Rocket CRAFT and DUO-VAC Operators Guide Rev 36 Nov 2021

Operators Guide

52 Pages

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File Size: 1.47 MB

File Name: zdock105_craft_pump_user_manual_rev_36_4-11.pdf

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Page 1

OPERATORS GUIDE CRAFT™ and DUO-VAC™ Suction Pumps

CRAFT™ Suction Pumps – Operators Guide

1. CONTENTS 1. CONTENTS ... 2 2. GENERAL ASSEMBLY ... 3 2.1. CRAFT™ DUO-VAC™ Suction Pump ... 3 2.2. CRAFT™ Suction Pump ... 4 3. GENERAL INSTRUCTIONS ... 5 3.1. COPYRIGHT ... 5 3.2. MODEL NUMBERS... 5 3.3. MANUAL REVISION: ... 5 3.4. MANUFACTURER: ... 6 3.5. SERVICE AGENTS ... 6 4. SAFETY INSTRUCTIONS ... 7 4.1. PATIENT PROFILE ... 7 4.2. MANUAL USAGE ... 7 4.3. USER TRAINING ... 8 4.4. SUPPLY VOLTAGE SELECTION... 8 4.5. ELECTROMAGNETIC COMPATIBILITY ... 8 4.6. PACKAGING ... 8 4.7. POSITIONING and PLACEMENT of the DEVICE ... 8 4.8. WARNINGS... 9 4.9. SYMBOLS USED ON CRAFT™ SUCTION & CRAFT DUO-VAC™ PUMPS ... 10 4.10. SYMBOLS USED ON R57685 WATER TRAP SET FOR CRAFT™ PUMPS ... 11 5. GENERAL INFORMATION:... 12 5.1. GENERAL DESCRIPTION: ... 12 5.2. INDICATIONS ... 12 5.3. CONTRAINDICATIONS ... 12 5.4. REFERENCES ... 12 6. OPERATING THE PUMP ... 13 6.1. TABLE 1 RECOMMENDED VACUUM SETTINGS ... 15 6.2. PROCEDURE ... 17 7. CONSUMABLES ... 18 8. CLEANING THE PUMP CASING ... 19 9. YEAR OF MANUFACTURE:... 19 10. RETURNING THE PUMP FOR SERVICE... 19 11. STORAGE & TRANSPORTATION ... 20 12. OPERATING ENVIRONMENT ... 21 13. WARRANTY... 22 14. DISPOSAL: ... 22 15. TECHNICAL SPECIFICATIONS... 23 15.1. CLASSIFICATION ... 23 15.2. SPECIFICATIONS ... 23 15.3. EMC Tables... 24

Rocket Medical plc.

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Rev: 36

2021-11-04

CRAFT™ Suction Pumps – Operators Guide

2. GENERAL ASSEMBLY 2.1.

CRAFT™ DUO-VAC™ Suction Pump

1. Illuminated O/I Mains Power On/Off 2. Vacuum Control Dial – clockwise to increase, anticlockwise to decrease the set value 3. Vacuum Display mmHg-1 4. Footswitch connection ports 5. Water trap connection port for use with R57685 CRAFT™ Pump Water Trap Sets 6. R57685 Water Trap Set for CRAFT™ Suction Pumps 7. Footswitch: Medium Vacuum 0-200mmHg-1 & High Vacuum 440mmHg-1

Rocket Medical plc.

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2021-11-04

CRAFT™ Suction Pumps – Operators Guide

2.2.

CRAFT™ Suction Pump

1. Illuminated O/I Mains Power On/Off 2. Vacuum Display mmHg-1 3. High Vacuum (440mmHg-1) control button 4. Vacuum Control – clockwise to increase, anticlockwise to decrease the set value 5. Patient Connection Port, for use with R57685 Water Trap Set for CRAFT™ Suction Pumps 6. R57685 Disposable Rocket CRAFT™ Pump Water Trap Sets 7. Medium Vacuum 0-200mmHg-1 footswitch connection port 8. Single footswitch

Rocket Medical plc.

