VENTIremote alarm Remote alarm case VENTIremote alarm 10 m WM 27745 VENTIremote alarm 30 m WM 27755 Device description and instructions for use
Overview VENTIremote alarm 5 Stand-by indicator 1 Battery indicator 2 Alarm indicator 4 ODU socket 3 Nameplate 6 Connecting cable 7 Bayonet connector 8 ODU connector Key 1 Battery indicator If this yellow LED flashes, the battery needs changing. 2 Alarm indicator In combination with the buzzer, this red LED indicates an alarm of the therapy device or a malfunction of the VENTIremote alarm. 3 Nameplate Provides information about the device, such as serial number and year of manufacture, for example. 4 ODU socket This is where the ODU connector (two white arrows) for the connecting cable to the VENTIremote alarm is connected. 5 Stand-by indicator This green LED indicates that the VENTIremote alarm is working correctly. 6 Connecting cable This connecting cable passes alarms from the therapy device to the VENTIremote alarm. 2 EN Overview
7 Bayonet connector This connects the connecting cable to the therapy device. 8 ODU connector This connects the connecting cable to the VENTIremote alarm. Special markings on the device VENTIremote alarm VENTI remote alarm Name plate 1 2 3 Symbols SN Serial number Name plate Significance Year of manufacture Follow information in the instructions for use Do not dispose of device in domestic waste 1 2 Display fascia Red LED illuminated: alarm Yellow LED flashing every six seconds: battery almost dead 3 Stand-by indicator: the green LED must light briefly every six seconds during operation Special markings on the device EN 3
Safety information in these instructions Safety information in these instructions for use is marked as follows: Warning! Warns of risk of injury and potential material damage. Caution! Warns of material damage and potentially false therapy results. Note: Contains useful tips. 4 EN Safety information in these instructions
Contents 1. Description of device.......... 6 1.1 Intended use................. 6 1.2 Description of function........ 6 2. Safety instructions............ 7 3. Set up and operate the device.. 9 3.1 Initial commissioning.......... 9 3.2 Set up and connect the device.. 10 3.3 Operation with the therapy device 11 3.4 Change battery.............. 11 4. Hygienic preparation......... 13 4.1 Cleaning................... 13 4.2 Disinfecting................ 13 4.3 Sterilizing.................. 13 4.4 Change of patient........... 13 5. Function check.............. 14 5.1 Intervals................... 14 5.2 Performing the function check.. 15 6. Troubleshooting............. 17 7. Servicing................... 18 7.1 Storage.................... 18 7.2 Disposal................... 18 8. Scope of supply............. 19 8.1 Standard scope of supply...... 19 8.2 Accessories and spare parts.... 19 9. Technical data............... 20 9.1 Specifications............... 20 9.2 Safety distances............. 21 10. Warranty................... 22 11. Declaration of conformity..... 23 12. Index...................... 24 Contents EN 5
1. Description of device 1.1 Intended use VENTIremote alarm is for the remote transmission and display of acoustic and visual alarm signals issued by the VENTIlogic LS and VENTIlogic plus therapy devices. With VENTIremote alarm, alarms relating to respiratory physiology and device faults can be remotely monitored independent of any nurse-call system which may be installed. VENTIremote alarm helps in particular nursing staff and family members when caring for a ventilated patient in the home environment. VENTIremote alarm can only be operated in conjunction with the Weinmann VENTIlogic LS and VENTIlogic plus ventilation devices. 1.2 Description of function VENTIremote alarm has a connecting cable (10 m and 30 m long) to connect it to the therapy device. If the therapy device issues alarms, the VENTIremote alarm converts these into visual and acoustic signals and outputs them. The device is powered by a 9 V battery pack (lithium). 6 EN Description of device
2. Safety instructions Read these instructions for use carefully. They are an integral part of the device and must be available at all times. Only use the device for the intended purpose described (see 1.1 Intended use on page 6). For your own safety and the safety of your patients and in accordance with the requirements of Directive 93/42/EEC, please note the following: Operating the device Warning! Ensure that the VENTIremote alarm is free-standing and not covered up, otherwise alarm volume is reduced. This can lead to a risk to the patient and to damage to the device. Maintain a safe distance between the VENTIremote alarm and equipment that emits HF radiation (e.g. cell phones), otherwise there may be malfunctions. Caution! To prevent infection or bacterial contamination, observe section 4. Hygienic preparation on page 13. Ensure that the connecting cable is correctly connected to prevent the connector being pulled out inadvertently and to ensure that the VENTIremote alarm works correctly. Note: Always keep a full U9VL-BP-type battery to hand. Transport/Replacement parts/maintenance/storage Caution! If the VENTIremote alarm has been stored or transported outside the operating temperatures quoted in the instructions for use, the VENTIremote alarm should be commissioned only once the temperature of the device is within the permitted range for operation. Safety instructions EN 7
