing positions of intermediate shelves The product columns contain holes for the intermediate shelves. You can reposition the shelves to suit the size of the equipment being mounted.



On delivery The product is delivered with the shelves fitted in the positions shown in Figure 4.4.

275mm

35mm

215mm

35mm

Shelf fixing holes 25mm apart

292mm

Drawer unit not shown

Figure 4.4 20

MOBILE WORKSTATION WM-NP2