ZDOCK105

Rev: 36

2021-11-04

CRAFT™ Suction Pumps – Operators Guide

3. GENERAL INSTRUCTIONS WARNING: READ THIS MANUAL CAREFULLY: Please familiarise yourself with the contents of this manual before attempting to use the device. Failure to observe these instructions may result in damage to the pump or cause injury to the patient or user. This device should only be used by suitably qualified personnel.

3.1.

3.2. MODEL NUMBERS: CRAFT™ Suction Pump (110v) CRAFT™ Suction Pump (240v)

R29654 R29655

CRAFT™ DUO-VAC™ Suction Pump (240v) CRAFT™ DUO-VAC™ Suction Pump (110v)

R29660 R29661

3.3. MANUAL REVISION:

WARNING: ELECTRIC SHOCK HAZARD. The equipment is to be used only with electrical systems complying with all IEC, CEC and NEC requirements.

CAUTION: Any adjustment, modification or repairs to the equipment should be carried out by authorised service agents.

Disposal of this device must be undertaken with regard to the WEEE directive (2002/96/EC).

This manual contains information that is subject to copyright. All rights reserved. This manual should not be photocopied, duplicated or distributed completely or in part without the approval of Rocket Medical plc.

Revision 8

New specification based on Rev 7

25/05/10

Revision 9

Updated CSD address graphics

07/06/10

Revision 10

Symbol tables & storage/transport

28/10/11

Revision 11

CE Mark, manufacturer data

21/11/11

Revision 12

Update to consumables info, voltage

01/12/11

Revision 13

Terminology change Low-Medium

05/12/11

Revision 14

Amend voltage statement in Section 4

07/12/11

Revision 15

CE mark amendment

07/12/11

Revision 16 Revision 17 Revision 18 Revision 19

Symbol correction Correction to annotated images Update images with new footswitch Update to latex statement and symbol

30/05/12 29/06/12 30/09/13 06/11/13

Revision 20

Image to clarify footswitch controls

14/11/13

Revision 21

Amend EMC revision

15/04/14

Revision 22

Update to: YOM, consumption, footer

16/07/14

Revision 23

Update to LRQA CE mark

27/08/14

Revision 24

Gauge images, water trap cleaning ins.

17/12/14

Revision 25 Revision 26

Addition of Portuguese language version Added EMC Tables, Procedure IFU, Labelling and additional warnings

01/08/16 09/05/17

Revision 27

Standards references

23/05/17

Revision 28 Revision 29

Update to Warnings, duty cycle Update to images, patient profile, training Amend rating specificationsAmend Warranty period & US address & EU Rep

10/11/17 19/12/17

Revision 30

Amend rating specifications

05/01/18

Revision 31

Amend Warranty period & US address & EU Rep

25/02/19

Revision 32

Update to Service Agents & CE marks

19/08/20

Revsion 33

Inclusion of Italian translations. Update to Warnings, Update to Product Names and section 6.2.

Revision 34

Addition of hyphen in DUO-VAC™

Revision 35

Modification of Patient Population and CE symbol. Update to vacuum ranges. Addition of phthalate symbol to Symbol Table for R57685 Water Trap Set

12/10/21

Revision 36

Accuracy Settings

04/11/21

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3.4. MANUFACTURER: Rocket Medical plc Sedling Road WASHINGTON Tyne & Wear NE38 9BZ UK. Rocket Medical GmbH, Am Rosengarten 48, 15566 Schöneiche. Germany

3.5. SERVICE AGENTS: CRAFT™ Pumps typically require little routine maintenance; however, they must be serviced and calibrated annually at a Rocket Medical plc approved service facility. Failure to service the pump at the indicated intervals may invalidate the Warranty. UK & European Service Agents: IVF Synergy Ltd., Old School, Tresillian, Cornwall TR2 4BA Tel: +44 (0) 1872 487224 Email: [email protected] Website: www.ivfsynergy.co.uk

UK Customer Services: Rocket Medical plc. Sedling Road. WASHINGTON. NE38 9BZ. ENGLAND Tel: +44 (0) 191 419 6988. Fax: +44 (0) 191 419 6989 Email: [email protected]

Australia Service Agent: DTS Q-Tech, 8/79 Newton Road, Wetherill Park, NSW 2164 Australia Tel: +61 2 9729 4214 Email: [email protected] Website: www.dtsqtech.solutions US Office: Email: [email protected] Rocket Medical 50 Corporate Park Drive. Suite 890. PEMBROKE. MA. 02359. USA Tel: +1 781 749 6223

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4. SAFETY INSTRUCTIONS WARNING: This manual contains important information. Please familiarise yourself with these safety instructions before using the device.