If third-party items are used, functional failures may occur and fitness for use may be restricted. Biocompatibility requirements may also not be met. Please note that in such cases, any claim under warranty and liability will be voided if neither the accessories nor genuine replacement parts recommended in the instructions for use are used. Have servicing and maintenance work carried out only by the manufacturer, Weinmann, or by specialists expressly authorized to do so by the manufacturer. Have modifications to the device carried out only by the manufacturer, Weinmann, or by specialists expressly authorized to do so by the manufacturer. Note: Remove the battery if the VENTIremote alarm is in storage or not being used for an extended period. In the event of questions about faults, see the section entitled 6. Troubleshooting on page 17. 8 EN Safety instructions
3. Set up and operate the device 3.1 Initial commissioning Before you can operate the VENTIremote alarm as described below, you have to insert the U9VL-BP-type battery included in the scope of supply. To do so, proceed as follows. 1. Open the battery compartment as shown in the adjacent drawing. 2. Connect the battery to the connecting cables. 3. Put the battery and the connecting cables in the battery compartment. Note: Ensure that the connecting cables are underneath the battery in the battery compartment, so that the connecting cables are not trapped when the battery compartment is closed. 4. Push the battery compartment cover closed until it engages with an audible click. VENTIremote alarm is now ready for operation. Set up and operate the device EN 9
3.2 Set up and connect the device 1. Place the VENTIremote alarm on a level surface. Warning! Ensure that the VENTIremote alarm is free-standing and not covered, otherwise alarm volume will be reduced. This can lead to a risk to the patient and to damage to the device. 2. Connect the bayonet connector of the connecting cable to the remote alarm connection of the therapy device. 3. Connect the ODU connector (two white arrows) of the connecting cable to the ODU socket of the VENTIremote alarm. To do so, turn the ODU connector so that the arrows on it and the arrow on the ODU socket are pointing at one another. As soon as the ODU connector is connected to the VENTIremote alarm, the VENTIremote alarm automatically performs a function check. Note: Ensure that the connector engages correctly in the socket. 10 EN Set up and operate the device
3.3 Operation with the therapy device Switch on VENTIremote alarm VENTIremote alarm is switched on as soon as it is connected to the therapy device by the connecting cable. The stand-by indicator (green LED) on the VENTIremote alarm comes on briefly every six seconds during operation to indicate operational readiness. Output of alarms If an alarm is issued on the therapy device, the alarm indicator (red LED) of the VENTIremote alarm comes on permanently and a continuous acoustic signal sounds. All alarms of medium and high priority, together with the power failure alarm (low priority if the internal battery of the therapy device is charged) are passed on to the VENTIremote alarm. Look at the display of the therapy device to establish which alarm is involved. A precise description of the alarm can be found in the instructions for use for the VENTIlogic LS and VENTIlogic plus therapy devices. The alarm can be cancelled by switching off/acknowledging the alarm on the therapy device. Switch off VENTIremote alarm Switch off the VENTIremote alarm at the end of therapy by pulling out the ODU connector of the connecting cable of the VENTIremote alarm. 3.4 Change battery VENTIremote alarm is operated with a battery of the U9VL-BP type. As soon as the battery indicator (yellow LED) comes on every six seconds and an acoustic alarm is issued every six seconds, the battery of the VENTIremote alarm must be replaced. To do so, proceed as follows: 1. Open the battery compartment as shown in the adjacent drawing. 2. Take the battery off the connecting cables. 3. Connect the new battery to the connecting cables. Set up and operate the device EN 11
4. Put the battery and the connecting cables in the battery compartment. Note: Ensure that the connecting cables are underneath the battery in the battery compartment, so that the connecting cables are not trapped when the battery compartment is closed. 5. Push the battery compartment cover closed until it engages with an audible click. Note: Always keep a full U9VL-BP-type battery to hand. 12 EN Set up and operate the device
