STI Sterisets WB1000F User manual

Operator
Manual
Model: WB1000F
REF: 85000
Blanket
Warming
Unit
Sterisets International BV
Ketelmeer 3 | 5347 JX Oss | The Netherlands
P+31 (0)412 667 755 | [e-mail]
www.sterisets.com

Dongguan Kaiser Technology Co., Ltd.
No.6, 2nd Road, Sanjiang Industrial Block,Hengli Town, Dongguan City, 523462
Guangdong P.R.China
Sterisets International BV
Ketelmeer 3. 534JX Oss, The Netherlands P [phone]
info @ sterisets.com www.sterisets.com
EC REP MedNet EC-REP GmbH
Borkstrasse 10, 48163 Muenster,
Germany.
pag. 1
U9978 16-02-2023

pag. 2
Instruction manual page 3
Overview page 4
Control panel page 4
Attach Flexible Hose page 4
Mount on an I.V. Pole page 4
Attach Blanket page 5
Instructions for use page 5
Over temperature Condition page 5
User Requirements page 6
System Fault Troubleshooting page 6
If system fault occurs page 6
Routine Maintenance page 6
Filter Change page 6
Diagnostics page 6
Cleaning page 6
Operating Environment page 6
Transportation and Storage page 7
Disposal page 7
Specications page 7
Labeling Symbols page 7
Annex I HEPA lter replacement page 8
Annex II Blanket Assortment page 9
Table of Contents

Instruction Manual
General Description
The Sterisets® Blanket Warming System is a forced-air warming system, using convective
warming to prevent and treat hypothermia. It consists of two components: a Blanket Warming
unit and a single-use blanket.
The blanket is connected to the exible hose of the warming unit. Warm air from the warming
unit passes through the hose into the blanket.
Through the small holes in the underside of the blanket the warm air is distributed evenly
over the patient.
The clinical staff using the device are anesthetists, anesthetic assistants, operating
department practitioners and nurses in theatre, the recovery room and critical care unit.
Read this manual carefully before use. Failure to follow may cause severe injuries.
Indications Contraindications
Prevention and treatment of hypothermia
DO NOT apply heat directly to open wound or ischemic limb.
DO NOT apply to extremities during surgeries when an artery
to the extremity is clamped.
Warnings Failure to follow may cause personal injuries Caution Failure to follow may cause
damage to product
To avoid the risk of electric shock, this equipment must only
be connected to a grounded electrical outlet.
DO NOT use this unit in any other manner other than
the purpose or the operation method described in this
instruction manual.
To prevent electromagnetic interference from other devices to the unit, the other devices
must meet EMC requirements. Use only the power cord specied for this product.
The Blanket Warming Unit meets medical electronic interference requirements. If radio
frequency interference with other equipment should occur, connect the unit to a different
power source.
DO NOT submerge, spray, pour, or spill any liquid on
the unit.
Continuously monitor temperature and skin when used on unconscious patients, elderly
patients, or pediatric patients.
DO NOT drop or hit the product. Store in a cool dry
place.
Risk of electrical shock, always unplug power cord before cleaning. DO NOT open or disassemble the unit.
DO NOT use on circulatory problem individuals, unless managed and monitored by healthcare
professional. No modication of this unit is allowed.
DO NOT use unit hose directly to patient without a blanket. The device can only be operated by qualied and
trained personnel.
DO NOT use hose under the patient or put any pressure on it. DO NOT operate if the hose is ruptured.
DO NOT obstruct vents of the device. Temperatures will vary according to the room
temperature and blanket sizes. DO NOT operate in a wet or moist condition.
DO NOT operate damaged or malfunctioning device.
DO NOT position the device where it is difcult to operate the
appliance plug and socket.
Device must only be opened or serviced by qualied personnel such as certied electronics
technicians or certied clinical engineers familiar with repair practices for servicing medical
devices, and in accordance with the Instruction manual.
This document was made taking
into account post market surveillance
and clinical evaluation data.
Model: WB1000F
REF: 85000
pag. 3

Overview
Handle
Control Panel
Trolley / I.V. Pole Bumper
Hose Port
Proximal Extremity
Distal Extremity
Hose Connector
Bedrail Bracket
Trolley / I.V. Pole Clamp
Securing Clip
Power Cord Holder
1
2
3
4
5
6
7
8
9
10
11
Control panel
Attach Flexible Hose
1 . Place the unit on a stable surface, make sure the power is not connected.
2 . Connect the electrical plug from the hose.
3 . Take the proximal end of the Flexible Hose and attach it to the Hose Port.
4 . Turn the outer ring clockwise until it is well secured.
5 . Attach the power cord and tighten security support.
Mount on an I.V. Pole
1 . Pull out the I.V. Pole Clamp and release the screw lock.
2 . Place the Warming Unit on the I.V. pole and align the I.V. Pole Bumper.
3 . Tighten the screw lock and make sure it is securely clamped to the pole.
4 . The Flexible Hose can be placed over the unit when not using it.
pag. 4