This manual describes the operation and intended use of the device and the associated consumables and it is essential that you use this document to familiarise yourself with the correct function and operation of the device before use. Failure to follow these instructions may result in serious injury to the patient or operator and can lead to damage or breakdown of the device. In case the device fails during an operation, a replacement device and replacement disposables should be kept within reach so that the operation may be completed.

4.1. WARNING: This device should only be operated by appropriately qualified personnel.

Intended Patient Population: Female patients between the ages of 18 – 46 undergoing oocyte aspiration for the treatment of Infertility with In-Vitro Fertilisation (IVF) or other gynaecological patients such as those undergoing oocyte retrieval for cryopreservation or those with ovarian hyperstimulation syndrome.

4.2. WARNING: This device must only be operated with approved consumables.

WARNING: Protect the device from ingress of liquid. Should any liquid enter the device, discontinue use immediately and refer to an authorised service agent

WARNING: Ensure the set vacuum level is appropriate.

PATIENT PROFILE

MANUAL USAGE:

This manual does not provide a detailed description of the oocyte harvesting procedure and is not intended as a training guide for users inexperienced in the technique. The device must be used with R57685 Water Trap Set for CRAFT™ Suction Pumps. The usage of non-approved tubing or filter sets may impair pump performance, lead to increased risk to patients and harvested oocytes and will invalidate the Warranty. The water trap sets are designed to prevent fluid contamination of the vacuum pump. If the device has been used with a non-approved filter set or there is any evidence or suspicion that the pump may have been contaminated with fluid during use, it must be removed from service and returned for examination immediately. Please contact your nearest Service Centre for advice. The use of high vacuum levels may lead excessive fluid flow rates which may result in damage to the oocyte and reduced fertilisation rates. Damage to oocytes in harvesting systems is principally caused by turbulent flow which can lead to physical shearing stresses on the cumulus sufficient to denude or damage the fragile zona (Reeves et al 1989). Flow rate is a function needle set configuration and vacuum applied. HIGH vacuum setting must only be used to clear blockages from a needle set. Refer to Table 1 for recommended vacuum setting for given needle set configurations. Refer all servicing to the manufacturer’s authorised service agent. Do not use in an area where flammable gases are present.

WARNING: No user serviceable parts inside.

WARNING: Device can cause explosion in the presence of flammable gases.

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4.3. WARNING: ELECTRIC SHOCK HAZARD. The equipment is to be used only with electrical systems complying with all IEC, CEC and NEC requirements.

USER TRAINING:

Rocket Medical or its authorised distributors and agents can provide end-user training on the preparation, connection, operation and cleaning of the device. Initial end-user training is recommended on installation with refresher training every 3 years thereafter as required. Training may include on-site visits, teleconferences, webinars and the provision of training support materials including this manual. Contact your local Rocket Medical sales office or distributor for further training support. See our website www.rocketmedical.com for details of your local office End User Training includes: 1. Introduction to the product a. Components b. Symbols used 2. Setup a. Mains supply b. Attachment of footswitches and patient connection sets 3. Operation a. Vacuum Settings b. Footswitch control/operation 4. Contamination control a. Cleaning b. Use of approved patient connection sets

4.4.

SUPPLY VOLTAGE SELECTION

The device operates at a voltage 220-240 VAC @ 50Hz. 40VA or 110VAC @ 60Hz as appropriate to the model. Ensure that the correct power cord is connected.

4.5.

