Instructions for Use
12 Pages
Preview
Page 1
Instructions for Use V1000 Foetal Heart Simulator
Instructions for Use - V1000
Manufactured by: Viamed Ltd. 15 Station Road Cross Hills, Keighley West Yorkshire, BD20 7DT United Kingdom Tel: +44 (0)1535 634542 Fax: +44 (0)1535 635582 E-mail: [email protected] Website: www.viamed.co.uk Distributed by:
This publication is protected by copyright and all rights are reserved. No part of this manual may be reproduced or transmitted in any form or by any means electronic or mechanical, including photocopying and recording for any purpose other than the purchasers personal use, without the written permission of Viamed Ltd. Information within this document is subject to change. Changes will be made without notice and incorporated in further issues. © Copyright 2016 Viamed Ltd.
2
Instructions for Use - V1000
Contents Section
Page
Introduction
4
Controls and Indicators
5
Operating the V1000
6
Low Battery Indication
7
Replacing the Batteries
7
Cleaning
7
Protection Rating
8
Routine Maintenance
8
Warranty
9
Disposal
9
V1000 Service Sheet
10 3
Instructions for Use - V1000
Introduction The V1000 Foetal Heart Simulator allows the operation and functionality of foetal heart monitors to be assessed. It is a hand held, portable unit for use in any environment where foetal heart monitors need to be tested: before use, when suspected faulty or after routine servicing. The V1000 simulates heart rates in the range of 30 BPM to 210 BPM. The V1000 is a simulator; it is not a calibration device, therefore should not be used to validate the accuracy of an individual monitor’s displayed foetal heart rate. Altering the intensity control on the front panel alters the amplitude, allowing the sensitivity of the transducer and monitor combination to be assessed. The V1000 can simulate continuously in excess of 2 weeks at maximum intensity, using 4 x 1.5V AA/MN1500/LR6 alkaline batteries. Areas of Application for the V1000 The following is a breakdown of when the V1000 can be used with foetal heart monitors: By Engineers for: Fault finding and diagnosis of the monitor. Soak testing of the monitor. As part of a Planned Preventative Maintenance procedure. Verification of correct chart paper installed. By Midwives & Clinicians for: Testing monitors and transducers prior to use. Verification of correct chart paper installed. For Teaching purposes: Simulation of the foetal heart and training in the use of monitoring equipment.
4
Instructions for Use - V1000
Controls and Indicators
Area for transducer
On/Off button
BPM selector Intensity control Auto mode indicator
Low battery indicator
BPM rate indicators
5
Instructions for Use - V1000
Operating the V1000 The V1000 can simulate at fixed heart rates between 30 BPM and 210 BPM at 30 BPM intervals. It can also run an automatic test routine of 30 seconds at 30 BPM followed by the same duration at 60, 90, 120, 150, 180 & 210 BPM. This test routine is continuous until auto test is deselected or the simulator is switched off. 1. Place ultrasound gel on the centre of the transducer placement markings on the front panel of the V1000. 2. Obtain a good contact between the transducer and the V1000, with the transducer remaining central, using the concentric markings as a guide. 3. Press the On/Off button and ensure that each of the LED indicators illuminates during the self-test routine. 4. When the self-test routine is complete, the 120 BPM indicator begins to flash. If the low battery indicator is flashing or illuminated, replace the batteries. 5. Adjust the intensity control until the foetal heart monitor under test begins to respond, then set the intensity control as necessary. 6. Pressing the BPM selector button adjusts the output rate of the V1000, pressing the button whilst at 210 BPM sets the V1000 into the automatic test routine. 7. To switch off the V1000, press the On/Off button. Ensure that all rate indicators extinguish, detach the transducer and remove any residual gel using a damp cloth.