Attach Blanket
1 . Insert the Distal End of the Flexible Hose into the selected Sterisets Blanket.
2 . Tie up the blanket on the Flexible Hose.
3 . Ensure that it is well secured.
Instructions for Use
1 . Connect the unit to the power source. It will run a 1 second power-on self light test
and nish with the standby light ON (orange) and the preset High Fan light ON (green).
2 . Select the desired Temperature
It will start blowing and the Standby
light will go OFF.
Once the temperature Display reaches
the selected temperature
+/- 2°C, the TEMP. IN RANGE light
will light up.
3 . Select the desired Fan setting.
It can be changed anytime while operating.
Ensure the blanket is well inated.
4 . Press Standby button to stop operating.
Standby will light up (orange).
Reselect the temperature to start.
Over Temperature Alarm
If the temperature reaches > 48°C, it will automatically shut down the heater and the fan.
The OVER TEMP light will light up and the alarm will go of. Press any button (except FAN settings
button) to turn OFF the sound.
In case of OVER TEMP:
1 . Disconnect the Power cord.
2 . Contact Technical Support.
pag. 5

User Requirements
The device is to be operated by a skilled professional only. Please request your supplier for any
additional training if desired.
System Fault Troubleshooting
When the system fails, it will automatically turn off the heater and fan. The screen will display
fault code, OVER TEMP and TEMP IN RANGE light indicator will ash simultaneously. Press any
button (except FAN settings button) to turn OFF the sound.
If system fault occurs
1 . Unplug the power cord and wait for 5 minutes.
2 . Reconnect the power cord. The device will start the power-on-reset operation and
stay on standby mode.
3 . Reselect the desired temperature.
4 . If it doesn’t return to normal operating condition, contact technical support.
Routine Maintenance
Maintenance on the device should be performed by qualied personnel such as certied
electronics technicians or clinical engineers. Additional service maintenance is available.
Please request your distributor for a digital copy.
Filter Change
The FILTER light will light up after 500 hours or every 12 months of use to remind to replace
the lter. Replacing the lter should be done by qualied service personnel only.
Diagnostics
A qualied service technician can perform over-temperature detection system testing,
temperature output testing, operating temperature calibration and fault code troubleshooting.
Cleaning
ALWAYS power off the device and unplug the power cord from the outlet before cleaning.
·Device can be cleaned with a neutral disinfectant wipe or with a damp cloth, no residue of
detergent may be left on the control panel.
· DO NOT wash the device or hold under running water.
Operating Environment
· Operating temperature
· Relative Humidity: 2,000 -> 2.000 M
· Altitude: Max 2,000m
pag. 6
Do not use aggressive cleaning materials.

Disposal
Please dispose the device in accordance with EC Directive - WEEE (Waste Electrical and Electronic Equipment).
If you have any questions, please contact the local authorities responsible for waste disposal.
Transportation and Storage
· Temperature: +5 to +/-45°C
· Relative Humidity: 80% RH maximum
Specications
· Temperature Setting (°C) : Low 32 / Med 38 / High 43
· Fan Setting: HIGH / LOW
· Input: 220~240V, 50/60Hz, Max. 4.5 A
· Heating Element: 500W
· Power Consumption: 500W (1.000W peak)
· Fuses: Fast acting ceramic fuses, 250 VAC / 5A
· Device Classication: Class IIa
· The device complies with the following standards: EN 60601-1-2, EN 60601-1
· Dimentions: H 373 x W 223 x D 172 mm
· Weight: 2.3 kg
· Hose: 1.8 meters lenght, exible
· Power Cord: 4.5 meters
· Filter: HEPA 0.2 µm
Consult operators manual
Warning / Caution
European Union WEEE Directive Logo
Device type BF (Protection against electric shock)
Item number
Batch number
Serial number
CE mark
Manufacturer
0197
Labeling Symbols
pag. 7

pag. 8
HEPA Filter Replacement - Instruction Manual
The FILTER light will light up after 500 hours or every 12 months of use to remind to replace the lter.
Warnings
. ALWAYS power off the device and unplug the power cord from the
outlet before lter replacement.
. DO NOT operate the warming system with the back cover removed.
Caution
. ONLY qualied service personnel should replace the filter.
Equipment Required for HEPA Filter Replacement
HEPA Filter Change
Filter Timer & Light Reset
1. Plug the blanket warming unit.
2. Press both buttons together, until display ON release both buttons immediately.
3. If display , means RESET success and FILTER light will turn OFF.
Annex I HEPA lter replacement

Sterisets International BV
Ketelmeer 3 | 5347 JX Oss | The Netherlands
P+31 (0)412 667 755 | [e-mail]
www.sterisets.com
Ref Description Size (cm) Packaging
85100 Full Body 195 x 100 4 x 10
85110 Multi Access 195 x 100 4 x 10
85120 Abdominal Access 192 x 180 4 x 10
85150 Adult Tube 217 x 91 4 x 10
85200 Lower Body 120 x 100 4 x 10
85300 Upper Body ARM IN 124 x 94 4 x 10
85310 Upper Body ARM OUT 192 x 57 4 x 10
85400 Pediatric Neonatal 92 x 89 4 x 10
85410 Pediatric Child 99 x 136 4 x 10
85450 Pediatric Tube 113 x 56 4 x 10
Annex II Blanket Assortment
pag. 9