ELECTROMAGNETIC COMPATIBILITY

CRAFT™ Oocyte Aspiration Pumps comply with the electromagnetic compatibility (EMC) limits for medical devices as specified by BS EN 60601-1-2:2015. The device must be operated according to the instructions contained in this manual to ensure continued electromagnetic compatibility. WARNING: ELECTRIC SHOCK HAZARD. Do not immerse the device.

4.6.

After unpacking, re-assemble and retain the packaging for transport for servicing when required.

4.7. WARNING: Device can cause explosion in the presence of flammable gases.

PACKAGING

The packaging has been designed to allow secure transportation of the pump and its accessories.

POSITIONING and PLACEMENT of the DEVICE

CRAFT™ Oocyte Aspiration Pumps must be placed on a secure, level surface, away from sources of heat, water splashes, mists or cooling vents. Do not expose to direct sunlight. Do not expose to flammable gases. Operating temperature Range: +5°C and +35°C

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4.8.

WARNINGS:

Users should be familiar with and adhere to all warnings, cautions and instructions for use that are labelled on the device and included in the User Manual. WARNING: This device must only be operated with approved consumables.

WARNING: Device can cause explosion in the presence of flammable gases.

•

This device should only be used by, or under the supervision of, appropriately trained personnel and in conjunction with current local clinical practice guidelines.

•

To avoid the risk of electric shock this equipment must only be connected to a supply main with a protective earth.

•

The device can be isolated from the mains supply by removal of the mains supply cord from the rear of the equipment.

•

The device is not approved for connection to any other device except the R57685 Water Trap Set for CRAFT™ Suction Pumps

•

The R57685 Water Trap Set for CRAFT™ Suction Pumps is single use and its instructions for use must be followed at all times.

•

Do NOT use the R57685 Water Trap Set for CRAFT™ Suction Pumps if the packaging is broken. DUTY CYCLE: The pump should be operated for 15 minutes ON with a 15-minute period OFF prior to re-operation.

•

WARNING: Protect the device from ingress of liquid. Should any liquid enter the device, discontinue use immediately and refer to an authorised service agent

• •

Do not use in an area where flammable gases are present. Regular periodic maintenance of the device is recommended annually.

•

Precautions for EMC safety should be observed. The device complies with EN60601-1-2:2015 for use in a Professional healthcare facility, however: o Electronic equipment in the vicinity of the device may affect its operation and potentially cause unpredictable operation of the device. o Wherever possible the device should be distanced from surrounding electromagnetic equipment and cables to this equipment in order to reduce possible electromagnetic interference. o The CRAFT™ Pump device power cable should only be connected to a correctly wired receptacle in order to avoid the risk of electrical shock and ONLY use the cable supplied by Rocket Medical. When positioning the unit, ensure that access is available to the AC power cable located on the rear of the unit.

• •

Fluids should not be allowed to enter the device as this may result in damage to the system.

•

User should be aware of the status of unit at all times during the procedure.

•

Only qualified personnel should service the device and the device must not be opened except by these personnel due to the risk of hazardous electrical shock and premature damage to the device. All service requirements should be referred to a Rocket Medical authorised representative.

•

All equipment should be thoroughly cleaned after each use (refer to section 6 Cleaning Guidelines).

WARNING: Do not modify this equipment without written authorisation of the manufacturer. WARNING: Ensure the suction level is appropriate.

The use of high suction levels may lead excessive fluid flow rates which may result in damage to the oocyte and reduced fertilisation rates. Damage to oocytes in harvesting systems is principally caused by turbulent flow which can lead to physical shearing stresses on the cumulus sufficient to denude or damage the fragile zona (Reeves et al 1989). Flow rate is a function needle set configuration and the suction applied. Therefore, the 440mmHg-1 (Max) suction setting must only be used to clear blockages from a needle set and must NOT be used in contact with the patient. Refer to Section 6 for recommended suction setting for given needle set configurations.

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4.9. SYMBOLS USED ON CRAFT SUCTION & CRAFT™ DUO-VAC™ PUMPS. These tables describe their respective meanings.