4. Hygienic preparation 4.1 Cleaning Caution! The VENTIremote alarm must be completely dry before starting up. Wipe the VENTIremote alarm and the connecting cable with a soft, damp cloth. 4.2 Disinfecting If required, e.g. following infectious diseases or unusual contamination, you can also disinfect the housing of the VENTIremote alarm and the connecting cable. We recommend TERRALIN for this purpose. See the instructions for use for the disinfectant used. For disinfecting, we recommend that suitable gloves (e.g. domestic gloves or disposable gloves) are used. 4.3 Sterilizing Sterilizing is not permitted. 4.4 Change of patient Disinfect the VENTIremote alarm when changing patients as described in 4.2 Disinfecting on page 13. Hygienic preparation EN 13
5. Function check As soon as the ODU connector is connected to the VENTIremote alarm, the VENTIremote alarm automatically performs a function check. Note: VENTIremote alarm starts the function check even if the connector is not yet fully engaged. Ensure that the connector engages correctly in the socket. If you find faults during the function check, you may not use the VENTIremote alarm. Try to eliminate the fault with the aid of the information in the section entitled 6. Troubleshooting on page 17. If this should prove impossible, have the VENTIremote alarm repaired by the manufacturer, Weinmann, or by specialists expressly authorized by the manufacturer. A complete function check includes the following. VENTIremote alarm function check on page 15 Battery function check on page 15 Function check of the entire system on page 16 5.1 Intervals Perform a function check daily and each time before the device is used. 14 EN Function check
5.2 Performing the function check VENTIremote alarm function check In order to perform a function check, connect the connecting cable to the VENTIremote alarm as described in the section entitled 3.2 Set up and connect the device on page 10. Note: If the connecting cable is already connected to the VENTIremote alarm, briefly pull out the ODU connector and then reconnect it to the ODU socket. VENTIremote alarm is working correctly if all three LEDs come on briefly at the same time and a short acoustic signal sounds. Battery function check To establish the charging state of the battery, proceed as follows. 1. Check the battery indicator The charging state of the battery is OK if the battery indicator does not come on. If the battery indicator comes on every 6 seconds, the battery needs changing. 2. Check the stand-by indicator The charging state of the battery is OK if the stand-by indicator comes on every 6 seconds. If the stand-by indicator and the battery indicator do not come on every 6 seconds, the battery needs changing. Function check EN 15
Function check of the entire system To check the connection between the VENTIremote alarm and the therapy device, proceed as follows. 1. Connect the VENTIremote alarm to the therapy device (see 3.2 Set up and connect the device on page 10). 2. Switch on the therapy device and then pull out its power plug. The therapy device and thus the VENTIremote alarm are working correctly if both now issue an alarm: VENTIremote alarm is working correctly if the alarm indicator (red LED) comes on continuously and a continuous acoustic signal sounds. The therapy device is working correctly if the yellow LED comes on and an acoustic signal sounds. The alarm window No power supply appears in the display. 16 EN Function check
6. Troubleshooting VENTIremote alarm does not switch on Fault Cause of fault Remedy Buzzer and/or LEDs not working Battery display (yellow LED) flashes and buzzer sounds every 6 s Alarm indicator (red LED) on + alarm sound Stand-by indicator (green LED) does not come on after 6 s Battery discharged Insert new battery Check connecting cable for Connecting cable damaged damage and replace if necessary Check if bayonet connector is Bayonet connector not properly connected to the connected to the therapy device therapy device Alarm on the therapy device Battery discharged Check alarm on the therapy device Insert new battery ODU connector not correctly Make sure ODU connector is connected to VENTIremote alarm engaged in ODU socket Troubleshooting EN 17
7. Servicing VENTIremote alarm requires no servicing. 7.1 Storage Always store the VENTIremote alarm dry. Remove the battery if the VENTIremote alarm is in storage or not being used for an extended period. 7.2 Disposal Do not dispose of the device as domestic waste. To dispose of the device properly, contact a licensed, certified electronic scrap disposal merchant. You can find out their address from your environment officer or from your municipal authorities. The device packaging (cardboard and inserts) can be disposed of in paper recycling facilities. Disposing of batteries/rechargeable batteries Used batteries/rechargeable batteries may not be disposed of in household waste. Please contact WEINMANN or your public body responsible for disposal. 18 EN Servicing