6
Instructions for Use - V1000
Low Battery Indication When the V1000 detects that the batteries are nearing depletion, the low battery indicator will begin to flash red. The V1000 can still be used, but the user should consider that simulation may cease at any time without further warning. Replacing the Batteries The V1000 operates using 4 x 1.5V AA/MN1500/LR6 alkaline batteries. To replace the batteries, remove the battery door on the rear panel, remove the existing batteries and insert new ones, observing the polarity indications inside the battery compartment. Depleted batteries should be disposed of as per local regulations. Caution: only use batteries of the type specified. Note: If the V1000 is to be removed from service or stored, the batteries must be removed. Cleaning With reference to the Medical Devices Agency document “Sterilization, disinfection and cleaning of medical equipment: guidance on decontamination from the Microbiology Advisory Committee to Department of Health Medical Devices Agency” (known as the MAC Manual), “Introduction to Part 1 - Table 1: Classification of infection risk associated with the decontamination of medical devices”; the V1000 Foetal Heart Simulator is classified as low risk, due to being “In contact with healthy skin, or not in contact with the patient”. The recommended decontamination method for low risk items is to clean in accordance with the guidelines in the MAC Manual “Part 2; Cleaning (manual) - non-immersion”.
7
Instructions for Use - V1000
Protection Rating The V1000 is manufactured to an ingress protection rating of IP41. Routine Maintenance It is recommended that the V1000 be checked at least annually to ensure correct performance. Perform functionality checks as detailed on the Performance Evaluation Sheet overleaf. There are no user serviceable parts inside: if the device does not meet the specification or if performance is suspect, please return it to Viamed for evaluation or repair. Note: The output BPM is governed by the firmware and the microcontroller - there is no adjustable calibration control. If required, units can be returned to Viamed for annual service and testing. Part number 1480000: V1000 Service & Testing (includes Certificate of Calibration). If a service is not deemed necessary, but a Certificate of Calibration is required in order to comply with local standards; then units may be returned to Viamed for testing and a Certificate of Calibration will be reissued. Part number 1480001: V1000 Certificate of Calibration.
8
Instructions for Use - V1000
Optional Accessories Part Number
Description
1420000
Wall mount for Foetal Heart Simulator
1420001
Case protector for use with Foetal Heart Simulator, model V1000. Colour: Grey
0013110
Carrying case Colour: Blue
Warranty Viamed warranty ensures that goods are free from defects of manufacture for a period of one year from the date of shipment from Viamed. Disposal The V1000 should be disposed of as WEEE (Waste Electrical and Electronic Equipment) in accordance with local ordinances and regulations, or it can be returned to Viamed. You are responsible for the return packaging and carriage costs, but we will process the returned WEEE free of charge on your behalf. Return address for WEEE: Viamed Ltd. - WEEE Processing 15 Station Road, Cross Hills, Keighley West Yorkshire BD20 7DT United Kingdom
9
Instructions for Use - V1000
Version:
1.1
V1000 Foetal Heart Simulator Performance Evaluation Sheet Date: Serial Number: Action
Pass
Fail
On control: Press on/off to switch on and activate the self test routine. Pass: If self test activated and completed Fail: If self test not activated, replace batteries. If low battery indicator is flashing red, then replace the batteries.
BPM Control - sequentially press the rate button and verify operation of the associated LED indicator BPM 120
Yellow LED
BPM 150
Yellow LED
BPM 180
Yellow LED
BPM 210
Yellow LED
BPM Auto function
Green LED
BPM 30
Yellow LED
BPM 60
Yellow LED
BPM 90
Yellow LED
Connect the V1000 to a foetal heart monitor, select BPM auto function and verify the functionality of the heart rates Intensity Control Functionality Off control: Press on/off button to switch off
Performance evaluation: PASS/FAIL Signed: Name:
10
Instructions for Use - V1000
Notes
11
Viamed Limited � 15 Station Road � Cross Hills Keighley � West Yorkshire � BD20 7DT � United Kingdom Tel: +44 (0)1535 634 542 Fax: +44 (0)1535 635 582 Email: [email protected] Website: www.viamed.co.uk Instructions for Use V1000 Foetal Simulator V4 May 2016
Specifications Subject to Change
*1490001*
V1000 Instructions for Use: 1490001 V1000 Part Number: 1410000