Mains Power ON/OFF

This device is Type B

Footswitch connection port

Dispose of this device in accordance with WEEE directive (2002/96/EC)

Earthed

Read the manual before connection and use

Consult the Instructions for Use

Usage Duty cycle: 15 minutes ON followed by 15 minutes OFF

CE Mark

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4.10. SYMBOLS USED ON R57685 WATER TRAP SET FOR CRAFT™ PUMPS

Read the Instruction for Use before connection and use

Device is for Single Use Only

Device is sterilised by Ethylene Oxide

The device is not manufactured with natural rubber latex

Do not use if pack is opened or damaged

CE Mark

CONTAINS or PRESENCE of PHTHALATES

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5. GENERAL INFORMATION: 5.1. GENERAL DESCRIPTION: The CRAFT™ Suction Pumps Pumps have been developed to provide smooth, low volume vacuum at a pre-determined negative pressure. Vacuum is activated by a foot operated toggle air switch controlled by the surgeon performing the oocyte collection. The range of vacuum is infinitely variable from 0-200mmHg-1 in medium vacuum mode and at a pre-set 440mmHg-1 in high vacuum mode. CRAFT™ Oocyte Aspiration Pumps require a R57685 Water Trap Sets for CRAFT™ Suction Pumps supplied separately, sterile and for single use.

5.2. INDICATIONS: For the generation of medium vacuum between 0-200 mmHg-1 to permit the aspiration of follicular fluid, oocytes and ovarian fluid as part of the treatment of infertility relating to IVF and other gynaecological procedures. This device may only be used by, or under the supervision of, appropriately trained personnel in conjunction with clinical practice guidelines such as those published by the National Institute of Clinical Excellence (NICE 2004) and the Human Fertilisation & Embryology Authority. (HFEA April 2010 – as amended).

5.3. CONTRAINDICATIONS: Not intended for use where ovarian aspiration or the aspiration of ovarian fluid is contraindicated. For short term operation only. NOT for continuous drainage.

5.4. REFERENCES: Craft I, McLeod F. Edmonds K, ‘Human embryo transfer technique’. Lancet 1961 ii 1104-5 Craft I, Diahanbakch O. McLeod F et al ‘Human pregnancy following oocyte and sperm transfer to the uterus.’ Lancet 1992 i 1031-3 Craft I, (1984) ‘Clinical Methodology’ British Journal of Hospital Medicine 90-102 Reeves G, Scott R T, et al (1989) Journal of Assisted Reproduction and Genetics Volume 6, Number 6 / December, 1989

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6. OPERATING THE PUMP

WARNING: This device must only be operated with approved consumables.

CRAFT™ Suction Pump: 1. Unwrap the footswitch and attach the air tubing to the ports on the front of the pump casing. The footswitch is normally left attached to unit in daily use unless removal for storage is required.

CRAFT™ DUO-VAC™Suction Pump:

WARNING: Protect the device from ingress of liquid. Should any liquid enter the device, discontinue use immediately and refer to an authorised service agent

2. Unwrap the footswitch and attach the air tubing to the male/female ports on the front of the pump casing. The footswitch is normally left attached to unit in daily use unless removal for storage is required.

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3. Connect the correct mains lead to an electrical supply 110-240VAC 50-60Hz. Model dependent. WARNING: ELECTRIC SHOCK HAZARD. The equipment is to be used only with electrical systems complying with all IEC, CEC and NEC requirements.

4. Turn the power switch 0-I (front panel) to on. The green light illuminate.

5. Using aseptic technique, un-pack the R57685 Water Trap Set for CRAFT™ Suction Pumps and attach the short tubing length to the water trap connection point. 6. Pass the longer patient connection tube into the operative field. The R57685 water trap set is for single patient use and must be replaced for each patient.

7. Refer to Table 1 for recommend vacuum values for various needle and tube set combinations. WARNING:

Ensure the set vacuum level is appropriate to the patient’s needs taking into consideration the needle and tube set configuration

8. Occlude the patient tube set, distal to the water trap. 9. Activate the foot switch. 10. Rotate the control knob clockwise to increase to the desired value on the gauge. 11. To decrease the set value: rotate anticlockwise. 12. When the desired value is reached, release the footswitch and tubing set occlusion. 13. Repeat from Step 8 to ensure stable value.