8. Scope of supply 8.1 Standard scope of supply VENTIremote alarm, 10 m, packed WM 27745 Description Order no. VENTIremote alarm WM 27764 Connecting cable, 10 m, VENTIremote alarm WM 27789 Battery, 9 V, lithium WM 12166 Instructions for use for VENTIremote alarm EN WM 66731 VENTIremote alarm, 30 m, packed WM 27755 Description Order no. VENTIremote alarm WM 27764 Connecting cable, 30 m, VENTIremote alarm WM 27758 Battery, 9 V, lithium WM 12166 Instructions for use for VENTIremote alarm EN WM 66731 8.2 Accessories and spare parts You can order accessories and spare parts separately if required. A current list of accessories and spare parts can be ordered on the Internet at www.weinmann.de or via your dealer. Scope of supply EN 19
9. Technical data 9.1 Specifications VENTIremote alarm Battery type Dimensions (WxHxD) in cm Weight Temperature range Operation Storage Signal volume Battery life Classification to EN 60601-1-8:2007 Standards applied 9 V lithium, U9VL-BP 60 x 25 x 96 250 g +5 C to +40 C 40 C to +70 C 80 db ±4 db with a full battery at 1 m distance approx. 100 days at 1 min alarm a day Internal power supply 9 V EN 60601-1:2006, EN 60601-1-8:2007 We reserve the right to make changes to the design. 20 EN Technical data
9.2 Safety distances Recommended safety distances between portable HF telecommunications devices (e.g. cell phones) and the VENTIremote alarm Nominal output of HF equipment in W Safety distance depending on transmission frequency in m 150 khz - 80 MHz 80 MHz 800 MHz 800 MHz 2.5 GHz 0.01 0.04 0.04 0.08 0.1 0.11 0.11 0.22 1 0.35 0.35 0.70 10 1.10 1.10 2.20 100 3.50 3.50 7.00 Technical data EN 21
10. Warranty Weinmann offers a warranty that the product, when used in accordance with requirements, will remain free from defects for a period of two years from date of purchase. For products whose durability is clearly indicated as less than two years, the warranty expires on the expiration date indicated on the packaging or in the user s manual. Claims against the warranty can be made only when accompanied by the sales receipt, which must show salesperson and date of purchase. We offer no warranty in the case of: Disregard of usage instructions Operating errors Improper use or improper handling Third-party intervention by non-authorized persons for the purpose of device repair Acts of God, e.g., lightning strikes, etc. Transport damage as a result of improper packaging of returned items Lack of maintenance Operational and normal wear and tear, which includes, for example, the following components. Filters Batteries / recheargable batteries Articles for one-time usage, etc. Failure to use original spare parts. Weinmann is not liable for consequential harm caused by a defect if it is not based on intention or gross negligence. Weinmann is also not liable for minor physical injury to life or limb resulting from negligence. Weinmann reserves the right to decide whether to eliminate defects, to deliver a defect-free item or to reduce the purchase price by a reasonable amount. If Weinmann rejects a claim against the warranty, it assumes no expense for transport between customer and manufacturer. Implied warranty claims remain unaffected by these changes. 22 EN Warranty
11. Declaration of conformity Weinmann Geräte für Medizin GmbH + Co. KG declares herewith that the product complies fully with the respective regulations of the Medical Device Directive 93/42/EEC. The unabridged text of the Declaration of Conformity can be found on our website at www.weinmann.de Declaration of conformity EN 23
12. Index A Accessories 19 Alarm indicator 16, 17 Alarmanzeige 2 Alarms 11 B Battery 9, 11, 12, 15 Battery compartment 9, 11, 12 Battery indicator 2, 15, 17 Bayonet connector 2, 3, 10, 17 C Change of patient 13 Cleaning 13 Connecting cable 2, 17 D Declaration of conformity 23 Description of device 6 Description of function 6 Device, connect 10 set up 9, 10 switch off 11 switch on 11 Disinfecting 13 Disposal 18 F Function check 10, 14 Intervals 14 Performing the check 15 Function check, entire system 16 H Hygienic preparation 13 I Initial commissioning 9 Intended use 6 M Maintenance 7 Markings on the device 3 N Name plate 2 O ODU connector 2, 3, 10, 11, 14, 17 ODU socket 2, 15 Operation with the therapy device 9, 11 Overview 2 R Replacement parts 7 S Safety distances 21 Safety information in these instructions 4 Safety instructions 7 Scope of supply 19 Service 18 Specifications 20 Standard product 19 Stand-by indicator 2, 15, 17 Sterilizing 13 Storage 7, 18 Switch off the VENTIremote alarm 11 T Technical data 20 Transport 7 Troubleshooting 17 V VENTIlogic LS 6 VENTIlogic plus 6 VENTIremote alarm function check 15 W Warranty 22 24 EN Index
Weinmann Geräte für Medizin GmbH+Co.KG P.O.Box 540268 D-22502 Hamburg Kronsaalsweg 40 D-22525 Hamburg T: +49-(0)40-5 47 02-0 F: +49-(0)40-5 47 02-461 E: info@weinmann.de www.weinmann.de Center for Production, Logistics, Service Weinmann Geräte für Medizin GmbH+Co.KG Siebenstücken 14 D-24558 Henstedt-Ulzburg T: +49-(0)4193-88 91-0 F: +49-(0)4193-88 91-450 WM 66731b - 05.2011