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6.1. TABLE 1 RECOMMENDED VACUUM SETTINGS WARNING: Ensure the set vacuum level is appropriate to the patient’s needs taking into consideration the needle and tube set configuration

Tube Set Length 55cm 70cm 90cm

Single Lumen Double Lumen 16G 17G 16G 17G Recommended Vacuum -mmHg 80 110 130 150 90 130 150 170 100 150 170 190

1. Connect the patient filter set to a suitable luer fitting (indicated) such as the Oxford Tube Set found on Rocket Medical Single and Double Lumen Oocyte Aspiration Needles. Attach a collection tube to the bung.

If vacuum lines become blocked due to debris or viscous fluids, a temporary high vacuum (440mmHg-1) can be obtained to unblock the needle and tubing set by following the procedures below.

WARNING: HIGH VACUUM MODE must NOT be used to aspirate oocytes as this may result in damage to the oocyte and lead to reduced fertilisation rates.

CRAFT™ DUO-VAC™ 2. To activate the HIGH vacuum, depress the WHITE HIGH VACUUM Pedal – the pump will immediately deliver a vacuum of 440mmHg-1.

CRAFT™ Suction Pump 3. To activate the HIGH vacuum, occlude the RED button and depress the footswitch – the pump will immediately deliver a vacuum of 440mmHg-1. 4. Removing the occlusion will cause the vacuum to revert to its previously set level.

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WARNING: This device must only be operated with approved consumables which are specifically designed to provide the correct flow rates and vacuum characteristics Should any liquid enter the device, discontinue use immediately and refer to an authorised service agent

5. If water, media or any other material is allowed to enter the water trap chamber, the pump must be stopped immediately. 6. Replace with a R57685 Water Trap Set for CRAFT™ Suction Pumps. 7. The pump must NOT be operated if fluid is present in the water trap. 8. Should the water trap become full and there is a risk that fluid has entered the pump, it must be withdrawn from service and returned to an authorised service agent for inspection and repair.

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6.2. PROCEDURE Preparation: ROCKET MEDICAL PLC strongly recommends confirmation of the position of the uterus and pelvic organs by ultrasonography prior to the procedure. Similarly, the presence of developed follicles should be confirmed by serial ultrasound during the ten days prior to the procedure. The procedure is normally carried out under local analgesia and/or supplemented light sedation. General anaesthesia may be necessary in very anxious patients. Follicular Aspiration: It is essential for a successful outcome that oocytes are harvested with the least possible trauma to both patient and ova. Using aseptic technique: 1. Following the manufacturers guidelines, cover the transvaginal ultrasound probe with a sterile sheath. A small amount of ultrasound gel may be added to the sheath to improve picture definition 2. Select a sterile needle guide approved for use with the vaginal ultrasound probe and assemble following the manufacturers instructions. 3. Open the needle pack carefully, taking care not to touch or damage the needle bevel. The use of damaged needles will cause increased discomfort to the patient and may result in loss of the oocyte. 4. For double lumen needles/flushing technique: prior to inserting the needle into the needle guide, attach a syringe of flushing media to the flushing port, open the tap and flush the channel with 2ml of media. Close the 2-way tap. For single lumen needles: prime (if required) using the connection port on the underside of the bung/stopper. 5. Attach a sterile sample (Falcon) tube to the bung/stopper. 6. Connect the tubing connector to a low power vacuum pump such as the R29655 CRAFT™ Suction Pump. 7. For double lumen needles/flushing technique: set the pump to deliver a vacuum of 200mmHg. Aspirate 2-5ml of flushing media into the Falcon tube and discard. 8. Place the needle into the needle guide following the manufacturer’s instructions. Figure 1 shows a common probe and needle assembly. 9. Set the aspiration vacuum level to your personal preference using the table as a guide. 10. Ensure all connections are air tight and the tube set is free from any constrictions as these cause turbulences which greatly increases the risk of oocyte damage. 11. With the patient in lithotomy, introduce the needle/probe assembly into the vagina, advancing into the anterior fornix to visualise each ovary. Once the ovaries have been identified, introduce the needle and advance through the vaginal wall and ovarian stroma into the target follicle. 12. Activate the vacuum pump and aspirate the follicular fluid into the sampling tube. Check microscopically for the presence of an oocyte. For double-lumen needles, if desired, 2-5ml of media can be injected via the flushing limb (after opening the 2-way tap) to distend the follicle prior to subsequent aspiration. When using single lumen needles, follicular flushing can be performed via the flushing port on the underside of the bung/stopper. Complete the harvesting from one ovary before commencing on the other. 13. If the needle becomes blocked during the procedure, rotate the needle within the follicle to ensure that the needle is not blocked by follicular wall tissue Single lumen blockage: if the needle remains blocked, remove the needle from the patient and flush through with media using the flushing port on the underside of the bung/stopper. Double lumen blockage: the needle can be flushed without removal from the ovary. Check that the needle is clear by aspirating media through the needle set. If the blockage is still present, high vacuum aspiration (400-500mmHg) may be performed with the needle outside the patient. WARNING: the use of high suction when the needle is inside the ovary should not be performed. This may lead to turbulent flow, which may damage the oocyte. 14. Flushing may be performed following harvesting to clear the needle prior to oocyte identification.

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CRAFT™ Suction Pumps – Operators Guide

7. CONSUMABLES

WARNING: This device must only be operated with approved consumables which are specifically designed to provide the correct flow rates and vacuum characteristics

R57685 Water Trap Set for CRAFT™ Suction Pumps glass water trap bottle 2.0m patient connection tube with male luer connector. Supplied sterile, for single use in cartons 10 units.

Should any liquid enter the device, discontinue use immediately and refer to an authorised service agent

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CRAFT™ Suction Pumps – Operators Guide

8. CLEANING THE PUMP CASING At the end of each clinical session, turn off the device at the front panel and disconnect the device from mains power supply. WARNING: ELECTRIC SHOCK HAZARD. Do not immerse the device.

Using an aqueous solution of 70% alcohol (IMS or isopropyl BP), moisten a cloth and wipe all external surfaces of the device. If the surface has become contaminated with proteinaceous material, remove with a light detergent solution before surfacing cleaning with alcohol. Do NOT use a 100% alcohol or any other solvent to clean the device as this may cause damage to the casing surface and display.

WARNING: Do NOT attempt to sterilise the device

WARNING: Protect the device from ingress of liquid. Should any liquid enter the device, discontinue use immediately and refer to an authorised service agent

Prevent any fluid from entering the device.

9. YEAR OF MANUFACTURE: Units manufactured before 2014: The year in which the device was manufactured is indicated by the first 2 numbers of the serial number. For example: a serial number starting 11180776 indicates the device was manufactured in 2011 For units manufactured after 01/04/14, the year of manufacture is shown on the rear rating plate label opposite the model number.

WARNING: No user serviceable parts inside.

HAZARD: Do NOT include used consumables as these pose a significant contamination risk

10. RETURNING THE PUMP FOR SERVICE: All devices to be returned must be prepared as described below for the protection of the servicing team and for safety during transport. 1. Surface clean the pump as described in the Section above. 2. Seal in a plastic bag and seal within a second plastic bag. 3. Place in the original packaging.

IMPORTANT A decontamination certificate MUST be included with every returned pump. Repair or servicing cannot be commenced unless the service agent is in possession of this certificate

4. Enclose the following information: • Contact name • Centre address • Decontamination Certificate • Description of the fault or service required • Accompanying Order to authorise servicing – contact your local Customer Services Team for details.

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11. STORAGE & TRANSPORTATION: The device must be transported/stored at temperatures between -10°C to + 50°C

The device must be transported/stored at relative humidity levels between 20% to 95%

The device must be stored in a clean, dry condition, ideally in its original packaging which should be retained to return the unit for servicing Protect the device from ingress of liquid. Should any liquid enter the device, discontinue use immediately and refer to an authorised service agent

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